We consider validation of decontamination equipment when we review if the practice is safe. This relates to regulation 15 (premises and equipment) and regulation 12 (safe care and treatment).
Maintaining and servicing decontamination equipment appropriately is essential to ensure that equipment performs to an optimum standard. This should be done in accordance with the manufacturer’s instructions. In the absence of these instructions, the various periodic tests and schedules for decontamination equipment can be found in:
Mandatory requirements
Professional guidelines: Pressure Systems Safety Regulations 2000
Sterilisers are maintained by an appropriate and competent person. As sterilisers are pressure vessels, a suitable written scheme of examination needs to be in place for each one. Once in place, sterilisers need to be examined in accordance with the written scheme of examination. The maximum interval between these safety inspections is 14 months. Current certification must be available for inspection.
Professional guidelines: HTM 01-05: Decontamination in primary care dental practices
All decontamination equipment should be validated, tested, maintained and serviced as recommended by the manufacturer. Validation is needed for new decontamination equipment at installation and annually thereafter.
A record of every single sterilisation cycle should be made. This record should demonstrate that the steriliser is working within validated parameters such as time, temperature and pressure, using the machine’s own indicated measurements on the display.
Records need to be kept for a minimum of two years.
Recommended practice
Professional guidelines: HTM 01-05: Decontamination in primary care dental practices
Best practice:
- Use data loggers.
- Store data copy records on a computer with easy access.
Acceptable practice to meet Essential Quality Requirements:
- Carry out periodic tests in accordance with the manufacturer’s instructions or as set out in HTM 01-05 for:
- sterilisers
- ultra-sonic baths
- washer disinfectors
- Documentation should be available for inspection
- Keep hard copy records with the steriliser log book, either within the log book or in a separate folder.