FDA Reversal on COVID-19 Mask Decontamination Follows MNA Opposition, Demonstrates Urgent Need for Implementation of Frontline Nurse and Healthcare Professional Guidance

June 8, 2020

FDA reversed its position on the use of N95 masks that have been decontaminated on Sunday, June 7, aligning with the Massachusetts Nurses Association’s longstanding opposition to these unproven and potentially dangerous practices.

The FDA wrote in a public statement on Sunday: “In response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the agency is reissuing certain emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination. Based on the FDA’s increased understanding of the performance and design of these respirators, the FDA has decided that certain respirators should not be decontaminated for reuse by health care personnel.”

RN and MNA President Donna Kelly-Williams said in response to the FDA reversal: “Government officials and healthcare executives wasted time and resources and put frontline workers at risk chasing the unproven and dangerous dream of mask decontamination. Nurses and healthcare professionals caring for patients during this pandemic knew all along that these processes lacked rigorous evidence, could damage N95 masks and may create lasting health problems.

“The MNA spoke out strongly against decontamination early on, instead urging government and healthcare leaders to make sure every frontline healthcare worker had a new N95 mask to protect them against exposure and limit the spread of COVID-19,” Kelly-Williams said. “The FDA’s reversal on decontamination is a glaring example of why nurses and healthcare professionals on the frontlines must be heard.

“Prioritizing the opinions of healthcare executives and hospital lobbying groups over the guidance of those fighting in the trenches of this pandemic has placed nurses and patients in jeopardy,” Kelly-Williams said. “As healthcare facilities re-open additional services, it is absolutely essential – for the safety of caregivers, patients and the public – that the recommendations of those on the frontlines are heard and implemented.”

The MNA has taken a leadership position in opposing the use of these products due to the risks to the health and safety of nurses and other healthcare workers who are caring for patients. In a position statement released to the public on April 29, the MNA called for the halt of decontamination of masks, and that nurses and healthcare professionals have the right to consent or refuse to use decontaminated masks.

“The lack of reliable information on these practices, as well as the potential safety risks of these decontamination procedures, pose risks to the health and safety of health care workers, as well as the general public at large require that these practices be halted,” reads the MNA position statement.

The reversal of the FDAs position has resulted in the agency’s reissuing of the Emergency Use Authorizations (EUAs) for the following products:

“…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. As such, health care personnel should not reuse a respirator that is incompatible with an authorized decontamination system but has nonetheless been decontaminated. 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.”

These changes prohibit the decontamination of N95 respirators that were manufactured in China, which accounts for the majority of available products utilized across the globe. The MNA is calling on healthcare organizations to act immediately to procure an adequate supply of new personal protective products (PPE) that meet the standard that had been in place pre-pandemic.

The MNA also calls on the state to follow the FDA’s lead and prohibit all hospital systems for utilizing decontaminated masks, and for the federal government to fully activate the Defense Production Act to mobilize immediate production of safe and appropriate N95 masks to allow for the safe reopening of health care services, as well as to prepare for a potential second wave of COVID-19 exposure in the fall. If proactive steps are not taken to secure these products now, the risks to public health and worker safety may be irreparable.

More information and additional MNA COVID-19 recommendations can be found here.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The KnowU incorporates the sensor that the Company plans to submit to the FDA for clearance. This proprietary sensor has been tested and proven stable and accurate in the lab setting. It was included in the Company’s prototype to validate stability outside of the lab, and is now miniaturized and wearable.
The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.
"Taewoong Medical becoming an Olympus group company is also a major milestone in our global growth strategy," said Henry Shin, CEO of STARmed. "We look forward to our products being made available to more patients through Olympus' global distribution network."

By using this website you agree to accept Medical Device News Magazine Privacy Policy