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.

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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.

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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.

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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/

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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.

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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

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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.

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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

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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.

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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

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ISL Answers: There are two tiers to HTM01-05; 'Essential Requirements' and 'Best Practice'.

Compliance to essential requirements is required by April this year. No date has been given for compliance to best practice.

According to HTM01-05, to comply with the initial essential requirements you must have a validated method of cleaning and disinfecting your instruments prior to sterilization. This means that you can continue to hand wash, but only if you can prove that it is done consistently each time, and that is what is meant by a validated method. You need repeatability and evidence of repeatability in order to comply, whether you are hand washing or processing through a machine.

To qualify for Essential requirements you can hand clean instruments, process them through an ultrasonic cleaner or both. Many practices prefer both and have implemented this for a number of years. In order to qualify for Essential requirements you need to be able to validate these methods and provide evidence of the validation.

Using an ultrasonic cleaner provides you with a validated, repeatable method of cleaning your instruments that is easier to prove than hand washing. However, section 3.33 (page 20) of HTM01-05 tells you how to organise a validated method of hand washing instruments that is repeatable and provides evidence of the fact.

Best practice requires you to use a washer disinfector but this is not required yet unless your PCT tells you otherwise. You should ask your PCT how they want you to process your instruments. If you are not able to obtain this information then you need to rely on HTM01-05.

When using an ultrasonic cleaner a weekly HTM01-05 requirement is a protein residue test using a product such as Cleantrace (www.htm01-05.com/inc/sdetail/2534). This test proves that all surgical soiling is being removed from an instrument prior to sterilization. To further validate your hand washing method you could apply this same weekly check to back up your manual cleaning procedure.

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Ensuring your instruments are clean and free of contaminant prior to sterilization is vital to the decontamination cycle. If an instrument is not clean it cannot be sterilized. Any debris will prevent steam contacting the surface so even if your sterilizer passes the process, the load will not be sterile.

Essential requirements are the current goal with regards to compliance with HTM01-05. To comply with essential requirements you must have a validated method of cleaning your instruments prior to sterilization whether you hand wash, use an ultrasonic cleaner or a washer disinfector. Essential requirements needs you to include just one of these methods, however you must be able to prove that the process is repeatable and validated.

Proving this with an ultrasonic cleaner or a washer disinfector is relatively easy. The process is mechanical, there are test products available to check the effectiveness of the cycle and results are documented in a log book.

Hand washing instruments is a much more difficult process to validate and probably the reason why HTM01-05 consistently pushes for repeatable mechanical processes over manual cleaning. Decontamination machines are an expensive investment and one that will be required upon a release date for Best Practice. Until then, if it is at the moment practice policy to manually clean and you do not own an ultrasonic cleaner or washer disinfector, it may be worth while persisting with it during this current period of uncertainty. If this is the case then you must be able to prove the validity of your chosen cleaning process.

It should be noted that even if you are using machines to clean, every practice should maintain a manual cleaning process in the event of breakdown with staff aware of the responsibility of this aspect of the decontamination process.

So how do you create a repeatable and validated manual process? HTM01-05 does contain a section regarding manual cleaning on page 63. These instructions are good and will help you create an extremely structured and repeatable process. Any instructions you create should be clearly visible at the point of cleaning. The question then is how to validate the procedure.

When validating the cleaning efficiency of an ultrasonic cleaner or washer disinfector you should visually inspect a processed load once a day then chemically inspect a processed load once a week. The same protocols can be applied to validate your manual cleaning. As part of your instructions indicate that a daily visual inspection for signs of contaminant should be performed, preferably by a different person from the one who manually cleaned to add further weight to the validation. Then once a week perform a chemical check using a protein detection pen such as Cleantrace to back up the visual check, just as you would with a mechanical process. Make sure that you record the batch number and expiry date of which ever product you use as evidence of the test.

Information relating to protein detection methods can be found on our website www.HTM01-05.com

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Have you been told that you need to purchase and install a washer disinfector to comply with HTM01-05 ‘essential’ requirements?

According to HTM01-05 this is incorrect.

The information found on pages 11 and 15 of HTM01-05 clearly states that a washer disinfector is required for best practice requirements not essential requirements. It is essential requirements that will be audited from April 2011, or earlier depending on your PCT.

The decontamination process for surgical instruments is clean, disinfect and sterilize. Most dental practices will already be hand washing and/or processing through an ultrasonic cleaner prior to sterilization. The importance of the first two stages is huge, sterilization cannot take place if an instrument is not clean and disinfected.

