BESTPRACTICE. HTM01-05 Q&A: You can now follow us on Twitter! We have launched our HTM01-05 questions and answers service on Twitter.

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1 ISSUE 4 BESTPRACTICE For Essential Requirements, hand washing is still a viable method of cleaning your instruments, but how do you validate for compliance with HTM01-05? 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 HTM 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 Isopharm Sentry example of a weekly manual validation cleaning schedule with space to record test results, product used and who carried out the test. 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 HTM01-05 Q&A: You can now follow us on Twitter! We have launched our HTM01-05 questions and answers service on Twitter. Questions posed to us through our HTM01-05 website are also tweeted to all our followers. Follow us on Click the Twitter link on to see the latest HTM01-05 information from Isopharm Sentry.

2 PRODUCT FOCUS How to use: STEP 1 Remove the swab from the holder and add two drops of sterile water. Product Focus: Protein Residue Testing: Cleantrace Test Pens Cleantrace is an easy way to perform the HTM01-05 weekly protein residue test on your ultrasonic cleaner and washer disinfector. STEP 2 Swab your instrument. STEP 3 Replace the swab into the pen and click down into the cap. STEP 4 Wait 10 minutes. STEP 5 Take your colour reading (green is a pass), and dispose of the pen. STEP 6 Record the results in your machines log book. SEN-3023A Pack of 25 Cleantrace Protein Detection Pens vat RRP Order online vat SEN-3023P Pack of 50 Cleantrace Protein Detection Pens vat RRP Order online vat SEN-3023 Pack of 100 Cleantrace Protein Detection Pens vat RRP Order online vat During the weekly protein residue test, are Cleantrace pens used without an incubator satisfactory to pass HTM 01-05? There are two ways to obtain results from the Cleantrace pens. The easiest method is to simply take the colour reading ten minutes after swabbing an instrument. The other method is to incubate at 37 C for 45 minutes after swabbing. The reason for incubation is that the colour change reaction is more sensitive when incubated and will provide a test result that is equivalent to a protein test described in the hospital HTM guidelines. Incubating the pen produces a more sensitive test result whilst ensuring the test is repeatable. Both methods are currently used to comply with HTM guidelines in hospitals and it is the same within dental practices. If you have been given no instruction from your PCT then it is our view that as long as you are performing a protein test once a week, incubated or not, then you are complying with HTM If you are unable to obtain information on the subject from your PCT then using the pens without an incubator means that you are at the very least still performing a protein test which is what HTM01-05 requires. I recently purchased the Clean Trace test pens. After the first test, the tip and solution turned green within 10 minutes. Today, I have gone back and the solution is purple! Are we supposed to keep the tested pens for evidence or does this mean there is protein present on our instruments? Please help! When using Cleantrace you should only rely on the colour reading at the time of the test. After a few hours the pen will change to purple regardless of the result at the time of the test. Each pack of Cleantrace is supplied with a batch number and an expiry date and it is these that should be recorded as evidence as well as who performed the test and whether the result was a pass or a fail. The pen should be disposed of safely when the test is completed. ISL dental log books provide you with all the necessary documentation to create evidence of this and all other HTM01-05 required tests, details can be found on our website.

