What is the Different between Validation, testing service and maintenance of benchtop autoclaves?

We are always asked what the difference between servicing, validation and PSSI (PVI) of benchtop autoclaves is.

The servicing aspect includes ensuring the device is mechanically and electrically operating safely and correctly. The autoclave has water and steam passing through it so the plumbing will need attending to.

While servicing is important, it is completely different from autoclave validation. The validation process ensures that the steam penetration, pressure, time, and date functions are performing as they should. It also confirms that the bacteria is completely killed once the sterilisation cycle is complete.

To complete this task effectively, Dental Decontamination uses independent wireless temperature and pressure probes, calibrated regularly.

HTM01-05 Section 11.1 states… All decontamination equipment should be subjected to validation, testing, maintenance and servicing as recommended by the manufacturer/ supplier. All records of these procedures should be retained for audit/inspection.

HTM01-05 Section 12.1 states. The sterilizer should be maintained and serviced following the manufacturer’s instructions

Dental Decontamination are extremely thorough when it comes to annual validation and support practices with periodical testing carried out by the decontamination lead.

Dental Decontamination carry out the following tests:

VACUUM AUTOCLAVE VALIDATION

1. Maintenance and Safety Checks
2. 1st Air Leakage Test
3. 2nd Air Leakage Test [Equipment Attached]
4. Thermometric Tests for a Small Load
5. Automatic Control Test [ACT]
6. Verification of Calibration of Steriliser Instruments
7. Steam Generator Overheat Cut-out Test
8. Thermometric Tests for a Full Load
9. Thermometric Tests for a Solid Load & Dryness Test
10. Air Detector System Function Test
11. 3rd Air Leakage Test
12. Steam Penetration Test

NON-VACUUM AUTOCLAVE VALIDATION

1. Maintenance and Safety Checks
2. Steam Generator Overheat Cut-out Test
3. Thermometric Tests for a Small Load
4. Automatic Control Test [ACT]
5. Verification of Calibration of Steriliser Instruments
6. Thermometric Tests for a Full Load
7. TST Steriliser Test

All steam sterilisers are subject to the Pressure Systems Safety Regulations 2000 and must be examined periodically by a Competent Person (Pressure Vessels).

When the devices are correctly validated they can future proof the device as the independent probes will highlight any malfunctions.

Statutory guidance

Standards References:
BS EN 13060
BSEN 17665
MDA DB 2002 (06)
MDA DB 9804
Guidelines: Health Technical Memorandum 01-05 (2013) re N

Author – Nigel Bannister MD Dental Decontamination Ltd