Sterilisation protocol

All our Products are delivered NON STERILE, unless we specifically say otherwise.

  • It is not our responsibility to ensure sterilisation and validation of sterilisation equipments.
  • Your sterilisation manager can contact us directly if they have any question that we may be able to help with.
  • Re-sterilisation: If re-sterilisation is required, ensure that the Product is not damaged or contaminated, still fits the model of the defect and does not contain sharp edges before re-sterilising it using the methods described below.
  • The Instructions For Use (IFU) are always sent with the implants, however we understand that it may happen that you need access to the sterilisation instructions, hence the summary below.
  • The Instructions For Use also contain other information, including how to use the product(s), intended conditions of use, possible adverse effects and contra-indications, so, just like you would do with any medical product, take time to read and understand to IFU in full.

 

Titanium (not silver-treated) and PEEK Implants

  • The patient specific implants are delivered NON STERILE, unless we specifically say otherwise. Prior to implementation, clean the implant with mild detergent (4<pH<8). An automated cleaning process running standard HTM2030 parameters is adequate. Then steam sterilise the implant using an autoclave. The autoclave should operate within the parameters set out in HTM 2010 with the sterilisation hold time of 134-137 degrees centigrade (the time depends on your country regulations and this should not be less than 3.5 minutes) in a porous load steriliser.
  • The above does not apply to silver-treated titanium implants.
  • Do not use the implants if the package was opened or damaged in delivery.

 

Silver-treated TitaniumĀ Implants

  • The silver-treated titanium patient specific implants will be delivered STERILE unless we have a different specific arrangement in place with your hospital.
  • Do not use the implants if the package was opened or damaged in delivery.

 

Nylon Defect Model and Cutting Guide

  • Nylon models and cutting guides are supplied NON STERILE, unless we specifically say otherwise. If sterility is required, clean with mild detergent (5<pH<8). Then steam sterilise using an autoclave. The autoclave should operate within the parameters set in HTM 2010 with the sterilisation hold time of 134-137 degrees centigrade (the time depends on your country regulations and this should not be less than 3.5 minutes) in a porous load steriliser.

 

Resin Defect Model

  • The custom made model of the defect is delivered NON STERILE. If sterility is required, use 25-35kGy gamma irradiation.