3 Myth BUSTING ISL HTM01-05 Myth Busting: The Automatic Control Test Have you been told that having a printer or data logger recording cycle process data from your sterilizer means that you do not have to perform the daily HTM01-05 automatic control test?? According to HTM01-05 this may or may not be correct; this aspect of the guidance document has been interpreted in several different ways The automatic control test This is a daily procedure that demonstrates that the cycle is functioning as intended. Using a stopwatch, the observer should note the length of the sterilizer stage, the minimum and maximum temperatures and pressure reached using the machines own display. A successful test should demonstrate that: The machine is operating at the correct temperature and pressure during sterilization as stated in the machines own manual. The door cannot be opened until the cycle is complete A Cycle Complete message is displayed The aim of the automatic control test is to ensure that the cycle is a repeatable process. Logging these cycles will show the observer if the machine deviates from normal operating parameters. Interpretations of the guidance Ever since the launch of the NHS hospital guidance HTM2010 back in 1995 it has been common place to use printers and data loggers as a means to document cycle data automatically and not perform the daily automatic control test. HTM01-05 does state that you do not have to manually record process data if you have a printer or data logger attached however does not actually refer to the automatic control test itself. In the section that states how to perform the test there is no advice as to the role of a printer or logger attached to the machine. This leads to the question of whether you still need to perform the manual test even if you have an automated logging device recording cycle data. The full requirements of the test obviously cannot be performed by an independent cycle monitor. Checking that the door cannot be opened is a good safety check that should still be observed and most cycle loggers are not able to monitor pressure. HTM01-05 does indicate reference to the Medical Devices Agency bulletin MDADB2002(06) for many procedures. This document contains specific instructions that the Automatic Control Test does not need to be performed if a logging device is fitted to the machine. Many PCTs are in agreement with MDADB2002(06) and are advising that the Automatic Control Test is not required if a cycle logger is fitted. In some areas however, PCTs are requiring manual recording to be done alongside automatic logging ensuring a human element to the procedure as HTM01-05 seems to imply. What to do The first port of call must be to your PCT to enquire what specifics they require regarding the Automatic Control Test. If you are unable to obtain this information then you should be able to rely on the documents that HTM01-05 refers to and that is MDADB2002(06). You should try to obtain a copy of this document as evidence of why you are not performing the Automatic Control Test manually. One thing to note is that if you are relying on an automated method of collecting cycle data you must indicate that you yourself are monitoring the information being created. The manual test is done and logged so that you have evidence of your machine working within cycle parameters. You should review automatically collected data regularly to ensure you know how your machine is performing.

4 Purchasing New Equipment? Make sure you know the cost of ongoing validation before you buy! The range of decontamination machines available is enormous, all of which are probably marketed as HTM01-05 compliant. It is difficult to compare machines that offer the same quick and efficient processing of surgical instruments so price is the obvious fallback position when choosing. But be warned: The machine you purchase may be a lot cheaper than its rival however the ongoing cost of HTM01-05 validation testing daily and weekly often eclipses the initial saving. Sterilizers are a very good example of this. A type S vacuum sterilizer will be cheaper than a type B vacuum sterilizer. However, looking at just one of the tests HTM01-05 requires you to perform daily, the Steam Penetration Test, you can see the huge difference in daily cost: Steam Penetration Test Method #1 TYPE B HELIX TEST Steam Penetration Test Method #2 TYPE S HELIX TEST Steam Penetration Test Method #3 BOWIE DICK TEST Some vacuum sterilizers are able to make use of the type B steam penetration helix test SEN At vat for 250 tests this is the cheapest method of performing the daily steam penetration test but only if your machine is able to process it. Be warned that not all type B sterilizers will pass the type B helix test! What it is: A TST strip is sealed at the end of a length of tubing. The sterilizer must be able to pull all the air out of the tube and push steam back into it to contact the TST strip. The strip will change colour indicating a pass result. DAILY COST 0.40+vat YEARLY* COST vat Some vacuum sterilizers require a specific helix test that the manufacturer has validated for use with their particular sterilizer. An example is E which provides 100 tests for vat. What it is: A TST strip is sealed at the end of a length of tubing. The sterilizer must be able to pull all the air out of the tube and push steam back into it to contact the TST strip. The strip will change colour indicating a pass result. The difference between a type S helix and a type B helix is usually the length of the tube. DAILY COST 2.69+vat YEARLY* COST vat Some vacuum sterilizers, type B and S, are not able to pass a helix test and must make use of Bowie Dick test packs to prove the steam penetration capability of the machine. An example product is SEN-1015 which provides 20 tests for vat. What it is: The pack is made up of many sheets of porous paper with a TST indicator in the middle. The sterilizer must be able to pull all the air out of the pack and push steam back into it to contact the TST indicator. DAILY COST 3.18+vat YEARLY* COST vat * Based on one test daily for five days a week for fifty two weeks 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.

