research topics on medical waste

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Medical Waste

Management of Pharmaceutical Hazardous Waste

State Medical Waste Regulations  

Medical waste is a subset of wastes generated at health care facilities, such as hospitals, physicians' offices, dental practices, blood banks, and veterinary hospitals/clinics, as well as medical research facilities and laboratories. Generally, medical waste is healthcare waste that that may be contaminated by blood, body fluids or other potentially infectious materials and is often referred to as regulated medical waste.  

On this page: 

Since the 1988 Medical Waste Tracking Act Expired in 1991

Disposal of medical sharps/needles, treatment and disposal of other medical wastes, who regulates medical waste.

Medical waste is primarily regulated by state environmental and health departments. EPA has not had authority, specifically for medical waste, since the Medical Waste Tracking Act (MWTA) of 1988 expired in 1991. It is important to contact your state environmental program first w hen disposing of medical waste . Contact your state environmental protection agency and your state health agency f or more information regarding your state's regulations on medical waste .

Other federal agencies have regulations regarding medical waste. These agencies include Centers for Disease Control (CDC), Occupational Safety and Health Administration (OSHA), U.S. Food and Drug Administration (FDA), and potentially others.

For historical information regarding EPA’s work under the Medical Waste Tracking Act of 1989 including several draft studies related to medical waste management, please search EPA’s archive using the term "medical waste".

Concern for the potential health hazards of medical wastes grew in the 1980s after medical wastes were washing up on several east coast beaches. This prompted Congress to enact The MWTA of 1988. The MWTA was a two-year federal program in which EPA was required to promulgate regulations on management of medical waste. The Agency did so on March 24, 1989. The regulations for this two year program went into effect on June 24, 1989 in four states - New York, New Jersey, Connecticut, and Rhode Island and Puerto Rico. The regulations expired on June 21, 1991. 

EPA concluded  from the information gathered during this period  that the disease-causing potential of medical waste is greatest at the point of generation and naturally tapers off after that point . Thus, risk to the general public of disease caused by exposure to medical waste is likely to be much lower than risk for the healthcare workers. 

After the MWTA expired in 1991, states largely took on the role of regulating medical waste under the guidance developed from the two year program.

• Model Guidelines for State Medical Waste Management

Most states have since further developed their own programs resulting in each state program differing  significantly   from each other. 

Treatment and Disposal of Medical Waste

Improper management of discarded needles and other sharps can pose a health risk to the public and waste workers. For example, discarded needles may expose waste workers to potential needle stick injuries and potential infection when containers break open inside garbage trucks or needles are mistakenly sent to recycling facilities. Janitors and housekeepers also risk injury if loose sharps poke through plastic garbage bags. Used needles can transmit serious diseases, such as human immunodeficiency virus (HIV) and hepatitis.

Refer to the following documents for information on proper management of needles and sharps:

• Community Options for Safe Needle Disposal.
• Protéjase usted mismo, y proteja a los demás (Spanish Translation)(pdf) (455.3 KB).
• Protect Yourself, Protect Others: Safe Options for Home Needle Disposal (Chinese Translation) (pdf) (799.3 KB).
• Safe Needle Disposal - a project of NeedyMeds - promotes public awareness and community solutions for safe disposal of needles, syringes, and other sharps.
• Centers for Disease Control and Prevention: Sharps Safety for Healthcare Settings.

Medical Waste Incineration 

More than 90 percent of potentially infectious medical waste was incinerated b efore 1997 . In August of 1997, EPA promulgated regulations creating stringent emission standards for medical waste incinerators due to significant concerns over detrimental air quality affecting human health. EPA’s Office of Air Quality Planning and Standards continues to review and revise the Hospital Medical Infectious Waste Incinerator (HMIWI) standards as required most recently in May of 2013.

Alternative Treatment and Disposal Technologies for Medical Waste 

Potential alternatives to incineration of medical waste include the following: 

• Thermal treatment, such as microwave technologies; 
• Steam sterilization, such as autoclaving; 
• Electropyrolysis; and 
• Chemical mechanical systems, among others.

With EPA's tighter HMIWI standards, the number of HMIWIs in the United States has declined since 1997. This has lead to an increase in the use of alternative technologies for treating medical waste. The alternative treatments are generally used to render the medical waste non-infectious then the waste can be disposed of as solid waste in landfills or incinerators. Many states have regulations requiring medical waste treatment technologies to be certified, licensed or regulated. Check with your state  for additional regulation regarding treatment of medical waste.

EPA has jurisdiction over medical waste treatment technologies, which claim to reduce the infectiousness of the waste (i.e. that claim any antimicrobial activity) by using chemicals. This jurisdiction comes from the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Companies wishing to make such claims must register their product under FIFRA through EPA's Office of Prevention, Pesticide, and Toxic Substances (OPPTS), Antimicrobial Division .

• Regulations
• Non-Hazardous Secondary Materials
• State Authorization

COMMUNITY CASE STUDY article

A whole systems approach to hospital waste management in rural uganda.

• 1 Bwindi Community Hospital, Kanungu, Uganda
• 2 College of Life and Environmental Science, University of Exeter, Exeter, United Kingdom
• 3 Institute of Medicine, University of Chester, Chester, United Kingdom

Introduction: Safe waste management protects hospital staff, the public, and the local environment. The handling of hospital waste in Bwindi Community Hospital did not appear to conform to the hospital waste management plan, exhibiting poor waste segregation, transportation, storage, and disposal which could lead to environmental and occupational risks.

Methods: We undertook a mixed-methods study. We used semi-structured interviews to assess the awareness of clinical and non-clinical staff of waste types, risks, good practice, and concerns about hospital waste management. We quantified waste production by five departments for 1 month. We assessed the standard of practice in segregation, onsite transportation, use of personal protective equipment, onsite storage of solid waste, and disposal of compostable waste and chemicals.

Results: Clinical staff had good awareness of waste (types, risk) overall, but the knowledge of non-clinical staff was much poorer. There was a general lack of insight into correct personal or departmental practice, resulting in incorrect segregation of clinical and compostable waste at source (>93% of time), and incorrect onsite transportation (94% of time). In 1 month the five departments produced 5,398 kg of hazardous and non-hazardous waste (12; 88%, respectively). Good practice included the correct use of sharps and vial boxes and keeping the clinical area clear of litter (90% of the time); placentae buried immediately (>80% of the time); gloves were worn everyday by waste handlers, but correct heavy-duty gloves <33% of the time, reflecting the variable use of other personal protective equipment. Chemical waste drained to underground soakaways, but tracking further disposal was not possible. Correct segregation of clinical and compostable waste at source, and correct onsite transportation, only occurred 6% of the time.

Conclusion: Waste management was generally below the required WHO standards. This exposes people and the wider environment, including the nearby world heritage site, home to the endangered mountain gorilla, to unnecessary risks. It is likely that the same is true in similar situations elsewhere. Precautions, protection, and dynamic policy making should be prioritized in these hospital settings and developing countries.

Introduction

Health care waste management is a global concern. All health care activities generate waste, which when poorly managed can affect the environment, the community, and domestic and wild animals. It is an issue of growing concern as the number of health care facilities is increasing while population growth reduces space for waste disposal ( 1 ). Waste generated by human activities and changes associated with lifestyles threatens both human beings and natural resources ( 1 – 3 ).

The World Health Organization (WHO) defines medical waste as waste generated by health care activities including a broad range of materials, from used needles and syringes to soiled dressings, body parts, diagnostic samples, blood, chemicals, pharmaceuticals, medical devices, and radioactive materials ( 4 ).

Health care waste is defined as all types of waste produced in health facilities such as hospitals, health centers, and pharmaceutical shops ( 2 ). The majority (85%) of the waste is non-hazardous, compostable/biodegradable, and non-compostable, which does not require specialist disposal. The remainder is hazardous waste: 10% infectious and highly infectious, and 5% is toxic chemicals, radioactive, and pharmaceuticals ( 5 , 6 ), all of which requires special care and processing. Placentae are classed as highly infectious in settings such as Uganda, where blood-borne viruses are common, and need to be handled carefully ( 7 ).

Waste from health care activities can have a long-lasting impact on human health, including people handling the waste and the public in general ( 7 – 10 ) and the environment can be contaminated through underground water sources polluted by untreated medical waste buried in, or drained into, the ground ( www.who.int/water_sanitation_health/medicalwaste/020to030.pdf ).

People can be infected either through direct contact with contaminated waste or infected people, or indirectly via contamination of soil, ground water, surface water or air, or through affected animals. Direct or indirect exposure through environmental contamination by pharmaceutical and laboratory waste can also lead to disease, both in the human and animal populations ( 11 – 14 ).

Twenty-three percent of global deaths and 22% of global disability adjusted life years (DALYs) were attributable to environmental factors in 2012, including, but not limited to waste ( 15 ). Blood borne diseases like HIV and viral hepatitis B can be acquired through mismanagement of hazardous hospital waste.

In some industrialized countries, institutions that generate lots of waste, including health care waste, have a legal responsibility to manage such waste. As a result, they monitor the amount of hazardous waste generated and there are clearly organized structures for handling every type of waste. Different expensive and highly technical waste management methods are used, including solidification, elementary neutralization, carbon absorption, separation, filtration, and evaporation. This is as a result of considerable investment by authorities and organizations in waste handling and management, but these methods are not available in resource-poor countries. In these countries other, cheaper, but reasonably effective, methods like incineration, land filling, and composting are used to manage health care waste ( 16 , 17 ).

Background and Rationale

In low- and middle-income countries, health care waste management receives little attention as the health sector competes with other sectors of the economy for very limited resources. In most of these countries, health care waste is still handled and disposed of as domestic waste, with the resulting appreciable threat to the waste workers, the public, and the environment ( 5 , 7 , 18 ).

The literature about a whole systems approach to hospital waste management, from segregation of waste to disposal, that was relevant to rural, privately-funded hospitals in resource-poor countries, was limited ( 19 ). In a published paper from Uganda, waste generation rates in a public and a private hospital in Kampala, the capital city vary according to patients' circumstances (type and state of condition, number of people nursing a patient, number of visitors to a patient, items carried into ward) ( 8 ), but there is no clear mention of rural hospitals in a recent review across the developing world ( 1 ). The review concluded that the issue of health care waste management has received little attention and needs highlighting to create greater awareness.

In Uganda there is no legal framework requiring health facilities to take any special care with their waste disposal, and very limited finance available to address any such issues, either within the budgets of these facilities or from the government or other funding agencies. It is, therefore, possible that staff working in health facilities and people living nearby may be exposed to unnecessary risks, including possible environmental contamination ( 7 , 15 ).

Bwindi Community Hospital, in southwest Uganda, has had its own waste management program since its inception in 2004 as part of its wide-ranging community health program. It generates heath care waste internally across departments, and externally during outreach health activities. The waste includes pathological, infectious, sharps, pharmaceutical, chemical, tissue, as well as non-infectious waste. The waste generated was thought to be systematically managed through a series of activities (including segregation at source, regular departmental collection, safe transport, storage, and disposal), to reduce the risk of any adverse outcome.

The hospital is located in a low land surrounded by forested hills of the impenetrable national park, a mile away, and several small water bodies, including one that generates hydro power that is supplied to the nearby trading center with a growing urban population in a radius of two kilometers. This is the first Uganda study in a rural hospital and such studies are still infrequent globally. Improper health care waste management can compromise health, safety and puts the environment at risk for all stakeholders in this community setting ( 1 , 9 ).

This study evaluated the knowledge of clinical and non-clinical staff at Bwindi Community Hospital and assessed the current management of health care waste (hazardous waste—sharps, infectious, chemical, and pathological—and non-hazardous waste—compostable and non-compostable) during the month of October 2017.

