New Regulations in Dentistry – HTM 01-05 Decontamination

Dental Regulations

In 2009 the Department of Health published document ‘HTM 01-05 decontamination – guidance’ for dental practices. This document is aimed in particular at primary care dental practices in the U.K. and is designed to ensure that all dental practices meet ‘essential quality requirements’ and ‘best practice’ standards set by the Department of Health.

Although there is currently no specific date for all practices to comply with HTM 01-05 guidance, there are deadlines set locally by some PCT’s and it is generally accepted that all practices should show that they are moving towards changes being made within a year of the document being published.

There is talk that private dental practices will have to register with a body – perhaps the PCT, by mid 2011, and that this body will be able to perform inspections within private practices and will ultimately have the power to say whether a dental practice is able to remain open for business or not –  depending on whether standards have or haven’t been met, however this is just talk at the moment and is one of many subjects that many dental professionals are unsure about with regards to HTM 01-05.

The publication is allegedly based on scientific evidence with regards to cross infection control and decontamination and is also concerned with the possibility of prion transmission through protein contamination of dental instruments.

The most widely known changes this document will demand are the need for central sterilisation areas, the use of washer/disinfectors, quarterly audits of the decontamination process, and lots of paperwork about procedures and policies that must be followed!

The document itself includes guidance on a number of specific topics, and is broken down into various sections including;

1) Decontamination of instruments

This section of the document includes information about

  • General requirements
  • Use of washer/disinfectors
  • Ultrasonic cleaning
  • Cleaning procedure
  • Instrument inspection and care before sterilisation
  • Acceptable types of autoclave
  • Storage of sterilised instruments

2) Recommended set up of Decontamination area

This section of the document includes information about

  • Separate clean and dirty zones
  • Airflow within the decontamination area
  • Recommended number of rooms

3) General Hygiene Principles

This section of the document includes information about

  • Hand hygiene
  • Dental unit water lines
  • Surface decontamination
  • Instrument decontamination
  • Decontamination of orthodontic appliances, impressions and other prostheses

4) Engineering, Technology and standards

This section of the document includes information about

  • General standards and guidelines
  • Policy on new re-usable instruments
  • Testing and validation
  • Documentation
  • Waste

Although many points made in this publication are rather controversial –  due to a lack of evidence supporting the need for certain changes to be made, and the refusal for NICE (National Institute for Clinical Excellence) to review the Department of Health’s  findings, dentists still have to meet the standards set within these published guidelines.

Once dentists have fought their way through this huge and very specific document it will be necessary for changes to be made within all dental practices. The changes which take place will be costly and time consuming; however, if these regulations prevent any dental practice from thinking they are able to cut corners with little regard for hygiene standards then perhaps the changes are worthwhile?

One thing is for certain, the Department of Health need to make specific details about the imminent changes to be made in dental practices more simple and clear so that dental practice principals know without any doubt  what they need to do and when!

Information about HTM 01-05 decontamination can be found on the Department of Health’s website .

About the author

I’ve been a dental nurse for over 13 years, and have worked in various parts of the country in orthodontic practices, general dental practices, within the community dental services, for both NHS and private practices. Within that time I’ve seen quite a few changes, not only with the way services are provided, changes in laws and regulations but also with the use of new materials and more advanced treatments. The one thing that hasn’t changed at all in my time as a dental nurse is the importance of people receiving and understanding clear information about dentistry, treatments, regulations and jobs for example.


  1. Lauren says:

    This information is very useful.

    I have been working as a dental nurse for over a year and a half now & have just passed my dental nursing exams. I would really like to further my career & I am very interested in studying the dental hygiene course. I have GCSE’s & A levels however none of my A levels are science based subjects. Would I be best going to study a science A level or should I contact the training school first before I do anything?

    Your advice would be much appreciated.

  2. Dental Nurse says:

    Hi Lauren, thanks for getting in touch.
    In answer to your question I would advise you to contact the dental school that you’re interested in attending and see what they suggest, although most dental training institutes do prefer their potential students to have a science based A level, there are always exceptions, plus if you contact them you will get a definite answer about what your next move should be. You have nothing to lose by contacting them first!
    Good luck.