5 ISL HTM01-05 Questions & Answers At Isopharm Sentry we are inviting questions to be posed regarding HTM01-05 and the decontamination process. You can send us your questions using the form at. Recently asked questions: Can the ultrasonic cleaner foil test be carried out by the practitioner or must it be carried out by an engineer? The foil test does not have to be carried out specifically by an engineer and can be done by the practitioner. HTM01-05 requires that this test is performed once a quarter; however some machine manufacturers are requesting this to be done with more regularity. You should contact the manufacturer to see if they have their machines specific test schedule as this 'overrules' HTM If the manufacturer does not have a specific test schedule then you must follow the guidance within HTM01-05 and perform the test yourself each quarter. 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. Does an ultrasonic cleaner require weekly protein tests or can I just carry out the foil test? According to HTM01-05 you have to perform both the foil test and the protein test on your ultrasonic cleaner. 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 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 HTM 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. Regarding the daily automatic control test for autoclave machines; is it true we have to record the process for EACH cycle or just once daily if done manually along with test strips for compliance with HTM01-05? As far as we are aware HTM01-05 requires this to be performed once daily, not on each cycle. The procedure demonstrates that the cycle is functioning as intended. The observer should note the length of the sterilizer stage, the minimum and maximum temperatures and pressure reached using the machines own display. A successful test should demonstrate that: 1) The machine is operating at the correct temperature and pressure during sterilization as stated in the machines own manual. 2) The door cannot be opened until the cycle is complete 3) A Cycle Complete message is displayed The aim of the test is to ensure that the cycle is a repeatable process. Logging these cycles will show the observer if the machine deviates from normal operating parameters. Our dental log books provide you with record keeping for this and all other HTM01-05 tests: Although this is as HTM01-05 states, it should be noted that your PCT may have different requirements for this and other tests. You should contact them to make sure you are performing tests to their requirements.

6 Have you got to use an ultrasonic bath, or can you just do hand scrubbing and then process in the autoclave - we do not have a washer dryer 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 HTM 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 hand washing method you could apply this same weekly check to back up your procedure. During the weekly protein residue test, are clean trace pens used without an incubator satisfactory to pass HTM 01-05? There are two ways to obtain results from the Cleantrace pens. The easiest method is to simply take the colour reading ten minutes after swabbing an instrument. The other method is to incubate at 37 degc for 45 minutes after swabbing. The reason for incubation is that the colour change reaction is more sensitive when incubated and will provide a test result that is equivalent to a protein test described in the hospital HTM guidelines. Incubating the pen produces a more sensitive test result whilst ensuring the test is repeatable. In answer to your question, both methods are being used in PCTs across the country to comply with their HTM guidelines. It is the PCT that should clarify which method they want you to use, however this information may not be readily available. Our opinion on the subject is that if you are not able to obtain an official test method from your PCT then use the Cleantrace pens without an incubator. The majority of dental practices we have been in contact with are using the ten minute method rather than purchase an incubator they may not actually need. Some practices have purchased an incubator for the test but this is purely due to the instruction from their PCT. Both methods are currently used to comply with HTM guidelines in hospitals and it is the same within dental practices. If you have been given no instruction from your PCT then it is our view that as long as you are performing a protein test once a week, incubated or not, then you are complying with HTM If you are unable to obtain information on the subject from your PCT then using the pens without an incubator means that you are at the very least still performing a protein test which is what HTM01-05 requires. It is worth noting that you should only take the colour reading at the time of the test as the pen will change to purple after a few hours. When documenting your test results you should provide evidence of the Cleantrace batch number and expiry date as well as time of test, test result and who carried out the test. We have just received your Clean Trace pens. Can you advise on the source of sterile water for moistening the swab during the test? Is the distilled water we prepare for the Autoclave suitable? Cleantrace requires the swab to be moistened so that it has a better chance of picking up residual protein from an instrument. 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. Ask Isopharm Sentry your HTM01-05 questions at