Specifically, we (a) assessed the knowledge and practice of health care waste management by clinical staff and non-clinical staff, (b) measured the weight of waste generated and assess the effectiveness of the segregation of hazardous and non-hazardous waste in different clinical departments, (c) assessed the appropriate use of personal protective equipment by the porters, (d) reviewed the methods of on-site waste transportation, storage, and disposal of all waste, and (e) described the arrangements for offsite disposal of the hospital waste.

Description of Case

Staff are trained when first employed to segregate waste at the point of generation by using color-coded bins with matched color-coded liners. Waste is collected daily from each department, except in two departments (Surgery and Sexual Reproductive Health) that produce a high volume of hazardous waste. In these two departments, waste is removed several times a day, after procedures have been carried out. Non-hazardous waste is separated into bins for compostable and non-compostable waste at the point of generation in the hospital.

Collection, including ensuring that all bin liners are securely closed, and transportation of waste to the storage site, is done by hospital porters, who should use appropriate personal protective equipment (gumboots, surgical face masks, heavy duty gloves, and plastic aprons).

The estates manager (SK) was aware of some shortcomings in the waste management system. Given the hospital vision, “ a healthy community free from preventable disease, and accessible health care for all,” he realized that there could be wider implications in addition to the risk to hospital staff. It was therefore imperative to assess how the hospital waste was being managed and see if more could be done to ensure safe waste management, so as to mitigate the risks from pollution and infection.

Study Design

The study was a mixed-methods design, with a quantitative, descriptive, cross sectional study of waste management, with simultaneous qualitative in-depth interviews. This design was used to increase the breadth and depth of understanding of health care waste management.

Uganda is a land locked country in East Africa, bordering the Democratic Republic of Congo, Rwanda, Tanzania, Kenya, and South Sudan. It has a population of 39 million people, half of whom are under 18 years. It is classed as a low-income country and 70% of the population are subsistence farmers ( 20 ). There are 165 hospitals in Uganda, with 40% government, 43% private not-for-profit, and 17% private for-profit ( 21 ).

Bwindi Community Hospital is a rural private not-for-profit hospital run by the Church of Uganda in Kanungu District, South-Western Uganda, with a large community health program, as reflected in the hospital vision. It is located over 500 kilometers from the capital city Kampala, and borders the Bwindi Impenetrable Forest National Park and the Democratic Republic of Congo. There is a poor road network, and no reliable source of power, or nearby facilities that can handle health care waste or recycling.

The community health program of the hospital includes health promotion, prevention, immunization, mental health, and support to over 500 community health volunteers. The volunteers are supported by 12 health centers and the hospital. The hospital provides general surgery, orthopedics, pediatrics, sexual, and reproductive health, adult inpatient and outpatient care.

Study Population

The quantitative study population was hospital departments that generate waste. The qualitative study population was purposefully selected clinical and non-clinical staff directly involved in health care waste management.

Data Variables and Sources

We assessed the knowledge and practice of health care waste management by clinical staff and non-clinical staff through semi-structured interviews. These in-depth interviews were conducted with purposive selection of staff (clinical and non-clinical) to elicit responses on the broad themes: segregation, collection and transport, disposal, risk, and concerns. Interviews were conducted by the principal investigator and another researcher, both experienced in qualitative methods, after obtaining written informed consent. An interview guide with open-ended questions was used. Interview questions focused on (a) types of waste generated (b) color coding for waste bins, (c) hazards posed by improper waste handling, (d) waste transportation, (e) storage and disposal, (f) concerns on waste handling (g) risk to population, and environment. All interviews were recorded with permission. Saturation was reached.

The quantitative data variables were each measured over 31 days, in October 2017, and included (a) the weight of each type of waste produced, and adequacy of its segregation by each clinical area, (b) if there was correct use of personal protective equipment by porters transporting the waste, (c) how waste bags were transported to the storage site, (d) if there was safe on-site storage and off-site removal of waste, (e) if the use of compost pits was appropriate, (f) if the disposal of laboratory and X-Ray chemicals was safe, and (g) if the burial of placentae and still-borne infants was appropriate and safe.

We also described the arrangements for offsite disposal of the hospital waste.

Operational Definitions as Used in the Hospital

Correct waste management practices.

Acting according to hospital waste management guidelines: source segregation at generation points, proper transportation, and storage and disposal waste.

Segregation of Waste

The recognition and division of waste into the correct waste receptor.

Compostable Waste

Non-hazardous waste that will break down, safely, and relatively quickly, by biological decomposition.

Clinical Waste

Waste containing human tissue, blood, other body fluids, pharmaceutical products, or any items used directly in providing health services, unless rendered safe.

Hazardous Waste

Waste that poses any biological, chemical, radioactive or physical hazard.

Infectious Waste

Waste from patients with infections.

Highly Infectious Waste

Material used in patient care that is heavily contaminated by blood.

Interviews were recorded and transcribed and evaluated by two independent investigators to reduce bias and increase interpretive credibility. Any difference between the two was resolved by discussion to arrive at a consensus. A thematic network method, as described by Attride-Stirling, was used to analyze the data employing a global theme, organizing themes, and basic themes ( 20 ).

We undertook descriptive analysis of all quantitative data.

In total, over five tons (5,398 kg) of health care waste were produced by five departments of Bwindi Community Hospital in the study month. Of this, 12% (662 kg) was classed as hazardous and 88% (4,735 kg) as non-hazardous ( Table 1 ).

Table 1 . Type and weight of waste produced by clinical departments of Bwindi Community Hospital, Uganda, October 2017.

The Sexual and Reproductive Health department produced over a third (35%) of the total waste in the study ( Table 1 ). Adult Inpatients generated a quarter (26%) while Pediatrics produced a fifth (22%). HIV and Outpatients departments produced about 8% each.

Compostable waste, from food preparation by patients and their relatives, constituted nearly three quarters (3,902 kg, 72%) of the waste collected. This came particularly from the Sexual and Reproductive Health and Adult Inpatients.

Hazardous waste (highly infectious + infectious) made up 12% of all the waste in the study. The largest amount of hazardous waste was produced by the Sexual Reproductive Health and HIV departments.

In-depth interviews were conducted with 15 clinical staff (nurses, midwives, clinical officers, lab staff, and medical doctors) and 6 non-clinical staff (administrators and porters). All interviewees had some knowledge about hospital waste types and gave examples. They knew the basics about hospital waste and the reasons why handling such waste is important. We report the findings under the organizing themes (segregation, transport, disposal, risk, and concerns) found through analysis of the interviews ( Figure 1 ).

Figure 1 . Thematic network showing the global theme (lozenge), organizing themes (ovals), and basic themes (rectangles) found through analyzing the qualitative interviews.

Segregation

Waste should be collected in color-coded waste bins, with matching bin liners. There were sufficient waste-collecting bins throughout the hospital, but the correctly colored bin liners were often not available to order and so were not supplied consistently to the hospital wards. Staff used the available waste bins inconsistently. It was not clear if this was just them using the nearest available bin, expecting others to correctly segregate the waste later, or due to not being able to easily distinguish different bins ( Table 2 ). A non-clinical staff member said, “ Training is one thing. Doing another.” Segregation of waste was seen by some clinical staff as the job of the porters who transport the waste. “ If waste segregation is improved, the rest would be at rest ,” said a clinical staff member.

Table 2 . Percentage of days with correct waste management practices by clinical departments in Bwindi Community Hospital, Uganda, October 2017.

However, the use of sharps and vial boxes and keeping clinical areas clean of litter showed good practice on most days ( Table 2 ).

One clinical officer noted that there were no brown bin liners for pharmaceutical waste. This affects waste collection since pharmaceutical waste may be put in the wrong bins and may end up in the wrong disposal route. “ Supply [of brown bins] would put us at the level of people who handle waste very well .

Clinical waste (393 kg) was largely carried incorrectly by hand rather while non-clinical waste (3,903 kg) was transported within the hospital in a wheelbarrow. A clinical officer was concerned about the nature of waste transportation by porters: “ Waste is transported by porters on their backs .” One non-clinical staff member said that he would like each department to have their own wheelbarrow for transporting waste because there is only one wheelbarrow in the hospital and most times it is in use, taking too long to become available.

Transportation to the storage facility was carried out incorrectly on most days ( Table 2 ). The use of personal protective equipment by porters varied by equipment and between departments (porters are largely assigned to one department). While gloves were worn every day, the type of gloves worn were largely incorrect. Face masks were only used about a third of the time. The practice of wearing protective aprons varied by departments ( Table 3 ).

Table 3 . Percentage of days with correct use of personal protective equipment (PPE) by porters in Bwindi Community Hospital, Uganda, October 2017.

Bwindi Community Hospital has a secure waste storage site that is ventilated and well fenced, preventing entry by domestic animals, pets, pests including marabou storks ( Leptoptilos crumenifer ), and unauthorized humans. The hospital waste was, at the time of the conception of the study, disposed of by incineration, burying, placenta pit, and open burning, according to the different waste types.

At the time of the study, compostable waste was transported to compost pits within the hospital land, and placentae were buried in a dedicated pit. Inspection of the compost pits showed the same lack of segregation of compost and non-compost waste as was seen in all the departments, with paper and plastics being the most common contaminant, although no hazardous waste was seen.

Placentae were usually quickly disposed of correctly after deliveries and did not remain on the ward. The only still birth in the month of study was taken for burial by the family ( Table 4 ).

Table 4 . Disposal of placentae and still born infants in Sexual and Reproductive Health department of Bwindi Community Hospital, Uganda, October 2017.

In October 2017, hospital waste was not disposed of on-site, as previously (incineration, and open burning). Instead, such waste was transported from the storage site to a processing plant in Eastern Uganda by an internationally funded health care waste handling company in a dedicated refrigerated vehicle. This new arrangement has been running since July 2016, after the study was conceived.

The collection and off-site transportation of the non-compostable and hazardous waste by the national contractor was irregular. The hospital understood that waste would be collected every 5 days; however, this was not adhered to. During the month of the study, waste was collected four times out of an anticipated six. The intervals between collections varied between three and seven days. Despite the inconsistency in timing of waste collections, on all occasions all stored waste was removed from the hospital.

But not everyone on the hospital staff thought that such transport was appropriate. “ We should dispose of our waste, not send it away,” said a clinical staff member.

One non-clinical staff member was concerned about the indiscriminate disposal of clinical waste that arises from incorrect segregation. He said, “ You find blood stained gauze mixed with empty intravenous fluid bottles and urine bags .”

Ionizing radiation in x-ray waste was a concern as identified by a senior clinical officer, who said, “ There seems to be no clear way of handling ionizing waste .” It proved impossible to quantify the laboratory and X-ray chemical waste, since the fluids were disposed of directly down the drains. These drains run into deep soakaways under grassed areas and were separate from other drainage systems. It was not known how the continued use of such soakaways over years had contaminated the local groundwater, which drains into the river, which in turn is used as a water supply by humans and animals.

The respondents correctly identified a number of risks that include cross infection (“ waste that is infectious contains pathogens” clinical officer ) , occupational hazards, and direct injury (“ can cause harm to health care workers and patients ” clinical staff), pollution of the environment (“ leads to environmental pollution” clinical staff; “ minimize contamination of water… reduce air pollution” non-clinical staff). These risks can affect people immediately or in the future, directly or indirectly.

A non-clinical staff member said that safe handling of hazardous waste is of medium priority because of the limitation of funds availed for such activities, but was quick to note that this topic should be highly prioritized because of the risks involved. This recognizes that there is a degree of risk for all staff who are involved in hazardous waste management.

