BULLETIN Community Equipment Loan Stores –

Community
Equipment Loan
Stores –
Guidance on
Decontamination
BULLETIN
MHRA DB2003(06)
September 2003
The Medicines and Healthcare products Regulatory Agency (MHRA)
was formed from a merger of the Medical Devices Agency (MDA) and the
Medicines Control Agency (MCA) on 1 April 2003.
The Medicines and Healthcare products Regulatory Agency (MHRA) protects and
promotes public health and patient safety by ensuring that medicines, healthcare
products and medical equipment meet appropriate standards of safety, quality,
performance and effectiveness, and are used safely.
The MHRA is an executive agency of the Department of Health.
Contents
1
Executive summary .................................................................... 2
2
Introduction ................................................................................ 2
3
Safe systems of work ................................................................. 3
3.1 Decontamination of items ..................................................... 4
3.2 After decontamination........................................................... 6
4
Guidance on decontamination .................................................... 9
4.1 Cleaning ............................................................................. 10
4.2 Disinfection......................................................................... 11
5
Legal and other requirements................................................... 11
6
Antibiotic resistant bacteria and other infectious agents .......... 12
7
Glossary ................................................................................... 12
8
References and bibliography .................................................... 13
Appendix 1
Certificate of decontamination .................................................. 15
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1 Executive summary
This document provides general advice for staff dealing with
community equipment in loan stores.
There is a small risk of cross infection from the reuse of medical
equipment issued by community equipment loan stores for use in the
home setting. This risk can be minimised by some simple
precautions. We provide advice on the handling of devices and
equipment returned from use and give guidance on the nature of
decontamination required and the generic methods to be used.
Putting safe systems in place to manage the decontamination of
equipment will contribute to meeting the requirements of the
Department of Health's Integrating Community Equipment Services
(ICES) initiative [1].
2 Introduction
Decontamination is the combination of processes used to make an
item safe for handling by staff and for further use. The effective
decontamination of reusable items is essential in reducing the risk of
transmission of infectious agents.
The aims of decontamination are to make reusable items safe to be
handled or used by:
• loan store staff
• subsequent patients, carers or the patient's family
• maintenance staff.
Decontamination is also important because subsequent users of
equipment expect to receive equipment that both looks and is clean.
There are three levels of decontamination:
• cleaning
• cleaning followed by disinfection
• cleaning followed by sterilization
The decision about the level of decontamination required depends not
only on how the item is used, but also the risk of the equipment
transmitting infection or acting as a source of infection. The vast
majority of loan equipment will not require much more than cleaning
and occasionally disinfection. Given the nature of its use, it is unlikely
that equipment loaned for use in the community will require
sterilization.
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3 Safe systems of work
A local protocol for decontamination activities should be established
with technical input, as required, from the following:
•
•
•
•
•
equipment manufacturers
infection control team
clinical nurse specialist / equipment provision
risk manager
health and safety officer
You may also wish to get advice from:
•
•
appropriate government bodies e.g. MHRA, ICES, Health
Protection Agency (HPA)
appropriate professional bodies e.g. Infection Control Nurses
Association (ICNA), National Association of Equipment Providers
(NAEP), Hospital Infection Society (HIS), Institute of Sterile
Service Managers (ISSM).
Staff handling used medical equipment should assume that it may be
contaminated and take precautions to reduce the risk of transmission
of infectious agents through contact with blood and other body fluids.
Personal protective equipment should be used, in accordance with
local policy, for the handling of potentially contaminated and soiled
equipment.
A local policy for the management and transport of equipment from
the point of use to the store should be implemented. Vehicles used
for the delivery and collection of loan equipment should ideally be
adapted to allow for segregation of those items being collected from
those being delivered. The interior of the vehicle should be capable of
being cleaned and disinfected. The walls and floors should be
impermeable and should be compatible with cleaning and disinfection
agents. It should be cleaned and disinfected on a weekly basis and
also when visibly soiled.
