Procurement of Infection Control and Decontamination Items
For effective infection control, including decontamination, it is important that new items and equipment are of suitable quality and fit for purpose. Reusable instruments must be compatible with the decontamination methods employed by the practice. Single-use items, identified by the symbol shown below, are disposable and not intended to be reprocessed for use on the same or another patient. Note that this symbol will appear on packaging but might not be present on individual items.
Examples of items that might have the single-use symbol include, endodontic instruments, masks, matrix bands, plastic impression trays, prophy cups and brushes.
The re-use of a single-use device has legal implications. Anyone who reprocesses or re-uses a device intended for use on a single occasion bears full responsibility for its safety and effectiveness.
Health Facilities Scotland have a service providing expert help and advice to anyone within a dentistry setting up a local decontamination unit (LDU) and/or purchasing new decontamination equipment. Reference may also be made to the National Procurement’s Approved Decontamination Equipment List hosted on the Decontamination page of the Scottish Dental website.
Write a policy for the purchase of re-useable items, single-use items and decontamination equipment (see Procurement of Infection Control and Decontamination Items Policy template).
Document the practice’s specific requirements, price comparisons and advice sought from various manufacturers.
Ensure items are fit for purpose, compatible with existing equipment, easy to decontaminate or clean (e.g. hard surfaces of decontamination equipment), and maintain.
Ensure products have the CE mark which signifies the manufacturer’s compliance with the Medical Devices Regulation (EU) 2017/745, in effect in UK law as Medical Devices Regulations 2002 (SI 2002 No 618, as amended)
* Note: Following Brexit, medical devices placed on the GB market will have a UKCA mark. This UKCA mark is a requirement of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)
Review current decontamination procedures in relation to devices purchased for the first time.
Sources of Information
- Decontamination Services Health Facilities Scotland, National Service Scotland
- Regulation (EU) 2017/745 of the European Parliament and of the Council, on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (2017)
- Medical Devices Regulations 2002 (SI 2002 No 618, as amended)