ACG Presidential Blog
by Dr. Mark B. Pochapin
Current Information on Appropriate PPE, including N95 Masks and Other N95 Equivalent Respirators
Dear Colleagues:
ACG is committed to helping GI practices successfully re-open as soon as possible. We understand that among the challenges GI practices will face in this process are shortages of personal protective equipment (PPE) for members and staff. We want to provide you with the current information on appropriate PPE, including N95 masks and other N95 equivalent respirators.
GI Joint Society Statement on PPE
On April 1, ACG and the GI societies released a joint-society position statement on the use of PPE in endoscopy. Among the recommendations:
“All members of the endoscopy team should wear N95 respirators (or devices with equivalent or higher filtration rates) for all GI procedures performed on patients with known SARS-CoV-2 infection and those with high risk of exposure. Given the high rate of infection transmission from pre-symptomatic individuals, all patients undergoing GI endoscopy in an area of community spread need to be considered ‘high risk.’”
Since COVID-19 is a fluid situation, these recommendations are also fluid. ACG will continue to review these guidelines in light of CMS and state governments starting to modify policies on elective procedures.
Shortages of N95 Masks & Impact on GI Practices
ACG does not take lightly the recommendations’ potential impact on GI practices and recognizes that many GI practices preparing to re-open endoscopy centers may have difficulty finding adequate supplies of N95 masks. As mentioned in the joint-society statement, “where recommendations are based on circumstantial evidence and expert opinion, the principle of putting the health and safety of GI providers first is being applied.”
The Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) have subsequently released guidance, listed below, on allowable PPE and masks as this shortage continues, including information on the manufacturer and models. This guidance may help GI practices find adequate PPE suppliers in order to help ensure the safety of staff.
For any mask, N95 or alternative, the mask must be fit-tested to ensure adequate fit and protection. Fit-testing is done by every hospital caring for COVID-19 patients.
For more information regarding FIT-testing, click here.
FDA: Emergency Use Authorizations
During public health emergencies, the FDA can declare “Emergency Use Authorizations” (EUAs), to help make medical products available as quickly as possible. This allows medical products to reach patients/providers in need when there are no approved and/or alternatives available. Recent FDA EUAs include:
FDA Issues Emergency Use Authorization for Sterilizing N95s
FDA issued an EUA to decontaminate compatible N95 or N95-equivalent respirators for re-use by health care workers in hospital settings. The FDA issued the EUA to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide.
FDA also issued an EUA to Advanced Sterilization Products (ASP) for the STERRAD Sterilization Cycles that has the potential to decontaminate approximately 4 million N95 or N95-equivalent respirators per day in the U.S. for single-user re-use by health care workers in hospital settings.
What other PPE and masks are allowed by the FDA under EUAs?
Below is a list and descriptions of PPE that have been authorized for emergency use. This includes N95 masks as well as others, such as the KN95, FFP2, and PAPR models. Masks are listed under “respirators.” You can also search on the type of mask (“KN95” or “FFP2” to find the manufacturers.)
https://www.fda.gov/media/136702/download
Other FDA Guidance on Authorized, Non-NIOSH Approved PPE
Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
The CDC List of Approved PPE and Manufacturers
This web page provides a table of approved N95 respirators, listed alphabetically by manufacturer. You can select a particular manufacturer by clicking on the first letter of their name on the index below.
https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/N95list1-a.html
The College understands that there is a significant shortage of all PPE at this time, even these alternative options. The College hopes having the list of allowable models and the manufacturers will help GI practices be more informed when working with vendors and as ACG continues to review this position statement and make appropriate changes that balance the safety needs of the provider team and patients.
Regards,
Mark B. Pochapin, MD, FACG
President, ACG
Director, Division of Gastroenterology and Hepatology
NYU Langone Health