A Paradigm Shift Toward Terminally Sterilized Devices

Clin Spine Surg. 2018 Aug;31(7):308-311. doi: 10.1097/BSD.0000000000000675.


Given the complexity of the sterilization process, and the risk involved in absence of strict adherence to the protocol described by the medical device manufacturers, terminally sterilized devices are emerging and being promoted in the field of medical practices. The characteristics associated with conventional reprocessing are demanding logistics, costs of delay, operations and adverse events, and unacceptable liability. Demanding logistics were a result of decoupled staff between the operating room and sterilize processing department, understaffed and high-volume processing with an additional burden due to inventory management and inefficient training. Other costs arose from upkeep, delay in operating room, and surgical-site infections. Liability arose from the repeatedly use of an unquantifiable process thus adding uncertainties, limited shelf life of the reprocessed implants, contingency of flash sterilization and introduction of newer technology with higher demand on cleaning performances. In contrast, terminally sterilized single-use devices do not carry any of the aforementioned-characteristics, deeming it to be the simplest solution to the current conundrum. This review serves to provide an evaluation of logistics, costs, and potential adverse effects, both directly and indirectly, associated with current practices in the sterile processing department, and also describes as to how the use of terminally sterilized devices can help circumvent those.

MeSH terms

  • Equipment and Supplies* / economics
  • Health Care Costs
  • Health Resources
  • Humans
  • Organization and Administration
  • Sterilization* / economics
  • Surgical Wound Infection / economics