Decontamination of Reusable Medical Devices Policy
Responsible Directorate:
Public Health
Responsible Director:
Dr Judith Hooper
Date Approved:
25 March 2009
Committee:
Governance Committee
NICE GUIDANCE Once NICE guidance is published, health professionals are expected to take it fully into account when exercising their clinical judgment. 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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Version Control Document Title: Document number: Author: Contributors: Version: Date of Production: Review date: Postholder responsible for revision: Primary Circulation List: Web address: Restrictions:
Decontamination of Reusable Medical Devices 1 Jane O’Donnell Kirklees Infection Prevention and Control Team 2 March 2009 March 2011 Deputy Director of Infection Prevention and Control
Standard for Better Health Map Domain: Core Standard Reference: Performance Indicators:
First domain, Safety C4, C4b, C4c, C4e. 1.
Reduction in the incidence of healthcare associated infections
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Contents
Section
Page
1
Introduction
4
2
Associated Policies and Procedures
4
3
Aims and Objectives
4
4
Scope of the Policy
5
5
5
7
Accountabilities and Responsibilities Classification of Infection Risk Associated with the Decontamination of Medical Devices Written Procedures
8
Decontamination of Life Cycle
7
9
8
12
Record Keeping Transportation of Contaminated Reusable Medical Devices Decontamination of Healthcare Equipment Prior to Inspection, Service or Repair Equality Impact Assessment
13
Training Needs Analysis
9
14
Monitoring Compliance with this Policy
10
15
References
11
16
Appendices
12
Definitions Key Stakeholders consulted/involved in the development of the policy/procedure Equality Impact Assessment Tool Examples of Equipment and the Decontamination Method Declaration of Contamination Status
12
6
10 11
6 7
8 9 9
Appendices A B C D E
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13 14 15 17
Policy Statement NHS Kirklees will ensure the safe and effective decontamination of reusable medical devices to minimise the risk of transmission of healthcare associated infection. 1.
Introduction Improving and sustaining reusable medical device decontamination services forms an important part of the Chief Medical Officer’s strategy to combat healthcare associated infection and is included in the reports “Winning Ways” and “Getting Ahead of the Curve”. Healthcare Providers are required by the Health Act 2006, Code of Practice to provide a safe decontamination service that is embedded within the service culture of the organisation in support of successful clinical outcomes and the associated wellbeing of patients and staff.
2.
Associated Policies and Procedures This policy should be read in accordance with the following Trust policies, procedures and guidance. ● Hand Decontamination Policy ● Universal Standards Precaution Policy ● Health and Safety Policies ● Incident Reporting Policy ● Waste Management Guideline ● Decontamination, Disinfectants and Antiseptics Policy ● Records Management Policy ● Medical Devices Policy
3.
Aims and Objectives The key aims are: ● To ensure high standards of decontamination of reusable medical devices, decontaminated according to its function, so as to protect as far as reasonably practical the health, safety and welfare of staff, patients and those recipients who are involved in inspection, service, repair or transportation of medical devices or equipment.
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● To reduce the associated risks to patients and healthcare workers from the transmission of healthcare associated infections. ● To ensure compliance with the Health Act 2006, The Code of Practice for the Prevention and Control of Health Care Associated Infections. ● To ensure that single use items are never reprocessed for reuse. 4.
Scope of the Policy This policy must be followed by all NHS Kirklees employees who are developing policy and procedural documents or developing guidance for colleagues. It must be followed by all staff who work for NHS Kirklees (the PCT), including those on temporary or honorary contracts, bank staff and students. Breaches of this policy may lead to disciplinary action being taken against the individual. Independent Contractors are responsible for the development and management of their own procedural documents and for ensuring compliance with relevant legislation and best practice guidelines. Independent Contractors are encouraged to seek advice and support as required.
5.
Accountabilities and Responsibilities The Chief Executive (CE) is accountable for ensuring that effective arrangements for decontamination of reusable medical devices are in place within the PCT. The Director of Infection Prevention and Control (DIPC) has responsibility to give assurance to the Board and to have direct accountability for the decontamination of reusable medical devices in the PCT. The Infection Prevention and Control team will: ● Ensure this policy is reviewed as required and work with Heads of Service to implement necessary changes in practice. ● Act as a resource for the purchase and monitoring of equipment. ● Act as a link between the PCT and specialist agencies and networks. ● Take a role in investigating incidents related to decontamination and managing associated hazards. Heads of Service are responsible for ensuring that healthcare professionals involved in the decontamination of reusable medical devices adhere to policy. Employees will: ● Will co-operate and assist with the implementation of the Policy, and its associated procedures.
