Restocking and sterilisation of non-sterile single-use implants for use in orthopaedic procedures

November 2005

The restocking of orthopaedic implant sets with non-sterile replacement implants prior to sterilisation for use in orthopaedic procedures, and the subsequent re-sterilisation of the unused implants in these sets, are not regulated as manufacturing activities under the Therapeutic Goods Act 1989.

It is common practice for manufacturers to supply non-sterile orthopaedic implants* for restocking implant sets prior to sterilisation for use in orthopaedic procedures. The manufacturer provides instructions on how to process and sterilise these implants prior to use and although they are only intended to be used once (single use), those unused implants have been designed and manufactured to undergo re-sterilisation in accordance with the manufacturer's instructions.

Once the sterilised set of implants is opened in the operating suite, the unused implants within the set are regarded as "opened but unused single use medical devices". The subsequent re-sterilisation of the unused implants is undertaken in accordance with the manufacturer's instructions. The intended purpose of use for the device has not been changed, there is no reuse occurring and the reprocessing and re-sterilisation is in accordance with the manufacturer's original instructions.

However if one of these single use devices is used or inserted in a wound, the device is taken to be used and cannot be re-manufactured for reuse on another person unless the re-manufacturing is undertaken in a certified manufacturing facility. The re-manufacturer must be able to demonstrate though scientific and clinical evidence that the re-manufactured device is equivalent to the original and will continue to perform without additional risk.

*(The implants referred to above consist of, but are not limited to: screws, hooks, rods, plates, cages, discs, washers, nuts and associated spinal, trauma and CMF implants)