ISSUE 8 BESTPRACTICE Isopharm Sentry Limited Tel: +44 (0) 800 840 0105 TO POUCH OR T TO POUCH That is the question! This is a query that we get asked on numerous occasions. HTM 01-05 states: Instrument storage and wrapping recommendations: (i) where packaging is not applied, instruments may be stored on covered trays and used within that treatment session. Instruments will need to be reprocessed if not used within that treatment session; (ii) alternatively, if instruments are wrapped either before or immediately after decontamination, storage in accordance with (m) below should be applied. Develop a quality system approach so that the storage of wrapped instruments does not exceed 21 days for instruments sterilized in a nonvacuum (type N) sterilizer or 60 days if sterilized in a vacuum (type B or S) sterilizer So whilst HTM 01-05 states that you can use unpouched instruments if they are to be used in the same session the view that we at Isopharm Sentry take is somewhat different: below is our explanation why. If you don't want to pouch all instruments then you MUST use them within the same session: a session being defined as 'morning' or 'afternoon' therefore anything you didn't use before lunch must be reprocessed (sterilised) before the afternoon period starts. Likewise with overnight, if you didn't use it in the afternoon you have to sterilise before the next morning...this leads to a number of issues: 1) How can you be 100% certain that a nurse does not 'forget' to reprocess before the next session, even the most conscientious of nurses may not have time, or understand the relevance. 2) Instruments are not really meant to be left overnight unless absolutely necessary, if you have a number of instruments that haven't been used you are going to have this, you cannot put them in the autoclave and leave it running overnight because of the need to drain it so are your nurses expected to stay after the last patient and wait for the autoclave to finish? 3) Our biggest concern with not pouching: Patient perception......a patient who sees you open a pouch in front of them will get the impression that they are getting a 'fresh' set of instruments just for them, however they do not get the same impression with an open instrument taken from a drawer etc. ISL Dental Business Development Manager: Becky Blackmore ISL have had an exciting few weeks. Following on from a hugely successful exhibition at the dentistry show we have been inundated with calls and e-mails on compliance issues, which we are delighted to answer. We are continuously adding new products to our range we will continue to provide you informative articles relating to these products and all aspects of HTM01-05. t: +44 (0)7972 888 317 e: becky.blackmore@isopharm-sentry.com We have been busy out and about providing practice training sessions as well as arranging some hands on training sessions in our new purpose built decontamination room. Look out for more training dates coming soon. At ISL we strive to offer impartial advice and information on HTM01-05. For dental compliance guidance please contact customer services on +44 (0)800 8400105. Food for thought? How do you currently pouch your instruments? Have you considered pouching sets of trays, (you can get bags big enough)...this would reduce the amount of pouching needing to be done but still give the patients the same experience. Having attended a lecture recently where the Dental Protection spoke, their view on all aspects of infection control is that the tables have turned and the majority of cases they have to deal with (in relation to infection control) are where the patient feels they have not experienced the level of service they believe they deserve and whilst you could argue that you are following HTM 01-05 guidelines we believe that patient perception should be at the forefront of any practices mind. If you are pouching instruments and storing them It is important to ensure that the pouches do not exceed the storage date (as mentioned above). Finding you need that particular set of forceps that you use infrequently only to find the pouch has passed the 21 or 60 days rendering you unable to use those instruments is frustrating and could actually inhibit your ability to complete a particular procedure with relative ease. So what is required? The answer is simple, good housekeeping and a log! Ensure that your instruments are rotated, first in, first out which will ensure that frequently used instruments never surpass the expiry date Have a box/drawer of infrequently used instruments and have time set aside and a log to check this drawer at regular intervals (once or twice a week) Any instruments that are going to expire before your next check is due should be reprocessed.you may find that you are sterilising instruments before they have expired but as mentioned before it would be better to do that than not have the equipment that you need AT THE POINT AT WHICH YOU ACTUALLY NEED IT.
