Sterile Implants leaflet
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Surgical Technique Technical Report Hip

PRE-STERILIZED SPINE IMPLANTS Technical Report PR E - S T E R I LI ZE D S P I N E I M P L A N TS - TECHNICA L REPORT 1 INTRODUCTION

IMPLANTS LIABILITY 5 FULL TRACEABILITY 5 COST EFFECTIVENESS 5 STERILIZATION METHOD ISSUES RELATED TO NON-STERILE IMPLANTS TRANSFER OF LIABILITY 6 LACK OF COMPLIANCE 6 UNPROVEN CLEANING ASSOCIATED COSTS 8 CONCLUSION 8

PRE-STERILIZED SPINE IMPLANTS Technical Report A NEW TREND OF IMPLANTS: STERILE, SINGLE PACKAGED AND BARCODED To prevent any concerns related to reprocessed implants, all Medacta Products are pre-sterilized and ready for implantation, which offers a multitude of benefits to the surgeon and the hospital. Pre-sterilized implants eliminate the risks of reprocessing: Contamination in the OR Transfer of liability Unproven cleaning Material corrosion Cost of sterilization The FDA mandates obligatory tracking of both lot and reference numbers of all implants. Medacta offers a solution to this...

I M PL ANTS LIABILIT Y SURGICAL TECHNIQ UE: Anterior Cervical Discectomy and Fusion (ACDF) As the healthcare facility is not involved in reprocessing, there is no transfer of liability from the vendor to the hospital in regards to implant sterility and integrity. When potential claims arising from insurance companies or patients as a consequence of surgical wound infection, the use of sterile implants is becoming critical to demonstrate that the healthcare provider made use of every available technology to reduce the risk to the patient. FULL TR ACEABILIT Y SURGICAL TECHNIQ UE: Anterior...

PRE-STERILIZED SPINE IMPLANTS Technical Report ISSUES REL ATED TO NON -STERILE IM PL ANTS «[...] Using up old stock would simply prolong what we now recognize as suboptimal clinical practice.»[1] To ensure safety and compliance, Medacta, a spinal device company with its origin in Switzerland, has offered sterile single packaged barcoded implants for almost 10 years. Using sterile packaged implants is a safer, simpler and cost-effective solution to mitigate the risk of infection. «The cost and risk associated to infection can be mitigated by ensuring appropriate implant sterilization»...

UNPROVEN CLEANING SURGICAL TECHNIQ UE: Anterior Cervical Discectomy and Fusion (ACDF) Despite sterilization, the endotoxins retain biological activities: A significant concern is the ability to properly sterilize the implants. The implant sets are exposed to hazardous contamination and the hospital is responsible for the sterility. The caddies that hold the implants are not designed to enable optimal cleaning but more to facilitate the selection of the size in the OR. Therefore, when the caddy is cleaned through an automated washer, cleaning and rinsing of each individual implant becomes...

PRE-STERILIZED SPINE IMPLANTS Technical Report ASSOCIATED COSTS The costs associated with reprocessing are often ‘hidden’ and transferred by the vendor to the healthcare facility. The implant trays are checked at different stages after reprocessing prior to OR use. This time-consuming practice often result in trays returned from the OR for being considered non-compliant. A non-compliant implant set at the time of the surgery may result in important costs in the form of delays and cancellations. 10 CONCLUSION Postoperative infections and their costly consequences call for a deeper...

REFERENCES [1] Scottish Executive. Directorate of Finance. NHS HDL (2007). [2] Implant contamination during spine surgery. Jesse E. Bible, MD, MHSa, Kevin R. O’Neill, MDa, Colin G. Crosby, MDa, Jonathan G. Schoenecker, MD, PhDa, Matthew J. McGirt, MDb, Clinton J. Devin, MDa. The Spine Journal 13 (2013) 637-640. [3] Schultz,Janet.Monitoring and Load Release for Implants Sterilized by Steam Within Healthcare Facilities. Managing Infection Control. Jan 2004. [4] MHRA (Regulating Medicines and Medical Devices). Bulletin 2006. [5] Implant contamination during spine surgery. Jesse E. Bible, MD,...

Medacta International SA Strada Regina - 6874 Castel San Pietro - Switzerland Phone +41 91 696 60 60 - Fax +41 91 696 60 66 info@medacta.ch PRE-STERILIZED SPINE IMPLANTS Technical Report Find your local dealer at: medacta.com/locations All trademarks and registered trademarks are the property of their respective owners. Last update: July 2017