FDA says to decrease reuse of devices, CMS removes some blanket waivers

by A.J. Plunkett (aplunkett@decisionhealth.com)

Be aware that as COVID-19 cases are declining and vaccination rates are climbing, the emergency waivers and measures approved by the federal government to get through the public health emergency (PHE) will be changing.

The FDA sent a notice to hospitals and others today (April 9) encouraging healthcare organizations to start moving away from the emergency measures taken to preserve and reuse medical devices and other supplies early in the PHE.

“The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse,” according to the online alert.

“Based on the increased domestic supply of new respirators approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) currently available to facilitate this transition, the FDA and CDC believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems.”

Similarly, CMS on April 8 told its state survey agencies that it was ending some blanket waivers for long-term care facilities regarding notification of room changes and discharges because “nursing homes have developed policies or other practices that we believe mitigates the need for certain waivers.”

Blanket waivers for hospitals and other facilities are only in effect until Health and Human Services (HHS) declares the PHE has ended. The current PHE is good through April 21, but HHS has promised it will give at least 60 days’ notice before the legal end of the emergency.

While the PHE continues for now, things will be changing.

By now you should know that unannounced, onsite surveys are resuming after several months and weeks of only virtual or delayed visits by CMS and accreditation organizations. And you should know that surveyors don’t have to show they’re vaccinated when they do show up (although, as always, follow your hospital policy on screening.)

FDA recommendations

Regarding devices and supplies, the FDA announced included these recommendations for healthcare personnel and facilities:

  • Limit decontamination of disposable respirators. Decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new filtering facepiece respirators (FFR) or if you are unable to obtain any new respirators.
  • Transition away from a crisis capacity strategy for respirators, such as decontamination of N95 and other FFRs.
  • Increase inventory of available NIOSH-approved respirators—including N95s and other FFRs, elastomeric respirators, including new elastomeric respirators without an exhalation valve that can be used in the operating room, and powered air-purifying respirators (PAPR). Even if you are unable to obtain the respirator model that you would prefer, the FDA recommends that you obtain and use a new respirator before decontaminating or bioburden reducing a preferred disposable respirator.

CMS issues nursing home memo

In CMS Quality, Safety and Oversight group memo QSO-21-17-NH, “Updates to Long-Term Care (LTC) Emergency Regulatory Waivers issued in response to COVID-19,” CMS said it is announcing it is ending:

  • The emergency blanket waivers related to notification of Resident Room or Roommate changes, and Transfer and Discharge notification requirements

The emergency blanket waiver for certain care planning requirements for residents transferred or discharged for cohorting purposes.

The emergency blanket waiver of the timeframe requirements for completing and transmitting resident assessment information (Minimum Data Set (MDS).

  • CMS is providing clarification and recommendations for Nurse Aide Training and Competency Evaluation Programs (NATCEP)

Find the four-page CMS memo here.

Found in Categories: 
COVID-19, Emergency Management, PPE