The store should maintain a one-way flow of equipment from receipt
to issue in order to prevent cross-contamination and returned items
being put into storage without first being decontaminated and
inspected.
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3.1 Decontamination of items
Devices that are obviously contaminated with blood, body fluids
or faeces should be handled with care and subjected to cleaning
followed by disinfection in accordance with the manufacturer's
instructions.
Devices in contact with intact skin or not in contact with the user at all
are generally considered to present a low risk of infection to those
handling the equipment. These devices usually require cleaning only.
Items of equipment that come into contact with intact mucous
membranes or are obviously contaminated with blood or other body
fluids present an increased risk of infection and therefore require
cleaning followed by disinfection.
Appropriately trained personnel who are provided with suitable
equipment and personal protective equipment should carry out
decontamination activities in accordance with the equipment
manufacturer's instructions.
Decontamination should be carried out in dedicated facilities that are
fit for their intended purpose. Further information on decontamination
is available in the MAC manual [2].
Table 1 illustrates the categories of risk and provides some examples
of reusable equipment along with a suggested method of
decontamination in between each patient use. This list is not
exhaustive and staff decontaminating equipment should always first
refer to the equipment manufacturer's instructions.
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Table 1
Examples of equipment and categories of
decontamination
Example of equipment
assistive listening device
bed lever
bedside rail
blanket support
communication aid for speech impediment
domestic lighting
fall alarm
flashing doorbell
gas escape alarm
grab rail
hoist
lever tap
liquid level indicator
low vision optical aid
special cutlery
split leg table
stool
teapot tipper
textphone
transfer board
trolleys
walking aids
2- and 4-section bed frame
bath board
lift & seat
bed pan
commode
hoist sling
male & female urinal
mattress and cover
pressure relief mattress
raised toilet seat
shower chair & seat
special seating
toilet frame & seat
wheelchair frame
wheelchair seating
Suggested method of
decontamination *
Cleaning
Cleaning and disinfection
* Suggested protocols for the methods of decontamination are provided in
section 4 of this document. Note: Always follow the equipment
manufacturer's instructions for decontamination.
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Items subject to investigation, service or repair (either in the loan
store or at the manufacturer's / suppliers premises) should be
decontaminated prior to these activities (see DB 2003(05) [3]). Items
requiring service or repair in the client's home should be safe to be
handled by service personnel. The equipment may require to be
cleaned and disinfection prior to service. Further advice should be
sought from the manufacturer or service agent. Any loaned items
being returned to a manufacturer or supplier should also be
decontaminated.
Organisations should have in place a system to enable adverse
incidents involving equipment to be reported to the Medicines and
Healthcare products Regulatory Agency (MHRA). This is a key ICES
milestone.
3.2 After decontamination
Once the decontamination process has been completed, items should
be inspected and any maintenance carried out to ensure that they are
safe and fit for reuse. They should then be labelled with a certificate
of decontamination. An example of a certificate of decontamination
is provided in Appendix 1. Whilst a certificate of decontamination for
every single item processed may seem unachievable in reality, loan
stores need to consider ways of documenting the processes
undertaken. There may be other ways of recording this information
and a local protocol should be established based on equipment
throughput and resources available.
A diagrammatic representation of the recommended workflow using a
‘dirty in / clean out’ approach is given in Figure 1. The facilities and
equipment required in each of these areas for the activity being
undertaken is outlined in Table 2.