According to HTM01-05, to comply with the initial essential requirements, which is the first tier of decontamination auditing, you must have a validated method of cleaning and disinfecting your instruments. This means that to comply with HTM01-05 essential requirements you can continue to simply hand wash, but only if you can prove that it is done consistently each time, and that is what is meant by a validated process. You need repeatability and evidence of repeatability in order to comply, which ever HTM method of cleaning and disinfecting you choose to use.

A washer disinfector is the best method of cleaning and disinfecting your instruments. You can prove it works correctly using the tests described in HTM01-05 and therefore prove that every cycle is processing instruments in exactly the same way as the previous cycle. Most modern washer disinfectors are competent enough to not require instruments to be either hand washed or run through an ultrasonic cleaner prior to processing, however check with the manufacturer if this is the case. To qualify for best practice you will as part of the requirement need a validated washer disinfector, but a deadline for best practice has not yet been officially stated.

Essential requirements are currently scheduled to be audited from April, however some PCTs have asked for compliance sooner due to their own internal audits starting in preparation for the external audit process.

To qualify for essential requirements you can hand clean instruments, process them through an ultrasonic cleaner or both. Many practices prefer both and have implemented this for a number of years. In order to qualify for essential requirements you need to be able to validate these methods and provide evidence of the validation.

Section 3.33 (page 20) of HTM01-05 tells you how to organize a validated method of hand washing instruments that is repeatable and provides evidence of the fact. The document also tells you how to validate your ultrasonic cleaner as again you need to prove the machine is working as intended.

So for now, unless told otherwise by your PCT or decontamination auditor, you do not have to purchase a washer disinfector to qualify for essential requirements. However, whatever method of cleaning and disinfecting you use must be a validated and documented process.

The March 2011 issue of Isopharm Sentry’s HTM01-05 BEST PRACTICE newsletter has been released so contact us on our website www.HTM01-05.com to make sure you receive your copy.

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Firstly it is worth bearing in mind that there are two levels of compliance to HTM01-05, 'essential quality requirements' and 'best practice requirements'.

Essential quality requirements are what need to be in place for April 2011, although some PCTs are requesting this to be earlier so you need to check. Unless your PCT states otherwise, you do not actually have to have a washer disinfector to comply with essential quality requirements. As long as you have a validated method of cleaning your instruments prior to sterilization (whether this is hand washing, ultrasonic cleaner or washer disinfector) and are able to provide evidence of validating whichever process you use to an auditor. HTM01-05 provides ways to validate all these methods. You can also contact Isopharm Sentry for advice.

Best practice requirements however do stipulate the use of a modern validated washer disinfector and you will need to check with your PCT as to when they require you to conform to this level of HTM01-05.

If you already have a washer disinfector then you may not need to use an ultrasonic cleaner as well. The manufacturer of the washer disinfector can tell you this so you need to contact them for an official reply. As your decontamination process will be audited we would advise getting this in writing so that you can show an auditor why you are not using an ultrasonic cleaner. If the manufacturer states that you need to use an ultrasonic cleaner before processing though their washer disinfector then this is what you should do.

Isopharm Sentry has an extensive knowledge base of manufacturer instructions and guidelines so contact us to see how we can help you comply.

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As far as we are aware there have been no indications as to the role of
the non vacuum sterilizer with regards to Best Practice.

HTM01-05 only indicates progression towards achieving best practice and
highlights the following:

1) The installation and use of a washer disinfector for cleaning
instruments.
2) Separating the decontamination process from other dental practice
activities ie: creating a dedicated decontamination room with distinct
areas and flow for dirty to clean to sterilized instruments.
3) Improved storage of instruments after the decontamination process.

Sterilization using a vacuum autoclave allows you to package instruments
and keep them stored sterile longer. Vacuum sterilizers are also capable
of processing loads defined as hollow, something that a type N autoclave
can not do.

It is possible that at some point Best Practice will require the use of
a vacuum sterilizer but at the moment we have seen no indication of
this. It may be that the need for vacuum machines will be looked at when
the requirement for a dental practice to use a washer disinfector has
been achieved. This would be sensible as the introduction of HTM01-05 is
costly enough as it is without having to upgrade sterilizers as well as
obtain a washer disinfector.

If you are looking to purchase a vacuum sterilizer you should also look
at what is required on a daily basis for validation to HTM01-05. Cheaper
sterilizers may in fact cost far more in ongoing validation consumables
than the price saving between different types of vacuum machines.

Visit www.HTM01-05.com for a list of machine manufacturers and the
Isopharm Sentry range of decontamination validation test consumables.

