Schumer: Amidst New Shortage of Vital Sterilization Product that Could Have Forced Surgeries at Syracuse Hospitals to Be Canceled, FDA Heeds...

Schumer: Amidst New Shortage of Vital Sterilization Product that Could Have Forced Surgeries at Syracuse Hospitals to Be Canceled, FDA Heeds Senator's Call to Address National Product Shortage, Approves New Company to Temporarily Provide Product

WASHINGTON, June 19 -- The office of Sen. Charles E. Schumer, D-N.Y., issued the following news release:

Today, U.S. Senator Charles E. Schumer announced that, in light of an additional nationwide shortage of a critical chemical used to sterilize equipment for surgeries and more, the federal Food and Drug Administration (FDA) has heeded his call to provide direction to hospitals about how best to handle the shortfall and has approved an additional company to distribute the chemical. Schumer explained that Syracuse-area hospitals such as Crouse, St. Joe's and Upstate University have been experiencing an unexpected shortage of Sterrad Cyclesure 24 Biological Indicators, due a disruption in the sole manufacturer's - Advanced Sterilization Products' (ASP) - supply chain. Schumer called attention to this shortage in March 2014 and said both ASP and FDA needed to address the situation because it was threatening hospitals' ability to plan and complete important surgeries without delay and to handle any potential catastrophe in Syracuse that could require the need for multiple surgeries. After Schumer's push in March, ASP committed to weekly shipments to Syracuse-area hospitals, which temporarily addressed the shortage, but a technical problem at ASP's plant has led to a new shortage of Sterrad Cyclesure 24 Biological Indicators that the FDA is now addressing.

"Without a steady supply of this critical sterilization chemical, hospitals in Syracuse and across the state would have been forced to delay surgeries and been unable to handle a major catastrophe," said Schumer. "It is clear that this new shortage of 'biologic' chemical entails a better game plan, and I commend the FDA and ASP for stepping up to address the situation. I am pleased that the FDA has recognized how vital this chemical is to the health of hospital patients in Syracuse and around New York, and that they are doing what is right - communicating with hospitals around how to manage the shortfall and allowing a new company to step in to distribute this absolutely vital product."

The Sterrad Cyclesure 24 Biological Indicator is a product used with Sterrad sterilizers to monitor and confirm the effectiveness of the device sterilization process. Due to a supply chain issue at ASP earlier this year that was significantly hindering production, many Syracuse-are hospitals - including Crouse, St. Joe's, Upstate University, and Oswego Hospital - were being forced to ration this vital product. Other New York hospitals were being forced to share supply as well.

After Schumer pushed ASP to expedite shipments of Sterrad Cyclesure 24 Biological Indicator to Syracuse-area hospitals, ASP began weekly shipments, alleviating what could have been a dire situation. However, on May 16, ASP informed the FDA that due to what the FDA calls "machine performance issues on its production line," ASP would not be able to meet current product demand until potentially July 2014. According to Schumer, this would have forced Syracuse-area hospitals to ration the 'biologic' product again.

As a result of the new 'biologic' shortage at ASP, and Schumer's push for more communication between ASP, FDA and hospitals who rely on this product, the FDA has issued an important Safety Communication to hospitals and surgical centers; the full text of which can be accessed here. The Safety Communication is meant to "provide hospitals with information that will help them appropriately plan and prioritize use of the existing Sterrad Cyclesure 24 Biological Indicators," and "inform hospitals about an alternative biological indicator that can be used [instead of Sterrad Cyclesure 24 Biological Indicators]."

The alternative biological indicator that the FDA is now permitting for use is the Steris VERIFY 24 biological indicator--normally used only in Steris sterilizers. According to the FDA Safety Communication, the Steris VERIFY 24 biological indicator is currently FDA cleared, although it is not yet specifically cleared for use with Sterrad sterilizers. The FDA has reviewed performance data supporting the Steris VERIFY 24 biological indicator's use in Sterrad sterilizers and the agency is satisfied that the data supports its safe and effective use. Therefore, the FDA has authorized Steris to distribute the VERIFY biological indicators for use with Sterrad sterilizers until November 17, 2014.

Schumer explained that Sterrad Cyclesure 24 Biological Indicator is critical for hospitals to sterilize equipment used in medical procedures, both before and after surgery, and any shortage could require hospitals to delay surgeries to make sure they do not run out of the chemical entirely. Schumer said that such a necessity could endanger patients and, furthermore, means that the hospitals would be unable to handle a potential medical catastrophe that would cause the need for multiple surgeries, especially at a trauma center like Upstate.

Copies of Senator Schumer's original letters to the FDA and to ASP are available upon request.

TNS 30TagarumaMar-140620-4773893 30TagarumaMar