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● Bring to the notice of management, any problems of failings associated with the decontamination process. ● Attend training as required. ● Make themselves aware of, and follow safe systems of work and control methods (including personal protective equipment) provided for their safety and the safety of others. ● Promptly report all incidents concerning the decontamination process in accordance with the Trust’s Policy and Procedure on reporting incidents. ● Report any adverse ill health effects arising from the decontamination process to both the Health & Safety Department and the relevant Occupational Health Department. ● Seek specialist advice as necessary. 6.
Classification of Infection Risk Associated with the Decontamination of Medical Devices Risk High
Intermediate
Low
Application Items in close contact with a break in the skin or mucous membrane or introduced into a sterile body area. Items in contact with intact skin, mucous membranes or body fluids, particularly after use on infected patients or prior to use on immunocompromised patients. Items in contact with healthy skin or mucous membranes or not in contact with patient.
Recommendation Sterilisation eg, instruments used in nail surgery. Sterilisation or disinfection required, eg, auriscope.
Cleaning eg, baby scales, beds.
Three processes of decontamination are commonly used: ● Cleaning A process, which physically removes contamination but does not necessarily destroy microorganisms. The reduction of microbial contamination is not routinely measured and will depend upon many factors, including the efficiency of the cleaning process and the initial bioburden. Cleaning removes microorganisms and the organic material on which they thrive.
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● Disinfection A process used to reduce the number of viable microorganisms but which may not necessarily inactivate some microbial agents, such as certain viruses and bacterial spores. Disinfection may not achieve the same reduction in microbial contamination levels as sterilisation. ● Sterilisation A process used to render an object free from microorganisms including viruses and bacterial spores. Normal sterilisation methods will not destroy prions. 7.
Written Procedures Individual services will prepare written procedures and standards on the decontamination of equipment used in that particular service. This procedure should contain the following details: -
an identified member of staff who will be responsible for overseeing decontamination procedures
-
the types of equipment used and details of the cleaning required
-
the types of equipment used and details of the decontamination required
Appendix D illustrates examples of equipment and the decontamination method. 8.
Decontamination Life Cycle Effective decontamination requires the attainment of acceptable standards at all stages of the life cycle. Failure to address issues in any of these stages will result in inadequate decontamination. At all stages of reprocessing, the following issues need to be taken into account. ● The location and activities where decontamination takes place. ● Facilities and equipment ensure the decontamination agents used are compatible. ● Ensuring equipment used for decontamination is fit for purpose, is validated, maintained and tested in accordance with manuafacturer’s guidelines and legislation. ● Decontamination processes are undertaken in a controlled manner to protect the health and safety of patients and staff. ● Prior to procurement of re-usable medical devices the need to ensure the decontamination processes are available within NHS Kirklees.
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● Documented training scheme must be in operation with individual training records for all healthcare workers involved in decontamination activites. Healthcare workers undertaking decontamination must be competent, properly trained and supervised. Line managers are responsible for detailing an individual’s core competencies, and any training received which must be maintained and updated regularly. Manufacturers of reusable medical devices are required to supply information on the appropriate decontamination process to allow reuse, including cleaning, disinfection and where appropriate the method of sterilisation. If a healthcare worker is unfamiliar with loan equipment or newly purchased devices, line managers must arrange training from the supplier / manufacturer to ensure equipment is decontaminated correctly and to minimise the potential for damage. It is important to be able to trace reusable medical devices through the decontamination processes and also to the patient on whom they have been used. 9.
Record Keeping The Consumer Protection Act (1987)(60 in particular Product Liability has implications for the processing of devices used for patient care. In particular, it is essential to maintain adequate records that demonstrate how a particular device was processed; a description of the method/s employed and details of available trained personnel with copies of training records. The organisation should have the ability to demonstrate how instruments/equipment have been processed through the decontamination cycle. For surgical instruments records must be maintained and retained, to enable instruments to be traced to individual patients. Records relating to decontamination should be maintained by the organisation for a minimum of eleven years.
10.
Transportation of Contaminated Reusable Medical Devices All used medical devices present a risk of infection. To minimise the risk, reusable medical devices must be placed in closed, secure containers and transported to the decontamination area as soon as possible following use. Transport containers must protect the medical device during transit and the handler from inadvertent contamination and therefore must be: ● Leakproof, capable of being closed securely. ● Easy to clean. ● Rigid to contain instruments and robust to prevent instruments being damaged in transit. Healthcare workers handling contaminated medical devices must wear personal protective equipment and be vaccinated against hepatitis B. After each use, transport containers must be cleaned, disinfected and dried. Page 8 of 17
11.