Practice Name The disinfection of impressions, prostheses and ortho appliances The responsibility of ensuring impressions have been cleaned and disinfected before dispatch to the dental laboratory lies solely with the dentist. Uncertainty of impression disinfection risks both the health of the receiving dental technician and potential repeat disinfection of an already disinfected impression with detrimental consequences for its dimensions HTM 01-05 states that impressions, prostheses and orthodontic appliances must be decontaminated prior to and after placing in a patients mouth. Decontamination of these devices is a multi-step process to be conducted in accord with the device or material manufacturer s instructions. The procedure should be as follows 1) Immediately after removal from the mouth, any device should be rinsed under clean running water. This process should continue until the device is visibly clean from saliva, blood or debris. 2) All devices should receive disinfection according to the manufacturer s instructions (Where these are available). This NEW IMPRESSION DISINFECTANT LOG BOOK ISL are pleased to present the impression disinfection log book to compliment our range of already very popular log books for testing and validation. The new impression log book is designed to allow you to record the disinfection of all lab work before sending to the lab and after receiving the work prior to placement in the mouth. will involve the use of specific cleaning materials, please visit for a range of suitable options After disinfection, the device should again be thoroughly washed. This process should occur before and after any device is placed in a patient s mouth. If the device is to be returned to a supplier/ laboratory or in some other fashion sent out of the practice, a label to indicate that a decontamination process has been used should be affixed to the package. There are two methods of disinfection: immersion and dipping. Immersion in disinfectant (following the manufacturer s recommendations if available for dilution and duration) can be effective but may be compromised by the limited working life of the disinfectant, which is affected by the frequency of use and the presence of biological debris. Dipping avoids the prolonged immersion that can distort hydrocolloid and polyether impression materials. The recommended contact time is still necessary, during which the impression must not be allowed to dry out. HTM01-05 Log Book Impression Disinfection Surgery (ie 1, 2, 3) Log Book Start Date Log Book End Date Please place this log book where all relevant personnel have access INTRODUCTORY OFFER Part No. LOGIM001 25.00+vat (RRP 30.00 +vat) Isopharm Sentry Limited, Decontamination Support Centre, Taylors Court, Rotherham, S62 6NU, United Kingdom Tel: +44 (0) 800 840 0105 Email: info @ isopharm-sentry.com For further information please call 0800 840 0105 or visit ISL Log Books are also available for your ultrasonic cleaner, washer disinfector, steriliser and manual cleaning process. Protein Testing Q & A Is cleantrace sensitive enough to perform the HTM01-05 weekly protein residue test? Protein detection tests in hospital sterile services, based on HTM2030, use what is known as the ninhydrin method. As the sensitivity of Cleantrace is better than the nunhydrin method, when incubated, it may be used for the weekly HTM01-05 test. Do I need to incubate Cleantrace? To obtain maximum sensitivity Cleantrace needs to be incubated, either at 37ºC for 45 minutes or 56ºC for 30 minutes. If Cleantrace is used without incubation its sensitivity is less than the hospital HTM2030 ninhydrin. As the HTM01-05 requirement was taken from HTM2030 any protein detection test needs to be at least as sensitive. What does incubation actually do to improve the Cleantrace test, does it alter anything? Similar to most chemical reactions the sensitivity of Cleantrace improves with temperature rise. Therefore incubation increases sensitivity of Cleantrace, which is a current trend with protein detection methods. As CJD/BSE is a protein material it is important that traces of these proteins is not carried from one patient to another via medical instruments. Incubators are an additional cost so is it my choice to decide whether I incubate the test or not? The incubation of Cleantrace reaction increases sensitivity. Therefore to obtain the best results from the test incubation is required. As an incubator is purchased only once its actual cost is divided by the number of tests performed to give the incubation cost per test. It is advised to incubate Cleantrace tubes to satisfy any audit inspection. If my machine manufacturer says I do not need to incubate the test, is that enough to satisfy HTM01-05 requirements? Any audit will take the contents of the HTM as a guide, not the advice of the machine manufacturer. Therefore the residual protein test should be as sensitive as practicable, not adjusted to the ability of the washer to clean. Protein detection is becoming more sensitive as new methods are devised. The equipment may need adjustment by the manufacturer to clean to a higher level and pass these tests. I tested Cleantrace myself to see what a fail result looked like. However the test passed even though there was a visible spot of staining on the swab which surely casts doubt on the test product. Cleantrace is a test designed to illustrate the presence of protein only. Staining of instrument may be due to a range of other reasons, such as rust stains, chemical or cement deposits. If several instruments show signs of staining it may be more to do with the quality of the instrument metal than protein deposits. Can I use tap water to moisten the swab? If the tap water can be shown to be protein free then it may be used. If in doubt use pure water, it may be obtained in small volumes for convenience of use. How long can I leave the swab if I am not incubating? If a Cleantrace swab is take from the test surface and replaced into the reaction tube, but not pushed down into the reaction liquid, it can be left for several hours. Once the swab is pressed into the reaction liquid the time should be measured in accordance with the manufacturers instruction, i.e. 30 minutes at 56 C. How long and at what temperature do I incubate? Cleantrace incubation: room temperature 10 minutes 37 C 45 minutes 56 C 30 minutes Why does the pen always change to purple after a few hours even though the test result was initially a pass? Similar to many chemical reactions it does not stop at the end of the test time. It is important to read the test result within a few minutes of the recommended incubation time else a negative result will slowly turn to a positive and is not valid. If a record is required of the result place the test swab on a clean sheet of white paper and take a photograph. It is not possible to keep the swab due to the continued colour change.