Surprisingly, a few staff had no concerns about the waste management of their department or the hospital. “ I don't have any concerns,” commented a clinical staff member, while another said, “ Hazardous waste is handled very well”. One non-clinical staff member had an understanding of the size of the issue the hospital faces: “[The] issue is not hazardous waste, but the issue is [all] waste .”

However, many of the concerns expressed centered on the porters. Their knowledge about waste management, especially waste handling was seen as not adequate, confirming other findings in this study ( Table 3 ). One clinical officer said, “ The porters are not aware of the dangers of poor waste handling .” Another said, “ Porters need a refresher about waste management .” A third commented that, “ [I'm] not sure about the immunization status of porters against Hepatitis B .” The porters were mainly using soft medical disposable gloves, which concerned a clinical officer who emphasized that porters should be given heavy duty gloves.

Some of those who expressed concern about the porters were less aware of their own responsibility to segregate waste properly at source.

Summary of the Findings

Over five tons of health care waste was produced in the month observed. Only 28% was clinical waste, while the remainder was compostable waste from food preparation by patients or their relatives. Clinical staff had a good awareness about health care waste management. Unfortunately, this did not translate into proper segregation of waste into the different categories at the point of generation. Non-clinical staff involved in health care waste management had limited awareness of the risks involved in their roles. Their incorrect use of personal protective equipment while transporting the waste put them at risk of infection as well as occupationally-induced issues such as back problems. Disposal of chemicals directly into the ground posed a potential risk to water sources.

Strengths of the Study

Strengths of the study include following the complete waste disposal process within the hospital from waste generation to removal from the site for disposal. We also assessed staff awareness and practice about waste management. Data was collected for a whole month.

A weakness was that only five out of eight hospital departments were assessed and no other health centers or service delivery points were included. Details of quantities and kinds of waste fluids disposed of by pouring down drains and where the soak-away may drain to were not available, so the safety of fluid waste disposal could not be effectively assessed. This needs further work.

Reasons for Findings

The considerable amount of compostable waste from the Sexual and Reproductive Department (SRD) and adult inpatients was generated by relatives providing meals for the large number of in-patients, including 28 beds reserved for the use of pregnant women living in the hospital while awaiting delivery. The food waste includes bulky plantain skins from preparation of the local staple, bananas (matooke).

The relatively large amount of hazardous (highly infectious + infectious) produced by SRD (including maternity) were due to placentae and blood-contaminated materials from deliveries. The placentae not removed at the time of inspection indicate the on-going nature of deliveries, not the inadequacy of removal ( Table 4 ).

A large percentage of the hazardous waste from the HIV department was from items contaminated by body fluids during patient investigations.

Poor segregation of waste unnecessarily increased the amounts of apparently hazardous waste, and therefore the cost of disposal, whether to the hospital directly, or as at present to the private internationally funded waste company. The issue of incorrect segregation means that waste can be disposed of incorrectly. This is still true now that both non-compostable and hazardous waste are transported from the storage site to the processing plant in Eastern Uganda.

Comparison of Findings

The proportions of hazardous (12%) and non-hazardous waste (87%) was similar to that reported in other low- and middle-income countries ( 22 , 23 ). Segregation was incorrect across all departments; this is a common problem reported in other studies ( 24 , 25 ). From the interviews it was clear that clinical staff did not entirely apply the knowledge they had during segregation of waste in all departmental generation points, as found elsewhere ( 26 – 28 ). This is complicated by the lack of supply of the correctly colored bin liners to BCH.

The poor segregation and handling of waste increased the risk of infection to staff, patients, and visitors ( 9 ). Cross infection was taken seriously in both the hospital and the community health centers, with a dedicated infection control committee which is ready to act on conclusions of the study ( 28 ).

Overall, in our clinical areas, sharps were well handled, although globally sharps contribute the biggest morbidity of the waste ( 29 ).

Transportation within the hospital to the storage area was done manually by porters who did not use personal protective equipment correctly. This practice increases the risk of direct contact with contaminated waste and of injuries from sharps and also of spills of waste from the bin liners to the pathways and the compound. It is of note that the porters' basic knowledge about all aspects of proper waste handling was severely limited ( 30 ).

Water source contamination by chemicals from laboratory and X-ray has also been described in Haiti ( 31 ). Contamination of water sources may affect livestock and humans directly through drinking, and farming fields through irrigation, which is very important because the local community largely depends on agriculture for its livelihood. In Bwindi Community Hospital, while we do not know the existence or extent of any water contamination, the study has highlighted the need to investigate this in the future.

Human to animal spread of infection has been documented many times [reviewed in Chartier ( 16 )]. Cross contamination leading to transmission of infection in the catchment area of the hospital and community project could lead on to exposure, directly, or indirectly through intermediary species, not only of the human population but of the gorilla ( Gorilla beringei beringei ) population in the adjacent world heritage site ( 13 ). Environmental degradation, particularly deforestation ( 14 ), enhanced by waste pollution, may further endanger the nearby gorilla population, a responsibility the hospital is taking increasingly seriously.

Lessons Learnt

Knowledge of clinical staff is largely adequate with regard to the importance of recognizing the different waste types. Unfortunately, except for sharps and vials, this is not applied in the practical management of waste in the hospital.

Non-clinical staff involved in waste handling show little understanding of the resultant risks leading to possible adverse occupational outcomes and hospital contamination. As a result of this study, the hospital management more clearly recognized the risks to the health of the wider community, the natural environment, including contamination of water sources, and even possibly cross infection to local wild animals.

Implications

There is a need for the hospital to develop systematic methods to improve waste management for the benefit of staff, patients, and the wider community. This could be achieved through three approaches: education, audit, and review of the drain design.

• Continuous education for all hospital staff about safe and proper waste management with emphasis on segregation at point source, PPE, transport, storage, and disposal. Staff need to realize that they are the primary stake holders in ensuring that a clean and safe working environment. Clinical and non-clinical staff should contain a regular component on waste management.

• Waste audits should become more regular and consistent. Collection by the waste handling company for offsite management should be monitored to ensure consistency to avoid prolonged stay of waste which would lead to scavenging by rodents. Periodic close monitoring and evaluation of waste management would impart a sense of security against occupational health risks, increasing the moral among hospital workers.

• The procedures for disposal of potentially hazardous liquid waste draining into the ground should be reviewed. Liquid waste could be treated by dilution and liquid treatment before disposal. The hospital may need some investment to re-engineer the waste flow.

The hospital should prioritize health care waste management with dedicated budget line allocations. Over three tons of compostable waste was produced in 1 month. How this could be better managed to support the local agricultural community requires further work. Subsequent monitoring and auditing of the waste management protocols and policies will improve resources and ensure a cleaner and safer health care institution and the surrounding environment.

Health care waste management at Bwindi Community Hospital still faces many challenges and does not meet WHO standards that would ensure safety for staffs, clients, and the surrounding environment from hospital-related infections. The five departments in the study produced over 5,000 kg of waste in 1 month, a large amount that needs to be properly managed to minimize infections, water source contamination, and environmental pollution.

The hospital should arrange sufficient on-going training programs for clinical and non-clinical staff, and use of personal protective equipment by porters should be emphasized. Efforts should be made to improve the minimization of waste at source. Audit of waste management across the hospital, as well as re-engineering for the chemical wastes, is needed to ensure the lessons learned in this study are not lost but built into BCH's waste management policy and practice.

Data Availability

All datasets generated for this study are included in the manuscript and/or the supplementary files.

Ethics Statement

Ethics approval was obtained from the Bwindi Community Hospital Health and Scientific Committee local Ethics Committee, and also from the Ethics Advisory Group of International Union Against Tuberculosis and Chronic Lung Disease, Paris, France.

Author Contributions

SK conceived the study. SK, EW, AS, AD, and BM designed the study protocol and all authors read and approved the study protocol. SK collected the data. All authors contributed to analyzing and interpreting the data. SK and AS drafted the manuscript and all authors critically revised the manuscript for intellectual content. All authors read and approved the final manuscript. SK and BM are guarantors of the paper.

The program was funded by personal sources. The United Kingdom's Department for International Development (DFID) and The Union supported travel costs for some of the overseas mentors. The Special Programme for Research and Training in Tropical Diseases at the World Health Organization (WHO/TDR) supported the costs for open access publication. The external funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Conflict of Interest Statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Acknowledgments

We acknowledge the contributions of Sheila Asimwe, research assistant, and the clinical and non-clinical staff of Bwindi Community Hospital. This research was conducted through the Structured Operational Research and Training Initiative (SORT IT), a global partnership led by the Special Programme for Research, and Training in Tropical Diseases at the World Health Organization (WHO/TDR). The training model is based on a course developed jointly by the International Union Against Tuberculosis and Lung Disease (The Union) and Medécins sans Frontières (MSF). The specific SORT IT program and the mentorship and coordination of the three SORT IT Workshops which resulted in this publication were implemented by authors affiliated with: Bwindi Community Hospital, Bwindi, Uganda; The University of Chester, Chester, UK; University of Exeter, Exeter, UK; and The Union, Paris, France.

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Keywords: hazardous waste, compostable waste, SORT IT, operational research, mixed methods, personal protective equipment, zoonoses

Citation: Kwikiriza S, Stewart AG, Mutahunga B, Dobson AE and Wilkinson E (2019) A Whole Systems Approach to Hospital Waste Management in Rural Uganda. Front. Public Health 7:136. doi: 10.3389/fpubh.2019.00136

Received: 15 February 2019; Accepted: 13 May 2019; Published: 06 June 2019.

Reviewed by:

Copyright © 2019 Kwikiriza, Stewart, Mutahunga, Dobson and Wilkinson. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Stuart Kwikiriza, kwikirizastuart6@gmail.com

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

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Journal information: Bioresource Technology

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CDRH Issues 2024 Safety and Innovation Reports

Reports highlight CDRH actions to advance medical device safety and innovation and build on these efforts this year.

FOR IMMEDIATE RELEASE April 17, 2024

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH)

Today, CDRH is issuing two companion reports that detail the Center's commitment to further advance our core pillars of safety and innovation. The CDRH 2024 Safety Report is an update to our 2018 Medical Device Safety Action Plan and features steps we have taken in recent years to assure the safety of medical devices keeps pace with the evolving technology. The CDRH 2024 Innovation Report highlights our work to advance innovation and the progress we have made to make the U.S. market more attractive to top device developers.

As we have long stated, safety and innovation are not polar opposites, but rather two sides of the same coin. Our focus on safety and innovation stems from our vision to protect and promote the public health by assuring that medical devices on the U.S. market are high-quality, safe and effective, and that patients and providers have timely and continued access to these devices.

Since 2009, CDRH has focused our efforts on advancing the development of safer, more effective medical devices that provide a significant benefit to the public health. As such, we enhanced our clinical trial and premarket review programs, including the 510(k) and De Novo pathways, and created new programs like the Breakthrough Devices Program , the Safety and Performance Based Pathway and the Safer Technologies Program to help reduce barriers for innovators. As a result of these actions and other past and ongoing efforts, the number of innovative medical devices authorized annually in the U.S. has increased five-fold since 2009.

In parallel, we took significant actions to improve device safety and enhanced our ability to identify and address new safety signals. We achieved an ambitious set of goals outlined in our 2018 Medical Device Safety Action Plan to help ensure patient safety throughout the Total Product Life Cycle (TPLC) of a medical device. We made improvements and updates to our medical device reporting programs, including updating the Manufacturer and User Facility Device Experience (MAUDE) database, vastly improved our recalls program, and took steps to ensure the timely communication and resolution of new or known safety issues.

And throughout, we partnered with patients and incorporated their voices into our work, including establishing our Patient Science and Engagement Program, because at the end of the day, improving the health and the quality of life of people is at the core of our public health mission.

