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How to Deal With Instrument Trays from Outside off Your Facility (Part II) In Part I of this blog we discussed the fact that when it comes to new surgical...

How Should You Deal With Instrument Trays From Outside Of Your Facility (Part I) As surgical instrumentation has become ever more complex it has also become significantly more expensive. Not...

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...

FDA to Leverage Standards with New 510(k) Premarket Clearance Process One of the many important tasks handled by the Food and Drug Administration is the approval of new medical devices...

Update on Scope Reprocessing Recently the FDA issued a statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated rates of duodenoscope contamination...

The Continuing Call For Validated IFUs In a new article in Healthcare Purchasing News, noted author and reprocessing expert Rose Seavey said that “Many reusable devices pose great...

What About Loaner Instruments & Items That Do Not Have An IFU?(Part II) In Part I of this blog post we began looking into the problems and issues that occur...

What About Loaner Instruments and Items That Do Not Have IFU? In 2018 the FDA approved more 510(k) submissions for new medical devices than in any previous year.1 A significant...

Biofilm Formation and the Increased Risk of a Surgical Infection Biofilms that remain on or inside of surgical instruments after reprocessing have long been a suspected source of surgical infections....

What's Inside Of The Instruments That Are Used Inside Of Your Patients? A recurring question that haunts CS/SPD personnel after reprocessing is whether or not they have removed all of the...