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The 1980s scare that occurred when medical waste, including hypodermic needles, washed up on the shore of some East Coast beaches in the U.S. This brought attention to the potential hazards of medical waste, specifically those that could transmit diseases to people, animals, and ecosystems. Initial federal guidelines were established that included defining the types of medical waste, storage, transporting and disposal as well as training of employees for their safety from exposure. Many of the guidelines were transitioning to the responsibility of individual states, and they continue to coordinate with federal agencies including DOT (Department of Transportation).
PIMW (Potentially Infectious Medical Waste) has been defined as waste that is generated in connection with the treatment, diagnoses, or immunization of humans or animals, as well as any research that pertains to medical services or biological testing. There are a variety of PIMW types and each one must be addressed as to the method(s) required for rendering it harmless.
Both infectious and non-infectious medical waste is mostly generated by healthcare organizations. While hospitals generate the most medical waste, other healthcare environments can include but are not limited to: physician offices, clinics, dentists, veterinarians, long term care facilities. Other types of companies can also generate medical waste and can include but are not limited to: funeral homes, coroner’s offices, research labs, tattoo parlors, and body piercing businesses.
While each state has established their own guidelines, all states have adopted the cradle-to-grave level of responsibility for PIMW. This means that the individual organization or company that generated the medical waste is responsible for all steps, from the moment of creation to the final destruction rendering it harmless. Generators are required to ensure that they contract licensed professionals to monitor from start to finish, and be supplied the required documentation that is needed for transportation and ultimate disposal. Lack of compliance can result in the leverage of fines and fees as well as loss of licenses.
Most states have established their own division of OSHA (Occupational Safety and Health Administration) for staff training for safety in handling of medical waste. Any state that lacks their own OSHA defaults to the federal OSHA programs. A majority of states share in the same guidelines for medical waste storage and labeling, although some states vary in requiring more details than others. State laws may differ on the volume of PIMW that can be stored for specific times. Storage of the medical waste includes specific types of bags that are leak and puncture proof, labeled with biohazard label, and placed in sturdy containers that are labeled and identified for the specific type of medical waste.
All states require that generators that work with licensed and trained medical waste disposal companies that comply with the Department of Transportation (DOT) laws as well as the individual state laws for licensing, permits, and fees required to transport medical waste. Transporters are required to supply the generators completion documents indicating that their medical waste was transported and the final facility location that it was taken.
The treatment selection of PIMW depends upon the medical waste type. The ultimate goal of all treatment facilities is to receive the medical waste and render it harmless. Medical waste can be treated in a variety of ways including: autoclaving, chemical/mechanical treatment, incineration, microwaving, vitrification, and irradiation.
Today we have strict guidelines and laws governing the proper handling and disposal of medical waste, however, this was not always the case. In the past, very little thought was given to the potential hazards of medical waste and as time passed, the problem continued to grow until there were a series of major issues. The problem seemed to reach a crescendo in the 1980s when medication, syringes, and other types of medical waste washed up on the east coast shores. These critical health problems caused the government to stop, research, and develop appropriate methods of healthcare waste management and disposal with the Medical Waste Tracking Act of 1988.
Historically, the U.S. and much of the world didn’t place any priorities on proper handling of any type of waste. Attention to pollution of the air, water, and land was brought on the first Earth Day, but the focus for change seemed to be on the major methods of polluting, with little attention to medical waste.
For years, medical waste was treated as standard waste/trash, putting everything in landfills or in some cases, just dumping it into the ocean. Naysayers of the time said that the ocean was far too big to be affected by anything dumped into it, however, it didn’t take long for the trash, including medical waste, to begin to cause environmental and population health problems.
In 1987, a “30-mile garbage slick” showed up on mainly New Jersey and New York beaches that was mostly made up of medical and household wastes. As both state and federal investigations continued they made the discovery that the waste originated from the New York City marine transfer stations and the Southwest Brooklyn incinerator and particularly the transfer station. It was believed that the garbage was an intentional pollution effort as the tops of many of the garbage bags had been cut off so that the contents inside could escape into the ocean. During that time many of the private waste contractors had to pay high fees and it was thought that this action was taken to bring attention to illegal dumping to avoid the fees.
The incident became worldwide news and the topic of medical waste was brought to the attention as part of the pollution problem as well as a health and safety issue. The EPA (Environmental Protection Agency) had regulations in place for various forms of pollutants, however, the Medical Waste Tracking Act of 1988 added to the laws as a pilot study for determining the life cycle of medical wastes.