We are proud of the progress we've made to advance innovation and improve the safety of medical devices, and we continue to build on these efforts, as resources and additional capabilities permit. One of the challenges we face, though, is the sheer volume of products and producers. Today there about 257,000 different types of medical devices on the U.S. market, made by approximately 22,000 manufacturing facilities worldwide, and CDRH authorizes roughly a dozen new or modified devices every business day. Despite that, the number of new or increased known safety issues involve only a small fraction of technologies and many can be addressed without any changes to the device itself. However, the impact to people can be significant, which is why we need to continuously take steps to advance both safety and innovation.

This year, we will take additional actions to help further ensure innovative, high-quality, safe, and effective devices are developed and marketed to U.S. patients. As further detailed in the 2024 Innovation Report, three actions we plan to take this year include: reimagining our premarket review program, expanding our footprint in geographical innovation centers, and launching a new home as a health care hub to extend first-class care into the home. Additionally, as detailed in the 2024 Safety Report, three actions we plan to take this year include: expanding a program to assist companies improve their device quality efforts, strengthening active surveillance, and enhancing the medical device recall process.

Through these new actions and the work detailed in the 2024 Safety and Innovation reports, CDRH remains committed to furthering our mission to protect and promote the public health and ensure our organization is well-positioned to meet the needs of all people and changes in the medical device ecosystem.

Additional Resources:

• 2024 Innovation Report
• 2024 Safety Report
• 2018 Medical Device Safety Action Plan

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Researchers achieve sustainable recovery of minerals from e-waste

by Karyn Hede, Pacific Northwest National Laboratory

There's some irony in the fact that devices that seem indispensable to modern life—mobile phones, personal computers, and anything battery-powered—depend entirely on minerals extracted from mining, one of the most ancient of human industries. Once their usefulness is spent, we typically return these objects to the earth in landfills, by the millions.

But what if we could "mine" electronic waste (e-waste), recovering the useful minerals contained within them, instead of throwing them away? A clever method of recovering valuable minerals from e-waste, developed by a research team at the Department of Energy's Pacific Northwest National Laboratory, is showing promise to do just that. Materials separation scientist Qingpu Wang will present recent success in selectively recovering manganese, magnesium, dysprosium, and neodymium, minerals critical to modern electronics, at the 2024 Materials Research Society (MRS) Spring Meeting on April 25, 2024, in Seattle, WA.

Go with the flow

Just as a prism splits white light into a dazzling rainbow of colors based on distinct wavelengths, so too can metals be separated from one another using their individual properties. However, current separation methods are slow, as well as chemical- and energy-intensive. These barriers make the recovery of valuable minerals from e-waste streams economically unfeasible.

In contrast, the PNNL research team used a simple mixed-salt water-based solution and their knowledge of metal properties to separate valuable minerals in continuously flowing reaction chambers.

The method, detailed in two complementary research articles and presented this week, is based on the behavior of different metals when placed in a chemical reaction chamber where two different liquids flow together continuously. The research team exploited the tendency of metals to form solids at different rates over time to separate and purify them.

"Our goal is to develop an environmentally friendly and scalable separation process to recover valuable minerals from e-waste," said Wang. "Here we showed that we can spatially separate and recover nearly pure rare earth elements without complex, expensive reagents or time-consuming processes."

The research team, which included materials scientist Chinmayee Subban, who also holds a joint appointment with the University of Washington, first reported in February 2024 successfully separating two essential rare earth elements, neodymium and dysprosium, from a mixed liquid. The two separate and purified solids formed in the reaction chamber in four hours, versus the 30 hours typically needed for conventional separation methods.

These two critical minerals are used to manufacture permanent magnets found in computer hard drives and wind turbines, among other uses. Until now, separating these two elements with very similar properties has been challenging. The ability to economically recover them from e-waste could open up a new market and source of these key minerals.

Recovering minerals from e-waste is not the only application for this separation technique. The research team is exploring the recovery of magnesium from sea water as well as from mining waste and salt lake brines.

"Next, we are modifying the design of our reactor to recover a larger amount of product efficiently," added Wang.

Recovering manganese from simulated battery waste

Using a complementary technique, Wang and his colleague Elias Nakouzi, a PNNL materials scientist, showed that they can recover nearly pure manganese (> 96%) from a solution that mimics dissolved lithium-ion battery waste. Battery-grade manganese is produced by a handful of companies globally and is used primarily in the cathode (negative pole) of the battery.

In this study, the research team used a gel-based system to separate the materials based on the different transport and reactivity rates of the metals in the sample.

"The beauty in this process is its simplicity," Nakouzi said. "Rather than relying on high-cost or specialty materials, we pared things back to thinking about the basics of ion behavior. And that's where we found inspiration."

The team is expanding the scope of the research and will be scaling up the process through a new PNNL initiative, Non-Equilibrium Transport Driven Separations (NETS), which is developing environmentally friendly new separations to provide a robust, domestic supply chain of critical minerals and rare earth elements.

"We expect this approach to be broadly relevant to chemical separations from complex feed streams and diverse chemistries—enabling more sustainable materials extraction and processing," said Nakouzi.

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• Int J Environ Res Public Health

Effective Medical Waste Management for Sustainable Green Healthcare

Sang m. lee.

1 College of Business, University of Nebraska-Lincoln, Lincoln, NE 68588, USA

2 College of Business Administration, Inha University, Incheon 22212, Korea

Associated Data

The data presented in this study are available on request from the corresponding author.

This study examines the importance of medical waste management activities for developing a sustainable green healthcare environment. This study applied a multiple methodological approach as follows. A thorough review of the literature was performed to delineate the factors that have been explored for reducing medical waste; hospital staff who handle medical waste were surveyed to obtain their opinions on these factors; the analytic hierarchy process (AHP) was applied to determine the priorities among the identified key factors; and experts’ opinions were consulted to assess the actual applicability of the results derived by the AHP. The study identified the following factors as the most important: medical waste management (26.6%), operational management issues (21.7%), training for medical waste management procedures (17.8%), raising awareness (17.5%), and environmental assessment (16.4%). This study analyzed the contributing factors to the generation of medical waste based on the data collected from medical staff and the AHP for developing a sustainable green healthcare environment. The study results provide theoretical and practical implications for implementing effective medical waste management toward a sustainable green healthcare environment.

1. Introduction

The impacts of the global COVID-19 pandemic on people’s daily life, the society, economy, and the environment involve trade-offs in many aspects. Technological innovations (e.g., rapid testing, tracking infected persons, online-based remote work and education, etc.) have been effective in preventing the spread of the pandemic. On the other hand, they also have drawbacks, such as waste treatment issues with the increased use of disposable products and inequalities due to social and digital divides. In particular, the increased volume of plastic waste due to COVID-19-related practices has significant ramifications that pose challenges with respect to ensuring a sustainable environment [ 1 , 2 ].

Penga et al. [ 3 ] predicted that 193 countries worldwide would generate an additional 8.4 million tons of plastic waste due to COVID-19-related activities, a 10% increase from the baseline since the World Health Organization (WHO) declared the disease a global pandemic in March 2020. Of the additional plastic waste generated during the pandemic, approximately 87.4% was discharged from healthcare institutions, including personal protective equipment (such as masks, sanitary gloves, and face shields), online packaging materials (due to increased online shopping), and virus test kits, accounting for 7.6%, 4.7%, and 0.3%, respectively. Geographically, waste generation was the highest in Asia (46.3%), followed by Europe (23.8%), South America (16.4%), Africa (7.9%), and North America (5.6%) [ 3 ]. In a simulation study of the dynamics of COVID-19-related plastic waste, Peng et al. [ 3 ] predicted that 3800 to 25,900 tons of debris have been released into the sea. With approximately 280 million confirmed COVID-19 cases at the end of 2021, the volume of medical waste is likely to be approximately 11 million tons, with about 34,000 tons being released into the sea [ 4 ].

In South Korea, medical waste generated due to COVID-19 is classified as “quarantine medical waste” according to the “Wastes Control Act” of 1999, and includes most items used by healthcare workers in COVID-19 treatment institutions, such as screening clinics [ 5 ]. With the rapidly increasing volume of medical waste during the pandemic, waste treatment facilities in South Korea have struggled despite operating at full capacity [ 5 ]. Furthermore, because massive amounts of medical waste are routinely incinerated, its environmental impact is not tomorrow’s problem, but an urgent current issue. In addition, the consequences of delays in collecting and/or disposing of medical waste could threaten the health of patients, guardians, healthcare workers in hospitals, and community residents. Therefore, joint efforts of healthcare providers and local communities are necessary to develop an environmentally sustainable healthcare system. As climate change, air pollution, plastic waste, and medical waste threaten human health and environmental sustainability, establishing an eco-friendly medical system can provide a better ecosystem and potentially offer long-term benefits to human health [ 2 , 6 ].

Considering infectious diseases caused by environmental pollution, there is an urgent need to develop a healthier ecosystem. Healthcare institutions generally use disposable products to minimize infection while treating patients. This strategy seems logical to prevent the spread of COVID-19. However, only 15% of all medical waste is considered “hazardous waste” which may be infectious or toxic, whereas 85% of the hospital-generated waste is general and non-hazardous waste, comprising food containers, packaging, and medical supplies (i.e., gloves and masks, among others) used in the screening process for patients without contagious diseases [ 6 , 7 ]. Different and more cost-effective approaches can be used to reduce medical waste from healthcare institutions, such as appropriately sorting the discharged waste and promoting the use of systems that employ high-temperature/pressure and chemical processes to sterilize medical equipment and materials. Great Ormond Street Hospital in London saved approximately USD 120,000 in expenses by eliminating 21 tons of plastic waste through training employees on the use of disposable plastic gloves [ 6 ].

Several initiatives and studies have investigated various aspects of medical waste, including the Medical Wastes Act [ 8 ]; treatment methods and the current status of waste management [ 9 , 10 , 11 , 12 , 13 , 14 ]; knowledge, attitudes, and practices of medical staff with respect to medical waste e.g., [ 1 , 15 , 16 ]; and COVID-19-related medical waste e.g., [ 3 , 6 , 17 ]. However, limited research is available on the sources of medical waste (e.g., healthcare institutions). Environmental protection and cost reduction through medical waste reduction depend on the activities and actions of related organizations and medical staff on the front lines of medical waste discharge. In addition, developing plans to initiate a change through healthcare workers can help establish a foundation for creating an eco-friendly healthcare environment.

The purpose of this study is to propose an operational plan for the effective management and treatment of medical waste generated in hospitals. Irrespective of how optimal a system or policy may be, an effective medical waste management program should address the following: (1) identify activities that can be implemented by employees who are generating medical waste; (2) determine the priority among these various activities; and (3) define the support needed at the organizational level to implement these activities.

To accomplish the study objectives, a thorough review was undertaken on relevant previous studies on the approaches and factors that were explored for reducing and managing medical waste. Second, to apply the AHP to determine the importance of the identified key factors, a survey of 16 hospital staff with more than 3 years of experience in handling medical waste was conducted to obtain their opinions on these factors for a pairwise analysis. Third, the AHP was applied to determine the priorities among the identified factors. Finally, three experts in medical waste management were interviewed to gain additional insights about the results of AHP and their actual application feasibilities. The study results can be used as a framework for developing a sustainable green healthcare ecosystem.

This paper is organized as follows. Section 2 reviews the relevant literature on medical waste and sustainable medical waste management. In Section 3 , research design is presented for identifying and assessing the importance of the key factors that contribute to the generation of medical waste. Section 4 provides the AHP results and the opinions of experts on application feasibility of the AHP results. Section 5 summarizes the results of the study, implications, limitations, and suggestions for future research.

2. Literature Review

2.1. medical waste.

