A conference track at MEDevice San Diego focusing on an end-to-end product development strategy for engineering and manufacturing will include a presentation titled "Planning for Product Validations: Designing for Biocompatibility, Sterilization, and Cleaning." Given by Emily Mitzel, a laboratory manager at Nelson Laboratories (Salt Lake City), the talk will discuss material selection and processing factors that affect biocompatibility, what developers should know about designing for sterilization, and human factors and designing for cleaning and reprocessing at the clinical site. Catch her presentation on September 11 from 2:30-3:15 p.m. In the meantime, Mitzel has the following advice for medical device designers and developers.
1 When approaching the problem of materials selection and processing to ensure biocompatibility, the best thing to do is approach materials with biocompatibility in mind and look for certifications for the material. Be careful with the choice of certification. While many people use USP Class VI as a certification, it does not include a cytotoxicity test, which historically is the most sensitive test. All in all, if you don't feel comfortable with your material choice, perform a cytotoxicity test on the raw material. This test is cheap and sensitive, and it will give you a good feel for the material's biocompatibility.
2 In order to anticipate sterilization issues, designers mainly need to think about air removal and steam penetration into all of the lumens, cracks, and crevices of each individual device and the entire tray of devices. Devices must remain in an open and unlocked position during the sterilization process.
3 Cleaning devices in a healthcare facility is challenging. This is due to the immense number of devices on the market as well as the fact that most every medical device has a different cleaning procedure. However, as the industry moves forward to more standardized instructions for how to clean medical devices, it will become easier to validate and clean them in healthcare facilities.
Bob Michaels is senior technical editor at UBM Canon.