The reasons for recalling a sterilization load are numerous, and 85% of the time the recall is because of human error. Every reprocessed medical device, especially an implant, should be fully traceable to the patient on whom it was used or on whom it is implanted.

A Departmental Policy and Procedure is where it all begins. Departmental Procedures describe the steps that must be followed to comply with the stated policy. The consequences of not having a process in place for a load recall can be disastrous for a patient.

Having an automated, seamless process in place to assist the technician with the retrieval of recalled items will allow the technicians to retrieve the affected items quickly and efficiently. Sterile Processing technicians play an essential role in the delivery of safe patient care and having such processes in place allows the staff to quickly recall the items necessary before they are used on a patient.

When a positive BI occurs, the following patient safety actions should be taken:

  1. Notify your supervisor
  2. Review the sterilizer printout/chart and CI results to verify sterilization parameters. If it is identified that a cycle had the wrong parameters, then rewrap and reprocess the load. No further action is needed.
  3. Notify the infection control department
  4. Using the information from the sterilization log and the load control identification, begin a recall of all items processed in the affected sterilizer back to the last known negative BI.
  5. Reprocess all the recalled items
  6. A BI test should be repeated in the next sterilization cycle and the load held until a negative result is obtained

For more help or insight on how to keep your patients safe, check out these additional resources:

  1. Infection Control Today Article – Patient Safety FDA requirements
  2. Managing Infection Control Article – Documentation, It’s Not Just Paperwork
  3. AAMI ST79, 10.7.5.1
Author: Michelle Gallagher, CRCST, CCSVP