DECONTAMINATION, DISINFECTANTS AND ANTISEPTICS Prepared by:
Kirklees Infection Control Team
Responsible Area: Approval Information:
Public Health Date Approved: COMMITTEE:-
Lead Director:
Dr Judith Hooper
Infection Control 15 August 2007 PEC
Version No. Approved:
Number one
Review Date:
July 2009
Reference to Standards for Better Health Domain
Department of Health 2004 Standards for Better Health First domain Safety
Core/Development standard
Developmental Standard D1, C4b, C4c.
Performance indicators
1.To reduce incidence of cross infection
History of Document Version 1:
CONTENTS Section No.
Page No’s 1
1.
Introduction
2.
Associated Policies and Procedures
1
3.
Choice of decontamination method
1
4.
How should decontamination be carried out
3
5.
3
6.
The Re Use of Medical Devices intended for Single Use only Disinfectants and Antiseptics
7. 8.
Environmental Disinfection References
6 8
4
NICE Guidance Once NICE guidance is published, health professionals are expected to take it fully into account when exercising their clinical judgement. However, NICE Guidance does not override the individual responsibility of health professionals to make appropriate decisions according to the circumstances of the individual patient in consultation with the patient and/or their guardian or carer.
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Introduction Kirklees PCT has a duty of care to keep patients, staff and visitors safe by having systems to ensure that all reusable medical devices are properly decontaminated prior to use or repair and that the risks associated with decontamination facilities and processes are well managed. Staff handling used medical equipment should assume that it is contaminated and take precautions to reduce the risk to themselves and others. The use of personal protective equipment/clothing must be considered. The Health and Safety at Work Act (1974) states anyone who inspects, handles, services or repairs any medical, dental, chiropody, surgical or laboratory equipment has the right to expect that such articles have been cleaned and properly treated so as to prevent or minimise the risk of infection. Equipment and articles which have been contaminated by/or in contact with blood and body fluids will require decontamination prior to examination by third parties. This may include engineers, manufacturers employees and others who perform maintenance and repairs and not employed with the NHS. Medical devices should be decontaminated and stored in accordance with legislative and best practice requirements. If the manufacturer’s instructions appear inappropriate or incomplete, report this to the MHRA as an adverse incident. Decontamination requirements should be considered before reusable medical devices are acquired to ensure they are compatible with the decontamination equipment available.
2.
Associated Policies and Procedures Records Management Incident Reporting Universal Precautions Hand Decontamination Waste Management Guideline
3.
Choice of decontamination method Decontamination is a series of processes to remove or destroy contamination so that infectious agents or other contaminants cannot reach a susceptible site in sufficient quantities to start infection or any other harmful response. Differing levels of decontamination are used depending on the device and the procedure involved. The levels of decontamination are: • •
cleaning cleaning followed by disinfection and or sterilisation
The choice of decontamination method should be related to the degree of infection risk associated with the intended use of the equipment.
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Classification of infection risk associated with the decontamination of medical devices Risk
Application of item
Recommendation
High
• In close contact with broken skin or broken mucous membrane • Introduced into sterile body areas
Cleaning followed by sterilisation
Medium
• In contact with mucous membranes • Contaminated with particularly virulent or readily transmissible organisms • Before use on immunocompromised patients • In contact with healthy skin. • Not in contact with patient.
Low
Cleaning followed by sterilisation or disinfection NB: Where sterilisation will damage equipment, cleaning followed by high level disinfection may be used as an alternative.
Cleaning.
Other factors to consider when choosing a method of decontamination include the: • • • • •
nature of the contamination time required for processing heat, pressure, moisture and chemical tolerance of the object availability of the processing equipment quality and risks associated with the decontamination method.
Cleaning A process which physically removes infectious agents and the organic matter on which they thrive, but does not necessarily destroy infectious agents. The reduction of microbial contamination depends on many factors, including the effectiveness of the cleaning process and the initial bioburden. Cleaning is an essential prerequisite to ensure effective disinfection or sterilisation. Cleaning followed by disinfection A process used to reduce the number of viable infectious agents but which may not necessarily inactivate certain viruses and bacterial spores. Disinfection does not achieve the same reduction in microbial contamination levels as sterilisation. Under certain defined conditions moist heat will also disinfect. Cleaning followed by Sterilisation Sterilisation - A process used to make an object free from all viable micro organisms including viruses and bacterial spores.
