Maintaining records on COVID-19-related policy/practice changes
The COVID-19 pandemic has forced many Sterile Processing departments (SPDs) to change some of their policies and practices to adapt to their facilities’ changing needs. Shortages of personal protective equipment (PPE) placed many facilities in a position of not being able to provide protective gear - specifically N95 face masks -- to frontline workers. That lack of required PPE made it necessary for many healthcare facilities to consider the possibility of reprocessing N95 masks.
Reprocessing a single-use device (SUD) is contrary to all that SP professionals have been taught regarding the reuse of SUDs; however, the pandemic created an emergency where there was no choice. It placed many SPDs 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 it as safely as possible.
FDA Emergency Use Authorizations
In February 2020, the Department of Health and Human Services 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. Note: The FDA’s EUA page can be found at: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019.
The EUA 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 better understand processes and requirements and determine processes that may be achievable for them. These documents include:
- A fact sheet for healthcare personnel;
- Instructions for healthcare facilities; and
- Instructions for healthcare personnel.
Risk assessment essentials
The planning for reprocessing SUDs begins with a thorough risk assessment to determine if an alternative process is necessary and, if so, what that alternative 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 and well documented. A process should be determined based on available facts.
It’s important to remember that “pandemic” does not mean “pandemonium.” Basic rules still apply. The SPD still needs to abide by standards and guidelines and follow standard operating procedures. For example, implementation of a new process requires written policies and procedures, and dedicated, documented training. Employees should be well trained on the new process and basic competencies should be completed to help ensure that the reprocessing is being performed according to specifications.
The SP manager should keep on file copies of the risk assessment and all other pertinent documentation. This includes, 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.
Conclusion
Although reprocessing N95 masks is a temporary situation, the decision to begin the process (along with 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, which plan was implemented, how staff was trained, and which other quality measures were made.
These are hectic times and when a review of the SPD’s response to the pandemic is conducted or a future surveyor asks what was done and why over the course of that time period, proper documentation will be critical.
Note: This article is meant to serve as a brief overview of the process. Sterile Processing professionals should check with their Risk Management department to determine which specific information and documentation they should be keeping on file.