Healthcare services enrich and prolong people’s lives through health promotion and disease prevention and treatment. However, healthcare services generate a large amount of medical waste in the process; 20% of such waste poses health risks, such as infection and exposure to hazardous chemicals or radiation [ 18 ].

The World Health Organization [ 19 ] provided the guidelines for medical waste management in its report “Safe management of waste from healthcare activities”. In these guidelines, the WHO defined healthcare waste as “all the waste generated by healthcare facilities, medical laboratories, and biomedical research facilities, as well as waste from minor or scattered sources”. ICRC [ 18 ] added that “medical waste covers all wastes produced in healthcare or diagnostic activities”. The United States Environmental Protection Agency (US EPA) [ 20 ] defined medical waste as “a subset of wastes generated at healthcare facilities, such as hospitals, physicians’ offices, dental practices, blood banks, and veterinary hospitals/clinics, as well as medical research facilities and laboratories”. In Article 2, No. 5, of the “Wastes Control Act” of South Korea, medical wastes are defined as “wastes discharged from public health and medical institutions, veterinary clinics, testing and inspection institutions, and other similar institutions, such as parts and extracts of human bodies and carcasses of laboratory animals, which may cause harm to human bodies by infection or otherwise and need to be specially controlled for public health and environmental conservation”. Although international agencies present diverse definitions of medical waste, their guidelines commonly include “waste generated from healthcare facilities” [ 18 , 19 , 20 ]. Hossain et al. [ 11 ] defined health care waste as “all types of waste produced in health facilities such as hospitals, health centers, and pharmaceutical shops”. In this study, medical waste refers to the waste generated during patient treatment processes (see Table 1 ).

Medical waste can be classified as hazardous or non-hazardous (general) waste. While non-hazardous medical waste does not pose a specific hazard, hazardous medical waste can cause diseases and environmental hazards [ 19 , 21 ]. The WHO [ 7 ] classifies medical waste into eight categories: ‘infectious waste, pathological waste, sharps waste, chemical waste, pharmaceutical waste, cytotoxic waste, radioactive waste, and non-hazardous or general waste’. As listed in Table 1 , although the definition of medical waste differs slightly between institutions and countries, its classifications and contents are similar. Table 1 provides a detailed summary of the separation and treatment of infectious medical waste by organizations, countries, and date.

Medical waste classifications and related details.

2.2. Medical Waste Management for a Sustainable Healthcare Environment

According to the WHO [ 7 ], 15% of all medical waste generated is hazardous. In high-income countries, 0.5 kg of hazardous medical waste is generated per hospital bed every day, whereas it is 0.2 kg in low-income countries. During the COVID-19 pandemic, medical waste generation has accelerated. According to the United Nations Environment Program [ 26 ], the volume of medical waste generated from medical facilities related to COVID-19 is 3.4 kg per person and approximately 2.5 kg per hospital bed each day worldwide. During the pandemic, China generated approximately 469 tons of medical waste per day [ 3 ]. Japan, India, and Indonesia generated 876, 608, and 290 tons per day, respectively [ 26 ], while South Korea generated 476 tons per day [ 27 ].

Hassan et al. [ 10 ] argued that medical waste problems are caused because of the lack of awareness and willingness on the part of healthcare employees and ambiguous policies and laws about proper management of medical waste. Hossain et al. [ 11 ] emphasized that inappropriate behavior of employees and improper disposal methods of medical waste in hospitals can increase serious health risks and environmental pollution due to the contagious nature of the waste. Therefore, healthcare institutions require an operational strategy to train stakeholders involved in medical waste generation to manage this critical problem.

Although previous research on medical waste management focused primarily on the treatment of hazardous waste, the emphasis has recently shifted to operational strategies on managing the disposal of all types of medical waste. The reason for this trend is that the safe handling and disposal of all medical waste is a key step to preventing potential hazards (disease or injury) and pollution of the environment [ 9 ]. Although the transmission of blood-borne viruses and respiratory and other infections through inappropriate medical waste disposal has yet to be explored completely [ 19 ], the potential risks to human health and the environmental issue are obviously high [ 15 ]. Thus, medical waste management is now regarded as a critical component of high-quality medical services [ 28 ]. This change is a result of reports which have demonstrated how environmental pollutants generated during waste treatment are threatening the in which we live ecosystem and human health. Penga et al. [ 3 ] claimed that over eight million tons of COVID-19-pandemic-related plastic waste had been generated globally, with more than 25,000 tons discharged into the sea. This could cause adverse long-term effects on the marine environment.

Windfeld and Brooks [ 8 ] suggested the need for a standardized classification method to educate medical workers in the efficient management of medical waste. Thakur et al. ([ 29 ], p. 357) presented six dimensions of medical waste management practices as ‘experience, relationship, environmental factors, technology and qualification, economic factors, and firm’s capabilities.’ Healthcare institutions should develop medical waste management plans which include the daily collection, processing, separation, and packaging of medical waste, as well as the implementation of regular monitoring and training programs [ 11 , 15 , 30 , 31 ]. The effective operation and maintenance of medical equipment and facilities can help prevent the frequent generation of medical waste. For example, the life cycle of medical equipment can be extended through proper maintenance. Therefore, the appropriate operation and maintenance require continuous management activities, such as personnel training and supply of appropriate materials and spare parts.

To create a sustainable medical environment through the reduction in and management of medical waste, an appropriate organizational culture must be developed, encouraging the participation of all stakeholders who partake in medical waste generation [ 1 ]. This also requires the involvement and cooperation of all stakeholders, including the various occupations/departments within the healthcare institution, as well as the collaboration of patients, guardians, subcontractors, and communities [ 32 ]. Healthcare institutions should develop an integrated approach for medical waste management [ 29 , 30 ]. Therefore, one specific department should not bear the complete responsibility for medical waste reduction; instead, these activities should be practiced by all hospital members throughout the course of their work. For instance, the department in charge of medical waste disposal should practice proper separation to prevent general waste from being included in medical waste. Healthcare departments should attempt to reduce emissions from infectious waste and single-use products. Through these general activities, healthcare institutions can reduce medical waste generation and related operating costs, thus developing a sustainable healthcare service environment.

2.3. Operational Strategies for Effective Medical Waste Management

A well-prepared action plan can reduce the amount of medical waste without decreasing the quality of medical services provided by healthcare workers. Kwikiriza et al. [ 16 ] emphasized that clinical staff need to be fully aware of their critical role in effective medical waste management, because they are the ones who sort the waste at the point of generation. They also suggested that non-clinical staff tend to have limited awareness and experience about the treatment, segregation, and/or knowledge of medical waste management. To implement appropriate measures or activities to reduce the generation of medical waste in their daily operations, healthcare providers should have accurate information about the volume of medical waste being generated by them. Reducing the volume of waste that requires treatment is an obvious approach to lower the cost of waste management and improve the operational efficiency of the organization. Efforts to identify and eliminate unnecessary waste generation sources can positively impact the efficacy of developing a sustainable healthcare ecosystem. Therefore, the efficiency of medical waste management can be improved through correct waste classification and sorting at the point of material use.

The Organization for Economic Co-operation and Development (OECD) introduced the sustainable materials management system, which promotes efficient resource management throughout the entire lifecycle of a resource based on existing waste-management-oriented policies [ 33 ]. The G7 Toyama Environment Ministers’ Meeting in 2016 introduced a resource efficiency policy for promoting the efficient use of resources for sustainable development [ 33 ]. To implement a resource recycling economy, Kim et al. [ 34 ] suggested the following approaches: (1) suppression of waste generation; (2) waste reuse; (3) promotion of waste recycling; (4) energy recovery; and (5) appropriate disposal. As these approaches imply, implementing the activities that can reduce medical waste should be focused on frontline healthcare workers. To identify in-hospital activities that can reduce medical waste generation, the flow of waste processing phases must first be examined. Table 2 shows the general flow of medical waste management implemented in healthcare institutions in South Korea, from the generation to the treatment process of medical waste.

Synopsis of the medical waste stream in Korean hospitals.

Source: ICRC [ 18 ].

As shown in Table 2 , after medicine and medical supplies are stocked in the purchasing department, goods are distributed at the request of each healthcare department. Medical waste is generated from this point onwards. For instance, medicine and medical supplies are purchased based on care departments’ needs for operations and patient treatment. These supplies become medical waste when they are used, disposed of, or their expiration dates are passed. Although expired medicine (i.e., drug ingredients) may be hazardous, medical supplies, such as syringes, surgical gloves, and gauze, are classified as general medical waste. However, even though such expired medical supplies, not in contact with patients, are considered general medical waste, they are often discharged as infectious medical waste or mixed with infectious medical waste for convenience, increasing the volume of generated infectious medical waste. Therefore, reducing unnecessary infectious medical waste is possible if healthcare workers, such as doctors and nurses, are aware of the value of proper waste classifications, separation processes, and emission reduction benefits for medical waste.

Johannessen et al. [ 30 ] suggested guidelines for evaluating and improving medical waste management based on the standard for >50-bed facilities and those with fewer than 50 beds with respect to the current medical service situation. The WHO [ 35 ], through its National Healthcare Waste Management Plan Guidance Manual, suggested a set of factors that should be considered prior to developing a medical waste management plan. The detailed contents of these factors can be summarized as follows. The medical industry and environmental protection are closely related [ 1 ]. For example, healthcare institutions that operate emergency and in-patient rooms emit greenhouse gases throughout the day. Medical waste is landfilled or incinerated, resulting in air pollutant emissions and water pollution due to landfill leaching, constantly raising concerns over environmental protection issues. Although hospitals are fully aware of the importance of medical waste management, they tend to assign the responsibility to a designated department. However, medical waste management cannot be achieved based solely on the role and efforts of the department in charge. Thus, medical waste management strategies should include operational standards and classification, as well as plans for potential waste disposal issues and operational implementation plans. Furthermore, relevant information about the effect of medical waste management on hospital operating costs should be disseminated to all organization members. In this perspective, medical waste treatment requires operational and management strategies.

Kwikiriza et al. [ 16 ] suggested that the incorrect use of personal protective equipment during the treatment/transport process of medical waste may cause infection risks as well as occupational hazard problems. Medical waste is often infectious; therefore, it must be stored safely for a certain period. Hossain et al. [ 11 ] indicated that although the safe handling and disposal of medical waste require a seamless process from the initial collection step to the final disposal stage, improper management practices are often prevalent. These problematic practices are caused by a lack of awareness, effective control, appropriate legislation, and specialized staff [ 11 , 16 ]. Thus, safety protocols should be established to continuously monitor the process to prevent leaks or other hazardous consequences.

The majority of medical waste can be classified as general waste; therefore, a classification policy or manual should be developed for implementation. Previous studies have provided convincing evidence that medical waste has a direct negative impact on the environment [ 9 , 10 , 16 ]. As such, every healthcare institution should endeavor to minimize environmental pollution by complying with the relevant policies and laws while providing a safe medical environment. In addition, because medical waste management involves social, legal, and financial issues, relevant authorities and associations should provide regular education to healthcare workers on new regulations, research findings, or new technologies [ 11 , 12 , 15 , 16 ]. Hospitals should provide education and training programs on the importance and impact of environmental management on organizational efficiency and community safety [ 31 ]. The prevention of possible problems that may arise in medical waste management is possible through effective training on the risks of erroneous waste classification and disposal, operational procedures, and responsibilities involved in medical waste management.

3. Methodology

3.1. analytic hierarchy process.

The analytic hierarchy process (AHP), a method developed by Saaty [ 36 ], is an effective decision-making tool for problems with multiple and conflicting evaluation factors and multiple alternatives solutions. In the AHP, after stratifying the evaluation factors for decision-making and reconstructing the primary factors into sub-items (secondary factors), the importance of each factor is determined through a pairwise comparison between factors prior to obtaining the final solution. The AHP approach is widely used because it allows flexible decision-making based on an intuitive perspective, including objective and subjective factors [ 37 ].

