Sterilisation

This section highlights the changes in the section 'Sterilisation' from the 2009 and 2013 editions of HTM 01-05.

4.0 Sterilisation

The information below shows the paragraphs from HTM 01-05 2013 Edition Section 4.0 that have changed from those within HTM 01-05 2009 Edition.


Paragraph 4.3

Records are required for every sterilization cycle.

What the changes mean and how do they affect your practice?

If you have a data logger, sterilisation cycles will be automatically captured. Likewise if you have a printer then all the printouts should be retained.

If you have neither of these then the only other recognised method to log data is to manually record the parameters of each cycle. Having someone watch each sterilisation process is usually unachievable. A pragmatic approach would be to use in each cycle a Class 6 TST strip which will only change colour if the temperature and time element of the sterilisation cycle are met.

If you have a faults table in your machine logbook, such as that within the range of Isopharm logbooks, you would need to record any cycle failure. This compensates for the ‘absence of a failure light’.

Having Class 6 TST strips as evidence of cycle performance should be evidence enough to prove that the cycles have been performed successfully.


Paragraph 4.7

Practices can seek the advice on the decontamination of handpieces from the handpiece manufacturer. Dental handpieces are constructed with a number of features that are difficult to clean and sterilise.

What the changes mean and how do they affect your practice?

This is not a major change to what was previously written in the 2009 Edition. The 2013 Edition provides the additional advice that the specific manufacturer's recommendations should be sought to determine how they should be decontaminated.


Paragraph 4.16

A record of the temperature and pressure achieved at the daily test, to ensure this is satisfactory before the autoclave is used for sterilizing instruments.

What the changes mean and how do they affect your practice?

The 2013 Edition provides less information than the 2009 Edition although the implication remains the same.

A daily periodic test (known as the automatic control test) should be carried out to ensure that the temperature and pressure of the autoclave are within the appropriate parameters. Once that information has been ascertained then the autoclave can be used to sterilise instruments.


Paragraph 4.19

The manufacturer’s advice should be sought on whether the daily tests can be carried out while instruments are being reprocessed.

What the changes mean and how do they affect your practice?

There are now instances where manufacturers may advise that a daily periodic test (the steam penetration test on a vacuum steriliser for example) can be carried out with instruments present within the chamber rather than the test being carried out using a separate cycle with an empty chamber.

Unless manufacturers say that this is an approved method of testing then it is advised that the test still be carried out independently of instruments being processed.


Paragraph 4.21

Any instruments processed in an unsuccessful cycle should not be used.

What the changes mean and how do they affect your practice?

An additional comment within the 2013 Edition, primarily for clarity. Instruments that have been decontaminated using a process that has failed should not be used until they have been reprocessed.


Paragraph 4.22 (a)

These instruments are suitable for storage for up to 12 months in their original packaging as long as their packaging is intact.

What the changes mean and how do they affect your practice?

This is a textual amendment to incorporate the new storage guidelines.

For more information on storage of instruments please see the relevant sections of the Isopharm website.


Paragraph 4.22 (b)

Immediately after removal from the sterilizer, instruments should be aseptically wrapped using suitable sealed view packs. This could be achieved by the use of forceps, clean gloves or any other appropriate process. In addition, the entire tray may be placed within a sealed pack for storage purposes. In both of these instances, storage for up to 12 months is recommended.

What the changes mean and how do they affect your practice?

This is a textual amendment to incorporate the new storage guidelines.

For more information on storage of instruments please see the relevant sections of the Isopharm website.


Paragraph 4.27

Unwrapped instruments should be transported and stored in a way that minimises contamination. Appropriate personal protective equipment is required for the aseptic transfer of instruments from a type N steam steriliser for storage (see paragraph 6.13). The worktop on which the tray or shelf of instruments is to be placed must be cleaned with a pre-prepared or single-use disinfectant wipe and allowed to dry. The decontamination area should be cleaned after each decontamination cycle is completed. The most important factor is to prevent direct or indirect contamination with patient blood and body fluid.

What the changes mean and how do they affect your practice?

This is an additional paragraph within the 2013 Edition which relates to the ‘clean’ area of the decontamination room when removing unwrapped instruments from a steriliser.

The decontamination room should be subject to cleaning after every use.

Contaminated instruments must never be placed on the work surface in the clean area of the decontamination room and vice versa.