Dear Mr. Taurasi:

I just could not help but respond to the second question in CS questions. Your answer was perfect. I am completely disappointed in this manager to point blame to the CS department. If this manager had a better understanding of the complete process maybe they would not be pointing fingers. Instead this manager should foster a working relationship and do a root cause to this situation. Communication is key between such high functioning departments. SPD is not stupid people in the basement. They work just as hard as the OR staff does. Nor do they just let processes pass them by. I am sure this department went through several steps to release the loads and sets. Nor would they tear down sets without justification or cause. If all indicators on the exterior, the test pack and load parameters were met they did exactly as they should. At the first line of communication to the department a recall should have been initiated – and a full investigation of why this happened. Blaming people will not get the job done. Furthermore, I question this manager’s abilities with leadership. Thanks for the response, Ray. As an OR nurse who now is the manager over SPD I can say understanding and communication is key for both areas. Pointing fingers is completely useless and VERY harmful to all in that environment.

Here is a STERIS concern that no one is addressing.

On 12/4/2009 we received a notice from STERIS regarding an FDA warning. I work at a hospital and this device warning has sent ripple shockwaves throughout the medical community. The FDA has released a notice dated December 3, 2009: "Concerns About the Steris System 1 Processor, Components, and Accessories, and FDA Recommendations". It states, "FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices". We as well as most hospitals depend on this machine daily to process devices used on patients. The widespread use of this machine has been since its release in 1988. According to STERIS Corp., more than 23,000 System 1 units have been used, approximately 30,000 devices sterilized daily. The FDA even while saying the units may not be safe or effective, gave initially 3-6 months and now 18 months to transition to alternate sources of processing medical devices. This seems very contradictory; either it does the job or does not; either it sterilizes the items or it does not; either it can be used on patients to provide good care or it can not. We in the medical settings, trying to provide quality patient care, are perplexed. In a recent conference call many callers who were allowed to ask questions shared as common theme: ‘Is it safe, was it ever safe, and can we use it?’

This is an extremely costly notice (nation wide) if, as FDA is telling us, we can no longer use the STERIS System 1 and must purchase new equipment.

More importantly is it providing quality patient care? If yes then why replace it, if not then why are we still allowed to use it for 18 months?

W. Doyle Baker, Perioperative Director
Coffee Regional Medical Center

Dear Mr. Baker:

In my opinion, you ask fundamentally sound and valid questions and make some spot-on observations. Until December 2009, STERIS presumably provided the FDA with all of the requisite paperwork for initial agency clearance of the product, as well as subsequent changes (e.g., updates, upgrades). Also, STERIS is not making off-label claims nor is it encouraging off-label use to the best of my knowledge. 

A one-year extension to switch to an alternate product does deflate the direness of the FDA’s warning. What really inspired the reversal, which is what this is? Better yet, because the FDA okayed this product for more than two decades, who’s really liable/responsible if any patient infections, mortalities have emerged that may be reasonably traced to the use of the product,though the FDA has stated that none have been reported?

Bottom line: Each hospital that uses the STERIS product should consult with and obtain a defendable decision by its attorneys on how to proceed, and by all means maintain an open, fluid and honest dialogue with STERIS; as well as work with supply chain management to evaluate product alternatives.