The 1988 Medical Waste Tracking Act pilot program monitored medical waste life cycle for two years, amending the existing Solid Waste Disposal Act for medical waste identification, handling, storage, transportation, destruction, and final disposal. It specifically included the following:
During the two-year time period the EPA gathered information from the four major states that had been affected: New York, New Jersey, Connecticut and Rhode Island, as well as Puerto Rico. The results of the program and research provided a model for the federal government as well as some states, to create an all-inclusive medical waste program. MWTA also required that the EPA establish a variety of technologies that could treat medical waste to render it harmless, including: on and offsite incinerators and autoclaves, microwave units, and various mechanical and chemicals systems.
The purpose of the program was to identify all aspects of medical waste and it allowed the creation of an outline program that is described as “cradle-to-grave;” which means from the moment that the waste is generated to the moment that it is rendered harmless.
The MWTA expired in 1991, however, it did establish the criteria necessary to identify medical waste types and create federal guidelines for compliance. Individual states took over the procedures for monitoring, tracking, and ultimate disposal. In some cases, state established their own OSHA (Occupational Safety and Health Administration) Departments for employee health training. Various states also established the laws required for medical waste generators, waste disposal companies, and waste treatment facilities. Other Federal organizations involved in medical waste treatment and disposal monitoring and tracking include the FDA (U.S. Food & Drug Administration) and the CDC (Centers for Disease Control).
Healthcare waste generators is any business or organization that generates any type of medical waste and defines specific volume amounts that can identify them as a large or small generator. Each state establishes their criteria for both division types for documentation, fees and applications. Most states agree on the definition of small generators as those generating between 50 and 220 pounds of medical waste per month. Generators that have medical waste transported off of their site must keep records that are available for audit at any time and should include: the medical waste program plan, an emergency treatment plan, a detailed list of each type of medical waste and the volume/amount, results of any spore or assay tests, the pickup date and time when removed from site, the disposal company name and contact information. Generators that have onsite medical waste disposal must keep records and documentation stating the type of waste, results of any spore/assay tests, the method of disposal, the date/time of disposal, and post disposal testing results.
Medical waste disposal companies are held to strict DOT (Department of Transportation) laws including full training for those driving and picking up waste, an emergency waste accident plan with all equipment necessary to handle the emergency, full documentation on the medical waste pickup including type, volume, generator name and contact information; final destination for treatment rendering the waste harmless including date/time; test results of any residue that is to be sent to a sterile landfill. All medical waste disposal companies must be licensed by the state(s) that they operate in, with vehicles sterilized based on state requirements. The transport companies are required to have records/documentation of all fees and up to date state licenses available upon request. They are also responsible for supplying the generator the documentation stating the medical waste has been treated and rendered harmless according to laws/guidelines.
Healthcare waste treatment disposal facilities are responsible for one or all of three different types of disposal: sterilization, disinfectant, decontamination/sanitization; or a combination.
Disposal facilities are required to comply with all state and federal laws, have current licenses, have trained staff, and have emergency contingency plans in case of exposure including all PPE equipment and emergency supplies. Disposal facilities undergo testing to ensure that the facility does not harbor any toxic or infectious medical waste. Documentation that is maintained includes total volume and type of medical waste transported, the generator, the date/time, confirmation of destruction, and copy of documents supplied to the generator. When final waste product is rendered harmless and is intended to be placed in a sterile landfill, facility is required to test prior.
Medical waste can be part of a few categories including some that are considered to be hazardous and others to be thought of as nonhazardous. Biohazard waste is any type of medical waste that contains or could contain infectious agents that can be transmitted to humans, animals, the community or the environment.
Prior to 1997, around 90% of medical waste that was potentially infectious was incinerated. However, in 1997, the EPA (Environmental Protection Agency) established regulations that created strict medical waste incinerator emission standards. This was due to high level concerns about the air quality that was resulting from the incineration of medical waste and its effects on humans and the environment.
Alternative treatment and disposal methods of medical waste was required and the initially and continue to include: steam sterilization (autoclaving), thermal treatment such as microwave, chemical mechanical systems, and electropyrolsis. The alternative treatments render medical waste harmless so that it can be taken to incinerators or landfills. Companies were established to accommodate the needs of containing, transporting, and final destruction of the medical waste. These companies must be licensed and regulated within the states that they operate, and various states have different regulations. Since 1997, new rules and guidelines have been set along with required generator staff training, storage containers and labeling for medical waste, and emergency contingency plans in case of an accident or spill.
The healthcare waste management industry is a continual work in progress, especially with considerations of COVID-19. As the industry faces new challenges there are changes that are being made on the local, state, and federal levels to help to ensure that people and the environment are safe from contagious diseases.
