HTM 01-05 Dental Decontamination

HTM01-05 recommends that sterilization records should be kept for no less than two years (HTM01-05 page 22 section 4.3).

Hospitals do keep similar records for much greater lengths of time, sometimes up to 25 years. This is because cases of cross infection can be instigated many years after the supposed infection was contracted.

How long to keep records is the decision of the practice, compliance with HTM01-05 simply requires that this be greater than two years.

You can download a digital copy of the latest guidance document from the following location:

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_109363

A hardcopy was sent to all practices quite some time ago however you may be able to request a copy from the Department of Health via their website or by contacting their customer services on 020 7210 4850.

The purpose of the engineer validation on any type of decontamination machine is to prove that the process is functioning correctly. For a washer disinfector and a sterilizer this always requires a qualified engineer regardless of make or model.

Ultrasonic cleaners however are a little different. They range from larger units with digital readouts and temperature sensors to smaller single transducer baths. The difference in functionality is vast.

The first task must be to discover what the manufacturer requires you to do. We have manufacturer recommendations listed on our website at the following address:

http://www.isopharm-sentry.com/htm01-05/testing-validating-manufacturer-guidelines/

If you do not know what the manufacturer requires then it is our opinion that on a typical ultrasonic cleaner used in a dental practice the validation can be carried out by the practice itself. The tests that HTM01-05 requires you to perform daily, weekly, quarterly and annually are the very tests that a validation engineer would perform. The only exception to this would be if the ultrasonic cleaner has temperature readout and this should be checked by an engineer as the Operator/User test schedule does not include this.

If your ultrasonic cleaners are basic units then we suggest that you validate the unit yourself with either the manufacturer recommendations or the test schedule from HTM01-05, both of which can be found at www.HTM01-05.com.

Commonly known as the ‘Foil Test’ or ‘Foil Ablation Test’, the Ultrasonic Activity Test ensures that the transducers beneath the bath are working and that instruments are being processed correctly no matter where they are placed within the tank.

The test is commonly performed with nine strips of foil. This is because the average amount of transducers in larger NHS Sterile Services ultrasonic cleaners is nine. Smaller ultrasonic cleaners in a dental practice may have only one or two transducers which is why some manufacturers do not require you to perform this test on some machines.

View the manufacturer HTM01-05 guidelines on our website to see if your manufacturer requires you to perform the foil test:

www.isopharm-sentry.com/htm01-05/testing-validating-manufacturer-guidelines/

If you are required to perform the ultrasonic activity test then the procedure can be found on our website:

www.isopharm-sentry.com/htm01-05/foil-test-instructions/

According to HTM01-05 instruments that have been processed within a Type N (non vacuum) sterilizer for use within the current session do not have to be wrapped as they are not considered to be 'stored'. You must however cover the instruments on the tray to protect against dust and aerosols. At the end of the session, any instruments that have not been used must still be reprocessed through your decontamination cycle.

If you are storing instruments, HTM01-05 indicates that after processing through a type N sterilizer the load must be immediately wrapped using appropriate pouches. Additionally you may also then wrap the entire tray in a further pouch. It is important to note that instruments must be dry before packing. HTM01-05 states that 21 days is the maximum storage period for instruments processed and stored in this way.

As far as we are aware, there are two tiers to HTM01-05: 'Essential Requirements' and 'Best Practice'.

Essential Requirements is the minimum level of compliance to HTM01-05 and was to be in place by 1st April 2011.

Best Practice compliance has not yet been given a launch date that we know of, however it is our opinion that this will be quite some time away as dental practices strive to comply with Essential Requirements.

Some PCTs are issuing their own level of compliance with HTM01-05 so you should ask your Dental Decontamination Lead at your PCT what they expect from you. If you are unable to obtain these details then you should look to instigate Essential Requirements as a minimum as this means you would be compliant to HTM01-05 at this time.

With regards to validating your decontamination process equipment, our website contains a great deal of information on what tests to perform, when to carry them out and also what products are available.

www.HTM01-05.com

Steam penetration testing is an aspect of HTM01-05 that requires research before purchasing product for the test. HTM01-05 is universal in its description of test terminology and does not go into specifics regarding methods of test. The document needs to be generic due to the amount of different machines currently in use.

Isopharm Sentry has researched manufacturer guidelines extensively to ensure the correct product is purchased. To perform the steam penetration test on a Little Sister 3 vacuum sterilizer you need to use Bowie Dick packs. Helix devices are not compatible with this machine.

