Requirements in the Clinical Environment
Barry Quinn and Richard Johnson
Infection Control Requirements
All healthcare workers have a duty of care towards patients; a key component of care is preventing the hands from becoming a vehicle for cross‐infection and preventing the transfer of micro‐organisms to susceptible individuals. Staff compliance with guidelines for hand hygiene is often poor (Handwashing Liaison Group, 1999). The reasons why staff do not wash their hands include lack of available hand hygiene products, lack of time and the personal belief that they will not spread infection. Effective hand decontamination results in a significant reduction in the carriage of potential pathogens on the hands.
Hands must be decontaminated immediately before and after each and every episode of direct patient contact/care, and after any activity or contact that potentially results in hands becoming contaminated.
Considerations made prior to hand decontamination must include:
- The level of the anticipated contact with the patient.
- The extent of the contamination that may occur.
- The patient care activities being performed.
- The susceptibility of the patient.
The method of decontamination must be determined by the practitioner’s assessment of whether it is necessary to remove transient and/or resident hand flora.
Key factors in ensuring effective hand hygiene and the maintenance of skin integrity include:
- The duration of hand decontamination.
- The exposure of all aspects of the hands to the preparation.
- The use of vigorous rubbing to create friction.
- Thorough rinsing and ensuring that the hands are completely dry.
Basic Requirements to Achieve Effective Hand Hygiene
- Cover all cuts and abrasions with waterproof dressings.
- Keep nails short and clean. Do not wear nail varnish, artificial fingernails or extenders. Artificial nails and nail extensions harbour higher levels of micro‐organisms than natural fingernails, and these micro‐organisms are not removed easily during hand hygiene. It should be noted that artificial fingernails can also fall off, and this may pose an added risk during surgical procedures.
- Do not wear wristwatches, stoned jewellery, bracelets or rings (other than one plain band).
- Do not use nail brushes for hand hygiene levels 1 and 2 as scrubbing can irritate the skin, leading to increased risk of harbouring micro‐organisms.
- Long sleeves should be rolled up to ensure that effective hand hygiene may be applied to hands and wrists.
Micro‐organisms Found on the Skin
These can be described as:
- Resident flora: normal flora or ‘commensal organisms’, forming part of the body’s normal defence mechanisms and protecting the skin from invasion by more harmful micro‐organisms. They rarely cause disease and are of minor significance in routine clinical situations. However, during surgery or other invasive procedures, resident flora may enter deep tissues and establish infections. Removal of these organisms is desirable in these situations, by following the surgical scrub technique.
- Transient flora: those acquired by touch, e.g. from the environment, touching patients, laundry, equipment, etc. They are located superficially on the skin, readily transmitted to the next thing touched, and are responsible for most healthcare‐associated infections. They are easily removed by hand decontamination.
Technique for Hand Hygiene
An effective hand washing technique involves three steps: preparation, washing and rinsing, and drying (Figure 3.1). Preparation requires wetting hands under tepid running water before applying liquid soap or an anti‐microbial preparation.
Adequate facilities must be provided to enable staff to wash and dry their hands regularly and appropriately, to use alcohol hand gel, and to protect their skin with moisturiser. Clinical areas should have a dedicated hand wash basin, with no plug or overflow, that is easily accessible with elbow or foot operated taps (separate to a dedicated sink for cleaning equipment, etc.).
A wall‐mounted liquid soap dispenser, with an adequate supply of liquid soap, and a wall‐mounted paper towel dispenser should be available.
Each clinical area must also have easily accessible alcohol handrubs/gels (with emollients). Moisturising cream should also be available to maintain skin integrity. This should be supplied in wall‐mounted dispensers, located in suitable positions.
Liquid soap and running water will remove transient organisms and render the hands ‘socially clean’. The hands must be rubbed together vigorously for a minimum of 15–20 seconds, paying particular attention to the tips of the fingers, the thumbs and the areas between the fingers. This is sufficient for general social contact and most clinical care activities and must be used when dealing with patients who are known to be Clostridium difficile positive. Hands must be rinsed thoroughly prior to drying.
Clinical staff working in non‐clinical settings should be provided with liquid soap to utilise in settings where it is not available.
Alcohol‐based handrubs (Figure 3.2) are a practical and acceptable alternative to hand washing (especially when facilities are limited). An effective handrub technique involves ensuring that all surfaces of the hands are coated with the handrub, paying particular attention to the tips of the fingers, the thumbs and the areas between the fingers.