ISL HTM01-05 s & s Is weekly protein testing of ultrasonic cleaners essential or best practice? ISL s: The weekly protein test of ultrasonic cleaners and washer disinfectors is essential practice. The purpose of the test is to ensure that instruments do not have blood on them: meaning that the equipment is functioning correctly. Because there is no way of testing for blood itself you have to check for a derivative of that, one of which is protein. Because of the nature of this test it is not appropriate to only carry this out if you are achieving best practice, all of the tests and validations must be carried out, best practice is really only relating to the environment that you are carrying out decontamination in. To comply with HTM 01-05 does the ultrasonic lid need to be lockable? ISL s: There is no specific requirement for an ultrasonic bath to have a lockable lid. HTM 01-05 point 10.21 states that a hinged auto locking lid is preferred. However in the absence of such equipment should be clearly labelled warning users not to put their hands in the device when activated. The reason for HTM 01-05 suggesting a lockable lid is because they want to make it clear that the 'user' cannot add instruments to a load that is in the middle of being processed, as they will not benefit from the full cleaning cycle. As long as you have a clear protocol in place then you are fine to continue using a bath without a lockable lid. However, when you purchase a new machine the 'lid' needs to be taken into consideration. Some of the new style U/S baths still come without lockable lids however they have a cycle cut out which means if the lid is lifted the bath will only start a new cycle. How are we meant to dispose of plaster study models that are used when making dentures and crowns? ISL s: There are two things to look at when disposing of plaster models. 1) If they are contaminated they must be disposed of as clinical waste in the orange bags 2) If the are not contaminated then they must be disposed of by way of a special collection as they are not allowed to go into the general waste and in turn the general landfill. Your Clinical waste commercial company should be able to provide you with a quotation to remove the plaster models alternatively a cheaper option may be to speak to your local authority as they may offer a service. Do instruments need to be colour coded for needle stick injuries?? ISL s: We are not aware of any instruments requiring colour coding for needle stick injuries, in fact quite the opposite, PCT's are actually asking practices not to colour code instruments with bands due to the infection control risk: The question they asked was how can you show 100% that underneath that band is being cleaned? If you have a banded instrument and get a needle stick, the likely hood is that you will only be able to trace it back to a particular surgery not necessarily a certain patient. The advice as far as we can go would be to get different coloured transport trays for each surgery, that's about as much traceability as the bands are providing but we would certainly say remove them anyway! I have been informed that ultrasonic cleaning is best practice only: I understood it to be that if you didn t have a washer disinfector it was essential requirements to use an ultrasonic as part of the manual cleaning process, can you tell me which is correct please? ISL s: HTM 01-05 does not actually specify that you have to use an ultrasonic cleaner to achieve either essential quality requirements (EQR) or best practice. There are 3 types of cleaning that a dental practice can carry out under EQR: Manual Cleaning - Ultrasonic Cleaning - Washer disinfector cleaning. As HTM 01-05 EQR allows you to manually clean your instruments: meaning you have no other equipment other than a steriliser, you do not need to use an ultrasonic bath. However everything that you are doing to comply with HTM 01-05 needs to be evidence based and the reason that we would recommend you use an ultrasonic bath (when a washer disinfector is not available) is simply because the manual cleaning process cannot be suitably validated, There are no tests that can be performed and recorded unlike with an ultrasonic bath. Plus an Ultrasonic bath decreases the chances of needle stick injuries as although there may be some