Biocompatibility Testing: Are You Considering Interactions Between Packaging and Devices?

The biocompatibility and toxicological attributes of medical device packaging materials and systems should be evaluated, according to the general requirements section of ISO 11607. But if this recommendation hasn’t been enough of a reason to consider biocompatibility requirements in your evaluation plan, revisions to ISO 10993 just might be. At MD&M Minneapolis last month, Frank Bieganousky, director of package and medical device testing at Whitehouse Labs, a division of AMRI, told the audience that ISO 10993 revisions will speak about evaluating the biocompatibility of medical device packaging for the first time. He spoke November 9 in the Center Stage presentation, “How to Prepare Your Medical Device Packaging for a Regulatory Submission.” When it comes to biocompatibility testing, work is already being done to evaluate potential risks to patient from medical devices, Bieganousky said. What is needed now is “to look at the interaction between packaging and the device,” he said. “Packaging may impart leachables that may affect the safety of the device,” he explained. “You must consider what comes out of the package and into the product, as well as what comes out of the product and into the package.” As an example of why such interactions need to be evaluated, Bieganousky showed pictures of a damaged tray. “Plasticizer from the tube attacked the tray material and ate through the tray,” he said. Data is needed to characterize potential extractables a...
Source: MDDI - Category: Medical Devices Authors: Tags: Testing Source Type: news