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PERSONAL P ROT ECT ION EQUI PMENT


Contingency reprocessing of single-use PPE


The NHS has faced a shortage of personal protective equipment, prompting requests for advice on contingency reprocessing measures, to ensure availability of single-use PPE items during the COVID-19 healthcare crisis. Other EU countries have responded to the crisis by introducing contingency measures. This white paper, by Belimed, offers an insight into these approaches, while emphasising that reprocessing of single-use equipment should only be undertaken as a last resort.


Belimed does not recommend the reprocessing of medical equipment classified as a single- use product by its manufacturer, except in measures of last resort and with approval from the respective healthcare authority, such as the described emergency regulations during the COVID-19 pandemic, where the availability of critical supplies cannot be ensured otherwise. However, it is understood that in a crisis situation, such as the current COVID-19 pandemic, a reprocessed single-use product – while being associated with a higher risk or uncertainty than a new product – may still have a higher clinical utility (e.g. to significantly reduce infection risk of healthcare workers) compared to a situation of not having this product at all. Certain PPE equipment (e.g. FFP2 / N95 masks) have become scarce due to the globally increased demand associated with the pandemic. At the same time, healthcare providers (as employers) are generally mandated by law to offer sufficient protection to their employees – including gloves, gowns, face shields, FFP2 / N95 respirator masks etc, when they are working directly with COVID-19 patients. In this difficult situation, healthcare providers are asking reprocessing equipment manufacturers and suppliers of PPE for help. Equipment manufacturers cannot offer fully validated reprocessing methods for lack of time, resources and because single-use products, such as masks, were never designed for reprocessing. While it seems logical that a reprocessed PPE with small or virtually no change in perceivable properties, is better than having no PPE equipment at all, it is still difficult for hospitals and manufacturers to take


OCTOBER 2020


Healthcare workers across Europe are facing a shortage of PPE


responsibility to re-process items that were designed for single-use.


As neither PPE suppliers nor manufacturers of sterilisation equipment can easily recommend reprocessing solutions without exposing themselves to possible liability risks, this can lead to a stalemate situation. Promising and plausible approaches may exist today, but no one dares to implement them, out of fear of the possible legal consequences of using a practice that is not fully validated and approved by manufacturers and health authorities.


Hospitals have therefore asked for support from health authorities to offer solutions / give guidance how to act in this extreme situation:


l Finding ways to source additional single- use items


l Finding smart and safe ways to rationalise the use of existing supplies (e.g. extended use)


l Emergency regulations defining how the single-use items can be reprocessed.


This document describes six contingency measures implemented with approval of healthcare authorities in Austria, Germany, the Netherlands and France, namely: l Respiratory FFP2 / N95 Mask reprocessing (Austria, Germany and the Netherlands)


l Dry Heat Disinfection of FFP2 respiratory masks (Germany)


l Steam Sterilisation of Single Use OR gowns (France)


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