When central sterile processing staff identified a piece of ortho equipment as being difficult to sterilize, the manager stopped the line and immediately escalated the concern. Further investigation revealed a potential safety issue related to the manufacturer’s reprocessing instructions and construction of the device: Several locations within the health system had discovered fluid and/or bioburden (the number of bacteria on a surface that has not been sterilized) inside the device after reprocessing. Following discussion with the vendor, patient safety, infection prevention and service line leadership, the equipment was removed from use until the sterility of the equipment can be verified.
The health system contacted the device company and requested that in-house devices be replaced as soon as possible. It also requested that the company provide a representative versed in reprocessing to visit each location that uses this device to observe and advise on the sterilization process detailed in the product instructions for use. Through the central sterile processing manager and her team’s quick reaction and diligence, unsafe equipment was investigated and pulled from service, preventing patient harm.
