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Keeping records on policy/practice changes during COVID-19

By: Natalie Lind, IAHCSMM Education Director

April 29, 2020


The COVID-19 pandemic has forced many Sterile Processing (SP) departments to change policies and practices to adapt to their facility’s changing needs. Shortages of Personal Protective Equipment (PPE) placed many facilities in a position of not being able to provide protective gear, specifically N95 masks, to frontline workers. That lack of required PPE made it necessary for many facilities to consider the possibility of reprocessing N95 face masks. Reprocessing a single use device (SUD) is contrary to all that SP personnel have been taught regarding the reuse of SUDs, but the pandemic created an emergency where there was no choice. It placed SP departments in a situation where they needed to reprocess SUDs to provide critical items to the hospital staff and they needed to find a method to do so safely.

FDA Emergency Use Authorizations

In February 2020, the Department of Health and Human Services (HHS) determined that circumstances existed justifying the authorization of emergency use of personal respiratory protective devices (N95 masks) during the COVID-19 outbreak. As a result, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUA) for N95 mask reprocessing. The FDA’s EUA page can be found at: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019

This page includes the processes that have been approved (through an EUA) for emergency reprocessing of N95 masks. It includes links to documents to help facilities understand processes and requirements by providing additional documents including:

  • A fact sheet for healthcare personnel
  • Instructions for healthcare facilities
  • Instructions for healthcare personnel

Those documents can help a facility determine processes that may be achievable for them.

Risk Assessment

The planning for reprocessing SUDs begins with a risk assessment to determine if an alternative process is necessary and if so, what that process will be. That Risk Assessment should involve SP, Infection Prevention, Risk Management and other identified stakeholders.

Once the need for reprocessing is determined, EUAs, manufacturers’ instructions for use (IFU), safety guidelines and other pertinent information should be reviewed, well documented and a process determined based on available facts.

Sterile Processing Requirements

Pandemic does not mean pandemonium. Basic rules still apply. The SP department still needs to abide by standards and guidelines and follow standard operating procedures. For example, implementation of a new process requires written policies, procedures and dedicated, documented training. Employees should be trained in the new process and basic competencies completed to help ensure that the reprocessing is performed according to specifications.

The SP manager should keep copies of the risk assessment and all pertinent documentation. For example, IFU if available, information on the new process from equipment manufacturers, FDA EUA information and any other related information. Staff competencies should also be kept on file.

Although reprocessing N95 masks is a temporary situation, the decision to begin the process, supporting documentation, policies, procedures, training and the performance of the process itself must be recorded. Every department should be able to show how they made their decision, what plan was implemented, how staff was trained and what other quality measurements were made. These are hectic times and when a review of the SP department’s response to the pandemic or a future survey asks what was done and why, proper documentation is critical.

Note to readers:

This is meant to be a brief overview of the process. Please check with your Risk Management department to determine what specific information and documentation you should be keeping.