Becker's Clinical Quality & Infection Control

10 INFECTION CONTROL FDA warns Battelle about mask sterilization system By Maia Anderson T he FDA sent a warning letter to Battelle Memorial Institute, a company that makes a system to decontaminate face masks, saying it doesn't have adequate proce- dures for identifying adverse events. e National Nurses Union alleged the tech- nology is "not safe and may not work," STAT reported. Dozens of nurses have had negative reactions to decontaminated masks, including sore throats, headaches and nausea, Judith Pare, PhD, director of the nursing and occupational health and safety for the Massachusetts Nurses Association, told e Boston Globe in May. Masks decontaminated by Battelle have also been returned to healthcare workers with worn- out seals and respirator stains from previous users, Rick Lucas, BSN, RN, a union leader at Ohio State University Wexner Medical Center in Columbus, said in June. e FDA's warning letter doesn't mention any cases of potential patient harm from masks de- contaminated using its technology, but the letter says the company has lax internal procedures for identifying adverse events, something it warned about when granting the system an emergency use authorization in March. e company's in- ternal procedures don't include instructions on how to conduct an investigation into a potential adverse event, the FDA said. Battelle's system can sterilize up to 10,000 masks per cycle, with each cycle taking about 150 min- utes. Each mask can go through a maximum of 20 cycles. e FDA granted authorization for the system as a way to offset personal protective equip- ment shortages that have plagued hospitals across the country during the COVID-19 pandemic. e Oct. 7 warning letter doesn't carry a fine or sanction against Battelle, but if the company doesn't remedy the issue, the FDA can take more stringent measures, STAT reported. "We appreciate the clarity that the FDA's letter has provided, and we will be submitting our response in the coming days to continue to meet their requirements. It is of great importance to us to remain in compliance with the FDA's emergency use authorization, a Battelle spokes- person told STAT in October. n Dry winter air will fuel COVID-19's spread, health experts say By Erica Carbajal S tudies show that dry air encourages the spread of COVID-19, and health experts are sounding the alarm as temperatures start to cool, STAT reported. As temperatures drop, so does the humidity, leading to both drier air and respiratory tracts. Dry airways can hinder mucus' ability to remove debris and virus invaders, causing COVID-19 to spread more easily, experts said. These are the same reasons people are also more prone to colds and flu in the fall and winter. Infections increase when the relative humidity drops from the typical range of 40 percent and 60 percent in warmer temperatures to 20 percent in cooler temperatures, according to research on past virus outbreaks cited by STAT. The colder weather will also lead to more indoor gatherings, where social distancing is less effective, health experts said. Some scientists are now calling for the World Health Organization to provide public places like schools and nursing homes with guidelines to maintain relative humidity at 40 percent to 60 percent, which is "the optimal humidity for health and respiratory infection prevention," Akiko Iwasaki, PhD, an immunologist at New Haven, Conn.-based Yale School of Medicine, told STAT. Dr. Iwasaki is among those calling for health officials to add humidity guidelines to indoor-air standards via an online petition. n This simple change could cut surgical infection risk in half By Mackenzie Bean S witching the type of antiseptic used during a procedure may signifi- cantly reduce surgical infection risk, according to a study published in Annals of Surgery. Researchers from the University of Leeds in England and the University of Bern in Switzerland reviewed 17 existing studies to assess the efficacy of five antiseptics used in 14,593 surgeries. The original studies were con- ducted in North America, Europe, Asia, South America, and Australia and neighboring islands, and included a broad range of surgeries on adults. Researchers found alcoholic chlorhexidine gluconate cut the risk of surgi- cal infection in half for "clean" surgeries compared to the more commonly used antiseptic, povidone-iodine. Clean surgeries are defined as those outside the respiratory, urogenital and digestive system in which there are no signs of inflammation or infection and sterile technique is main- tained the whole time. "Even though the risk of infection in these types of surgery is low (about 3 percent), anything we can change to reduce this risk is very important," lead author Dr. Ryckie Wade, a clinical research fellow at Leeds' School of Medicine, said in a news release. "Our findings suggest that the number of infections may be halved if surgeons used a different skin cleaning agent before surgery." n

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