HTM 01-05 Testing Explained... in fact everything you need Traceability Sterilisation Storage Testing Packaging Transport Disinfection v.4.0 Inspection Cleaning to know about HTM 01-05 but were too afraid to ask! Washer Disinfectors & Washer Disinfector Performance Monitoring Sterilizers & Sterilizer Monitoring Manual Cleaning, Ultrasonics & Ultrasonic Cleaner Performance Monitoring New Products KEY Log Books available for ALL test products FREE OF CHARGE For use with all makes and models of decontamination equipment Did you know? Knowledge! Reference to the HTM 01-05 guidelines Detergents, Added Extras, Accessories & cassette packages Traceability & log books New Products Welcome to HTM 01-05 for Gummies This booklet is designed to take you step-by-step through testing your decontamination equipment, with helpful hints and tips along the way. What is Decontamination? As quoted in HTM 01-05 “Decontamination is the process by which reusable items are rendered safe for further use and for staff to handle…..Decontamination of instruments is a complex process that involves several stages, including cleaning disinfection, inspection and a sterilization step.” Please refer to the diagram below for a summary of how each individual stage links together to complete the entire decontamination process. Artemis Inspection Lamp HTM 01-05 Pg 18, 3.18 Refer to HTM01-05 with regards to visual inspection of your instruments. “After cleaning, inspect instruments for cleanliness and check for any wear or damage before sterilization. The satisfactory completion of this step means that these instruments may be clearly designated as ready for sterilization”. What is the importance of Decontamination? Simply “…Decontamination is required to minimise the risk of cross-infection between patients and between patients and staff.” Harmful micro-organisims can be transmitted from person to person if the decontamination process is inadequate. If its not clean. It cannot be sterilized. What is HTM 01-05? HTM 01-05 is a document released by the Department of Health and is to be used as a guideline in relation to decontamination in the Dental Practice. What is the purpose of HTM 01-05? It is intended to raise awareness of the decontamination of reusable dental instruments and your duty of care to staff and patients as a healthcare provider. Decontamination Cycle Acquire • With a washer-disinfector (WD); • With or without an ultrasonic cleaner; • manually Artemis Inspection Lamp Did you know?...Compact, free standing, mains powered with LED lights for longevity. ‘Easy Clean’ Keyboard HTM 01-05 Pg 39, 6.66 Our waterproof ‘Easy Clean’ Keyboard is medical grade and dishwasher safe, used by healthcare professionals worldwide Clean Disinfect if a WD is used Transport M20548 • Keys laser-etched to prevent fading • Can be disinfected with healthcare grade sprays without being disconnected • A ‘quick connect’ cable allows for the keyboard to go straight from the dishwasher to the desk • Location • Facilities Use • Equipment Inspect Repeat cleaning if necessary • Management Store (max. 21 days) • Policies and procedures Package Steam-sterilize unwrapped (Type N) Store (max. 60 days) Steam-sterilize in vacuum sterilizer (Type B or S) Package Washable Keyboard M20546 Did you know?... There is no specific time frame for cleaning your keyboard, we recommend once a week dependent on traffic. Ultrasonic Cleaner Performance Monitoring Manual Cleaning PPE Weekly Protein Residue Test HTM 01-05 Pg 58,13.4 residual protein test as defined in HTM01-05 Disposable Face Visors HTM 01-05 Pg 35, 6.30 Brushes HTM 01-05 Pg 63 D & F A test performed before your sterilization process to ensure your instruments are completely free of blood and saliva (forms of protein). This prevents Test 1 Until best practice is released, manual cleaning remains an integral part of the decontamination process cross contamination. • Accurate results in 10 seconds • Easy to use • Clear colour change • No incubation required Disposable Visors V3505040 200 Did you know?... Avoid touching the outer surface of the visor when removing & disposing of in clinical waste 3E-Zyme HTM 01-05 Pg 18, 3.15 (non foaming) • No test more sensitive • Brushes are designed to be single use • Will not leave bristles inside the instrument • Handy A3 wall chart available • Cost effective • Shelf life up to 2 years • Control Test included to ensure batch has not been compromised Variety of brushes available – please call for further info Did you know?...Some of our brushes are autoclavable Denta Check V3505095 10 Tests + 1 Control Test ‘Did you know?...’ Denta Check is universal and can be used on any brand of ultrasonic / is not specific to the Medisafe range. (This is also applicable to washer disinfectors!) If you are manually cleaning and looking to comply to HTM 01-05 are you aware of the comprehensive steps involved? Here are just a few: • Measure the volume of water to ratio of detergent Quarterly* Soil & Ultrasonic Activity Test Quarterly* Soil Test Quarterly Ultrasonic Activity Test Foil Test HTM 01-05 Pg 58,13.4 Standard PCD Kit HTM 01-05 Pg 61,15.6 • Using a mercury-free thermometer, As well as being used as part of your manual cleaning process, this detergent can be used in your ultrasonic and your Pico washer disinfector, therefore no need for multiple bottles. • Non foaming and pH neutral • Three in one, non-corrosive cleaner is safe and fast acting 3E-Zyme MED8035 continually record the temperature of the water & • Upon draining if water is heavily soiled, repeat the cleaning procedure Did you know?...You are required to document every step of this procedure! x1 (4L) Did you know?... This detergent can also be used as a pre-soak The PCD (Process Challenge Device) & CEI (Cleaning Efficacy Indicator) kit has been designed to closely replicate a hard-to-clean dirty instrument. • Easy to use – place CEI in PCD & load into full machine • Easy to read – visual inspection that soil has been removed • Quarterly as requested by HTM 01-05 unless stated otherwise by your Manufacturer – for the entire Pico range if you have a PAYGo service this test is required monthly. Standard PCD Kit Replacement CEI Did you know?.... You are required to verify your manual cleaning process. To comply to HTM 01-05 you are required to carry out and record the results of a weekly protein test. Denta Check (shown overleaf) fulfills this requirement and can also be used to test your ultrasonic cleaner and your washer disinfector • Ideal width for performing the foil test • High quality foil, does not perish Foil Roll M20230 (1 PCD & 12 CEI tests) V3502082 The ultrasonic activity can be investigated by the erosion pattern created on the aluminum foil exposed in the tank for a short period x10 Did you know?...This is a visual indicator that helps you to identify that the load has been cleaned efficiently and can be used as a daily check. We use materials to closely replicate your dirty instruments using sheeps blood and additives layered onto a stainless steel plate. Therefore recreating your dirty instrument. MED1002 50 Meters Did you know?... You should be comparing the erosion pattern against your last few test results to ensure the ultrasonic activity remains the same? Test 2 • Latex free & Anti fog (both sides) • Lightweight & fit comfortably over a surgical mask or over prescription eyewear Autoclave Performance Monitoring Washer Disinfector Performance Monitoring The same tests can be used to test both your washer & Ultrasonic 1 HTM 01-05 Pg 58,13.4 Test 1 residual protein test as defined in HTM01-05 2 A test performed before your sterilization process to ensure your instruments are completely free of blood and saliva (forms of protein). This prevents cross contamination. B&D Test Pack HTM 01-05 Pg 25,4.18 EN-ISO 11140-1 (CLASS 2 INDICATOR) EN-ISO 11140-4 Manufactured in EU OR Single use test pack for pre-vacuum STEAM sterilizers working at 134 ºC - 137 ºC for up to 3.5 min. Mimics air trapped within a hollow load and is made up of a length of tube attached to a small air tight container that holds a steam sensitive indicator. A successful process will remove air from the tube and then the container, allowing steam to contact the indicator – causing a colour change reaction • Compatible with ‘B’ type autoclaves • Indicator with self adhesive backing for easy documentation • Easy to use – easy to interpret brown when sterilized bruno quando