Decontamination of Healthcare Equipment prior to inspection, service or repair All re-useable medical devices and equipment to be inspected, serviced, repaired, returned to the lending organisation or disposed of should undergo decontamination. This is necessary to ensure that they are in a condition that makes them safe to be handled by all personnel who may come into contact with them during transit and subsequent handling. The device and equipment should not expose the recipient to a biological, chemical or radioactive hazard, This policy focuses on the aspects of reducing microbiological risks. Other methods of decontamination may be necessary to remove chemical and radioactive material. Advice should be sought from the device manufacturer in these cases. Manufacturers have a responsibility to provide information on the compatibility of their particular medical devices or equipment with methods and agents for decontamination. It is essential this information is available and followed as inappropriate methods or agents can damage equipment. If the manufacturer is unable to provide this information or it is inadequate the MHRA should be notified via the PCTs Risk Advisor. Devices designed for single use must not be reprocessed for reuse and should be disposed of after use into the appropriate waste stream. Once the decontamination process has been completed the items should be labelled with a declaration to identify their status. A copy of the declaration certificate is attached to this policy as Appendix E. The declaration of contamination status should be readily accessible to the recipient of the equipment. Instrumentation or equipment loaned, rented or leased to a patient for use in the community environment must be treated with the same level of caution and preparation. This also applies to items that have been used for demonstration purposes. Loaned equipment must be accompanied by manufacturer’s decontamination instructions. Decontaminate loaned equipment before and after use.
12.
Equality Impact Assessment This Policy was found to be compliant with this philosophy (see Appendix C)
13.
Training Needs Analysis The PCT is committed to the training and continuing development of all staff including independent contractors on all relevant issues surrounding the decontamination of reusable medical devices. All induction programmes and Infection Prevention and Control mandatory training will include decontamination of reusable medical devices. Heads of Service when procuring equipment must ensure that training needs are identified and implemented following an agreed action plan.
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14.
Monitoring Compliance with this Policy The PCT will have key indicators for the monitoring of decontamination of reusable medical devices and these indicators will be included in all performance processes including the Assurance Framework. ● Essential Steps audits to ensure key infection prevention and control policies are being implemented. ● Percentage of incident reports attributed to a failure in decontamination. Percentage of clinical and non-clinical staff undertaking mandatory annual infection prevention and control training. ● PCT Provider and Commissioned Services will have an Infection Prevention and Control premises audit conducted on an annusal basis undertaken by the Infection Prevention and Control team to ensure all services are implementing the National Decontamination Strategy. ● Healthcare associated infections due to inadequate decontamination identified after completion of Root Cause Analysis investigations. ● Quality indicators will be a part of normal performance monitoring against a set of local, regional and nationally, (nationally via the evidence for Standards for Better Health which will be superseded in 2009 by the Care Quality Commission).
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15.
References ● Winning Ways: Working Together to Reduce Healthcare Associated Infection in England, Chief Medical Officer, 2003 ● Getting ahead of the Curve: A Strategy for Combating Infectious Diseases, Department of Health, 2002 ● The Health Act 2006. Code of Practice for the Prevention and Control of Health Care Associated Infections. Department of Health. (Revised January 2008.) ● Professional Letter (PL) Decontamination of Surgical Instruments (CMO, Department of Health Feb 2007) ● HSC 2000/032: Decontamination of Medical Devices, Department of Health 2000 ● The Decontamination of Surgical Instruments in the NHS in England – Update Report – “A Step Change.” Department of Health (June 2005) ● Shifting the Balance of Power the next steps. Securing Delivery – Human Resources Framework, Department of Health, January 2002 ● Medical Devices Directive 93/42 EC, (Annex 1 Essential Requirements) EU Council 1995 ● National Decontamination Project. A process for commercial involvement in improving NHS Decontamination. NHS Estates June 2003. ● About the Healthcare Commission. Inspecting, Informing, Improving. Commission for Healthcare Audit and Inspection 2005. ● Standards for Better Health. Legislative Basis Section 46 of the Health and Social Care (Community Health and Standards) Act 2003. ● Department of Health 2007 – Decontamination Health Technical Memorandum 01-01 Decontamination of Reusable Medical Devices
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16. Appendices Appendix A – Definitions Decontamination This strategy recognises the National Decontamination Strategy definition of decontamination. The definition of decontamination is defined as: “The combination of processes (including cleaning, disinfection and sterilisation) used to make re-useable surgical instruments safe for further use on patients and handling by staff. This is primarily aimed at those re-useable instruments that are invasive by intent or could be invasive inadvertently”. Medical Device This strategy recognises the Medical Devices Directive definition of Medical Devices. The definition of a medical device is defined as: “Medical Device means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: ● ● ● ●
Diagnosis, prevention, monitoring, treatment, treatment or alleviation of disease. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap. Investigation, replacement or modification of the anatomy of physiological process. Control of conception.
And which does not achieve its principle intended action in or on the human body by pharmacogical; immunological or metabolic means, but which may be assisted in its function by such means”. Infection Control Infection control is the use of evidence based practice, training and education, policies and procedures to prevent or minimise the risk of cross infection, through a managed environment, which minimises the risk of infection to patients, staff and visitors.