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4.
How should decontamination be carried out? All decontamination processes should be operated and carried out in accordance with the equipment manufacturer’s instructions. Assurances shall be obtained from the medical devices manufacturer that the decontamination process chosen is appropriate and not harmful to the device. Use only chemicals compatible with the device and at the correct concentration as recommended by the manufacturers. Decontamination equipment should be properly: • • •
commissioned validated and revalidated subject to planned maintenance by properly trained and competent staff
Only appropriately trained staff, provided with suitable equipment/clothing should carry out decontamination. Training in appropriate aspects of decontamination practice should be provided to relevant healthcare staff, including those working in a clinical environment. Staff involved in decontamination should be aware of the legal requirements and best practice and be up to date in these areas.
5.
The Re Use of Medical Devices intended for Single Use only Single Use – The expression ‘single-use’ means that the medical device is intended to be used on an individual patient during a single procedure and then discarded. It is not intended to be reprocessed and used on another patient. The symbol below is used on medical device packaging indicating ‘do not reuse’ and may replace any wording.
Safety Issues Reprocessing single-use devices may compromise its intended function. Single-use devices may not be designed to allow thorough decontamination and (if applicable) resterilisation processes. Reprocessing a single-use device may alter its characteristics so that it no longer complies with the original manufacturer’s specifications and therefore the performance may be compromised. Single-use device have not undergone extensive testing, validation and documentation to ensure the device is safe to reuse. Approval Committee: Version No: Date Approved:
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Legal implications, negligence and regulatory requirements User organisations, professional users and reprocessers who prepare single-use devices for further episodes of use, may be transferring legal liability for the safe performance of the product from the manufacturer to themselves, or the organisation that employs them. If a reprocessed device is supplied to another legal entity and the device is not fit for its intended purpose, the reprocessor and professional user may be committing an offence or contravening national guidance under one or more of the following: •
The General Product Safety Regulations 2005 (4)
•
The Medical Devices Regulations 2002 (1)
•
Health and Safety at Work Act 1974
•
Part 1 of the Consumer Protection Act 1987 (3)
There may be exposure to civil liability, with payment of damages for any injury caused to another person by the device, either on the basis of negligence or under the strict liability provisions of Part 1 of the Consumer Protection Act 1987; if the device is found to be defective (i.e. does not provide the expected level of safety).
6.
Disinfectants and Antiseptics Disinfection A process used to reduce the number of viable infectious agents but which may not necessarily inactivate certain viruses and bacterial spores. Disinfection does not achieve the same reduction in microbial counts as sterilisation. Many disinfectants are inactivated by organic matter such as blood, pus, food and faeces. Instruments and other articles must, therefore, be thoroughly cleaned before disinfection. Disinfectants are chemicals that destroy micro-organisms (not prions). However, they are not suitable for use on skin or tissue. Antiseptics are usually non-toxic chemicals that destroy or inhibit the growth of microorganisms on the skin or tissues. General considerations Dilution:
chemical disinfectants/antiseptics must be used at the recommended strength. Too high a concentration is wasteful, too low a concentration is ineffective.
Preparation:
check the shelf life of the disinfectant and ensure correct storage many disinfectants deteriorate after dilution. Solutions should always be freshly prepared, used once then thrown away.
Contact time: correct
no disinfectant/ antiseptic acts instantly. It is, therefore, essential that the contact time is observed.
COSSH Regulations The Control of Substances Hazardous to Health (COSHH) regulations 2002 require that an Approval Committee: Version No: Date Approved:
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assessment is made of any health risk that may arise from exposure to hazardous substances and that appropriate control measures must be provided to avoid the risk. Most disinfectants are hazardous to some degree and are, therefore, subject to COSHH regulations. A full assessment of the risks should be available and should be consulted. Managers are required to ensure that their staff are properly trained and fully aware of the dangers associated with the use of the various disinfectants. Always follow the instructions on the pack regarding dilution and handling. Contact with disinfectants can cause skin irritation therefore personal protective equipment must be worn. Accidental spillage of irritant disinfectants onto skin or into eyes must be removed immediately with plenty of cold water. Please refer to individual COSHH risk assessment sheets available The following is a summary of the main risks arising from the use of disinfectants and is not intended to be comprehensive. COSHH Hazards
Alcohols
Highly inflammable: irritant to eyes, nose and throat; prolonged skin contact may cause drowsiness
Chlorhexidine
Generally of low toxicity. If concentrated may cause irritation to the eyes and skin. In normal use is non-irritant, but prolonged contact can occasionally cause hypersensitivity.
