FDA: No More KN-95 Respirators (and No Advanced Notice or Transition Period)
Is your dental office using KN-95 respirators? If yes, read on!
As if keeping up with the barrage of changes in guidelines hasn’t been challenging enough throughout the COVID-19 pandemic the FDA is here to ‘help’ one more time (and you have no time to prepare unless you heeded my warning from this past Spring when I predicted this situation).
The FDA announced the revocation of the agency’s Emergency Use Authorization (EUA) for KN-95 respirators effective July 6th, 2021.
In other words you can no longer get by using KN-95s, which may not be a problem for those of you who may use either N-95s respirators or surgical masks, in accordance with CDC Guidelines.
Wait, it gets better…
The FDA also ‘recommends’ that health care personnel and facilities:
- Limit decontamination of disposable respirators (think N-95)
- Transition away from crisis capacity strategy for respirators, such as decontamination of N-95 and other Face Filtering Respirators (FFR)
- Increase inventory of N-95s and other FFRs, elastomeric respirators and powered air-purifying respirators (PAPRs).
Hey FDA, how about a transition period?
Click here to read the FDA’s full announcement and recommendations.
If you need help navigating these rules, give me a call! Or you can click HERE to schedule a complimentary compliance consultation.
About the Author
A former Law Enforcement Officer/ Dental Board investigator, Duane Tinker is the CEO of Dental Compliance Specialists. Mr. Tinker provides compliance consulting, auditing and training services for dentists and Dental Service Organizations on compliance risks including OSHA, HIPAA, Dental Board rules/ regulations, state radiology rules, DEA and state drug regulations, and Medicaid. Mr. Tinker is a frequent speaker for dental societies and study clubs. He also hosts a podcast called Talking with the Toothcop. Mr. Tinker can be reached by calling (817) 755-0035 or through his company’s website DentalCompliance.com.