Bottom Line Up Front
The ongoing disruption in the single-use surgical tourniquet market has prompted the FDA to (finally) issue a shortage notice in the last week. Word around the industry is that this issue is caused by a disruption from Stryker and there does not appear to be a recovery date in the near term. Many parts of the country are experiencing product shortages, which in turn, is driving pricing volatility for alternative products.
More Detail
Health care facilities and providers in the United States are currently facing localized shortages of non-sterile, single-use pneumatic tourniquet cuffs. These devices are crucial in emergency and trauma settings as well as elective limb surgeries. The talk around the industry is that this is caused by a disruption from Stryker and there does not appear to be a recovery date in the near term. In response to the supply constraints, the U.S. Food and Drug Administration (FDA) has issued recommendations to mitigate the impact of the shortage. The FDA advises implementing conservation strategies, utilizing alternative products/suppliers, and reusing existing tourniquet cuffs after appropriate sterilization and disinfection procedures. These measures aim to ensure the quality and safety of patient care during this challenging
period.
The FDA recommends health care facilities and providers limit the use of pneumatic tourniquets based on surgical flow needs. Additionally, when non-sterile, single-use pneumatic tourniquet cuffs are not available in sufficient supply, they suggest reusing existing cuffs. To ensure safe reuse, healthcare professionals should clean the cuffs thoroughly, removing visible contamination and debris. Sterilization or disinfection methods, as advised by the manufacturer, must be followed meticulously. Proper storage and labeling of reprocessed cuffs are essential to avoid cross-contamination. It is important to consult the manufacturer for guidance on the maximum number of times each cuff brand can be safely reused.
Manufacturers, including Resilient Medical Solutions, are aware of the supply shortage and are actively working to increase availability. The FDA will continue to monitor the situation and provide updates to health care facilities, providers, and the public.