The primary responsibility of everyone involved in reusable medical device reprocessing is to minimize the risk of a surgical infection caused by a device that remains contaminated with organic debris...
In Part I of this blog we discussed how the use of robotic-assisted surgery systems has grown steadily in the U.S. over the past twenty years. This growth has...
Can your hospital modify medical equipment or a surgical instrument that it purchased, paid for and legally owns? Can you modify or alter an instrument or piece of equipment to...
The problem of wet packs has been around since we first started using steam sterilizers to process reusable medical devices. It is imperative that you and your staff immediately take...
Can A Healthcare Facility Etch Their Surgical Instruments? (Part II) Over the past few years there has been a growing consensus among regulatory agencies that using colored tape or markers on...
What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part I) The FDA mandates that all reusable medical device manufacturers provide instructions for successfully reprocessing their...
New Study Finds Amyloid Protein Transmission Through Contaminated Instruments A new study by the University College London Institute of Neurology finds that Amyloid beta pathology - protein deposits in the...
FDA List of “Greater Risk” Medical Devices and Validated IFUs: Part IV In Part I of this blog (1/26/18) we discussed the fact that the FDA has identified a subset...
FDA List of “Greater Risk” Medical Devices and Validated IFUs: Part III In Part I of this blog (1/26/18) we began an analysis of the FDA’s list of “Greater Risk”...
FDA List of “Greater Risk” Medical Devices and Validated IFUs: Part II In Part I of this blog (1/26/18) we discussed the fact that the FDA has identified a subset...