In this study, the AHP was applied because it is well suited to decision-making for medical waste management issues that involve complex and sometimes conflicting operational activities. The AHP is a subjective approach that focuses on a specific issue; therefore, the judgment of experts with practical experience is more appropriate than that of a large sample size [ 38 , 39 ]. Several previous studies used sample sizes between four and nine e.g., [ 40 , 41 ]. On the other hand, other researchers employed sample sizes greater than 30 [ 42 , 43 ]. In applying the AHP, the general suggested number of respondents ranges from 4 to 30. Medical waste occurs at the various medical service encounter points. Thus, in this study, we tried to involve personnel at many service encounter points, resulting in 30 participants.

3.2. Identification of Key Medical Waste Management Factors

To identify important factors in medical waste management and treatment processes in hospitals, this study analyzed the measures that can effectively reduce medical waste and develop a practical assessment method based on the input from managers of medical waste at tertiary healthcare institutions in South Korea.

A preliminary questionnaire was prepared to develop the measurement items that represent the operational and treatment activities of medical waste. As a pilot study, the questionnaire was distributed to staff who had sufficient experience in medical waste management activities in five Korean general hospitals. Based on the respondents’ suggestions, the measurement items were refined for clarity and accurate understanding. The identified measurement items of medical waste management for pairwise analysis are shown in Table 3 .

Measurement items for this study.

3.3. Data Acquisition Process

To ensure effective decision-making with the verified importance of factors by AHP, we executed several steps. First, the final questionnaire developed for pairwise comparison evaluations of measurement items used nine-point Likert scales to determine the importance of items [ 36 ]. Second, the AHP was applied to determine important factors for medical waste management. Third, three experts who were in charge of medical waste management in their hospitals were interviewed to discuss the AHP results and their practicality. In this paper, AHP was applied to perform the following: (1) simplification of the evaluation item structure, (2) comparison of evaluation results, and (3) presentation of operational efficiency measures through decision-making based on the evaluation results.

The ultimate goal of the application of AHP was to determine the priority of factors involved in medical waste management activities and treatment processes to secure a safe, waste-free environment. Figure 1 presents a schematic of the AHP framework employed in this study.

The analytic hierarchy process framework.

3.4. Data Collection

In this study, our survey respondents were restricted to healthcare workers with more than 3 years of experience in medical waste management activities (e.g., separating and disposing of wastes such as syringes, alcohol swabs, gloves, and general medical waste). Waste disposal workers at the hospital moved waste containers to a storage area first; then, they are transferred to an external treatment contractor.

For the AHP application, the survey was conducted during 10–25 January 2022, targeting 30 healthcare workers in hospitals with more than 500 beds. We received 23 responses (76.7%), although 7 were discarded due to incomplete items. Thus, the sample included 16 responses (69.6%). Table 4 presents the sample profile. Approximately 25.0% of respondents were from general wards, and the remaining 75.0% were from isolation wards, emergency rooms, intensive care units, and operating rooms in participating hospitals. The participants had knowledge related to medical waste at the following levels: high (50.0%), medium (37.5%), and low (12.5%). These results imply that the participants had a great deal of knowledge about medical waste. The proportion of respondents who participated in waste management training was high: 87.5%. The participants responded to the importance of medical waste management with the following activities (multiple responses): practice (100.0%), attitude (75.0%), and education training (25.0%).

Respondents’ demographic characteristics.

Total respondents: 16 (100.00%).

4.1. Consistency Test

To apply the AHP, a validity verification was first performed on survey items based on the consistency ratio (CR). Saaty [ 36 ] reported that a CR value of 0.1 or less is desirable, indicating that the probability of obtaining a logically impaired decision is less than 10%. When the CR value is ≤0.2, it indicates an acceptable range. In this study, the CR value was set to ≤0.2 based on the requirement of a pairwise comparison for each item [ 36 ]. The CR values for the five key items proposed in this study were all < 0.2; therefore, the criteria for decision-making in this study were satisfied. For the substitutability index, the opinions of respondents were not within the range of CR values due to the small sample size. A pairwise comparison matrix was analyzed using the geometric mean for the five factors that were considered most important in the management and treatment activities for reducing medical waste in healthcare institutions.

4.2. AHP Results

Table 5 shows the weights of five items and twenty detailed items used to prioritize important factors in managing medical waste based on the Expert Choice 2000 program. The results indicate that medical waste management (26.6%) is the most important factor for reducing medical waste generation, followed by operational management issues (21.7%), training for medical waste management procedures (17.8%), raising awareness (17.5%), and environmental assessment (16.4%). The interpretation of these analysis results is as follows.

Results of the pairwise comparison matrix.

First, medical waste management must be implemented safely with prescribed pro-cedures that should be executed by medical staff at contact points with medical waste to reduce its generation. The second priority factor to be considered is the operational issue of medical waste management (21.7%) such as standards and procedures. The third im-portant factor is training for medical waste management procedures (17.8%), indicating the need to provide a basic method easily accessible through education on medical waste management for healthcare workers or other organization members. Fourth is raising awareness (18.1%) about the impact of effective medical waste management. Reducing the volume of medical waste is only possible when the activities of the responsible depart-ments that generate waste are integrated into daily work activities, along with employee awareness of medical waste management. Finally, environmental assessments are neces-sary to understand the broad impact of medical waste on the medical environment.

First, medical waste management must be implemented safely with prescribed procedures that should be executed by medical staff at contact points with medical waste to reduce its generation. The second priority factor to be considered is the operational issue of medical waste management (21.7%) such as standards and procedures. The third important factor is training for medical waste management procedures (17.8%), indicating the need to provide a basic method easily accessible through education on medical waste management for healthcare workers or other organization members. Fourth is raising awareness (18.1%) about the impact of effective medical waste management. Reducing the volume of medical waste is only possible when the activities of the responsible departments that generate waste are integrated into daily work activities, along with employee awareness of medical waste management. Finally, environmental assessments are necessary to understand the broad impact of medical waste on the medical environment.

Table 5 also shows the results of the analysis on the local weights for each of the five evaluation items. Based on the analysis, for recognizing the importance of good healthcare waste management, raising awareness was the highest (31.8%), followed by setting up a waste management team with responsibility (25.7%), integration into daily operations (21.9%), and establishing a committee to develop a waste management plan (20.6%). These results indicate the importance of recognizing the significance of proper management and treatment activities for reducing medical waste generation.

For operational management issues, the items deemed important were in the following order: operational standards for medical waste items (35.2%), develop and implement a medical waste management plan (29.3%), medical waste management cost (23.1%), and plan for potential medical waste treatment problems (12.4%). The results show that the standards for medical waste management are most important among operational management issues. Thus, the establishment and execution of management plans are key factors.

For medical waste management, the following items were deemed most important: the safe storage of secure leak-proof and infectious medical waste (33.4%), policies or manuals on separation of medical waste by type (28.3%), simple-to-implement medical waste management for staff (including ancillary staff) (20.4%), and regular monitoring to ensure compliance with procedures (17.9%). Based on these analysis results, classification policies and manuals for each type of medical waste are imperative in medical waste management to reduce liability issues (criminal liability) after appropriate waste classification and disposal.

For environmental assessment, the important items were: a safe medical environment from medical waste (30.5%), environmental and health impact monitoring (29.3%), environmental management and training (22.7%), and policy, legal, and administrative frameworks (17.5%). Providing a safe medical environment is not only important for patients, but also for the members of the organization and local communities. From this perspective, a safe healthcare environment from medical waste was rated most important among the detailed items in the environmental evaluation. Infectious medical waste can cause secondary infections in hospitals, which might have also been reflected in the results. Regarding training for medical waste management procedures, the items deemed most important were: training on staff responsibilities and roles in managing medical waste (29.8%), training on waste separation operations (27.8%), education on the risks of incorrect medical waste management (23.5%), and technical training on the application of waste management practices (18.9%).

Organization members often do not have opportunities to interact with those in other departments. However, medical waste management is a special task which offers a shared goal for the benefit of all members of the organization. Thus, general education and training of all employees, in addition to those who are directly involved with the task, would be imperative to engage everyone in this effort.

Based on the analysis results for the 20 global evaluation items, there was no significant difference among the items. Safe storage of secure leak-proof and infectious medical waste (9.1%) was the highest, followed by simple-to-implement medical waste management for staff, including ancillary staff (8.7%), and operational standards for medical waste (8.4%).

4.3. Experts’ Opinions on the AHP Results

After the AHP results were obtained based on the responses of 16 medical workers in tertiary hospitals, we conducted interviews with experts in the related fields to derive additional insights from the study results. These interviews provided insiders’ perspectives on developing an effective implementation plan for medical waste management activities at the operational level. The different activity plans can also be delineated between the department in charge of waste management and supporting departments based on the experts’ ideas.

The three experts invited for the interview were selected among team leaders with more than 5 years of relevant work experience at tertiary hospitals in South Korea. Although each hospital has its own unique characteristics (e.g., operational structure, number of beds and employees, care units, etc.), there was no significant difference in their medical waste management programs among the hospitals of the 23 survey respondents. Some hospitals had their own dedicated medical waste management programs, whereas others had outsourcing arrangements with the municipal sanitation department. The hospitals that relied on the municipal sanitation program for waste management moved medical waste bins/boxes from each treatment room to medical waste storage areas. The collected medical waste was then transported and disposed of by contracted external firms. The departments in charge of medical waste management at these hospitals (e.g., general affairs or facilities departments) perform all necessary administrative procedures.

Table 6 summarizes the common problems, causes, and solutions suggested by the three experts. Based on both the AHP results and the experts’ opinions, medical waste management stood out as the first priority item. However, there was a difference in the second priority item. In the AHP results, the operational management issues item was rated as the second priority item. However, the experts rated training for medical waste management procedures item as the second priority. This may be due to differences in perspectives among managers (“provide education and training to staff to ensure proper sorting”) and staff involved in waste generation, handling, and sorting (“developing a manual for proper sorting of waste”). There was no significant difference among the priorities for the remaining items.

Expert opinions on the analytic hierarchy process (AHP) results.

5. Conclusions

With the increasing concerns regarding contagious and infectious diseases, due to climate change as well as resistance to medications and treatments, the effective management of medical waste has become a strategic priority for healthcare providers. Packaging materials for medical devices are a recyclable resource. Medical waste, mainly incinerated for disposal, requires an eco-friendly treatment method to conserve the environment. Furthermore, healthcare institutions should properly classify and sort general hospital and medical waste in practice. The use of eco-friendly and low-risk containers is a constructive step in the classification and collection processes for medical waste.

This study analyzed the contributing factors to medical waste generation based on the data collected from medical staff and AHP for developing a sustainable green healthcare environment. The analysis results indicated the following priorities for the five key factors: medical waste management was rated the highest (26.6%), followed by operational management issues (21.7%), training for medical waste management procedures (17.8%), raising awareness (17.5%), and environmental assessment (16.4%). The analysis of local weights of the five factors revealed the following items as the most important: raising awareness—recognizing the importance of good healthcare waste management (31.8%); operational management issues—operational standards for medical waste (35.2%); medical waste management—safe storage of secure leak-proof and infectious medical waste (33.4%); environmental assessment—a safe medical environmental from medical waste (30.5%); and training regarding medical waste management procedures—training on staff responsibilities and roles in managing medical waste (29.8%).

