We are happy to announce that LSO is in the final phases of installation of two 8 cubic foot EtO sterilizers. We expect them to be certified and ready for production by the end of August, if not sooner. We are really excited about the opportunities these small batch sterilizers provide to our customers, and […]
Most medical device companies have product returns which are biohazardous. Some of these returns are biohazardous because hospitals didn’t follow their internal procedures, some are products that would have been disposed off by the hospital, but due to an issue in surgery they must be returned to the manufacturer, and some products are intended for reuse but must go through
A major issue when tasked with Cleaning and Steam Cycle validation parameters for reusable kit systems, is of course validating rugged processes at a reasonable cost. There are really two key drivers to sending validation costs into the stratosphere. The first is…
In the last 6 months the FDA has begun to focus more closely on ensuring that reusable instrument and implant kit systems have been properly validated and that the parameters listed in the kit systems’ Instructions for Use (IFUs) have a substantive validation to support them.
Times they are a-changin’. Anyone who remembers the lyrics to this Bob Dylan song and is involved in the healthcare market may well recognize the connection made here. The listener is, to paraphrase, reminded to embrace change or risk frustration and disappointment. Change is inevitable, and this is very evident when it comes to validation […]