sterilizzato braun wenn sterilisiert brun en stérilisé marron cuándo esterilizado Brązowe jeśli poddano sterylizacji • Accurate results in 10 seconds 4 3 • Easy to use Autoclave No.: Date: Store in dry, cool, dark conditions, before and after use Recommended 10°C - 30°C RH 30%-70% • Clear colour change • No incubation required The Valisafe Bowie Dick Test is a pre-assembled, disposable test pack for detection of defects in the sterilization process. It contains a large chemical indicator inside, which once the process is complete is removed from the pack and kept for your records. • No test more sensitive • Cost effective • Shelf life up to 2 years • Control test included to ensure the batch has not been compromised Denta Check HTM 01-05 Pg 25,4.18 EN867 Helix Device Test 1 Daily Steam Penetration Test Weekly Protein Residue Test V3505095 B&D Test Pack 10 Tests +1 Control Test V3501020 x20 Helix Did you know?... Occasionally suitable for ‘S’ type autoclaves, please refer to manufacturer Did you know?...Easy to use, this weekly test confirms that your cleaning process retains the capability of removing protein. 1 Helix + 250 indicators V3502034 Did you know?... Our Helix devices are sold as part of a kit (1 device and 250 indicators). Indicators cannot be supplied separately as each device is calibrated for 250 uses. Quarterly* Soil Test d in EU Manufacture Manufactured LOT 100834 LOT 100834 The Class 6 indicator offers the highest level of proof of RSAL achievement of sterility assurance in your trays. • NEW self adhesive indicators • Easy to use & record; just peel off the back and stick inside your log book M20230 1 PCD & 12 CEI tests V3502082 x10 Valisafe replacement CEI V3502080 x50 Did you know?...This is a visual indicator that helps you to identify that the load has been cleaned efficiently and can be used as a daily check. We use materials to closely replicate your dirty instruments using sheeps blood and additives layered onto a stainless steel plate. Therefore recreating your dirty instrument temperature & Steam Class 6, 3.5 min V3504065 x250 Did you know?...Verify your ‘N’ type autoclave with this independent test The Class 4 indicator monitors time and temperature parameters and are dual. (250 indicators split into 500 tests) • Clear accurate colour change • Easy to interpret, easy to record • For use in every tray or item Class 4 V3502038 x500 Did you know?...If used in conjunction with Class 6 Indicators in every tray, this provides the highest level of sterility assurance www.valisafe.com IVE • Monitors critical paraters for sterilisation; time, Valisafe replacement CEI LOT 100834 Release batch. No further action needed LOT 100834 Manufactured in EU Spot of test soil completely removed Manufactured in EU Dual multi parameter indicator EN-ISO 11140-1 Sterilizing conditions turn indicator from blue to dark geay or black otherwise by your Manufacturer – for the entire Pico range if you have a PAYGo service this test is required monthly. Dual multi parameter indicator EN-ISO 11140-1 Sterilizing conditions turn indicator from blue to dark grey or black Art. No.: V3502038 Successful cleaning process: UN LOT 100834 DUAL MULTI PARAMETER INDICATOR Class 4 121 ºC - 134 ºC In case of repeated insufficient cleaning process: Call service technician EU Manufactured in EU Manufactured in Spot of test soil slightly visible Art. No.: V3502038 indicator Dual multi parameter EN-ISO 11140-1 Sterilizing conditions turn indicator from or black blue to dark geay Art. No.: V3502038 Art. No.: V3502038 indicator Dual multi parameter EN-ISO 11140-1 Sterilizing conditions turn indicator from or black blue to dark grey ER INDICATOR DUAL MULTI PARAMET Class 4 ºC 121 ºC - 134 ER INDICATOR DUAL MULTI PARAMET Class 4 ºC 121 ºC - 134 Repeat test in EU in EU indicator parameter Dual multi EN-ISO 11140-1 Sterilizing conditions from turn indicator grey or black blue to dark Manufactured Art. No.: V3502038 d in EU 4 LOT 10083 INDICATOR PARAMETER Class 4 ºC 121 ºC - 134 indicator parameter Dual multi EN-ISO 11140-1 Sterilizing conditions from turn indicator geay or black blue to dark DUAL MULTI r indicator paramete Dual multi 11140-1 EN-ISO conditions Sterilizing from turn indicatorgrey or