It is important to note however that handrubs must not be used unless the hands are free of dirt and organic matter. The handrub needs to have evaporated from the skin before contact with the patient; this should take a minimum of 20 seconds. For physically clean hands, disinfection with alcoholic handrub is quicker and less likely to lead to skin irritation than repeated hand washing. It is recommended that soap and water be used after every five applications of handrub, as the emollients build up on the skin, making it sticky.
When dealing with patients with viral diarrhoea or other transmissible disorders the use of alcoholic handrub is mandatory. This is because hand washing is not effective at removing viruses from the hands whereas alcoholic handrub is effective at killing most viruses. In the event of a Clostridium difficile or norovirus infection, hand washing with soap and water must be carried out as alcohol gel is not effective at killing these microbes.
Anti‐microbial agents (e.g. chlorhexidine, povidone‐iodine) are used mainly in secondary care environments during the undertaking of invasive procedures into sterile body sites, especially on particularly susceptible individuals such as immunocompromised patients to reduce transient micro‐organisms and some resident flora.
A good quality paper towel should be used for hand drying. Paper towels must be disposed of in a foot‐operated bin to avoid recontamination of hands.
Damaged or dry skin leads to loss of smooth skin surface and increases the risk of skin colonisation with resistant organisms such as meticillin‐resistant Staphylococcus aureus (MRSA). Staff should have access to a good quality, non‐perfumed hand cream that does not negate the properties of antiseptics in other hand hygiene products or the integrity of gloves. Communal tubs of hand cream should not be used as these can become contaminated during use. Hand cream should be applied regularly to protect the hands from the drying effects of hand decontamination.
Any skin breaks must be covered by an impermeable waterproof dressing. Any skin irritation must be reported to your general practitioner. Staff with acute or chronic skin lesions/conditions/reactions should seek advice from their general practitioner.
Personal Protective Equipment
The provision and use of personal protective equipment (PPE) is governed by the Personal Protective Equipment at Work Regulations 1992 and its subsequent amendments.
The regulations define PPE as: ‘All equipment (including clothing affording protection against the weather) which is intended to be worn or held by a person at work and which protects them against one or more risks to their health and safety’. Selection of PPE to be worn must be made by the dental care professional following a risk assessment of the potential hazards associated with the procedure to be performed including the possibility of transmission of micro‐organisms.
Only PPE carrying the European CE mark denoting the product has met specified performance standards should be used because under European law PPE is classified as a medical device. Regulation requires that PPE is:
- Properly assessed to use to ensure suitability.
- Maintained and stored properly.
- Provided with instructions on how to use it safely.
- Used correctly by employees.
Protective clothing is used to reduce the risk of acquiring and transmitting micro‐organisms by:
- Protecting skin, eyes, mouth, respiratory system and clothing of staff from potentially infectious excretions, secretions and chemicals.
- Preventing contamination of skin and clothing by transient micro‐organisms which may pass to another patient.
Use of PPE
- PPE is used in addition to normal clothing and uniforms.
- Standard uniforms are not considered PPE.
- The need for protective equipment should be on a care episode related approach not disease specific.
- Selection of protective equipment should be selected based on an assessment of the risks of transmission of micro‐organisms to the patient and the risk of contamination of healthcare practitioners’ clothing and skin by patients’ blood, body fluids, secretions and excretions.
- PPE protects intact skin. Cuts, abrasions, exposed fresh unhealed body piercings, i.e. facial or exposed unhealed tattoos, must be covered by a waterproof plaster or other suitable dressing in addition to PPE.
- Hand decontamination must be used before and after PPE use.
- Arms must be ‘bare below the elbow’ to prevent contamination of clothing.
- PPE will not protect against sharps injuries; avoid the use of sharps where possible.
- Personal protective clothing identified by the manufacturer as single‐use must not be kept for reuse.
Clothing, Uniforms and Laundry
- Clothing worn to undertake decontamination should not be worn outside the clinical area. Neither should clinical clothing. Short sleeves are best practice; staff can protect their forearms by wearing long‐cuffed gloves or disposable long‐sleeved gowns.
- Clothing/uniforms become easily contaminated with micro‐organisms, so freshly laundered uniforms should be worn each day. Machine washing as per manufacturer’s instruction with a suitable detergent at a minimum temperature of 65°C will reduce microbial contamination.
Putting on PPE
- Plastic apron.
- Surgical face mask.
- Protective eyewear.
- Gloves – latex free to avoid allergic reaction.
- Remove watches and rings to facilitate effective hand washing.
- Cover broken skin, cuts and abrasions with waterproof dressings.
- Put on surgical face mask.