Hypochlorite
Irritant to nose, eyes and lungs; contact with acid (e.g. urine) gives off chlorine gas therefore avoid applying directly onto urine spills.
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Environmental Disinfection Hypochlorite 0.1% Solution Equivalent to 1,000 parts per million of available chlorine
For general clinical and environmental use where no body fluid is present
Hypochlorite 1% Solution Equivalent to 10,000 parts per million of available chlorine
For spillage of blood and body fluids
Hard Surface ALCOHOL Wipes
• To disinfect hard surfaces if visibly clean
The general environment i.e. the walls, floors, ceilings and furniture do not require disinfection unless contaminated with blood and body fluids. Hot water and a neutral detergent are generally sufficient. Disinfectants must never be poured down drains in an attempt to disinfect them.
National Colour Coding Scheme for Safer Hospital Cleaning
RED (DRED (DISPOSABLE) POSABLE) SANITARY APPLIANCES & WASHROOM FLOOR
BLUE BLUE
GENERAL AREAS (inc. wards, depts, office & Communication areas)
KITCHENS (dept & ward)
YELLOW
WHITE (DISPOSABLE)
WHITE (DISPOSABLE)
ISOLATION ROOMS
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WASHBASINS & WASHROOM SURFACES
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OPERATING THEATRES & ANTE ROOMS
Professional Concentrated Neutral detergent for environmental cleaning and washing up Directions for use Follow the manufacturer’s recommendation for dilution. General cleaning duties: The usual strength for environmental cleaning is 0.1%. (5mls of neutral detergent per 5 litres of hot water) For washing up crockery and general kitchen utensils:- 5 mls of neutral detergent in 10 litres of hot water Chlor-Clean Directions for use: For terminal cleaning and disinfection of patient surfaces during and following outbreaks of infection. Chlor Clean should be used at 1,000 parts per million available chlorine for ‘terminal cleans’ of areas or rooms/wards after use by infected patients. During outbreaks of infection areas/wards must be cleaned twice daily with Chlor Clean.
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References Aycliffe G., Hugo W. Russell A. (1992) Principles and Practice of Disinfection. Preservation and Sterilisation. Blackwell. London Control of Substances Hazardous to Health Regulations 2002. Statutory Instrument 2002 No 2677. ISBN 0 11 042919 2, http://www.opsi.gov.uk/SI/si2002/20022677.htm Department of Health (1993) HSG (93) 26 – Decontamination of equipment prior to inspection service or repair Health and Safety at Work Act (1974) HMSO. London. Management of Health and Safety at Work Regulations 1999. Statutory Instrument 1999 No. 3242. ISBN 0 11 085625 2. http://www.opsi.gov.uk/SI/si/1999/19993242.htm MHRA DB 2003(05) Management of medical devices prior to repair, service or investigation. 2003. http://www.mhra.gov.uk MHRA DB 2006 (05) Managing Medical Devices Guidance for healthcare and Social Services Organisations. DOH London. MHRA DB 2003(05) Management of medical devices prior to repair, service or investigation. 2003. http://www.mhra.gov.uk MHRA DB 2006 (04) Single Use Medical Devices: Implications and Consequences of Reuse. DOH London Personal Protective Equipment (PPE) at Work. Health and Safety Executive (HSE) 1992. The Environmental Protection Act 1990. The Stationery Office, London. The Medical Devices Regulations 2002. Statutory Instrument 2002 No 618. HMSO 2002. ISBN 0110423178 www.opsi.gov.uk UK Health Departments (1990). Guidance for Clinical Health Care Workers: Protection Against Infection with Blood-borne Viruses. Recommendations of the Expert Advisory Group on AIDS and the Advisory Group on Hepatitis.
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