Validation of ultrasonic baths, washer disinfectors and autoclaves
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 in England can be found in:
HTM, WHTM and SDCEP all require that the equipment used during the decontamination process are regularly checked by the practice daily and weekly. A qualified validation engineer should then check, quarterly or annually in accordance with the manufacturers guidance.
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 autoclave 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.
Pressure Systems Safety Regulations 2000 (PSSR 2000)
It is important that autoclaves are maintained by an appropriate and competent person. As autoclaves are pressure vessels, a suitable written scheme of examination needs to be in place for each one. Once in place, autoclaves 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.
Care Quality Commission
In England the CQC consider validation of decontamination equipment when they review if the practice is safe. This relates to regulation 15 (premises and equipment) and regulation 12 (safe care and treatment). Source: https://www.cqc.org.uk/guidance-providers/dentists/dental-mythbuster-12-validation-decontamination-equipment
- 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 (England) for:
- ultrasonic baths
- washer disinfectors
- Documentation should be available for inspection
- Keep hard copy records with the equipment log book, either within the log book or in a separate folder.