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 IFAI Expo 2020 education session, “Understanding Testing Requirements of Medical PPE.” Medical PPE are considered to be “medical devices,” which underscores the importance of understanding and following the regulatory and testing protocols.
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.
“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.”