Q: Do you believe that surgical instruments in opened-but-unused packagesmust be re-sterilized?
"Maintaining the sterility of a sterilized medical item until thepackage is opened, is one of the main functions of effective packagingmaterials, according to the Association of Advancement of MedicalInstrumentation (AAMI) Standards and Recommended Practices: Good HospitalPractices, Steam Sterilization and Sterility Assurance (2001). To break theintegrity of the seal of a sterile package other than for the immediate use ofthe item removed should be considered an event that renders the package contentscontaminated, and the item should not be returned to the sterile storage shelffor future use, but should be removed for re-sterilization. In my opinion, to dootherwise poses unnecessary risk of infection to patients, as the assurancelevel of providing a sterile product is greatly compromised.
In each healthcare facility, healthcare professionals responsible for thesterilization of reusable surgical instruments and medical items need to becollaborative partners with other disciplines, such as infection control andnursing services, to assure best practice policies and procedures addressingsterilization quality issues are developed and implemented in order to ensurethe best outcome for patients. The collective expertise of healthcareprofessionals is readily available by consulting guidelines and standards andrecommended practices from several professional sources including AAMI,Association of periOperative Registered Nurses (AORN), Association forProfessionals in Infection Control and Epidemiology (APIC), and American Societyfor 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 notjust re-sterilized, but reprocessed completely for two reasons. First, therewould be no way for central sterile processing (CSP) to know what the items wereexposed to while open. The change from expiration dating of sterilized packagesto event-related shelf life defines opened or compromised packaging as thetrigger to reprocess items.
However, I am intrigued by the question because we recently completed a studythat revealed nearly 70 percent of instruments opened for surgical procedures atone of our facilities remained unused and were returned for reprocessing(rework). Although the prospect of exploring reuse of the opened-but-unusedinstruments is fascinating, I don't believe there is a way to do so withoutcompromising the safety of the patients. Our objective is to provide physiciansand nurses that care for patients with clean, sterile instrumentation for everysurgical procedure.
We've worked to establish a quality program in CSP with standardizedprocedures and processes throughout our system. In order to accomplish this, wemust be consistent in how we handle all opened or otherwise compromisedpackages. 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, itmust be totally reprocessed, and I do not think that disposables should bereused at all. "Opened-but-unused" does not mean that the instrumentswere not contaminated or compromised. To introduce a policy like reprocessingunused disposables, (especially) without documentation from the manufacturer,opens the door to infection and litigation. If the product was worthy of reuseor reprocessing in the first place, the manufacturer (would) stand behind it andsupport it in writing. They don't want the liability so why should we? Withreusable trays, as during a total joint replacement case, think about the drillsand bone fragment involved. Who is to say that just being on the field did notcontaminate the set? Reprocess the reusable trays and dispose of the disposablesones."
H. Elaine Jordan
Quality Assurance Education Coordinator at Saint Joseph's Hospital ofAtlanta, and President of the Georgia Society for Healthcare Central ServicePersonnel