FDA addresses methanol hand sanitizer risks, revises EUA for respirator decontamination
By Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS
On August 14, 2020, the Joint Commission (TJC) removed its position statement, Preventing Nosocomial COVID-19 Infections as Organizations Resume Regular Care Delivery. As the accreditation agency noted, the guidance document was originally written in May when COVID-19 cases in the U.S. were declining, health care organizations were rapidly working to resume elective procedures and ambulatory care, and TJC was receiving many questions regarding reopening.
“We are now in a very different situation,” the agency noted in a prepared statement. “Health care organizations are trying to balance providing safe, routine care while combatting the continuing epidemic amidst persistent shortages of personal protective equipment (PPE).” The agency also acknowledged it heard from some professional societies and health care organizations that section of the TJC position statement were “problematic” due to changes in the pandemic and the agency’s understanding of the science surrounding COVID-19 transmission. Additionally, TJC stated that the Centers for Disease Control and Prevention updated its guidance to address some of the issues outlined in TJC’s position statement, including definitions of contingency strategies and crisis standards of care for PPE conservation and when they should be applied – which led TJC to deem its own position statement “no longer useful.” To read the full statement, visit: https://www.jointcommission.org/-/media/tjc/documents/covid19/removal-of-position-statement.pdf.
FDA list grows for dangerous methanol-containing hand sanitizers
Hand hygiene is a part of a sterile processing technician’s daily responsibilities. When the COVID-19 pandemic began, routinely used hand hygiene products were, at times, in short supply and replaced with other hand hygiene products. In July, the U.S. Food and Drug Administration (FDA) issued a warning to consumers and health care professionals about hand sanitizer products containing methanol, or wood alcohol; this substance, which is often used to create fuel and antifreeze, is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin (and life-threatening when ingested).
The FDA has seen an increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol), but that have tested positive for methanol contamination. Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma and/or permanent damage to the nervous system, or death. Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate medical treatment for potential reversal of toxic effects of methanol poisoning.
The FDA recommends that if using these products to immediately stop using them and dispose of the bottle in a hazardous waste container, if available, or dispose of as recommended by local waste management and recycling centers. These products should not be flushed or poured down the drain or mixed with other liquids. The FDA has and will continue to quality test hand sanitizers, including testing products entering the country through the U.S. border. The agency maintains a list of FDA-tested and -recalled hand sanitizers on its website, which is being continually updated as dangerous products are discovered. To access the information, visit: www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitzers-methanol.
Changes to types of respirators that can be decontaminated for reuse
Shortly after the COVID-19 pandemic began, the FDA issued emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination. During continued reviews and research, the FDA has ascertained from the Centers for Disease Control and Prevention’s (CDC’s) National Institute for Occupational Safety and Health (NIOSH) testing that authorized respirators manufactured in China may vary in their design and performance. Based on that information, the FDA has concluded that the available information does not support the decontamination of these respirators and, for that reason, the agency has revised the relevant EUAs. In addition, the FDA is also revising relevant EUAs to no longer authorize decontamination or reuse of respirators that have exhalation valves.
In an effort to ensure health care personnel are adequately protected, the FDA has announced it has revised and reissued a number of EUAs to amend which respirators are authorized to be decontaminated. According to the CDC’s recommendations, decontaminated respirators should only be used when new FDA-cleared N95 respirators, NIOSH-approved N95 respirators or other FDA authorized respirators are not available. The decontamination systems are only authorized to decontaminate non-cellulose compatible N95 respirators. Health care facilities should not reuse a respirator that is incompatible with an authorized decontamination system. It is important to note that users of any respirator (whether or not decontaminated) should always assess for proper fit after placement. Respirators with poor fit, visible soiling or damage should not be used.
Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS, serves as a clinical educator for the International Association of Healthcare Central Service Materiel Management (IAHCSMM) and has served as the IAHCSMM representative to the Association for the Advancement of Medical Instrumentation since 1997.