There has been a lot of media coverage recently about infection control in dental practices – and about instrument decontamination, in particular. As part of the drive for higher and higher infection control standards throughout the healthcare professions, dentists are keen to adopt current best practice. But what is regarded as best practice for dental surgeries and how do you adopt them? To understand the current dilemma faced by the profession – and to propose a way forward – first we need to look at the currently available guidance.
NHS and BDA guidelines
NHS Health Technical Memoranda (HTM) 20/10, 20/30 and 20/31 were developed some years ago and the guidance they contain pre-dates the generally understood and accepted infection control requirements of the 21st century. The current version of British Dental Association (BDA) guidance document A12 was published more than five years ago. Consequently, the need to update these guidelines is well understood and the profession is awaiting the new HTM 01-05 (Decontamination in Dentistry). This new document will refresh and update the old suite of reference documents by consolidating previous guidance into one, as well as incorporating best practice standards. It is expected that this document will be available in the next few months, but its essential content is already widely known.
Although there are several currently accepted ways of cleaning instruments, including manual methods, it is now accepted that the new guidelines will recommend the use of instrument washer disinfectors. It is envisaged that HTM 01-05 will cover all types of washer disinfector and steriliser, including autoclave equipment. The guidelines will include equipment design and pre-purchase specification, installation and maintenance requirements, verification procedures and record keeping, water supply requirements and operator training and management.
No need to wait
For some time, dentists have been aware of the need to upgrade their instrument decontamination equipment and operating procedures. In the absence of the new guidelines, however, many have been understandably reluctant to commit to significant capital expenditure at the current time for fear that the equipment they choose now will be deemed non-compliant in accordance with the new recommendations. So to allay this fear, let’s look at the latest developments.
In line with the market specification across Europe, an increasing number of dentists have adopted the use of vacuum autoclaves (Type B) in line with EN 13060 standard for the sterilisation of pouched, hollow and porous instruments. They may also choose a non-vacuum cycle autoclave (Type N) to sterilise non-wrapped, solid items. (There are also Type S autoclaves but the equipment manufacturer must define precisely which instruments they are suitable for and demonstrate that their equipment is capable of successfully sterilising those specific loads. The other significant development has focused on the adoption of washer disinfectors.
Indeed, if we look at the results of a recent survey by dentistry.co.uk (see pie chart), approaching 20% of dentists said that they have already invested in a washer disinfector and another 20% are planning to buy one in the near future. Typically the others still operate a decontamination regime consisting of manual instrument washing, coupled with a vacuum or non-vacuum autoclave and may still be considering what to do.
However, an increasing proportion of dentists said they are looking to upgrade their equipment, so this data supports the conclusion that there is a desire on the part of the profession to adopt new equipment and practices as soon as possible. As well as operating to the new guidelines, most surgeries are also looking to deliver best practice through the use of state-of-the-art techniques and equipment, by looking beyond the minimum expected requirements. In this way they will not just be able to satisfy pending guidelines but offer a superior service as well.
Most NHS Primary Care Trusts have funding available to assist with meeting the capital cost of purchasing new infection control equipment. In total the government has allocated up to £100 million for this purpose. Dentists who are looking to upgrade their instrument decontamination equipment can have confidence that some manufacturers are already offering equipment that complies with the new guidelines. Consequently there are a number of strong arguments in favour of investing in new equipment now.
Guidelines requirements for thermal washer disinfectors
There are standards already in place to cover a number of aspects of washer design and operation. These include:
• EN 15883 – All washer disinfectors must conform to this
• EN 1717 UK Water Regulations – These regulations cover the need for stricter infection control by including greater protection against pollution by backflow. Backflow causes movement of a fluid from downstream to upstream within an installation. This must be prevented by incorporating a specialist valve, which provides what is regarded as ‘ultimate prevention’ by using an air gap, which makes back-movement impossible.
• Periodic Validation Tests – All washers are required to
incorporate a thermocouple entry port to independently validate that the required wash temperature has been reached for the required time, thus ensuring full disinfection. (Currently part of HTM 20/30). It is anticipated that the new standards will cover a number of key features that the latest generation of washer disinfectors will have to incorporate. These cover washer design and operation and in particular they show why the current practice of manual instrument washing will no longer be acceptable.