black blue to dark DUAL MULTI PARAMETER INDICATOR Class 4 121 ºC - 134 ºC • Easy to read – visual inspection that soil has been removed • Quarterly as requested by HTM 01-05 unless stated Standard PCD Kit V3502038 Art. No.: Test 2 4 LOT 10083 & Check wash, temperature, dosage and time INDICATOR METER 4 Class - 134 ºC 121 ºC I PARA DUAL MULT Manufacture Do not release batch r indicator paramete Dual multi 11140-1 EN-ISO conditions Sterilizing from turn indicatorgeay or black blue to dark Spot of test soil visible The PCD (Process Challenge Device) & CEI (Cleaning Efficacy Indicator) kit has been designed to closely replicate a hard-to-clean dirty instrument. • Easy to use – place CEI in PCD & load into full machine HTM 01-05 Pg 61, 15.5 (Load Check) LOT 100834 Spot of test soil visible Dual Class 4 HTM 01-05 Pg 61, 15.3 V3502038 Art. No.: Spot of test soil completely visible 3.5 min Indicator Art. No.: V3502038 Insufficient cleaning process: Class 6, self adhesive INDICATOR PARAMETER DUAL MULTI Class 4 ºC 121 ºC - 134 Reference indicator: Test soil spot completely visible To be used in conjunction with the Load Check INDICATOR METER 4 Class - 134 ºC 121 ºC Action needed I PARA Assessment DUAL MULT Standard PCD Result Test 2 To be used in conjunction with the Automatic control test HTM 01-05 Pg 58,13.4 Compliance to Best Practice PICO Compliance to “Best Practice” HTM 01-05 at the touch of a button Compliance to “Best Practice” HTM 01-05 at the touch of a button Reliance PC+ Ultrasonic PICO Washer Disinfector All Pico’s (worktop and floor standing) share “one touch” operation, efficient HTM 01-05 compliance and give you fully automated traceability, as outlined in guidelines and standards. PICOevo - NEW Ultrasonic instrument cleaner. • HTM 01-05 compliant • HTM 2030 compliant • With interlocking lid • Ultra quiet • Fundamental safety and security • Traceability Reliance PC+ Lumen Flushing provides powerful cleaning for hollow or lumened devices. Hand pieces are reprocessed thoroughly inside and out, guaranteeing complex / critical instruments are free from soil residue. See Washer Disinfector page for more in the range MED1119PC PICO XL New innovative design increases instrument capacity and removes the need for a steam exhaust outlet by means of an internal condenser. Fast, simple, safe and reliable. Automated detergent dosing, forced air drying system, universal hand piece connectors, double rotary spray arms, in built water treatment system • HTM01-05, EN ISO 15883, EN1717ISO Niagara Nano PICOclave Autoclaves PICO evo hot/cold MED1360 N! M ING CO O SO See Autoclave page for more in the range Call our fully trained HTM 01-05 team +44 (0)1279 461641 • Cleans up to 8 handpieces PICO XL MED1301 PICO XL with drying MED1316 PICO WORK STATION - NEW PICO XXL Class B vacuum steam sterilizer • HTM 01-05 compliant • EN 13060 compliant • Rapid vacuum / Standard cycles • Touch screen • Large 17 litre capacity / 22 litre The XL slim under-counter model allows busy surgeries to reprocess high volumes. They carry all the features of benchtops but with higher volume lumen washing / disinfection facilities. Optional extras include drying cycles and Ezee Clip trays for maximum throughput thus optimising efficiency. The 600mm wide under-counter model allows busy surgeries to reprocess high volumes. They carry all the features of benchtops but with higher volume lumen washing / disinfection facilities. Optional extras include drying cycles and Ezee Clip trays for maximum throughput, optimising efficiency. • Cleans up to 12 handpieces PICO XXL MED1300 PICO XXL with drying MED1315 Pico Work Station MED1370 Sterilizers & Sterilizer Monitoring New products Vacuum (Type B) Autoclaves ‘Easy Clean’ Mouse HTM 01-05 Pg 39, 6.66 PICOclave 21ED 22 litre* PICOclave 21ED 17 litre* Our fully submersible ‘Easy Clean’ Mouse is also dishwasher safe, helping you to comply with HTM 01-05 guidelines. It contains a silver seal technology which protects the mouse between washing • With 24 K gold-plated USB connector to prevent corrosion and is manufactured to IP-68 standards Washable Mouse Class B vacuum steam sterilizer. • HTM 01-05 compliant • EN 13060 compliant • Rapid Vacuum / Standard cycles • Touch