Q: Do you believe that surgical instruments in opened-but-unused packages must be re-sterilized?
"Maintaining the sterility of a sterilized medical item until the package is opened, is one of the main functions of effective packaging materials, according to the Association of Advancement of Medical Instrumentation (AAMI) Standards and Recommended Practices: Good Hospital Practices, Steam Sterilization and Sterility Assurance (2001). To break the integrity of the seal of a sterile package other than for the immediate use of the item removed should be considered an event that renders the package contents contaminated, and the item should not be returned to the sterile storage shelf for future use, but should be removed for re-sterilization. In my opinion, to do otherwise poses unnecessary risk of infection to patients, as the assurance level of providing a sterile product is greatly compromised.
In each healthcare facility, healthcare professionals responsible for the sterilization of reusable surgical instruments and medical items need to be collaborative partners with other disciplines, such as infection control and nursing services, to assure best practice policies and procedures addressing sterilization quality issues are developed and implemented in order to ensure the best outcome for patients. The collective expertise of healthcare professionals is readily available by consulting guidelines and standards and recommended practices from several professional sources including AAMI, Association of periOperative Registered Nurses (AORN), Association for Professionals in Infection Control and Epidemiology (APIC), and American Society for Healthcare Central Service Professionals (ASHCSP)."
Carole A. Barksdale MS, RN, CNOR, ACSP, CSPDM
Coordinator of OR/CPD Materials Processing, Children's Hospital, Boston
A: "At first blush the answer would be a resounding 'yes' and not just re-sterilized, but reprocessed completely for two reasons. First, there would be no way for central sterile processing (CSP) to know what the items were exposed to while open. The change from expiration dating of sterilized packages to event-related shelf life defines opened or compromised packaging as the trigger to reprocess items.
However, I am intrigued by the question because we recently completed a study that revealed nearly 70 percent of instruments opened for surgical procedures at one of our facilities remained unused and were returned for reprocessing (rework). Although the prospect of exploring reuse of the opened-but-unused instruments is fascinating, I don't believe there is a way to do so without compromising the safety of the patients. Our objective is to provide physicians and nurses that care for patients with clean, sterile instrumentation for every surgical procedure.
We've worked to establish a quality program in CSP with standardized procedures and processes throughout our system. In order to accomplish this, we must be consistent in how we handle all opened or otherwise compromised packages. We reprocess all opened instruments, used or unused."
Crystaline A. Kuykendall, BS, MBA
Corporate Director, Central Sterile Processing, Detroit Medical Center, Mich.
A: "When a reusable tray that has been sterilized is opened, it must be totally reprocessed, and I do not think that disposables should be reused at all. "Opened-but-unused" does not mean that the instruments were not contaminated or compromised. To introduce a policy like reprocessing unused disposables, (especially) without documentation from the manufacturer, opens the door to infection and litigation. If the product was worthy of reuse or reprocessing in the first place, the manufacturer (would) stand behind it and support it in writing. They don't want the liability so why should we? With reusable trays, as during a total joint replacement case, think about the drills and bone fragment involved. Who is to say that just being on the field did not contaminate the set? Reprocess the reusable trays and dispose of the disposables ones."
H. Elaine Jordan
Quality Assurance Education Coordinator at Saint Joseph's Hospital of Atlanta, and President of the Georgia Society for Healthcare Central Service Personnel