The market size in 2016 for global medical waste was valued at 21.0 billion, with an expected growth at a CAGR of 5.4%. The volume is on a continuous rise due to advanced surgical, diagnostic, and treatment solutions combined with an aging population that is experiencing disease states such as cancer and other chronic disorders. An additional contributor is the growing development and manufacturing of drugs and medical devices within the pharmaceutical industry as well as the generation of more waste in hospitals and medical facilities, creating byproducts. The market is expected to hit USD 25.5 billion in 2020. In 2019, North America was listed as the largest regional market for medical waste management.
Developments in technologies have contributed to more efficiency and safety. In 2017 a company created a commercial hazardous waste incinerator that was constructed in the United States. In 2019, another company created the Hazardous Drug Spill Control Kit, which is a USP <800> compliant spill kit designed for chemotherapy cleanup and that of other hazardous drugs/spills.
Medical waste disposal services industry market size in the United States has grown 2.6% per year as an average from 2015-2020. The industry encompasses $3.3 billion in 2020, with around 388 medical waste disposal businesses.
The market size of the Medical Waste Disposal Services industry in the US has grown 2.6% per year on average between 2015 and 2020, with a maximum anticipated at 5.1% in 2020.
Medical waste is a major challenge for hospitals and clinics. U.S. healthcare facilities create 6 million tons of it each day. That’s 33 pounds of waste for every filled bed in our medical system. But what’s the difference between regulated and non-regulated waste? Who can dispose of it, and how?
Who can transport medical waste? What regulations govern its destruction? How does RCRA fit in, and do pandemics like the COVID-19 coronavirus change best practices? Let’s look at the key points around biohazardous waste so you and your staff can become the best healthcare providers you can be.
Medical waste is healthcare trash that contains infectious or potentially infectious items. It can come from hospitals, medical clinics, veterinary offices, dental clinics, research facilities, or medical laboratories. It can contain blood or other bodily fluids, or it can appear benign, like gloves or gowns.
According to the Medical Waste Tracking Act of 1988, it’s defined as any waste created during treatment, testing, immunization, research, or diagnosis of human beings and animals. Examples include sharps like scalpels or needles, tissue, fluids, glassware, swabs, culture dishes, or bandages.
Medical waste goes by many names, such as hospital waste, biohazardous waste, biomedical waste, and infectious medical waste. There’s also healthcare waste, clinical waste, and regulated medical waste (RMW). Even hospital office paper is medical waste, though it’s not regulated.
You know hospitals and doctor’s offices create medical waste. But blood banks, dental clinics, and urgent care clinics create it too. Pharmacies, veterinary clinics, medical testing labs, research labs, nursing homes, hotels where patients stay, and funeral homes also create regulated waste.
Even an office building can generate biohazardous waste. Why? Because if someone gets a nosebleed at work and uses a tissue to stop it, they’ve created regulated waste. The Wyndham hotel in Boston, next door to Mass General Hospital, was fined twice for medical waste violations from hotel guests.
The WHO identifies the 8 categories of medical waste as infectious waste, sharps waste, pathological waste, chemical waste, pharmaceutical waste, cytotoxic waste, radioactive waste, and nonhazardous general waste. Those types cover all the potential varieties and sources of regulated and non-regulated healthcare waste.
The maze of medical waste regulations can be a tangle to sort out. Historically, biohazardous waste was regulated by the Federal Government and the EPA. In 2020, state laws control hospital waste handling and disposal instead, but several federal agencies maintain lists of rules and guidelines.
The U.S. Centers for Disease Control (CDC), the Occupational Safety and Health Administration (OSHA), the Drug Enforcement Administration (DEA), the Department of Transportation (DOT), the USPS, and the Food and Drug Administration (FDA) all regulate different parts of the medical waste picture.
For instance, DOT regulation 49 CFR 173.22 assigns all responsibility for the safe conduct of all regulated waste to the shipper. That means if a hospital or clinic ships waste to a disposal facility and there’s an accident en route, the hospital assumes all liability and damages.
To learn the regulations governing the collection, storage, transport, and disposal in your state, see the EPA’s medical waste disposal state laws map. Also, contact your state’s health and environmental services agency. Finally, visit the federal agency pages shown in the links above.
Hospitals and clinics generate medical waste during daily operation. Doctors, nurses, and other healthcare workers collect the waste, and put it into designated biohazard bins. These can be as small as the wall-box you see in your dentist’s office or as big as a 60-gallon color-coded trash can.