screen • Large 22 litre capacity MED1905 PICOclave 21ED 22L M20547 Class B vacuum steam sterilizer. • HTM 01-05 compliant • EN 13060 compliant • Rapid Vacuum / Standard cycles • Touch screen • Large 22 litre capacity PICOclave 21ED 17L MED1930 Did you know?...The whole of Europe uses Vacuum Autoclaves - buying less expensive Type N machines may not serve you well in the future Did you know?...... Dishwasher safe and universal Also available in Non Vacuum Heat Sealer HTM 01-05 Pg 27, 4.26 Non Vacuum (Type N) Autoclaves Autoclave Tape Easy, safe and reliable sealing for sterile and hermetic packaging of your medical tools without the risk of burning the packaging material HTM 01-05 Pg 61, 15.8 Process Indicator Pen - PIP HTM 01-05 Pg 27, 4.26 • Compact table-top machine; easy-fit into surgery environment • Easy to use with light and acoustic signal • Can accommodate a larger selection of roll widths • A handy buzzer to indicate end of seal time and seal bar closure Heat Sealer M20550 Did you know?... Seal your pouches to fit your instruments- no waste! Colour change upon exposure to heat • Individually marked rolls with lot number and expiry date • Non-toxic • Lead free • Cost effective • Single rolls coming soon V3504040 19mm 48 rolls per bag V3504045 24mm 36 rolls per bag Did you know?...Autoclave tape will change colour when simply exposed to heat. Colour change does not confirm sterility The Process Indicator Pen or PIP pen can be used on all wrapped materials to indicate specific information requirements such as dentists / patient’s name, tray name and date. When exposed to the steam sterilization process the PIP pen ink changes from purple to green to indicate to you which packs have been sterilized. • Writes for over 400m • Non-toxic • Lead-free V3502140 1 Pen Did you know?.... Are you signing & dating your pack? Also include the expiry date! Traceability & Log Books Detergents 3E-Zyme HTM 01-05 Pg 18, 3.15 (non foaming) Medi-pH-Safe HTM 01-05 Pg 18, 3.15 (aluminium friendly) Traceability Medi-Logger 3-Ezyme - Is effective against and digests ALL residues and deposits normally found on surgical instruments and apparatus including proteins, lipids, carbohydrates and mucopolysaccharides. • Normal dilution rate for manual cleaning is 3-7mls of detergent to each litre of water dependent on how heavily soiled the instruments are. • Uses a combination of three high performance enzymes 3E-Zyme MED8035 x1 (4L) A unique formulation designed especially for use in hard water areas, which gives the cleaning benefits of an alkaline detergent with the protection offered by an enzymatic detergent • pH9 compositions result in fast efficient cleaning at high temperatures • Non foaming and low dilution rate Medi-pH-Safe M20011 x1 (5L) Did you know?... If your washer is validated & calibrated using one of the above detergents, you are required to revalidate your machine, if you decide to use an alternative detergent. Failure to do this could invalidate your warranties or even damage your machine. AWT HTM 01-05 Pg 18, 3.15 Deconozyme Advanced HTM 01-05 Pg 18, 3.19 Printer HTM 01-05 Pg 18, 3.19 OR Medisafe’s new Medi-logger can be adapted to fit most disinfection equipment. The data is stored in an active format which enables the user to identify the time that the data was captured for analysis. This information is encrypted and cannot be changed Medi-Logger Washer M20070G x1 Medi-Logger Autoclave M20070F x1 For monitoring and documenting all operational functions / parameters performed by the Pico washer disinfector range. Printer MED1014 x1 Printer roll MED1014.1 x1 Did you know?...Please call to ensure the MediLogger is compatible with your equipment, if not part of the Pico / Medisafe range. Did you know?...Does not require ink – information is thermally printed Although the Medi-Logger or Printer is recording the output information of your machine, it is still a requirement to independently validate your cleaning process with periodic testing. When audited you may be required to provide documentation that is evident of the successful periodic test and maintenance of your decontamination equipment Medisafe introduce our new annual log books... For use in addition to the detergent