  3. Mike says:

    Hi,all, I’ve recently been learning from the U.S. that the dental amalgam fillings that most of us carry around in our heads, due to the mercury content are actually very very toxic and that dental associations the world over are seemingly turning a blind eye to this. it’s not just the patients but the dentist and his nurse that are also at risk, possibly more so due to patient turnover. I just wonder whether dental nurses are made aware of this in their training especially if they are young and of child bearing age (most I should think). What’s worse is that if a dentist publicy voices concern over this, he will loose his licence to practise dentistry. What is going on here? any thoughts? Thanks Mike…

  4. Dental Nurse says:

    Hi Mike, I think there is a bit of scare mongering going on here……

    Amalgam fillings are made up of an alloy containing a variety of metals such as tin and silver, and some mercury. All of these materials are provided in a capsule, where the alloy and the mercury are kept seperate by a rubber diaphragm. Prior to mixing the alloy and mercury, the diaphragm is broken by compressing both ends of the capsule. The capsule is then placed in a machine known as an amalgamator and is mixed at high speed. The capsule is then opened and a soft ball of amalgam is tapped out into a dappens dish ready to be placed in a tooth as an amalgam filling. The nurse (or dentist) has no contact with the unmixed mercury during this process.

    Only when mercury is in an unmixed state is it harmful/toxic! There is some evidence to show that mercury levels in the body can increase temporarily when an amalgam filling is removed or placed, however it is temporary! If amalgam was so toxic that it was causing serious health problems then most of the population would be seriously ill, and I think if that were the case, dental practices would be among the first people to become aware of it!!!

    All dental practices must have, and know how to use a ‘Mercury Spillage Kit’, however, this bit of kit is rarely used nowadays as the risk of mercury spillage is so low now that amalgam capsules are used. The need for a mercury spillage kit was far more relevant in practice when nurses had to mix the alloy and mercury together themselves which obviously increased the risk of mercury spillage occurring.

    Dental care professionals are taught about mercury and its dangers, but are also taught that when mixed, it is safe!
    There are lots of potential health risks when working in the dental profession whether through needlestick injury, or radiation, risks are there, however those who work in the profession are educated on these risks and I would be very suprised to learn that any significant number of dental care professionals are particularly concerned about the risk of being poisoned by mercury used in amalgam fillings!!!

  5. julie says:

    Do you have to be a qualified/trainee dental nurse to work in these central sterilisation areas that all practices should be working towards?

  6. Kate says:

    Hi, I am concerned that I do not really know how to drain the compressor. I was told by my manager to drain it with a large bottle until all the excess water comes out. But from experience I have seen that they turn the tap off over night to drain them, in other practices I have worked at.

  7. Dental Nurse says:

    Hi Kate,

    There are lots of different compressors used in various dental practices and each one is turned on and off differently, is cleaned differently and drained differently. If your manager has told you how to drain your particular compressor I would trust what they say. Of course if you’re still not entirely sure that you are doing it correctly ask your manager to show you and express your concerns, so that your worry can be eliminated.

    I hope I’ve been of some help.


  8. Corrie says:

    We have a washer disinfector which has recently arrived in our practice. We are used to using ulra sonics. And we still do have ultrasonics.

    My question is that I have no idea what involved in the testing side of a washer disinfector for effeciency, protein test, soil test. What equipment do I need to order for my practice to carry out these tests?

  9. Dental Nurse says:

    Hi Corrie,
    Thanks for your question!
    You are correct, when using a dental washer/disinfector you should carry out visual check of instruments on a daily basis, protein test on a weekly basis and a soil test on a quaterly basis. It is also important to keep an accurate log book of all testing of the washer/disinfector!
    Everything you need in your washer/disninfector testing kit can be ordered from Isopharm Sentry, they also have a great deal of useful information regarding HTM-01-05 guidelines!
    I hope I have been of some help to you.

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