There is a specific Bowie Dick pack you can use that has been validated by the manufacturer, details can be found here:

http://www.htm01-05.com/inc/sdetail/2314/2331

The use of Bowie Dick packs has led many owners to review the cost of ownership of their sterilizer. The steam penetration test is a daily requirement and using Bowie Dick packs for this is expensive.

If in the future you look to purchase a new vacuum sterilizer, as well as the machine price you must also ask what product is required to validate daily and weekly to comply with HTM01-05. The ongoing saving on consumables may quickly eclipse the initial saving on buying a cheaper sterilizer. Even some modern sterilizers still require the use of Bowie Dick packs for steam penetration testing.

Before you purchase any new decontamination equipment you must first find out what the specific HTM01-05 test schedule is and what products are required to comply. From this you can identify the products required to validate and see what the ongoing cost of the machine will be after purchase and installation.

The light magnifier should be used as part of the daily HTM01-05 Visual Cleaning Efficacy Test.

This is a test for both ultrasonic cleaners and washer disinfectors. Once per day and for each machine you need to visually inspect a processed load for any indications of soiling or staining.

The test is done to make sure that instruments being sterilized after the cleaning process are visually clean. If there is any debris on instruments to be processed through an autoclave they cannot be sterilized properly as this will prevent steam contacting parts of the load.

You also need to backup your daily visual inspection with a weekly chemical test and this is the HTM01-05 Protein Residue Test for ultrasonic cleaners and washer disinfectors. For this you need to use a protein detection pen such as Cleantrace, details of which can be found here:

http://www.htm01-05.com/inc/sdetail/2534

You will need to provide evidence of both the daily visual inspection and the chemical weekly test in order to comply with HTM01-05.

Isopharm Sentry provides dental log books that provide 12 months of record keeping sheets that include these and all other requirements of HTM01-05, details of which can be found here:

http://www.htm01-05.com/online_store_act_and_log_books

On 15^th March 2011 the Minister for Health and Social Services agreed to publish HTM01-05 Welsh Edition Decontamination in Primary Care Dental Practices. This will bring Wales in line with the rest of the UK with regards to decontamination guidance. HTM01-05 Welsh Edition will aim to provide guidance to dental staff involved within the decontamination process. The document will follow the same structure as the Department of Health guidance whilst taking into consideration current Welsh policies and structure.

HTM01-05 is not only about improving the validation of your decontamination processes, it is also about providing the evidence to back up what you have done to ensure a minimum risk of cross infection.

When being audited you will have to provide documentation showing what was done, when it was done and who did it. Simply verbally stating everyday procedures along with providing several reams of cycle receipts and a bag of used TST strips will not be good enough.

Each ultrasonic cleaner, washer disinfector and sterilizer should have dedicated records kept of all tests and servicing carried out by you and your service/validation engineer that can be produced to an auditor as evidence of your decontamination validation. All daily and weekly tests need to be recorded by the person responsible for carrying out the test.

Tests that have no physical consumables, such as the daily visual check for soiling and staining on instruments processed through an ultrasonic cleaner or washer disinfector, still have to be logged as being done. Tests that do use a consumable product, such as the weekly protein detection test on an ultrasonic cleaner or washer disinfector, should be supplied with a batch number and expiry date and it is these details that should be logged as evidence rather than keeping hold of hundreds of spent test pens.

The same could be said of TST strips used in sterilizers, an auditor may be happy just seeing a batch number and expiry date of the test used, although if it is already common practice to hold onto these strips then continue to do so until your first audit and query if you need to carry on saving them.

You also need to record the time and date of each test, the cycle number from the machine if possible as well as who carried out the procedure.

Your reporting must also be consistent. Missing test dates would indicate a system that is not under control. Consistent testing is perhaps the greatest challenge for busy dental practices so clear and consistent evidence templates showing what should be done and when is essential. A precedent for dental staff who process used instruments must be established if you are to pass an audit after next April.

Isopharm Sentry has created dental specific log books that aim to help a dental practice maintain a documented validation process by logging evidence to present to an auditor. The log books provide enough records for one machine for a whole year and include daily, weekly quarterly and annual sheets based on the test schedules within HTM01-05.

ISL log books can be found on the following pages of our online store:

Ultrasonic Cleaner Dental Log Book

http://www.htm01-05.com/inc/sdetail/2702

Washer Disinfector Dental Log Book

http://www.htm01-05.com/inc/sdetail/2703

Benchtop Sterilizer Dental Log Book

http://www.htm01-05.com/inc/sdetail/2704