5.1. Theoretical and Practical Implications

The results of this study have several important implications. First, practical medical waste management is the most important step in management and treatment activities for reducing the generation of medical waste. Medical waste is typically generated in each treatment unit and staff can discard it in the containers provided [ 10 , 16 ]. However, general waste, which does not require the same treatment as medical waste, is often misplaced into medical waste containers. Approximately 85% of medical waste is from general operations; hence, some of this may be reused or recycled [ 44 ]. Therefore, hospitals should implement action campaigns based on evaluations of what items can be reused or recycled to reduce medical waste generation.

Second, healthcare organizations should pursue qualitative improvements in the treatment of diseases for patients. From this perspective, hospitals are generally known as institutions that consume a high volume of single-use plastic products to minimize infections [ 45 , 46 ]. Different medicines and medical supplies are used in each department; therefore, detailed instructions or manuals on the handling of waste should be provided to healthcare workers for proper sorting and disposal to reduce the volume of generated waste.

Third, because awareness and education on medical waste management are important factors [ 10 , 11 , 16 ], all members of the hospital should be encouraged to participate in education on the value of medical waste management, especially resource circulation through the proper collection and separation of waste they generate daily. In other words, the generation of medical waste must be reduced to the greatest possible extent, minimizing the impact on the environment by reusing/recovering waste and establishing an eco-friendly green environment. In addition, medicines and supplies are used or become medical waste when their expiration dates are passed. Thus, it is important to manage inventories to avoid valuable medical supplies to become waste after the expiration dates. One way to reduce medical waste would be to include an effective inventory management program in employee education and training courses.

Fourth, medical waste management is subject to strict treatment regulations such as the Medical Service Act and environmental laws. For example, because legal sanctions are imposed on disposing infectious medical waste as general waste, hospital employees must appropriately classify medical waste during the sorting stage to curtail waste generation.

Fifth, the AHP results and the opinions of the three experts indicated a slight difference in the priorities of the five key factors. Thus, healthcare organizations should provide support to front-line employees so that they can freely express their opinions and ideas for performing their medical waste management tasks that are most appropriate for each hospital.

Today, eco-friendly resource management has become important for creating a sustainable green enterprise due to increasing air pollution, climate change, and plastic waste that threaten human health. The global medical waste management market is expected to grow from USD 7.2 billion in 2020 to USD 12.8 billion by 2030 [ 47 ]. Thus, anticipating problems that may arise from medical waste generation would be important to all healthcare organizations. The results of this study provide new insights to developing strategic plans for treatment processes and activities to reduce waste.

The theoretical and practical contributions of this study can be summarized as follows. First, our study has broadened the topic and scope of medical waste management by analyzing the priority items that can significantly reduce medical waste generation, unlike previous studies which primarily focused on waste treatment methods. Second, our research method can be applied to other industries that are concerned about reducing waste generation or recycling resources. Finally, the evaluation items identified and analyzed in this study can also be applied to related industries that are struggling to manage waste. Medical waste management approaches may differ among healthcare providers due to their specific characteristics. This study identified and evaluated priority items (factors) that generate medical waste; therefore, the presented results can be used as useful data for developing strategies and policies for medical waste management.

5.2. Limitations and Future Research Directions

This study has several limitations. First, due to the small sample size (16), statistical verification for the substitutability index could not be performed. Second, although the amount of data required for AHP was appropriate, the fact that we received only 16 valid responses indicates the difficulties involved in the pairwise comparison for medical staff. Therefore, conducting additional surveys, including a pre-survey training session for respondents, would help collect objective and valid data. Furthermore, future studies should consider broadening the population base, as this study focused only on medical staff at the point of contact in generating medical waste. Third, due to a lack of previous studies on management and treatment activities for reducing medical waste produced by healthcare workers, the evaluation items were developed with a focus on items suggested in waste management research in general and the opinions of healthcare workers in handling medical waste. Future studies should consider the more in-depth development of priority items based on a survey of a broader population of medical personnel. Fourth, the causes and solutions of the medical waste problem were examined by comparing the AHP results with the opinions of three experts. However, because this study selected three experts randomly, it may be prudent to select more objective and representative experts in future studies. Fifth, this study focused on the strategies and activities to minimize medical waste; however, it did not explore other important issues related to medical waste management. For example, optimal economic efficiency and management of medical waste activities are critical topics that need to be researched to secure a sustainable healthcare environment. These are key future research areas of medical waste management. Lastly, because this study was conducted in South Korea, its global generalizability is limited. Therefore, future studies should perform comparisons by analyzing cases from more countries in varying degrees of healthcare services.

Funding Statement

This work was supported by INHA UNIVERSITY Research Grant (INHA-68945-1).

Author Contributions

All authors have conceptualization, writing the manuscript. All authors have read and agreed to the published version of the manuscript.

Institutional Review Board Statement

Not applicable.

Informed Consent Statement

Data availability statement, conflicts of interest.

The authors declare no conflict of interest.

Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Brain organoids and assembloids are new models for elucidating, treating neurodevelopmental disorders

Stanford Medicine research on Timothy syndrome — which predisposes newborns to autism and epilepsy — may extend well beyond the rare genetic disorder to schizophrenia and other conditions.

April 24, 2024 - By Bruce Goldman, Erin Digitale

In this 2019 photo, Timothy syndrome patient Holden Hulet, left, rides in a side-by-side ATV driven by his dad, Kelby Hulet, at sand dunes near their home in southern Utah.  Courtesy of the Hulet family

For a long time, no one understood that Holden Hulet was having seizures.

“He would just say ‘I feel tingly, and my vision kind of goes blurry,’” said Holden’s mom, JJ Hulet. “But he couldn’t communicate exactly what was going on.”

JJ and Kelby Hulet could see their son was having short spells of incoherent speech, rapid back-and-forth eye movements and odd physical changes. “He’d kind of go — I don’t want to say ‘limp’ because he would stand just fine — but his body would just be in zombie mode,” JJ said. The episodes lasted less than a minute.

The parents were puzzled and worried, as they had been many times since Holden was born in 2008 and they learned that their newborn had an extremely rare genetic disease. “I was thinking it was his heart,” Kelby Hulet, Holden’s dad, said.

Holden’s condition, Timothy syndrome, causes long, irregular gaps in heart rhythm. He spent his first six months hospitalized in a neonatal intensive care unit in his family’s home state of Utah while he grew big enough to receive an implantable cardioverter defibrillator. The device sends an electrical signal to restart his heart when it pauses for too long.

As a small child, Holden would sometimes pass out before the defibrillator shocked his heart back into action. When Holden started telling his parents about the blurry-vision episodes at age 6, Kelby initially believed it was a new version of the same problem, and he kept a time stamp on his phone for each episode. But the records from Holden’s defibrillator showed that these times did not line up with any heart-rhythm problems.

The family’s pediatrician was confused, too. Perhaps Holden was having periods of low blood sugar, another possible Timothy syndrome complication, he suggested. Initial testing at the local medical center did not turn up clear answers.

But Kelby, who was training to become an operating room nurse, realized Holden’s episodes reminded him of what he was learning about warning signs for stroke. JJ called Holden’s cardiologist in Utah and asked for a detailed neurologic evaluation, which enabled the mysterious episodes to be diagnosed as seizures. Holden began taking anti-seizure medication, which helped, to his parents’ great relief.

Researching a rare disease

A few months after Holden was born, Sergiu Pasca , MD, arrived at Stanford Medicine to pursue a postdoctoral fellowship in the lab of Ricardo Dolmetsch, PhD, then an assistant professor of neurobiology, who was redirecting his research to autism spectrum disorder. At the time, Pasca did not know the Hulet family. But his work soon became focused on the disorder that has shaped Holden’s life.

Caused by a defective gene on the 12th chromosome, Timothy syndrome is vanishingly rare, with no more than 70 diagnosed cases. Children with this disorder rarely survive to late adolescence. It is caused by a mutation in the gene coding for a type of calcium channel — a protein containing a pore that selectively opens or closes, respectively permitting or blocking the flow of calcium across cells’ membranes. While a prominent feature — severe heart malfunction — can be tackled with a pacemaker, most children with Timothy syndrome will end up with lifelong brain disorders including autism, epilepsy and schizophrenia.

By mid-2009, Pasca had succeeded in generating nerve cells from induced pluripotent stem cells (which can be induced to form virtually any of the body’s numerous cell types). These included cells derived from the skin of two patients with Timothy syndrome. Later that year he observed defects in how the patient-derived neurons were handling calcium. This advance — the creation of one of the initial in-a-dish models of brain disease, built from neurons with defects that precisely mirrored those of a patient’s brain — was published in Nature Medicine in 2011.

Pasca and colleagues continued to monitor these Timothy-syndrome neurons in standard two-dimensional culture — growing as single layers in petri dishes — over the next few years. While this two-dimensional culture method was limited in its ability to sustain viable neurons, it was soon superseded by a genuine scientific breakthrough.

Pioneering the first assembloids

The constraints of two-dimensional culture, including the inability to keep these neurons for long periods of time so that they could reach key stages of neural development, prompted Pasca in 2011 to start developing an unprecedented three-dimensional method. The novel technology produced what came to be known as brain organoids. These constructs recapitulated some of the architecture and physiology of the human cerebral cortex. The organoids can survive for several years in culture, enabling neuroscientists to view, non-invasively, the developing human brain up close and in real time. The scientists wrote a seminal Nature Methods paper , published in 2015, that described their discovery.

Pasca’s group subsequently showed that culturing brain organoids in different ways could generate organoids representing different brain regions (in this case, the cerebral cortex and a fetal structure called the subpallium). In a breakthrough set of experiments, Pasca’s team found ways to bring these organoids into contact so that they fuse and forge complex neuronal connections mimicking those that arise during natural fetal and neonatal development. Pasca named such constructs assembloids.

In their paper on the research, which was published in Nature in 2017, Pasca’s team showed that after fusion, a class of inhibitory neurons originating in the subpallium migrates to the cortex, proceeding in discrete, stuttering jumps. (See animation .) These migrating neurons, called interneurons, upon reaching their destinations — excitatory neurons of the cortex — form complex circuits with those cortical neurons.

But in assembloids derived from Timothy syndrome patients, the motion of interneurons as they migrate from the subpallium is impaired — they jump forward more often, but each jump is considerably shorter, so they fail to integrate into the appropriate circuitry in the cortex. This wreaks havoc with signaling in cortical circuits. Pasca’s team tied this aberrant neuronal behavior on the part of Timothy syndrome neurons to the key molecular consequence of the genetic defect responsible for the condition: namely, malfunction of the critical channels through which calcium must pass to cross neurons’ outer membranes.

A family’s struggles

While Pasca was developing assembloids, the Hulet family was progressing through their own journey of discovery with Holden. They faced painful uncertainty at every stage, starting when Holden was discharged from the NICU in the summer of 2009, after several months of hospitalization and multiple heart surgeries.

“Even when we brought him home, [his doctors] said ‘Don’t get your hopes up. We don’t usually see them make it past age 2,” JJ recalled. Many children with Timothy syndrome die from cardiac failure in early life.

“It’s really hard to be positive in that kind of situation, and for a long time I did let it get to me,” JJ said. “I finally got to a point where I said, ‘I have to live my life and we just keep fighting.’”

JJ runs a child care center and has years of experience working with special-needs kids, which motivated her to push for an autism evaluation when she saw signs of autism in Holden. He’s much more verbal than many children with autism, which paradoxically made it more difficult to get an official diagnosis.

“That was frustrating,” JJ said. Although the family’s pediatric cardiologist in Salt Lake City was familiar with the vagaries of Timothy syndrome, their local caregivers in the small town where they live in southern Utah were not. “They kept saying ‘Oh, no, it’s just developmental delays because he was so premature,’” she said. She wonders whether it would have been easier to have Holden’s autism diagnosed had more been known about Timothy syndrome at the time.

