Ebola: Conflicting Guidance and Regulations
What is Ebola?
The World Health Organization (WHO) and others classify Ebola (and items contaminated with the Ebola virus) as a Category A highly infectious disease, classified similarly to:
- Variola virus (Small Pox)
- Lassa virus
- Hantaviruses causing hemorrhagic fever with renal syndrome
- Monkeypox virus
- Other hemorrhagic fever viruses
All of the above are of major public health concern because of the severity of disease, lack of a vaccine or cure, and potential for epidemic spread. WHO and other agencies and organizations recommend heightened levels of precautions for such diseases.
What are the International Best Practices for Infection Control for Ebola?
The Centers for Disease Control and Prevention (CDC), the WHO, and other health policy experts have recognized the practice of inactivating pathogens found in highly infectious waste immediately, onsite, and as close to the point of generation as technologically possible as a best practice.
Are International Best Practices Being Followed?
Unfortunately, the U.S. Healthcare system has not yet constructed clear guidelines for infection protection, particularly in dealing with a Category A highly infectious substances. This has resulted an inter-agency struggle to offer proper and safe guidance to healthcare workers and the Healthcare Industry.
Initially, CDC’s recommendations (guidelines) for infection protection included:
- Avoiding contact with blood and bodily fluids of an infected person and not handling any items that may have come in contact with an infected person’s blood or body fluids
- Placing infected materials in Regulated Medical Waste (RMW) stream, which is below the WHO/United Nations standards that the U.S. Department of Transportation’s (DOT) regulations are based on
- For labs that deal with Ebola (BSL class 4), sterilize Ebola (and other such) pathogens on-site, which they state is a best practice
Among CDC’s conflicting recommendations about medical waste, they advised in their Ebola FAQ:
“Disposable materials (e.g., any single-use PPE, cleaning cloths, wipes, single-use microfiber cloths, linens, food service) and linens, privacy curtains, and other textiles in an Ebola patient’s room “should be placed in leak-proof containment and discarded as regulated medical waste. To minimize contamination of the exterior of the waste bag, place this bag in a rigid waste receptacle designed for this use. Incineration as a waste treatment process is effective in eliminating viral infectivity and provides waste minimization. However, check with your state's regulated medical waste program for more guidance and coordinate your waste management.”
What is the Difference between CDC Regulations and DOT Regulations?
Unfortunately, a difference now exists between the CDC regulations and the DOT regulations for Category A infectious substances. As a result, it is nearly impossible for such waste, in volumes produced by an infected patient(s), to be shipped. Most haulers do not ship untreated Category A infected waste, yet most medical centers are not prepared to sterilize such materials on-site.
What is a Category A Substance?
A Category A, Division 6.2, UN No 2814 Substance is defined as an infectious substance in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. Handling and packaging requirements for Category A waste far exceed precautions for RMW due to the heightened risk of transmission and fatality if exposure occurs. Category A infectious substances cannot be classified, packaged or accepted as RMW.
Has this Confusion Created Incidents of Ebola Risk?
Yes. While Emory University Hospital in Atlanta treated two Ebola-infected patients in August, the hospital’s waste management contractor refused to pick up the medical waste for several days. It has been reported that the Emory staff “went to home Depot and bought up every large trash can and sealed canister that we could get,” until they could bring in sterilizers to treat the waste so a contractor would take it.
Most waste haulers will not accept Ebola exposed substances as they are no longer regulated medical waste, but Category A highly infectious substances (hazardous materials), which require specific packaging and licensed and trained Haz Mat haulers for removal. For example, Stericycle, a medical waste hauler, maintains a policy of not accepting regulated medical waste that is untreated Category A highly infectious waste.
When a hospital recently announced that it had a suspected Ebola patient, it was appropriately notified by their contracted waste hauler that they were not allowed to transport the Ebola medical waste - nor was it their policy to do so. Thus, the hospital had to restart an on-site inactive medical waste sterilizer.
Why do CDC Regulations Leave Americans with Increased Concern?
- CDC guidance is weaker than DOT regulations and WHO/UN standards (DOT follows the higher international standard)
- CDC clearly contradicts itself regarding on-site sterilization of the same pathogen in a lab versus a hospital
- There are affordable, existing technologies for hospitals to properly treat substances infected with Ebola, and the other highly infectious pathogens that occur yearly, so that such infected substances don’t leave the hospital to be trucked many miles through local communities to be sterilized
Ebola: Conflicting Guidance and Regulations
The contradictions between international agencies and the U.S. Federal government over infection control recommendations for Ebola (and other exotic, emerging contagious diseases for which no cure or vaccine exist) and regulations for the handling and transportation of Ebola waste can pose a danger to healthcare workers and the public.
The outbreak in West Africa and the Arrival of Ebola in the United States have propagated an urgent effort to bring U.S. healthcare infrastructure up to acceptable standards to treat patients who are infected with Category A disease, i.e. Ebola. While progress is being made, consequences due to lack of preparedness and training are also occurring. Two nurses at Texas Health Presbyterian Hospital in Dallas, Texas who treated Thomas Duncan, the first American case of Ebola (who has since died) have tested positive for Ebola, with hundreds of others being closely monitored.
In Germany, 56 year old Abdel Fadeel Mohammed Basheer, became the first person to die of Ebola. Mr. Basheer had been working as a laboratory technician with the United Nations in Liberia. It was reported that Mr. Basheer had been in charge of the disposal of waste from Ebola patients prior to falling ill; a dangerous position due to the opportunity for exposure to highly infectious substances. Unfortunately, such exposure has claimed the lives of healthcare workers in the past. One notable case involved three workers in Washington State that contracted Mycobacterium tuberculosis through the improper handling of medical waste at a commercial waste processing facility. The investigation and study, which were published in the Journal of the American Medical Association’s October 2000 issue, found that one of the three individuals undoubtedly contracted the TB from waste handling; making him the first proven incidence of pathogenic infection due wholly to occupational exposure.
Contrarily, Biocontainment Units such as the facilities at Emory University in Atlanta, and Nebraska Medical Center are successfully treating patients in facilities that include total infection control and specialized staff. Thus far, no exposure or risk to staff has been documented from either facility. Both facilities have attributed their success at worker safety to rigorous and continuous drills and training for an occurrence of admitting a patient with a highly infectious disease, requiring isolation.
Updates to Regulations Pertaining to Ebola
The CDC has clarified that Ebola waste is Category A infectious material and should not be treated as regulated medical waste (RMW).
To address the issue of waste being generated at Texas Health Presbyterian hospital from now deceased Ebola patient Thomas Duncan, the Department of Transportation (DOT) issued a waste hauler a special permit to haul untreated Category A waste to a destination which could dispose of it.
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