| The FDA issued a notice on December 3, 2009 advising U.S. facilities utilizing a System 1 Sterile Processing System (SS1) to immediately begin planning a transition to alternative processing methods. The FDA cited ongoing concerns regarding patient and healthcare worker safety, and recommended that healthcare facilities in the US discontinue use of the SS1. On February 2, 2010, the FDA updated this notice and extended the compliance date at the request of some healthcare facilities. The FDA did reemphasize though that “…these facilities should be aware that the current SS1 is a misbranded and adulterated medical device because it has not been cleared by FDA as safe and effective for its labeled claims. Healthcare facilities should therefore transition to alternative reprocessing devices as soon as practicable.”
AVOID LIABILITY AND NEGATIVE ATTENTION
Given the high level of public attention this FDA notice has received including extensive coverage by the media, Hospitals that continue to use the SS1 will find themselves under greater scrutiny and potential liability following hospital acquired infections or patient injury involving those treated with devices that were reprocessed in the SS1 regardless of the actual source.
IT’S MORE COMPLICATED THAN YOU MIGHT THINK
Most organizations do not realize the full complexity of the change process from SS1 to suitable, compliant alternatives. This FDA notice will impact all surgical areas, Endoscopy and other procedural areas and Anesthesia. Meeting the required conversion date will demand organizations to acquire new or alternate equipment, develop new policies, and educate staff
THE TIME TO ACT IS NOW
ISH recommends that organizations start their conversion planning now. Although the FDA has just extended the compliance date by an additional fourteen months, most healthcare organizations have embraced this issue as a patient safety concern, a financial exposure concern, and a potential regulatory concern. This determination by the healthcare organizations is further supported by the FDA in their update notice:
- “…the current SS1 is a misbranded and adulterated medical device because it has not been cleared by the FDA as safe and effective for its labeled claims.”
- “FDA does not expect to take regulatory action against healthcare facilities for failing to replace SS1 units within the 18-month transition period [starting 2/2/10].”
- “Healthcare facilities should therefore transition to alternative reprocessing devices as soon as practicable.”
Simply put, the extended compliance timeframe doesn’t change the level of concern shared by healthcare organizations. The time to act is now!
WE CAN DO IT FASTER
ISH can aid your organization in this time critical change by performing an assessment of your needs, developing a facility conversion plan, implementing the new system, developing new policies and procedures and providing knowledge transfer for your Sterile Processing staff. And we can do it in a shortened time frame since we have copyrighted SolutionSets developed in our projects with a number of organizations who have already successfully completed their conversions.
Don’t miss the opportunity to engage the ISH team of clinical experts before the deadline encroaches.
The full transcript of the latest FDA update on the SS1 issue can be found at: www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm199567.htm.
For more information on our programs which can be customized for your organization, contact Mary Garland at mgarland@ishinc.com, or call us at 800-284-8018, extension 336, or Contact Us. |