manual cleaning required prior to using the ultrasonic the need for this is again reduced using an ultrasonic. For best practice compliance HTM 01-05 will only accept cleaning in a washer disinfector it is entirely up to the user/operator if they want to do this in conjunction with an ultrasonic as HTM 01-05 does not stipulate that this is mandatory. Again, we would recommend that an ultrasonic bath is used in conjunction with a washer disinfector as there are some instruments used in dentistry which are more effectively cleaned in an ultrasonic (re useable burs, intricate hinged instruments e.t.c.) So in essence our advice would be to continue to use the ultrasonic bath as an additional cleaning method to allow you to provide evidence of your cleaning processes. Why is my Load check soil test failing every test when my machine is passing all the other tests? ISL s: There are various reasons why the Load Check test soil would fail. Check that the test strip is not past the use by date, Load Checks have the shortest shelf life of all test soils available. When performing the test the holder, when loaded with a test strip, must be placed on its edge, not face down. No instruments should be present in the test cycle. Load Check should not pose a problem to an Ultrasonic Cleaner, however some Washer Disinfectors are not able to pass this particular test. Load Check was originally designed for use in hospital sterile services where the cleaning solution has a higher ph level than that used in dental practice washer disinfectors. Load Check requires a high ph level to fully clean the strip and not all machines supplied to practices provide this. Visit the manufacturer guidelines on the ISL website www.htm01-05.com for machine specific test soil advice. Can I purchase helix strips separately or do I need to buy the whole testing device again? ISL s: With regards to the Helix test, all the manufacturers recommend that the helix device is replaced once the strips have run out, simply because the tubing inside is plastic and they cannot guarantee that it won't become perished after being run for so many cycles. The only exception to this is the Helix device for the SciCan Statim, which is a metal helix therefore reusable.
PREPARATION & PROCESS ANALYSIS PREPARATION & PR Phase 1 Preparation (Still in surgery) Phase 2 Required Process Analysis Phase 3A Manual Cleaning Phase 3B Ultrasonic Cleaner Remain in PPE from surgery (refer to PPE protocol) Sort Instrument tray Contents Is a washer disinfector to be used? Perform hand hygiene prior to donning PPE Apply PPE Refer to PPE protocol Ensure that all HTM01-05 and machine manual housekeeping and safety checks have been carried out Are they single use instruments or consumables? Dispose Continue Place instruments in lidded lockable container If decontamination is not going to be carried out within 30 minutes, cover instruments with wetting agent/foam Remove PPE Refer to PPE protocol Dispose of as clinical waste Move instruments to Phase 2 Process Analysis Are the instruments heavily soiled? Phase 3A Manual Cleaning Phase 3C Washer Disinfector Is an ultrasonic cleaner to be used? Are the instruments heavily soiled? Phase 3A Manual Cleaning Phase 3B Ultrasonic Cleaning Phase 3A Manual Cleaning Add a measured amount of water to the sink, sufficient to completely submerge the instruments during washing. The water should be at the temperature specified by the detergent manufacture but never greater than 45 C Add a measured amount of detergent to achieve the concentration specified by the detergent manufacturer Use thermometer to ensure correct temperature, as specified by the detergent manufacturer, is maintained. Ensure thermometer is decontaminated between uses. Agitate/scrub the instruments, completely submerged in the cleaning solution, using long handled brushes with soft plastic bristles Drain any excess cleaning solution prior to rinsing Are any further cleaning processes to be carried out? Still donning PPE Are the instruments suitable for ultrasonic cleaning? Run cycle Proceed to cleaning method specified by instrument manufacturer (revert to phase 3A or move to 3C) Place instruments in ultrasonic cleaner basket as specified by the manufacturer / HTM01-05, lower into cleaner and close/ replace cover Once cycle is complete, verify cycle parameters and complete log book record and remove instrument basket from ultrasonic cleaner Rinse instruments with satisfactory potable (drinkable), freshly distilled or RO water Are any further cleaning processes to be carried out? Phase 3B Ultrasonic Cleaner or Phase 3C Washer Disinfector as required Fill rinsing sink with enough satisfactory potable (drinkable), freshly distilled or RO water to cover instruments Phase 3C Washer Disinfector Phase 4 Inspection Rinse instruments Complete log book record Phase 4 Inspection