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Appendix B Key stakeholders consulted/involved in the development of the policy/procedure Key Participant Yes/No
Feedback requested Yes/No
Kirklees Infection Control Committee
Yes
Yes
NHS Kirklees Policy Development Group
No
Yes
Stakeholders name and designation
Community Dental Services KCHS Podiatry Services HVMH – Day Surgery Unit
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Feedback accepted Yes/No
Appendix C Equality Impact Assessment Tool Insert Name of Policy / Procedure Yes/No 1.
Does the policy/guidance affect one group less or more favourably than another on the basis of: • Race
No
• Ethnic origins (including gypsies and travellers)
No
• Nationality
No
• Gender
No
• Culture
No
• Religion or belief
No
• Sexual orientation including lesbian, gay and bisexual people
No
• Age
No
• Disability - learning disabilities, physical disability, sensory impairment and mental health problems
No
2.
Is there any evidence that some groups are affected differently?
No
3.
If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable?
4.
Is the impact of the policy/guidance likely to be negative?
5.
If so can the impact be avoided?
-
6.
What alternatives are there to achieving the policy/guidance without the impact?
-
7.
Can we reduce the impact by taking different action?
-
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No
Comments
Appendix D Examples of Equipment and the Decontamination Method Equipment Cleaning Method Airways
Single use.
Auroscope ear pieces
Single use.
Babies changing mat
Change tissue after each baby, clean with detergent wipe and wipe disposable with paper towel.
Baby Scales
After each use wipe with detergent wipes, dry with disposable paper towel. Renew paper sheet.
Bedpan washers / macerators
These should be sued, cleaned and serviced according to manufacturer’s guidance.
Beds, backrests, bed cradles and mattresses
To be cleaned between users with hot water (35°C) and general purpose detergent between users. If soiling is evident then immediately clean as above and then wipe over with a Sodium Hypochlorite 1,000 ppm Chlorine.
Blood pressure equipment
Clean with either hot water and detergent or detergent wipes. Wipe with 70% alcohol wipe between each patient use (refer to manufacturer’s instructions). Use a cuff dedicated for known infectious patients which can be washed at the end of care episode or use disposables.
Bowls – patient washing Clean between each use with hot water and neutral detergent, using disposal paper towels. Rinse and store dry. Buckets
a) b)
Surgical – sterilise. Dressings – clean with hot water and detergent. Rinse and dry. Store inverted.
Catheter Drainage bags
Single use (disposable).
Cleaning cloths
Use disposables.
Commodes
Clean seat and frame with detergent and hot water or detergent. Wipes between each use. If contaminated clean and wipe with disinfectant, chlorine releasing agent.
Dressing trolleys
Clean with freshly prepared detergent.
Dressing trolleys
At the beginning and end of each session and / or when visibly soiled clean hot water 35°C and general purpose detergent or detergent wipes.
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ECG Equipment - Electrodes - Straps - Machine
Single use only Wash well with warm water Wipe over with damp cloth, keep covered when not in use.
Examination couches
Surface must be in good repair, clean hard surface detergent wipes at start and finish of each session or if it becomes soiled. Cover with disposable paper roll and change between each client use. Couch can be wiped with hard surface wipes between clients / patients. If visibly soiled treat as spillage. Refer to manufacturer’s guidelines.
Instruments
Where possible use disposables, single use items.
Oxygen masks & tubing
Single use only.
Shaving and toothbrushes Stethoscope
Single use.
Suction equipment
Wipe head with 70% isopropyl alcohol and leave to dry. Only disposable suction units (liner and tubing) should be used. After each use the disposable components should be disposed of as. NHS Kirklees Waste Management guidelines. Tubing should be single use disposable. Filters – these should be replaced between patient use and at appropriate intervals in keeping with the Manufacturer’s instruction.
Surgical instruments
Decontamination and sterilisation by a third party provider who is registered with MHRA.
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Appendix E - Declaration of contamination status From (consignor)
To (consignee)
Address
Address
Reference Emergency Tel:
Reference
Type of equipment:
Manufacturer:
Description of equipment:
Other identifying marks: Model No:
Serial No:
Fault:
Is the item contaminated?
Yes*
No
Don’t know
* State type of contamination: blood, body fluids, respired gases, pathological samples, chemicals (including cytotoxic drugs), radioactive material or any other hazard: Has the item been decontaminated?
Yes†
No‡
Don’t know
† What method of decontamination has been used? Please provide details: Cleaning Disinfection Sterilisation ‡ Please explain why the item has not been decontaminated: Contaminated items should not be returned without prior agreement of the recipient This item has been prepared to ensure safe handling and transportation: Name:
Position:
Signature: Date:
Tel:
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