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
So let’s say that we validate to those parameters and it turns out that a specific hospital runs to one of the others, how hard is it for hospitals to change parameters?
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.
Start-up companies are under constant pressure to use capital efficiently. A long-standing problem in the orthopedics industry is a company’s initial capital outlay for building the instrument sets necessary to implant their product and create revenue.
Reprocessing of reuseable medical devices continues to make news. Both the Today Show and MSNBC recently aired segments based on an investigation documented in Filthy surgical instruments...
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 [...]