• Drying – All designs will have to incorporate a drying process. This is vital to ensure that water droplets are removed from the instrument allowing immediate preparation for sterilisation. Moisture left on instruments after washing compromises the autoclave process as steam will not displace water droplets and so proper sterilisation cannot be assured.
• ‘Hands-free’ loading – The guidelines will express a preference for a design that incorporates trays containing instruments to be placed directly in the washer (as opposed to manual vertical stacking). This ensures minimal human contact, a key advantage of a washer system and significantly reduces the likelihood of sharps and other injuries.
• Independent Process Verification – A key requirement of the new standard will be in inclusion of a control system with software to validate the effectiveness of the cycle or the reasons for failure of the cycle.
• Detergent Dose Measurement – Addition of the correct detergent quantity ensures consistency. A system should be incorporated to ensure that the cycle will automatically shut down if there is insufficient detergent. Auto dosing machines will be favoured in the new standards because of this.
• Recordable Data – A printer, data-logger or PC interface will be required that can provide evidence of successful cleaning.
• Dental Hand-piece Cleaning – One of the primary purposes of a washer is to ensure consistently effective disinfection. This applies particularly to hollow instruments, as they are more likely to collect debris. So a facility to deal effectively with this type of hand-piece will be required.
The ideal solution
As with many aspects of running a busy dental practice, the ideal solution here is to find the balance between achieving the required level of washing/sterilisation as well as maximising throughput and productivity, at a reasonable capital cost. So the best solution for most dental practices is to use the latest generation of washer disinfector in combination with an autoclave that can run in vacuum or non-vacuum mode, particularly those incorporating a drying cycle. In view of the fact that the new guidelines will cover both washer disinfectors and autoclaves, the ideal solution will be to ensure that all aspects of instrument decontamination follow the envisaged guidelines by investing in the latest generation of both.
Whilst there are a number of alternatives available on the market, it’s important to remember that only washers that conform to EN15883, HTM20/30 (UK) and the medical devices directive (93/42/EEC) will comply. All equipment must be CE marked. Under the new guidelines, autoclaves must conform to BS/EN 13060. It should be safe to assume that equipment designed and manufactured in the EU conforms to these standards but this is not necessarily the case for equipment made elsewhere.
The regulatory regime for infection control in the dental profession is undergoing a period of rapid change, so it’s not surprising that there’s a considerable amount of confusion in many surgeries. Upgrading instrument decontamination equipment represents a significant investment so dentists want to be assured that the model they buy now will satisfy new best practice document requirements. Although the new document content and release date aren’t set in stone, there are a number of key points that are widely accepted will be included as already outlined. As can be seen from the complex options available to suit individual dental practice requirements, there are a number of choices to make when deciding on the right equipment to buy.
It’s important to talk to a knowledgeable supplier from the start. Ask the right questions to ensure they know what they’re talking about and can provide you with the appropriate solution. Look for a supplier who takes the time to find out about your individual requirements, specifies a solution that satisfies these, offers equipment designed with future as well as current requirements in mind and provides the right after sales back-up and service. Always follow hand-piece manufacturers’ advice and guidance about how best to treat their particular instruments in your chosen equipment.
Finally, don’t forget to give your local PCT a call to see if there is any available funding assistance towards the cost of new equipment.
About Prestige Medical
Prestige Medical Ltd is an ISO 9001-2000 / EN13485 accredited company and has established itself as one of the world\’s leading manufacturers of bench-top autoclaves with sales in excess of $10m to over 60 countries worldwide.
All Prestige Medical products are designed to meet the latest international standards for safety and performance. Our products are fully CE marked to the latest Medical Devices Directive 93/42/EEC and conform to all relevant specification standards.
Since the launch of our first steriliser in 1986 we have been committed to continuous research and development. The result has been a world-renowned range of bench-top autoclaves, designed to offer all healthcare professionals a cost-effective solution to the problem of cross infection.
It is Prestige Medical’s objective to maintain our position at the forefront of bench-top autoclave innovation. Prestige Medical provides the healthcare industry with versatile, effective products that help ensure good clinical practice, improve patient care and make the healthcare professional\’s job safer and easier.
• For more information, please contact: Prestige Medical
Limited, PO Box 154 Clarendon Road, Blackburn,
Lancashire BB1 9UG or ring 01254 682622, email
[email protected] or visit www.prestigemedical.co.uk.