- Put on protective eyewear.
- Wash and dry hands thoroughly using disposable paper towels.
- Put on gloves by holding one glove at the cuff, put opposite hand inside the glove and pull onto the hand. Repeat with the other glove. Gloves must fit properly and should be low in extractable proteins (<50 μg/g), low in residual chemicals and powder free. Latex gloves are used frequently in dentistry although some users report long‐term allergies. The use of vinyl or nitrile gloves may be a satisfactory substitute.
- Plastic apron.
- Surgical face mask.
- Protective eyewear.
- Remove gloves by grasping the glove at the cuff and pulling downward, so the glove turns inside out. Place gloves into a clinical waste bin.
- Wash and dry hands thoroughly.
- Remove eyewear by using ear rests (as not contaminated). Place eyewear on a disposable towel until it can be cleaned and disinfected.
- Slide the fingers of each hand under the elastic strap in front of your ears and remove the mask. Place the mask into a clinical waste bin.
- Remove the plastic apron by turning it inside out and place in a clinical waste bin.
Dental Instrument Management
Legal Framework in the UK
Health and Safety at Work Act, 1974
This Act establishes the employer’s and employee’s responsibility for health and safety issues, such as providing safe equipment, e.g. how to handle contaminated dental instruments.
Consumer Protection Act, 1987
Inadequately decontaminated dental instruments that cause an infection in a patient may lead to civil liability action being taken with payments for damages, for injuries received from a defective product.
Provision and Use of Work Equipment Regulations 1998
These regulations require that equipment such as decontamination equipment (autoclave, ultrasonic bath, washer/disinfector) is suitable for the intended use, safe for use, maintained in a safe condition and inspected. Staff using the equipment should be trained in its use.
Management of Health and Safety at Work Regulations 1999
These regulations require employers to make a systematic assessment of all the risks to the health and safety of their employees and others, arising from work activities.
Pressure Systems Safety Regulations 2000
Benchtop sterilisers must comply with these regulations, which are intended to prevent risk of injury from stored energy because of a failure of a pressure system.
Control of Substances Hazardous to Health (COSHH) Regulations 2002
COSHH regulations relate to biological and chemical risks. These regulations require a risk assessment to be carried out of all potentially hazardous substances.
Medical Devices Regulations 2002
Medical devices on sale within the UK must carry a CE marking and information on the processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of sterilisation of the device and any restriction on the number of reuses. Equipment such as benchtop steam sterilisers and washer/disinfectors is covered by these regulations.
HTM 01‐05: Decontamination in Primary Care and Dental Practices for Guidance on Conducting Decontamination at Local Level 2013
Dental nurses responsible and accountable for dental instrument management should refer to the Department of Health (DH) document HTM 01‐05: Decontamination in primary care and dental practices for guidance on conducting decontamination at local level.
Risk of Infection Assessment
Dental equipment can be categorised according to the risk of infection that the procedure poses during treatment (Table 3.1).
Table 3.1 Risk of infection assessment for instrumentation.
|Risk level||Definition||Suitable processes||Example|
|Items of equipment that have contact with intact skin or mucous membranes||Cleaning following manufacturer’s recommendations||Aspirator tubing|
|Medium||Items of equipment that are used in procedures where there may be a breach of the integrity of skin or mucous membranes||Sterilisation or use of single‐use items||Ultrasonic scaler|
|High||Items of equipment which penetrate or have contact with broken skin, mucous membranes or enter sterile areas||Sterilisation or use of single‐use items||Scalpel blade and handle|
Adapted from: Medical Devices Agency (2002) Guidance in Decontamination from the Microbiology Advisory Committee to the Department of Health. London: Medical Devices Agency.
Decontamination Control Assurance Standards require that a system should be in place that ensures that all reusable dental instruments are decontaminated prior to reuse, and that the risks associated with the decontamination process and facilities are managed. A record must be made and kept of each time dental instruments are used and decontaminated to provide demonstrable evidence that the equipment was functioning effectively and consistently in the unlikely event of an adverse incident. Records must be retained for the lifetime of the dental instrument plus 5 years.
The Medical and Healthcare products Regulations Agency (MHRA) defines the following terms:
Manual or ultrasonic cleaning of dental instruments should be undertaken prior to the chemical disinfection or sterilisation process. It is a method of decontamination for non‐invasive (low‐risk) items but should not be used for medium‐ or high‐risk dental instruments, where sterilisation or disinfection is required. The removal of all visible contamination reduces the number of relevant micro‐organisms present but does not destroy all micro‐organisms.
