FDA reissues decontamination system authorizations

FDA reissues decontamination system authorizations 

The Food and Drug Administration (FDA) has reissued emergency use authorizations (EUAs) for some decontamination systems to decontaminate certain respirators. The EUAs were reissued in recognition that availability of personal protective equipment (PPE) is an integral part of routine patient care during the COVID-19 pandemic, and that PPE shortages can cause risk to health care personnel. The decontamination systems allow health care personnel to decontaminate and reuse certain single-use disposable PPE items. The FDA has provided a table that includes authorization information for each decontamination system, as well as fact sheets for health care personnel and instructions to use the systems. 

CMS updates hospital survey process guidance

The Centers for Medicare & Medicaid Services (CMS) released updated guidance putting in place certain limitations on the hospital survey process, including limiting on-site surveys to immediate jeopardy complaint allegations. The limitations will remain in effect for 30 days with the potential for renewal of the guidance in additional 30-day increments, CMS says. The American Hospital Association has asked CMS to eliminate surveys, or at least severely limit them, while hospitals are dealing with significant surges in patients who are severely ill with COVID-19.

The Joint Commission issues pandemic sentinel alert 

The Joint Commission has issued “Sentinel Event Alert 62: Health care workers in the midst of crisis” to address the traumatic experiences shared by health care workers during the COVID-19 pandemic. This first in a series of special edition Sentinel Event Alerts addresses concerns received from health care workers and provides learnings and examples that may be helpful as health care organizations continue to respond to the current pandemic and prepare for future challenges that will require safe, healthy and engaged health care workers. The alert shares the top three concerns shared by health care workers: fear of the unknown, fear of getting sick and fear of bringing the virus home. It also discusses five ways to help health care workers navigate the pandemic. 

FDA steps up scrutiny of sanitizers from Mexico

As part of the Food and Drug Administration’s (FDA’s) continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. until the agency is able to review the products’ safety. The FDA’s analyses of alcohol-based hand sanitizers imported from Mexico found 84% of the samples analyzed by the agency from April through December 2020 were not in compliance with the FDA’s regulations. More than half of the samples were found to contain toxic ingredients, including methanol and/or 1-propanol, at dangerous levels.