to keep your machine running efficiently and to avoid limescale build up AWT M20059 x1 (4L) AWT MED1000.09 x6 (500ml) AWT MED1000.09T x2 (500ml) Did you know?... Only suitable for Medisafe Pico washer disinfectors New technology, now with water soluable tablets for pre-HTM 01-05 auto dosing Pico washer disinfector machines. Did you know?... Can also be used as a one dose tablet for ultrasonics and manual cleaning HTM 01-05 requests that you provide evidence of a validated cleaning process. Keeping all your records in different places can be confusing and poses a threat of records becoming damaged or even lost. Keep all of your records in our annual log book which provides daily, weekly, monthly and quarterly record sheets. Ultrasonic log book coming soon! Added Extras Cassette Packages Are you maximising the full capacity of your machine? Antibacterial Pen Eye Shields HTM 01-05 Pg 35, 6.27 PICOevo Consumable Package Benchtop Package Protect your staff and your patients Do you chew your pen? Don’t pass on your germs! • Kills 99.9% of harmful bacteria and viruses • Effective against MRSA, C.Difficile, H1N1, Salmonella, Enteriditis & Norovirus Antibacterial Pen Antibacterial Pen V3503905 1 Pen V3503905 x100 Pens Did you know?... This is the only pen approved to British Standards Ezee Clip Cassette Made from stainless steel the Ezee clip cassettes can be used as part of the cross infection/decontamination process ensuring staff & instruments are protected throughout. These cassettes will enable you to process more instruments per wash cycle and allow the greatest surface area of each instrument to be cleaned & thermally disinfected. Ezee clip cassettes available in size 3,5, 10 & 20 in various colours Did you know?... Reduces the risk of sharps injuries • Available in 10 stylish colours for easy identification • Latex free • Anti-fog & mist • Light weight & comfortable – distortion free • Protects from harmful debris & splashes • Fits with surgical mask and over prescription eyewear Eyeshields MED100.83 50 frames (assorted colours) plus 50 lenses • • • • • • 1 3E-Zyme (4L) 2 AWT (0.5L) 2 Ezee clip cassettes, size 20 4 Ezee clip cassettes, size 10 2 Ezee clip cassettes, size 3 1 Burr basket Benchtop Package • • • • • M20072 1 3E-Zyme (4L) 2 AWT (0.5L) 8 Ezee clip cassette, size 10 12 Ezee clip cassettes, size 10 1 Burr basket Manifold Package M20162 Did you know?...Various pack sizes available, please ask for details & prices XL Package Foam Spray HTM 01-05 Pg 16, 3.5 When immediate reprocessing is just not possible. Instruments cleaned as soon as possible after use are often more easy to clean than those left for a number of hours. The enzyme foam spray is intended to maintain a moist humid environment. PH netural and safe and effective for stainless steel, aluminium and brass instruments Foam Spray MED8050.1 XXL Package x1 (500ml) Did you know?...Prevents soil hardening on your dental instruments • • • • • • • 2 3E-Zyme (4L) 1 AWT (4L) 8 Ezee clip cassettes, size 20 8 Ezee clip cassettes, size 10 4 Ezee clip cassettes, size 3 2 “Toast Racks” 1 Burr basket XL Package • • • • • • M20073 2 3E-Zyme (4L) 1 AWT (4L) 12 Ezee clip cassettes, size 20 12 Ezee clip cassettes, size 10 3 “Toast Racks” 2 Burr baskets XXL Package M20074 Check List PERIODIC TESTING Ultrasonic Weekly Protein Test Quarterly Soil Test To see our testing products and machines in action, please head to : Quarterly Foil Test Washer/Disinfector www.youtube.com/medisafeint Weekly Protein Test Monthly / Quarterly Soil Test To view our product demo videos. Autoclave Daily Steam Penetration Test (Vac) Indicator Strips* (Vac & Non Vac) * See manufacturers recommendation W: www.medisafedental.com Please Contact: or phone +44 (0)1279 461641 for details of your nearest distributor Medisafe Internation al Twyford Road, Bishop’s Stortford, Hertfordshire CM23 3L J, U.K. Medisafe™ and Medisafe International™ are trading names of Medisafe UK Limited Prices quoted excl. delivery & VAT Testingforgummies MB 09/12 UK REV10 alisafe ® www.valisafe.com Valisafe is a division of Medisafe UK Ltd T: +44 (0)1279 461641 F: +44 (0)1279 461643 w w w. m e d i s a f e i n t e r n a t i o n a l . c o m E:info@medisafeinternational.com