CONCEPT

Medacta is on the side of efficiency: For more than 10 years we have been providing Spine implants which are pre-sterilized and ready for implantation. Pre-sterile implants can significantly help Healthcare providers to be more efficient, to reduce the risk of contamination, to save time and to reduce costs[7]. 
These aspects are extremely important especially during post covid-19 recovery.

  • Implants are provided in individual boxes, sterile and with double packaging, making the risk for contamination pre, peri and post implantation virtually non-existent[2].
  • The pre-sterilization makes the devices clean and free of contamination, which is  essential for preventing surgical infection and virus contamination[3].
  • Providing implants which are always sterile and pre-packaged allows Medacta to trace each implant that goes in every patient.

Pre-Sterilized implants can relieve the Healthcare provider from many costs arising from reprocessing: 

  • No extra time, costs and resources need to be spent after receiving the implants from Medacta. They are ready for usage. 
  • Each implant is barcoded, ensuring for the hospital that only the used implants will be billed and reducing costs.  
  • Barcoded implants reduce logistical challenges, as each implant location is always known.
  • By using “fresh” implants it can be demonstrated that all necessary precautions have been taken in order to prevent wound infections[2], which can be fundamental in case of a legal claim. 

Pre-sterilized implants eliminate the risks of reprocessing:

  • Contamination in the OR
  • Transfer of liability
  • Unproven cleaning

Despite sterilization, the endotoxins may retain biological activities[1] increasing the risk of an implant being contaminated.

When using pre-sterile implants there is no transfer of liability from the vendor to the hospital. This allows the healthcare provider to assure each patient that every available technology has been used in order to reduce the risk of surgical wound infection and virus contamination[3]

The usage of pre-sterilized implants drastically reduces the risk of using implants that might have been damaged by chemical or mechanical factors[6] which can occur during the reprocessing phase:

  • The reprocessing of non-sterile implants involves a certain level of mechanical and electrochemical corrosion, which can cause the metal to fracture, resulting in a greater likelihood of implant failure[6].
  • By offering pre-Sterilized implants, Medacta always guarantees to healthcare providers and to its patients stable and safe implants. 
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] Reprocessing of Implantable Screws and plates in Orthopedic Tray Sets, Michelle J. Alfa, Horizon Spring, AAMI 2012
[6] Single-Use Screws and Plates. Joanna Ford ET Al., Epub http://www.medidex.com/research/788-single-use-screws-and plates.html 
[7] Goldberg, et al., Logistical and Economic Advantages of Sterile-Packed, Single-Use Instruments for total Knee Arthroplasty, J Arthroplasty. 2019 Sep;34(9):1876-1883.
[8] Microscopical images of a new, unprocessed screw (top left image) alongside 2 images of screws that have undergone reprocessing on numerous occasions (images taken at 2 different magnifications).

Resources
For additional resources please visit resources.medacta.com