Lessons from the north
Elaine Fugard looks at attaining best practice with local decontamination in dentistry
It is widely accepted that decontamination of reusable medical devices plays a large part in the prevention of Health Care Associated Infections (HCAI) and, it must be remembered that improving and sustaining decontamination services forms an important part of ensuring patient safety.
idering the high volume of patients treated within a dental practice, the amount of daily instrumentation generated the potential for indirect patient-to-patient infection could be described as significant. Of importance too are the changing demographics of patients.
The increase in elderly
patients retaining natural teeth who are more susceptible to infection alongside the general increase in people living with impaired immunity highlights the requirement for high standards in decontamination1. This article will explore some of the key elements of compliance with national guidance in Northern Ireland (NI) for general dental practices (GDP) and communicate some lessons learnt from the journey.
A large scale survey commissioned by NHS Scotland in 20042 was tasked with focusing specifically on local decontamination processes and their application within primary care dentistry. The conclusions of this study determined a clear need for the review of decontamination within dental practices if the risk of transmission of pathogens was to be minimised.
This lead to a drive across the UK to introduce standards specifically for use in GDP focusing on improvement of practice and resulted in the implementation of HTM 01-05: Decontamination in primary care dental practice3, a document which was later reviewed in 2013. England, Wales and Northern Ireland adopted the guidance while Scotland was considerably ahead of the game and remained with the Scottish Local Decontamination Unit Guidance. The timeline set down by the Chief Dental Officer in NI required practitioners to be compliant with the first benchmark, essential quality requirements, of HTM 01-05, or as it is referred to in NI PEL (13)13, by November 2010 followed by full compliance with best practice by November 2013. A summary of some key elements of best practice in local decontamination included:
- Separate local decontamination facilities incorporating correct workflow (LDU)
- The use of a washer disinfector as a main cleaning process
- Validation and periodical testing of all decontamination equipment
- Clear processes and procedures.
What are the risks?
It is difficult to produce a strong evidence base for transmission of infection by the reuse of instrumentation in dentistry. However, anecdotal evidence would suggest transmission of viruses such as Hepatitis B and bacteria such as Staphylococcus aureus can take place as a result of dental treatment4,5,6. It is also important to highlight that within dentistry, post-operative infections are not always cultured and, as no surveillance takes place, it is therefore difficult to define the frequency of s.aureus-related infections, leaving open the possibility of the rate of MRSA-related post-operative infections. This may be an area for future research.
The emergence of variant Creutzfeldt-Jakob disease (vCJD) presented another challenge within decontamination and, although there has been no evidence of vCJD being spread through the practice of dentistry, there is a possibility that gingival tissues and dental pulp of patients who are carriers could carry the infective agent7.
However, this risk is often questioned by the dental profession in that this evidence is based on the significant levels of infectivity in the gingival tissue of mice and rats whose oral anatomy differs from humans. Considering also that there has been no trace of infectivity found in the gingival tissue or dental pulp in vCJD patients8 it raises the debate as to whether dentists are justified in questioning this risk.
When evaluating risk, one must take into consideration all of the possible theoretical outcomes and consider the restrictions which may have had a bearing on results, such as in tissues infectivity the tests were of limited sensitivity and the amount of samples available to test from humans were extremely limited.
As a result of this paucity of scientific evidence and remaining unknowns about the disease, advice to dentistry from the DOH had to adopt a worst case scenario based approach to risk assessment in this area. It seems rational, given our duty of care to protect our patients should we encounter a degree of uncertainty regarding their safety, we must err on the side of caution rather than be regretful if the worst should happen.
The road to compliance
The lonely and thankless task of evaluating and inspecting compliance in this area fell to the dental regulator in NI, the Regulation and Quality Improvement Authority (RIQA) during the year April 2013 to April 2014. When we consider the term ‘fully compliant’, it brings with it some problematic ideas in as much as it is not one measure but a combination of interrelated elements which, when combined, present the concept of compliance (see Figure 1).
An early objective in NI was to communicate to general practitioners that simply fulfilling the requirement to develop a shiny new LDU would not render them compliant. Elements highlighted above such as staff knowledge and training, correct processes being applied, correct use and maintenance of equipment and finally ensuring quality management throughout would need to be evidenced for compliance to be demonstrated.
Developing an LDU
The development of a separate decontamination facility presented a significant challenge for many practitioners on several levels. Available space was a major problem, with many practices located in older residential buildings and the capital outlay for the initial development together with the recognition of new ongoing consumable costs.
A further stumbling block was guidance and advice on the design, size and capacity of the facility to enable it to efficiently fulfil the needs of the practice. Some front running practitioners who went ahead and developed a facility without guidance and advice, consequently found themselves in a position either where the room was not compliant with recommendations or it was not fit for purpose to accommodate the demands of the practice.
Brief advice from lessons learnt:
- Determine your required capacity and volume of devices to be processed before beginning to plan the facility. This can be done by simply auditing instrument usage on a typical week.
- Determine how many washer disinfectors and sterilisers the room will need to house to process required capacity
- Seek advice on workflow and design of the room, think practical application in order to accommodate staff working in the area
- Seek infection control advice with regard to the build requirements, design of sinks, floors and worktops etc.
Manual cleaning has been the main method for cleaning of dental instruments for many years, however, deficiencies in this area identified within several studies is concerning when we consider that the effectiveness of subsequent processes may be compromised by the failure to remove all debris, soiling and prions9.
