Purchasing New Equipment

Before purchasing a reusable medical device, check that the manufacturer’s recommended reprocessing instructions are compatible with the local decontamination processes and products. If not, do not purchase.

Purchasing New Equipment

The MHRA provides the following guidance on the management of Medical Devices: 

  • Before purchasing a reusable medical device, check that the manufacturer’s recommended reprocessing instructions are compatible with the local decontamination processes and products. If not, do not purchase.
  • Always follow the manufacturer’s Instructions for Use (IFU) where appropriate and acceptable. If not, do not use.
  • Only reprocess medical devices which the manufacturer states as being reusable and do not reprocess those designated for single use only.
  • Reusable medical devices should be decontaminated using validated processes and equipment designated for the specific purpose.
  • Use of automated decontamination processes are preferable to manual processes in that they have the ability to control and monitor their own parameters within strictly controlled tolerances.
  • Medical devices should be decontaminated away from treatment/clinical areas and preferably within a dedicated area/room. Ideally this would be within a dedicated decontamination room.
  • Used devices should be segregated from those that have been processed and stored separately.

The first point on the MHRA list is especially important. Surgical instruments can be very expensive, especially so with dental instruments. They very often have specialist surface treatments to improve the corrosion resistance. These layers are only nanometres thick and may be damaged by the use of the incorrect processing chemicals or cleaning action. Instruments must never be scraped with metal or scoured as this layer will be scratched or removed leaving the instrument more vulnerable to corrosion and recontamination of the roughened surface.

Modern dental cements form a very strong bond on the surface of stainless steel instruments if they are allowed to cure on them. Cement must be removed during the treatment and wiped clean before the cement hardens. If it is necessary to scrape hardened cement off the instrument it should be carried out with a non-metallic implement designed for the purpose, or the instrument should be discarded to the clinical waste.

By definition, all medical devices sold (including instruments) must now comply with the MDD/MDR and carry the ‘CE’ mark.

The MHRA have published a ‘One Liner’ related to the management of medical devices which is available to download.