FDA issues warning to medical device makers over failure to validate cleaning IFUs (MPS On-Line, 8/18/15)
The Food and Drug Administration sent warning letters last week to three medical device manufacturers whose endoscopes have been blamed for spreading deadly bacteria. This is the agency’s strongest regulatory action yet since outbreaks in Los Angeles, Seattle, and elsewhere made headlines earlier this year. (See the full story in News.)
The Cost of a Surgical Site Infection:
Don’t let contaminated instruments harm your patients or your bottom line
We know how hard you work, and how much money your healthcare facility spends to ensure clean, sterile, moisture-free instruments for every surgical procedure to reduce your patients’ risk of contracting a surgical infection. Regretfully, far too many surgical instruments are difficult, if not impossible, to thoroughly decontaminate, clean and sterilize.
Nationally recognized expert Jahan Azizi, BS, CBET, spent over 20 years as the Risk Manager, Clinical Engineer at the University of Michigan Clinical Health System. During those years, Jahan conducted extensive, groundbreaking research into why certain medical devices are so problematic when it comes to the reprocessing challenges you face every day.
Attached is Jahan’s presentation that he gave at IAHCSMM’s National Meeting last month. His presentation is entitled “Clean Collaboration: Putting the Pieces of the Puzzle Together on Difficult to Clean Medical Devices.”
In his excellent, well-researched presentation, Jahan addresses:
- What are the most difficult/impossible to clean surgical instruments.
- What are the design issues with impossible to clean surgical instruments?
- Have the manufacturers’ Instruction For Use (IFU) been validated?
- Why current IFUs may not be effective.
- A Collaborative Case Study “A.I.M. Clear Flush® Kerrison Cleaning Validation Test”
We hope you find Jahan’s presentation to be of value to you and your staff as you face the daily challenge of providing clean, sterile, moisture-free instruments for every patient, every time.
Clean Collaboration: Putting the pieces of the puzzle together on difficult to clean medical devices a Collaboration approach: Presentation by Jahan Azizi BS, CBET, at the annual conference of International Association of Healthcare Central Service Materiel Management (IAHCSMM), May 2015