“I think research is important so that parents and children have the support they need,” she said, noting how lonely and painful it can be to advocate for a child when his condition is poorly understood — and when, as a parent, you may be doubted by medical professionals. “It’s a really hard thing to deal with.”

Her voice breaks briefly. She continues, “I think research brings validity to that.”

Sergiu Pasca

Implanting organoids

In 2022, Pasca published a  study in  Nature describing the transplantation of human cortical organoids into neonatal rats’ brains, which resulted in the integration of human neurons along with supporting brain cells into the brain tissue of rats to form hybridized working circuits. The implanted human organoids survived, thrived and grew. Individual neurons from the human organoids integrated into young rats’ brains were at least six times as big as those — generated the same way, at the same time — that remained in a dish. The transplanted neurons also exhibited much more sophisticated branching patterns. Pasca and his colleagues observed marked differences in the electrical activity of, on one hand, human neurons generated from a Timothy syndrome patient, cultured as organoids and transplanted into one side of a rat’s brain, and, on the other hand, those generated from a healthy individual and transplanted, as an organoid, into the corresponding spot on the other side of the same rat’s brain. The Timothy syndrome neurons were also much smaller and were deficient in sprouting branching, brush-like extensions called dendrites, which act as antennae for input from nearby neurons.

“We’ve learned a lot about Timothy syndrome by studying organoids and assembloids kept in a dish,” Pasca said. “But only with transplantation were we able to convincingly see these neuronal-activity-related differences.”

That same year, the FDA Modernization Act 2.0 was signed into law, exempting certain categories of new drug-development protocols from previously mandated animal testing. The act was predicated on the understanding that recent advancements in science offer increasingly viable alternatives to animal testing, so the findings based on the organoid- and assembloid-culture technologies may be adequate to justify clinical trials in some neurodevelopmental conditions.

Most recently, in a Nature paper published April 24, Pasca and his colleagues demonstrated, in principle, the ability of antisense oligonucleotides (ASOs) to correct the fundamental defects that lead to Timothy syndrome by nudging calcium-channel production toward another form of the gene that does not carry the disease-causing mutation. Using ASOs to guide production of the functional rather than defective form of this channel reversed the defect’s detrimental downstream effects: Interneuronal migration proceeded similarly to that procedure in healthy brains, and the altered electrical properties of the calcium channel reverted to normalcy. This therapeutic correction was demonstrated in a lab dish — and, critically, in rat-transplantation experiments, suggesting that this therapeutic approach can work in a living organism.

Pasca is now actively searching the globe for carriers of the genetic defect, in preparation for the pursuit of a clinical trial at Stanford Medicine to test the safety and therapeutic potential of ASOs in mitigating the pathological features of Timothy syndrome.

“We are also actively engaged in conversations with other scientists, clinicians in the field and ethicists about the best way to move forward and safely bring this therapeutic approach into the clinic,” he said.

Pasca added that the calcium channel that is mutated in Timothy syndrome is, in fact, “the hub” of several neuropsychiatric diseases including schizophrenia and bipolar disorder. So it may be that the lessons learned — and the therapies derived — from his 15-year focus on a rare disease may have broad application in a number of widespread and troubling psychiatric conditions.

‘Amazing’ teenager

Today, in defiance of his doctors’ warning that he might not live past age 2, Holden Hulet is 15 years old and doing well.

“I think a lot of times, autism is perceived as ‘They’re not neurotypical and they’re not capable of certain things.’ But he is brilliant,” JJ said. “He’s amazing with techie stuff or Legos. He’s funny and super honest and very self-aware.”

Kelby often takes Holden to visit the farm where he grew up. Holden loves to ride the farm equipment and enjoys hanging out with the animals, especially the farm dogs and calves. Like a lot of kids, he keeps an eye out for good rocks, Kelby said with a chuckle.

“He’s always either throwing them or collecting them,” JJ said. “That’s something I really like about him: He’s always got a pocket full of something.”

Although navigating a rare disease is one of the most challenging things they have faced, the Hulets see light in their situation, and would offer encouragement to any family facing a new Timothy syndrome diagnosis.

“There is hope,” JJ said. “There are people out there who care, people out there who fight for you who don’t even know you. I think that’s what is so important about research — that you’re fighting a battle for people you don’t even know.”

About Stanford Medicine

Stanford Medicine is an integrated academic health system comprising the Stanford School of Medicine and adult and pediatric health care delivery systems. Together, they harness the full potential of biomedicine through collaborative research, education and clinical care for patients. For more information, please visit med.stanford.edu .

Artificial intelligence

Exploring ways AI is applied to health care

IU researchers receive $4.8 million grant to study the role of misfolded protein TDP-43 in neurodegenerative diseases

IU School of Medicine Apr 23, 2024

INDIANAPOLIS—A new $4.8 million grant will support researchers from Indiana University School of Medicine and the Medical Research Council Laboratory of Molecular Biology to study how human neurodegenerative diseases are affected by the misfolding of the protein TDP-43. Misfolding occurs when a protein adopts a conformation which differs from the native one.

The researchers, funded by the National Institute of Neurological Disorders and Stroke, have developed an innovative approach to deciphering the role of TDP-43 misfolding in the pathology of frontotemporal dementias, limbic predominant age-related TDP-43 encephalopathy and Alzheimer’s disease. 

“The presence of misfolded proteins in the central nervous system is the hallmark of neurodegenerative diseases,” said Kathy Newell, MD , Jay C. and Lucile L. Kahn Professor of Alzheimer's Disease Research and Education at IU School of Medicine and a principal investigator of the project. “The argument for the pathogenic significance of various misfolded proteins results from the fact that mutations in the various genes encoding those proteins cause distinct genetically determined neurodegenerative diseases. Furthermore, misfolding of those proteins also occurs in sporadic neurodegenerative diseases.”

An international, multidisciplinary team has been assembled with expertise in neuropathology, digital pathology, molecular genetics, biochemistry, protein misfolding, proteomics, structural biology and cryogenic electron microscopy. The team is supported by experts in clinical neurology, protein misfolding and biostatistics, as well as by the Dementia Laboratory’s Brain Library. 

“The protein TDP-43 is central to the pathogenesis of half of all frontotemporal lobar degeneration cases. Finding out how TDP-43, when misfolded, gives rise to multiple proteinopathies is extremely important for the design of diagnostic and therapeutic compounds that will target pathologic TDP-43,” Newell said.

The project is called “Investigating the role of TDP-43 mislocalization, structure, and post-translational modifications in the neuropathologically heterogeneous TDP-43 proteinopathies.”

In addition to Newell, the other principal investigators are Laura Cracco, PhD, MS , assistant research professor of pathology and laboratory medicine at IU School of Medicine and Benjamin Ryskeldi-Falcon, PhD , group leader at the Medical Research Council Laboratory of Molecular Biology in the United Kingdom. This project is the first National Institutes of Health funded research for all three investigators as principal investigators.

About IU School of Medicine

The IU School of Medicine  is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability. According to the Blue Ridge Institute for Medical Research, the IU School of Medicine ranks No. 13 in 2023 National Institutes of Health funding among all public medical schools in the country.

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Critical Minerals Recovery from Electronic Waste

PNNL researchers achieve sustainable recovery of minerals from e-waste

Materials scientist Qingpu Wang of Pacific Northwest National Laboratory and his colleagues developed a nontoxic method to recover valuable minerals from electronic waste. 

(Composite image by Melanie Hess-Robinson | Pacific Northwest National Laboratory)

RICHLAND, Wash.—There’s some irony in the fact that devices that seem indispensable to modern life—mobile phones, personal computers, and anything battery-powered—depend entirely on minerals extracted from mining, one of the most ancient of human industries. Once their usefulness is spent, we typically return these objects to the Earth in landfills, by the millions.

But what if we could “mine” electronic waste (e-waste), recovering the useful minerals contained within them, instead of throwing them away? A clever method of recovering valuable minerals from e-waste, developed by a research team at the Department of Energy’s Pacific Northwest National Laboratory , is showing promise to do just that. Materials separation scientist Qingpu Wang will present recent success in selectively recovering manganese, magnesium, dysprosium, and neodymium, minerals critical to modern electronics, at the 2024 Materials Research Society (MRS) Spring Meeting on April 25, 2024, in Seattle, WA .

Go with the flow

Just as a prism splits white light into a dazzling rainbow of colors based on distinct wavelengths, so too can metals be separated from one another using their individual properties. However, current separation methods are slow, as well as chemical- and energy-intensive. These barriers make the recovery of valuable minerals from e-waste streams economically unfeasible.

In contrast, the PNNL research team used a simple mixed-salt water-based solution and their knowledge of metal properties to separate valuable minerals in continuously flowing reaction chambers.

The method, detailed in two complementary research articles and presented this week, is based on the behavior of different metals when placed in a chemical reaction chamber where two different liquids flow together continuously. The research team exploited the tendency of metals to form solids at different rates over time to separate and purify them.

“Our goal is to develop an environmentally friendly and scalable separation process to recover valuable minerals from e-waste,” said Wang. “Here we showed that we can spatially separate and recover nearly pure rare earth elements without complex, expensive reagents or time-consuming processes.”

The research team, which included materials scientist Chinmayee Subban , who also holds a joint appointment with the University of Washington, first reported in February 2024 successfully separating two essential rare earth elements, neodymium and dysprosium, from a mixed liquid. The two separate and purified solids formed in the reaction chamber in 4 hours, versus the 30 hours typically needed for conventional separation methods. These two critical minerals are used to manufacture permanent magnets found in computer hard drives and wind turbines, among other uses. Until now, separating these two elements with very similar properties has been challenging. The ability to economically recover them from e-waste could open up a new market and source of these key minerals.

Recovering minerals from e-waste is not the only application for this separation technique. The research team is exploring the recovery of magnesium from sea water as well as from mining waste and salt lake brines.

“Next, we are modifying the design of our reactor to recover a larger amount of product efficiently,” added Wang.

Recovering manganese from simulated battery waste

Using a complementary technique , Wang and his colleague Elias Nakouzi , a PNNL materials scientist, showed that they can recover nearly pure manganese (>96%) from a solution that mimics dissolved lithium-ion battery waste. Battery-grade manganese is produced by a handful of companies globally and is used primarily in the cathode, or negative pole of the battery.

In this study, the research team used a gel-based system to separate the materials based on the different transport and reactivity rates of the metals in the sample.

“ The beauty in this process is its simplicity ,” Nakouzi said. “Rather than relying on high-cost or specialty materials, we pared things back to thinking about the basics of ion behavior. And that’s where we found inspiration.”

The team is expanding the scope of the research and will be scaling up the process through a new PNNL initiative, Non-Equilibrium Transport Driven Separations (NETS), which is developing environmentally friendly new separations to provide a robust, domestic supply chain of critical minerals and rare earth elements.

“We expect this approach to be broadly relevant to chemical separations from complex feed streams and diverse chemistries—enabling more sustainable materials extraction and processing,” said Nakouzi.

The research studies reported at MRS received support from a Laboratory Directed Research and Development Program and the NETS initiative at PNNL.

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Pacific Northwest National Laboratory draws on its distinguishing strengths in chemistry , Earth sciences , biology and data science to advance scientific knowledge and address challenges in sustainable energy and national security . Founded in 1965, PNNL is operated by Battelle for the Department of Energy’s Office of Science, which is the single largest supporter of basic research in the physical sciences in the United States. DOE’s Office of Science is working to address some of the most pressing challenges of our time. For more information, visit https://energy.gov/science . For more information on PNNL, visit PNNL's News Center . Follow us on Twitter , Facebook , LinkedIn and Instagram .

Published: April 23, 2024

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