This process, when carried out using correct protocols and well-trained, diligent staff, can be both effective in results and cost. However, it has been shown that this is very often not the case and there are a large degree of variables which exist in the process9. These can range from untrained or unmotivated staff and a lack of diligence in performing the task, such as the use of wrong or on occasions no detergent1. Add these to the potential hazards to staff and the inability to validate the procedure and record repeatable parameters, it identified a need for an automated process to be applied in the form of washer disinfectors.
Washer disinfectors allow a validated cleaning process to take place, in that they perform the same task within the same parameters in every cycle. Each cycle is recorded by an independent data logger and, together with annual validation and a regular testing protocol, can provide us with a fully validated cleaning process. It has been shown that this cleaning process improves consistency in the cleaning of instruments11.
However the studies showing this case in dentistry are limited due to the small numbers of them in use within GDP. It is important to highlight that the correct use and loading of the washer disinfector is also imperative to produce the required outcome. Overloading of the machine can prevent inadequate cleaning and also prevent contact of heat with the surface of the instrument during thermal disinfection.
One lesson to learn from the north is guidance on the purchasing of a machine that is both fit for your purposes and has the ability to be compliant with requirements both now and in the future.
Validation and testing of sterilisers
“Sterilisation is a process whose efficacy cannot be verified retrospectively by inspection or testing of the product. For this reason sterilisation processes should be validated before use, the performance of the process should be monitored routinely and the sterilisation equipment should be maintained in accordance with the manufacturer’s prescribed schedule.”3
There are three key factors within steam sterilisation: temperature, pressure and time; the parameters of these three factors most commonly used within dentistry are a temperature of 134 to 137°C at a pressure of 2.1 to 2.2 bar gauge for a holding time of three minutes. The absence of attainment of these three parameters results in a failure of the cycle and as a result the instruments cannot be considered sterilised and therefore are not safe for reuse on patients.
Smith et al12 in surveying the sterilisation of dental instruments in GDP within Scotland identified a lack of educational and technical support for dental staff in this area. Considering the fact that we trust these pieces of equipment to kill or denature viable micro-organisms like bacterial spores, it raises concerns of patient safety if it cannot be affirmed that the equipment is achieving the required parameters to achieve this. Practical training and education on the requirements and performing of periodical testing has proved essential in the pathway to compliance in NI.
Decontamination of reusable medical devices is a complex procedure, the success of which is dependent on the inclusion of several correctly performed processes in order to complete the decontamination life cycle. This article has explored just some of the key elements of the process and looked at the difficulties they presented.
The Department of Health guidance HTM 01-05 (PEL (13) 13) has gone some way to provide direction for GDPs in NI on the application of local decontamination. However, published guidance without crucial on site practical support and robust educational programmes supporting implementation could present difficulties in compliance.
One very important lesson to be passed on from the north is the crucial existence of robust educational and training programs for dental teams in the realisation of implementing a change of practice in this area. It is clear that poor practice in the area of local decontamination has a significant impact on the safety of patients being treated in primary care dentistry and presents a challenge to the dental profession.
About the author
Elaine has worked as a dental care professional for 25 years and recently gained her postgraduate diploma as an advanced infection control practitioner from the University of Dundee. She currently works as a regional DCP tutor with the Belfast postgraduate dental deanery and has been involved in the development of educational programs to aid implementation of infection control standards in NI. She is also owner and director of Dental Infection Control providing training and consultancy to dental teams.
Contact Elaine at firstname.lastname@example.org
- Department Of Health. Getting ahead of the curve: a strategy for combating infectious diseases, 26346. London: 2002.
- Scottish Government, S.A.H. Sterile Services Provision Review Group: Survey of Decontamination in General Dental Practice, B37786 11/04.Edinburgh: 2004.
- Department Of Health Northern Ireland, Health Technical Memorandum 01-05: Decontamination in primary care dental practices, 13002. London: 2013.
- Redd, J.T. et al. Patient-to-patient transmission of hepatitis B virus associated with oral surgery. The Journal of Infectious Diseases 2007; 195(9):1311-1314.
- Kurita, H.et al. Nosocomial transmission of methicillin resistant Staphylococcus aureus via the surfaces of the dental operatory. British Dental Journal 2006; 201:297-300.
- Smith, A.J. Staphylococcus aureus in the oral cavity: a three-year retrospective analysis of clinical laboratory data. British Dental Journal 2003; 195: 701-703.
- Frosh, A., et al. Iatrogenic vCJD from surgical instruments. British Medical Journal 2001; 322(7302):1558-1559.
- World Health Organisation. Tables on tissue infectivity distribution in transmissible spongiform encephalopathies. Switzerland: 2010
- Bagg, J. et al. Pre-sterilisation cleaning of re-usable instruments in general dental practice. British Dental Journal 2007; 202(9):E22.
- Smith, A.J. et al. A method for surveying instrument decontamination procedures in general dental practice. British Dental Journal 2007; 202:E20-E20.
- Vassey, M. et al. A quantitative assessment of residual protein levels on dental instruments reprocessed by manual, ultrasonic and automated cleaning methods. British Dental Journal 2011; 210(9):E14
- Smith, A.J., et al. Sterilisation of re-usable instruments in general dental practice. British Dental Journal 2007; E16:912.