Unclear Rules Aren't Holding Up Transport Tests
Distribution testing requirements can often be unclear, but a majority of medical device professionals perform and validate such tests, a recent survey found. Marci-Ann Ando from Celera Diagnostics presented survey results during MD&M West 2006’s packaging validation conference. Ando conducted the survey as part of her master’s project for Michigan State University.
Sixty percent of the respondents perform distribution testing on both sterile and nonsterile medical devices. Less than half, however, perform engineering studies before final distribution testing validation to ensure success, she found.
More than 70% of the respondents follow ISTA standards, while nearly 62% follow ASTM D4169. Nearly 30% follow an in-house standard.
Eighty percent would like to see a specific standard for distribution testing for medical devices that outlines protocol requirements, sample-size requirements, and more- detailed post-distribution testing, she found.
“ISTA 4AB may satisfy these needs,” said one audience attendee, speaking of the new standard that presents distribution testing in a “cookbook-like” approach. Earlier in the day during another conference, another attendee had remarked, “Some of the older ISTA standards are pretty old.”
FDA requirements can be unclear, respondents agreed. And the agency has not recognized ISTA standards, another attendee remarked.
Despite the unclear requirements, respondents, most of whom said that packaging engineers are in charge of writing distribution testing protocols, said that performing the actual tests was easy.
“It is up to the engineer to decide the requirements for distribution testing validations for each application,” wrote one respondent. “The reason we are engineers is to see the proverbial checklist approach to engineering.”
Sent to more than 400 industry professionals, Ando’s survey was completed by 35 respondents.