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The regulatory path for medical PPE

November 3rd, 2020 / By: / Expo News

An afternoon session by Jing Liang, founder and president of Medical PPE Consulting LLC, walked participants through the regulatory process and testing for medical personnel protective equipment (PPE) In her session, “Understanding Testing Requirements of Medical PPE,” she noted the variety of PPE, which include gloves, shoe covers, goggles, gowns and masks. Her discussion centered on surgical gowns and surgical masks, as examples. 

In essence, each device or product is put into a certain class, which indicates how it can be used, and each class has a set of requirements and recommended testing regimens. There are detailed regulations and guidelines for each product or device on a certain regulatory path, which must be followed. She also reminded participants that medical PPE are considered to be “medical devices,” which underscores the importance of understanding and following the regulatory and testing protocols. 

“Before testing, have a plan in place – the big picture – of what testing is needed,” she said. This will include verification provided by testing, “to ensure that I’ve made the product correctly,” and validation, provided by clinical evaluations, “to be sure I’ve made the right product.”