7 Best Practice Back Issues A new lease of life for older decontamination equipment RRP vat Installation not included Logs all your decontamination process data electronically No more paperwork and easy record retrieval All data stored in an encrypted format Provides evidence of your due diligence and Good Practice For ultrasonic cleaners, washer disinfectors and sterilizers Provides instant local indication to the Operator of pass or failed cycles Visit for an online demonstration Designed, developed and manufactured in the UK by Isopharm Sentry Limited You can view the articles from previous editions of Best Practice on our website by visiting the News & Information section. You can also sign up to ensure you receive future copies ONLINE STORE 10% DISCOUNT CODE: BP4MAR11 PCD & CEI Test Soil Starter Kit For use in the HTM01-05 cleaning efficacy test. Test soil strips with a process challenge device to test the cleaning efficacy of a washer disinfector or ultrasonic cleaner. Kit contains 10 CEI test soil strips and a PCD process challenge device. Code Description RRP ONLINE SEN-3135 PCD & CEI Test Soil Starter Kit vat vat Scican Statim Process Challenge Device For use in the HTM01-05 steam penetration test. A process challenge device that provides a colour change passed or failed result. Type S for Statim 2000S and 5000S only (not suitable for extended cassette machines). Code Description RRP ONLINE SEN-1221 Process Challenge Device vat vat SEN Test Strips for Process vat vat Challenge Device Ultrasonic Activity Test Kit For use in the HTM01-05 ultrasonic activity test (foil test). Kit containing all products as stated in HTM01-05 for the detection of ultrasonic activity. Code Description RRP ONLINE SEN-3043 Ultrasonic Activity Test Kit vat vat Vacuum Sterilizer Helix Test (Type B Sterilizers) For use in the HTM01-05 steam penetration test. A hollow load process challenge device for type B sterilizers that provides a colour change passed or failed result. Includes 250 test strips. Please ensure before purchase that your sterilizer is able to process the device successfully. Code Description RRP ONLINE SEN-1230 Vacuum Sterilizer Helix Test vat vat (Type B Sterilizers)

8 Are you looking for manufacturer s instructions on how to validate your machines? ISL can help! With the amount of interpretation regarding HTM01-05, testing schedules and products there will be some dental practices that have purchased tests only to find that it is either not suitable for their machine or not required at all. HTM01-05 presents a universal schedule of tests for validating your decontamination machines and then directs you to the manufacturer for further clarification. For a dental practice with varying machine types this is not an easy task. There will be some dental practices that have purchased product to comply with HTM01-05 only to find that what they have bought is either not compatible with their machine or not even needed. For example, HTM01-05 requires that the steam penetration test is performed once a day on a vacuum sterilizer and you use either a helix test or a bowie dick pack. This sounds straight forward, but there will be many dental practices who have bought a version of these products only to find that their machine cycle fails the test. This is why manufacturer instructions for testing are important as they inform you what product is compatible with your specific machine to perform the test to comply with HTM Going back to the steam penetration test example, you also need to be aware of the type of cycle you are validating. A type B steam penetration test will not work with a type S vacuum sterilizer. Isopharm Sentry has collected a great deal of test information from manufacturers since the release of HTM We are helping dental practices find out exactly what tests need to be done, what products need to be used and what the manufacturers test schedule is. Our website has an online questionnaire where you can tell us exactly what machines you are using in your decontamination process. We will then provide you back with the correct HTM01-05 test procedures based on the manufacturer s own recommendations and identify the products you need to comply. ISL Dental Log Books 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 HTM We have been using the autoclave log books designed by Isopharm Sentry for the past 2 months now and they have proved invaluable. They are clear, concise and easy to use and are designed to reduce your HTM01-05 compliance workload. Shelley Hodgson - Practice Manager, Rawmarsh Dental Practice Each log book provides you with a years worth of test record keeping in compliance with HTM01-05 SEN-0105-UCLB Dental Ultrasonic Cleaner Log Book vat vat ONLINE SEN-0105-WDLB Dental Washer Disinfector Log Book vat vat ONLINE SEN-0105-BSLB Dental Benchtop Sterilizer Log Book vat vat ONLINE Isopharm Sentry Limited, The Validation Centre, Thornbury Hill Lane, Near Firbeck, Rotherham S81 8JW Tel: +44 (0) Fax: +44 (0) (sales) +44 (0) (accounts) info@isopharm-sentry.com