The reduction of microbial contamination will depend upon many factors including the efficiency of the cleaning process and the initial contamination. A further reduction will occur on drying, as some micro‐organisms cannot multiply on a clean dry surface. Thorough cleaning reduces the possible transmission of all micro‐organisms, including the abnormal prion protein that causes variant Creutzfeldt–Jakob Disease (vCJD).
- Appropriate PPE must be worn.
- A designated ‘dirty’ area for instrument cleaning must be used. A deep sink should be used so that instruments can be fully submerged.
- Use a clean disposable cloth or brush for cleaning.
- Use warm water and detergent.
- A separate sink for rinsing the instruments must be available.
- Dry thoroughly using a clean disposable cloth or paper towels.
- Instruments must be visibly checked to ensure all organic material has been effectively removed.
Ultrasound energy is used for the mechanical removal of contaminated waste or debris from dental equipment.
- Ultrasonic cleaners must comply with HTM 01‐05.
- Gross contamination should be removed by manual cleaning.
- Use as per manufacturer’s instructions, particularly on how long the instruments should stay in the bath for effective cleaning, ensuring regular change of water and regular decontamination of machine.
- Fill the bath with warm water and put in solution, which must contain a detergent or a disinfectant with detergent, not just a disinfectant.
- Place the instruments in the ultrasonic bath.
- Use the manufacturer’s recommended time for cleaning.
- Take the instruments out and rinse under clean water.
- Check for any residual debris.
- The water in the bath must be changed daily or sooner if gross soiling is evident.
- Use the manual cleaning method if debris is found.
Disinfection will not achieve the same reduction in microbial contamination levels as sterilisation. Disinfection is defined as a process used to kill or remove pathogenic micro‐organisms but which cannot usually kill bacterial spores.
The microbicidal effects of heat are used to achieve disinfection, e.g. a washer/disinfector with a heating cycle reaching 80°C for a minimum of 1 minute.
Appropriate chemicals are used to inactivate micro‐organisms and achieve disinfection. There are high and low levels of chemical disinfection:
- High‐level chemical disinfection, e.g. using peracetic acid. This is used in specialist settings for items which cannot withstand heat disinfection/sterilisation.
- Low‐level chemical disinfection, e.g. chlorine releasing agents or alcohol.
- Maintenance of equipment must be in accordance with HTM 01‐05.
- All maintenance to be carried out according to relevant dental team protocols.
Sterilisation ‘is a process used to render the object free from viable micro‐organisms, including bacterial spores and viruses’. Single‐use items avoid the need for re‐sterilisation and are a practical and safe method. Pre‐sterilised items must be stored using a stock rotation system according to the manufacturer’s instructions. Sterilisation of dental instruments must be carried out in accordance with the manufacturer’s instructions.
Ideally, sterile items should be processed and obtained from a sterile services department (SSD). Where it is not possible to use an SSD, a validated benchtop steam steriliser may be used to reprocess reusable dental instruments.
Validated benchtop steam sterilisers are unsuitable for processing:
- Porous products (e.g. drapes, dressings).
- Dental instruments that are hollow or have lumens (either wrapped or unwrapped).
- Dental instruments that are wrapped.
Vacuum benchtop steam sterilisers have a pre‐sterilisation active (vacuum) air removal stage to ensure steam penetration throughout the load. They also have a post‐sterilisation drying stage before the steriliser door is opened because dental instruments that are not dry cannot be considered to be sterile.
After the steriliser has been purchased it should be able to be validated and tested periodically according to prevailing standards.
All instruments that have been through the decontamination process must be inspected to ensure they are clean, functional and in good condition.
A dedicated clean area with good lighting and access to an illuminated magnifier is recommended to allow inspection of instruments to observe for residual contamination, debris or damage. All cleanliness failures should be recorded in a fault log and regularly reviewed. Instruments that are blunt, bent, rusted or damaged or show any signs of pitting or other corrosion must be discarded in a clinical waste container.
Single Patient Use Dental Instruments
Reprocessing dental instruments designated as single patient use has legal implications and requires extensive testing, validation and documentation. Dental practices reprocessing or reusing devices intended by the manufacturer for use on a single occasion take full responsibility for their safety and effectiveness. All legal obligations that would have fallen to the original manufacturer under Medical Devices Regulations will fall to the dental practice when a single patient use item is reprocessed and used again.
Reprocessing single‐use dental instruments may affect the capabilities and/or the materials from which the instrument is made. Single‐use instruments are not designed to allow thorough decontamination or re‐sterilisation processes.