Terumo—Sarns TCM and TCM II Cooling and Heating Systems and HX2 Temperature Management Systems: Manufacturer Advises Users to Discontinue Use of and Dispose Affected Systems Because of Safety Concerns Associated with Bacterial Growth in Water Systems
May 12, 2021 | Strategic Insights for Health System
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Problem: In an April 30, 2021, Urgent Medical Device Recall letter submitted by an ECRI member hospital, Terumo states that in recent years, regulators, including FDA, have raised safety concerns regarding water system quality of temperature controllers, regardless of the manufacturer. The concern stems from the potential for bacterial growth in the water systems that may be transmitted to patients during surgery and is likely related to the recommended water system cleaning practices and protocols employed. Terumo has collaborated with regulators to develop a revised cleaning protocol for the above devices; however, after significant efforts, the firm has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, Terumo will not develop an updated cleaning protocol. The firm has determined that the best course of action is...