OCESS ANALYSIS STERILISATION STORAGE Phase 3C Washer Disinfector Phase 4 Inspection Phase 5 Steriliser Phase 6 Inspect & Store Ensure that all HTM01-05 and machine manual housekeeping and safety checks have been carried out Still donning PPE Place instruments in washer disinfector as specified by the manufacturer / HTM01-05 Visually inspect all instruments under an illuminated magnifier Are instruments clean, functional and in good condition? Are instruments blunt, bent, damaged or showing signs of pitting or other corrosion? Ensure that all HTM01-05 and machine manual housekeeping and safety checks have been carried out Still donning PPE Will the instruments be processed via a vacuum cycle? Perform hand hygiene prior to donning PPE Apply PPE Refer to PPE protocol Carefully open the steriliser door and remove the trays. Note:- trays and instruments may be very hot take appropriate precautions Run cycle Remove PPE Refer to PPE protocol. Dispose of as clinical waste Discard Re-processing required Phase 2 Place instruments/sets in approved sterilisation pouches Have the instruments been processed via vacuum cycle? Perform hand hygiene Return to Surgery Once cycle is complete, verify cycle parameters and complete log book record Perform hand hygiene prior to donning PPE Apply PPE Refer to PPE protocol Remove instruments from washer disinfector Phase 4 Inspection Lubricate any relevant items prior to sterilisation with a non-oil-based lubricant certified for use on the instruments and compatible with the sterilisation process Go immediately to Phase 5 Sterilizer Place on steriliser trays as specified by the steriliser manufacturer Load trays into the steriliser as specified by the steriliser manufacturer, close & secure the door and select correct cycle Remove PPE Refer to PPE protocol. Dispose of as clinical waste Perform hand hygiene Once cycle is complete, verify cycle parameters and complete log book record Check pouch integrity, date and initial Dry using lint free cloth/paper towel Date pouch and initial if not to be used during same session Move to clean storage area Remove PPE Refer to PPE protocol. Dispose of as clinical waste Perform hand hygiene Did the cycle pass? Phase 6 Inspect & Store Refer to steriliser manufacturer instructions. Do not use instruments without fully reprocessing. When ordering your A2 poster please quote POSTDECONA2
How to carry out the HTM01-05 Ultrasonic Activity Test 1 Take a strip of foil that is longer than the depth of the bath. Roll up the end. This is to help weigh the strip down in the fluid. 7 Number each intersection so that the location of each foil strip can be recorded. 2 Measure the foil strip against the depth of the bath so that it is just above the bottom. Fold a tab at the top and remove any excess foil. 8 Using the tabs, attach the nine strips of foil to the underside of the tape where each row crosses over. 3 Create a further eight strips using the first as a template. 9 Run either a cycle that is recommended by the manufacturer for the foil test or if not known the same cycle usually used to clean instruments. 4 To help weigh the strip in the fluid further, paperclips can be added to the bottom. 10 After the cycle, carefully remove the foil strips making sure you know the position number of each one. 5 Fill the bath with liquid and detergent as normal for cleaning your instruments. Run a cycle to degas the liquid. 11 Erosion on each foil strip validates the cycle. If any strips have no erosion then this indicates that the bath is not working correctly. 6 Place three lengths of tape horizontally and three lengths of tape vertically across the top of the bath. 12 To provide evidence of test, attach the foil strips into the space provided in the ISL Ultrasonic Cleaner log book.