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You will need to keep the foil strips as evidence of the test. Our
dental log books provide you with all the logging requirements of this
and all other HTM01-05 tests in one 12 month book for presenting to an
auditor. There is a section in the ultrasonic cleaner log book for you
to be able to adhere your foil test strips.

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

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The protein test will assess the ultrasonic cleaner's ability to remove
surgical soiling (protein) from an instrument. HTM01-05 states that this
must be done once per week on a processed load. An example of a protein
test is Cleantrace. More information on this product can be seen on our
website:
www.htm01-05.com/inc/sdetail/2534

The foil test will assess the ultrasonic cleaner's level of cavitations
during the cleaning process. Underneath the bath there are transducers
that cause the cavitations in the liquid. They are usually spread evenly
in a three by three grid, depending on your bath. The strips of foil
used in the test are themselves positioned in a three by three grid to
ensure each transducer is monitored. During the process the cavitations
will erode the edges of the foil. After the process the foil strips are
compared with each other to make sure that an even amount of erosion has
taken place. If you find that one of the foil strips has no or very
little erosion this may indicate that one of the transducers has failed.
The test is checking that an instrument placed on one side of the bath
is achieving the same level of cleaning as an instrument in another part
of the bath. HTM01-05 requires this test to be performed once a quarter.

The above information is based purely on HTM01-05. It would be worth
checking to see if the manufacturer of the ultrasonic cleaner has a
HTM01-05 test schedule. Throughout HTM01-05 the guidance directs the
reader to contact their machine manufacturer as they are the authority
on how to test their specific machine. The manufacturer can 'overrule'
HTM01-05 in the subject of how often a test is performed but make sure
you obtain written evidence of why you have deviated from the HTM01-05
test schedule.

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In answer to your question, you can use the distilled water that you use
in your autoclave to moisten the swab of the Cleantrace test pen.

This is often the preferred source as sterile water can be expensive and
only a couple of drops are actually required to moisten the swab.

Tap water is not suitable as there is no way to evaluate possible
contaminants that could influence the result of the test.

Please let me know if you require any further information or assistance.

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There are two tiers to HTM01-05; 'Essential Requirements' and 'Best
Practice'.

Compliance to essential requirements is required by April this year. No
date has been given for compliance to best practice.

According to HTM01-05, to comply with the initial essential requirements
you must have a validated method of cleaning and disinfecting your
instruments prior to sterilization. This means that you can continue to
hand wash, but only if you can prove that it is done consistently each
time, and that is what is meant by a validated method. You need
repeatability and evidence of repeatability in order to comply, whether
you are hand washing or processing through a machine.

To qualify for Essential requirements you can hand clean instruments,
process them through an ultrasonic cleaner or both. Many practices
prefer both and have implemented this for a number of years. In order to
qualify for Essential requirements you need to be able to validate these
methods and provide evidence of the validation.

Using an ultrasonic cleaner provides you with a validated, repeatable
method of cleaning your instruments that is easier to prove than hand
washing. However, section 3.33 (page 20) of HTM01-05 tells you how to
organise a validated method of hand washing instruments that is
repeatable and provides evidence of the fact.

Best practice requires you to use a washer disinfector but this is not
required yet unless your PCT tells you otherwise.

You should ask your PCT how they want you to process your instruments.
If you are not able to obtain this information then you need to rely on
HTM01-05.

When using an ultrasonic cleaner a weekly HTM01-05 requirement is a
protein residue test using a product such as Cleantrace. This test
ensures all surgical soiling is removed from an instrument prior to
sterilization. To further validate your handwashing method you could
apply this same weekly check to back up your procedure.

I hope that this answers your question, please let me know if you
require any further information or assistance.

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We have had similar questions from many practices wanting to know more about the residual air test.

The residual air test is performed to determine the amount of air left in a vacuum sterilizer chamber after the initial air removal function of the cycle but just prior to the sterilization process. If too much air is present in the chamber this may prevent steam touching all parts of the load and increases the likelihood of un-sterilized instruments.

Many modern sterilizers can perform this test at the push of a button. If your machine can perform the test and then present you with a visual pass or fail result then you must carry out the test once a week and log the results in the machines logbook. 

If your machine cannot perform the test automatically then only a qualified engineer can do this test for you, ideally when visiting your practice to carry out your quarterly or annual machine validation and service.

You will need to look at your machine manual for indication of this test. If you cannot find reference then you should contact the manufacturer for clarification. If the test can only be done by an engineer then you also need the manufacturer to confirm this. An auditor may enquire as to why you are not performing the test weekly and you need the evidence from the manufacturer to support your schedule for the residual air test.

If you require any further assistance.

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