IAHCSMM VIEWPOINT


Maintaining records on COVID-19- related policy/practice changes


by Natalie Lind, CRCST, CHL, FCS


Shortages of personal protective equipment (PPE) placed many facilities in a position of not being able to provide protective gear -- specifi cally 9 face masks -- to frontline workers. hat lack of required PPE made it necessary for many healthcare facilities to consider the possibility of reprocessing 9 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 PDs in a situation where they needed to reprocess SUDs to provide critical items to the hospital staff -- and they needed to fi nd a method to do it as safely as possible.


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FDA Emergency Use Authorizations In ebruary , the Department of ealth and uman ervices determined that circum- stances existed justifying the authorization of emergency use of personal respiratory protective devices (9 masks) during the COVID-19 outbreak. As a result, the ood and Drug Administration (DA) issued Emergency Use Authoriations (EUA) for 9 mask reprocessing. ote he DAs EUA page can be found at httpswww.fda. govmedical-devicesemergency-situations-medical-devices emergency-use-authorizations#coronavirus2019. he EUA page includes the processes that have been approved (through an EUA) for emergency reprocessing of 9 masks. It includes links to documents to help facilities better understand processes and requirements and determine processes that may be achievable for them. hese documents include • A fact sheet for healthcare personnel; • Instructions for healthcare facilities; and • Instructions for healthcare personnel.


Risk assessment essentials he planning for reprocessing UDs begins with a thorough risk assessment to determine if an alternative process is necessary and, if so, what that alternative process will be. hat risk assessment should involve P, Infection Prevention, Risk anagement and other identifi ed stakeholders.


36 June 2020 • HEALTHCARE PURCHASING NEWS • hpnonline.com


he COVID-19 pandemic has forced many Sterile Process- ing departments (SPDs) to change some of their policies and practices to adapt to their facilities’ changing needs.


Once the need for reprocessing is determined, EUAs, manu- facturers instructions for use (IU), safety guidelines and other pertinent information should be reviewed and well document- ed. A process should be determined based on available facts. It’s important to remember that “pandemic” does not mean pandemonium. asic rules still apply. he PD still needs to abide by standards and guidelines and follow standard operating procedures. or 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 specifi cations. he P manager should keep on file copies of the risk assessment and all other pertinent documenta- tion. his includes, for example, IU (if available), information on the new process from equip-


ment manufacturers, DA EUA information and any other related information. Staff competencies should also be kept on fi le.


Conclusion Although reprocessing 9 masks is a temporary situation, the decision to begin the process (along with sup- porting documentation, policies, proce- dures, 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. hese are hectic times and when a review of the PDs re- sponse 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. HPN


Note: This article is meant to serve as a brief overview of the process. Sterile Processing professionals should check with their Risk Man- agement department to determine which specifi c information and documentation they should be keeping on fi le.


Natalie Lind, CRCST, CHL, FCS, serves as IAHCSMM’s Educa- tion Director.


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