The packaging of medical devices frequently takes place in a cleanroom, and the packaged devices normally undergo some kind of sterilisation. But it is the role of packaging to keep the device sterile right up until use. The correct selection of packaging, therefore, is a crucial but complex decision, and statistics suggest it is often not carried out correctly. According to Jouni Vikman, Director for Healthcare at Wipak, 10% of medical device recalls are attributable to packaging failures and 31% of those are due to a hole in the packaging. Vikman chaired a recent Medical Device Packaging seminar in Oxford, UK. The seminar looked at the criteria for selection of packaging along with the regulatory requirements and testing procedures for the different types of packaging. An overview of the current status of the relevant medical packaging standards (see panel opposite) was provided by Nina Tillaeus, a Member of the Board of the Sterile Barrier Association. Of the standards, ISO 11607-1 is among the most important. It states that medical device packaging should be.
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