By law, the bins are lined with special biohazard bags and labeled clearly as biohazardous. Each type of waste—from animal carcasses to lab waste to sharps has its own packaging and storage rules. For instance, sharps must be placed in puncture-resistant, leakproof, rigid containers.
Large, deep-pocketed hospitals may dispose of medical waste on-site. However, cost-restrictions and increasingly strict regulations make on-site incineration problematic for most facilities. More commonly, offsite biohazardous waste treatment is the cost-effective solution in today’s healthcare world.
Most hospitals and clinics today use a truck or box service. The first uses designated trucks operated by contractors. But an increasingly common cure for the modern medical waste disposal problem is the mail or box service. These use the U.S. Postal Service to ship waste safely via licensed vendor.
In 2020, regulated waste is neutralized in dedicated treatment facilities. Depending on the type of waste, it may be incinerated, steam autoclaved, or both. Some infectious waste is decontaminated chemically. Irradiated waste is stored in lead boxes and disposed of in designated, specially controlled landfills. Other waste, like mercury or other heavy metals, are separated and recycled.
Only licensed medical waste transportation entities can transport healthcare waste. These include large, well-funded hospitals or independent biohazard waste shipping companies. Independent vendors may pick up the waste in trucks, or send approved mail-back containers to ship through the U.S. mail.
To become a vendor—either by truck or mail-back service—a medical waste transportation company must be licensed by their state. Each state has a separate registration process. For instance, Texas issues permits based on a system of forms, deadlines, reporting, contracts, regulations, and fees.
Different states also maintain their own rules for what types of waste can travel through the mail. The regulations are a bit of a tangle, and in the end relying on a trusted, licensed vendor who stays up on local regs is the best path. Packaging must be able to withstand weather, trauma, and heat.
Licensed hospitals and registered medical waste disposal firms are legally allowed to dispose of biohazardous waste. In the 1980s, one of the most common ways to destroy the waste was in an onsite Hospital, Medical, and Infectious Waste Incinerator (HMIWI), but that’s far from common in 2020.
As state, federal, and local regulations tighten, dedicated waste disposal firms neutralize most bio-waste in the U.S. Regulations are governed by state agencies and federal bodies. Regulated waste is often decontaminated by autoclaving, dry heat, or incineration, then disposed of normally.
Before it’s decontaminated, medical waste is stored onsite in color-coded bins. Black is for non-hazardous waste. Yellow or red is for biohazardous waste. Expired medicines go in blue bins and cytotoxic drugs are stored in purple bins. All containers must be clearly marked, documented, and tracked.
RCRA is the U.S. Resource Conservation and Recovery Act. Enacted in 1976, Section V-9 gave the EPA “cradle-to-grave” authority over all healthcare waste in the country. However, the Medical Waste Tracking Act of 1988 expired in 1991. When that happened, the states took over regulation of the waste.
The RCRA creates a lot of confusion for healthcare officials and staff. That’s because it still contains language about the regulation of hospital waste. The issue? The portion of the act that covers regulated waste is all in the past tense. None of it applies anymore to current healthcare facilities like clinics or hospitals.
All healthcare workers should know and observe the best practices for medical waste collection, storage, transportation, and disposal. Know the laws, classify and separate all waste, and use a clear color-coding system. Don’t overfill containers, and keep non-regulated waste separate to cut costs.
OSHA recommends fines for hospital waste violations ranging from $5,000 to over $70,000 per violation. State and federal bodies carry their own fines. The most common sources of medical waste fines stem from improper employee training, incorrect container management, and mishaps during transportation.
Poor containering, improper labeling, incorrect or incomplete documentation, and illegal storage are other main sources of fines and arrests. Some vehicles may need onboard refrigeration. Even a lost record or an inadequately disinfected truck can lead to hefty financial penalties.
What changes about medical waste disposal during a pandemic like the H1N1 Swine Flu? What about the COVID-19 coronavirus outbreak? Some healthcare workers are surprised to find out nothing changes. Biohazardous waste regulations and best practices are designed to handle a pandemic.
That said, there’s a lot more waste generated when patient traffic increases. However, employees should redouble gloving, gowning, and hand-washing habits. During a regular flu season, face masks and disposable tissues used by flu patients are classified as regular, routine, unregulated solid waste.
Medical waste is one of the biggest challenges faced by today’s healthcare system. We create 6 million tons of it per year. Though 85% of that waste is harmless, 15% is hazardous. Biohazardous waste can be disposed of through steam autoclaving or incineration. But waste that contains mercury or other contaminants must be dealt with according to strict state and federal laws. Increasingly, offsite dedicated medical waste companies transport, receive, and neutralize the bulk of our regulated healthcare waste.
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