Myth BUSTING What aluminium foil should be used for the quarterly HTM01-05 ultrasonic activity test?? Although HTM01-05 does not provide specific details of what should be used for the ultrasonic activity test other than standard test foil, it is important to know that HTM2030, one of the guidance documents used to create HTM01-05, does. HTM01-05 provides a schedule of periodic tests that have all been proven as viable means of validating the equipment used in the decontamination process. These test methods and the products used to perform them are established across the range of HTM s so that the test remains the same. HTM2030 specifies that the foil used for the ultrasonic activity test must be a gauge of 0.015mm to 0.025mm and cut into strips of 20mm. The correct foil must be used in order to perform the test in compliance with the HTM method. Thinner foil will be totally destroyed leaving no validation evidence; thicker foil will be harder to erode and may provide misleading results. Tailoring the test to your machine HTM01-05 states that nine strips of foil should be used for performing the ultrasonic activity test. This is a direct copy from the test procedure within the hospital HTM2030 guidance document. The foil test is done to ensure that the transducers that lie underneath the tank and cause the cavitations are all working correctly. Typically, an ultrasonic cleaner used in a hospital sterile services department will have nine transducers and this is where the number of strips comes from. Ideally a strip of foil should be placed above each transducer. The cavitations caused by the transducers will erode the foil strip above. An even spread of erosion across all the strips provides evidence of consistent cleaning and validates the cycle. Any foil strip without erosion may indicate a faulty transducer and an area of the bath that would not clean instruments effectively. The introduction of HTM01-05 has meant that an enormous amount of ultrasonic cleaners that are significantly smaller than those used in a sterile services department now require an ultrasonic activity test. Trying to position the required nine strips of foil in an ultrasonic cleaner with a tank capacity of one litre is almost impossible. The test is to ensure an even spread of cavitations is being achieved. Therefore surely it is feasible to reduce the amount of test strips used based on the size of the tank. For example, a smaller tank would be adequately tested by reducing the amount of foil strips to four and placing one in each quarter. This still achieves the test requirement ensuring cleaning is taking place throughout the bath but makes it more sensible for the size of ultrasonic cleaner being validated. Large Medium Small Visit the ISL dental website! for full schedule of HTM periodic tests for you ultrasonic cleaner. Aluminium Foil Reel of 50m Part Number FOILR001 Ultrasonic Cleaner Log Book Part Number LOGUC001 Ultrasonic Cleaner Concentrate (Enzymatic) Part Number ULTRACL005 For the quarterly HTM01-05 Ultrasonic Activity Test. Specific gauge foil as dictated by the NHS HTM2030 for testing of ultrasonic cleaners. Provides 12 months of testing and validation record keeping. Includes test sheets to attach foil strips from the ultrasonic activity test.. Non-toxic, non-corrosive. 5L concentrate makes 200L. Effective fungicidal action within 10 minutes. For pre-cleaning and decontamination of medical devices such as hand instruments.
Isopharm Sentry at The Dentistry Show 2012 ISL exhibited at The Dentistry Show at the NEC, Birmingham at the beginning of March. Our stand was visited by hundreds of delegates and we would like to extend our thanks to everyone we met, we thoroughly enjoyed providing face to face HTM01-05 guidance. If you visited our stand you may have been lucky enough to obtain samples of two new products that are now available to purchase: NEW Splatter Zone Silicone Cup Covers Revolutionary design to keep your drinks in surgery free from the splatter! NEW GEL TOTTLES Single Tottle with uniform clip. As demonstrated by ISL at the Dentistry Show 2012 Code Description Price Online Price CUPCV001 Pack of 5 Cup Covers 15.00 + VAT 13.90 + VAT Code Description Price Online Price TOT001 Single Tottle 2.99 + VAT 2.80 + VAT Unit L1, Tyburn Trading Estate, Ashold Farm Road, Erdington, Birmingham. B24 9QG For more information contact Email: neweyenquiry@isopharm-sentry.com Telephone : 0800 840 0105 Bespoke design solutions without the price tag to create compliance Beechwood Dental Care, Woodlesford, Leeds Dental surgery, Wimbourne Decontamination room, Birmingham Specialist fitters for dental and GP surgeries. Our experience in this area means we are able to offer a complete service, including: Providing everything from conception to completion.