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Figure 1 – Workflow for community equipment loan store
Collection from user
Return to store
Logging in
Clinical
waste
disposal
Segregation
Dirty
area
(see Table 2a)
Disassembly
Equipment
disposal
Decontamination
Complete certificate of contamination status
Reassembly
Inspection, testing, maintenance and/or
repair
Packaging
Clean
area
(see Table 2b)
Storage
Record dispatch
Delivery to user
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Table 2a – Facilities and equipment for the dirty area
Activity
Facilities
•
•
Collection of equipment from user
•
•
Logging in of returned equipment
•
•
Dirty area
Segregation of equipment to be sorted
by level of decontamination required
Disassembly of equipment where
necessary
Cleaning or cleaning & disinfection
depending on the type of equipment
and the nature of contamination
•
•
•
•
•
•
•
•
•
•
•
•
Completion of certificate of
decontamination
DB2003(06) September 2003
•
•
•
•
suitable vehicle to allow segregation of
clean and dirty items
the inside of the vehicle should be able to
be cleaned and disinfected on a regular
e.g. weekly basis and when visibly soiled.
the vehicle driver must have access to
personal protective equipment and a first
aid kit. The driver must be adequately
trained to handle contaminated items.
impermeable off-floor shelving which
should be cleaned regularly
dedicated hand decontamination facility
e.g. hand wash basin
foot operated pedal bin and black bags for
domestic waste stream
foot operated pedal bin and yellow bags
for clinical waste stream
personal protective equipment e.g. plastic
aprons, latex/nitrile/vinyl gloves, and face
visors
personal protective equipment
dedicated hand decontamination facility
sharps bin
equipment manufacturer's reprocessing
instructions
utility sink and drainer
adequate ventilation
appropriate drainage facilities
lockable chemical storage cupboard
appropriate cleaning / disinfection
equipment
personal protective equipment e.g.
coveralls, latex/nitrile/vinyl gloves, non-slip
footwear and face visors
dedicated hand decontamination facility
sharps bin
pedal operated clinical waste bin
COSHH assessments & material safety
data sheets should be available.
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Clean area
Table 2b – Facilities and equipment for the clean area
Activity
Facilities
Reassembly of equipment following
completion of decontamination process
A certificate of decontamination (or some
other means to identify that it has been
decontaminated) should accompany all
equipment from here onwards.
Inspection and testing for
maintenance and / or repair as part of
the quality control process
•
•
•
equipment manufacturer's instructions
personal protective equipment
dedicated hand decontamination facility
Packaging of equipment as
appropriate for storage or dispatch
•
•
personal protective equipment
dedicated hand decontamination facility
•
Impermeable off-floor shelving which
should be cleaned regularly
robust, secure outer door
Storage of equipment prior to dispatch
•
•
Record of dispatch of equipment for
delivery to user
•
suitable vehicle to allow segregation of
clean and dirty items
the inside of the vehicle should be able to
be cleaned and disinfected on a regular
e.g. weekly basis and when visibly soiled
4 Guidance on decontamination
Cleaning is an essential prerequisite for disinfection. In some cases,
cleaning alone may be sufficient. Although mechanical methods of
cleaning are generally preferred, some of the equipment handled by a
community equipment loan store cannot be decontaminated using a
mechanical washer-disinfector. If after cleaning it is necessary to
disinfect the item, the chosen method of disinfection must be
compatible with the equipment.
Decontamination should be carried out in accordance with the
equipment manufacturer's instructions. If there is no reprocessing
information provided with the product, then you should contact the
manufacturer for guidance. If the manufacturer is unable to provide
this information or if it is believed to be inadequate, notify the MHRA.
Reusable medical devices placed on the UK market after June 1998
must be provided with reprocessing instructions.
Generic protocols for decontamination are provided in the MAC
manual [2]. Listed below are suggested methods for dealing with
community equipment.
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4.1 Cleaning
This is the removal of dirt by washing using a suitable detergent
solution. Depending on the detergent manufacturer’s instructions, the
solution may be heated. Ideally devices and equipment should be
immersed in the detergent solution and the equipment scrubbed or
brushed. The detergent solution should be rinsed from the equipment
with clean water. Cleaning can be done by hand or by using an
automated washer. Brushes used for manual cleaning must be
cleaned frequently and replaced regularly.
Automated washers are available which allow equipment to be loaded
into the machine and processed through a cycle of defined
parameters resulting in cleaning to a consistent standard. This type of
equipment is expensive and will require regular testing to
demonstrate that it is still performing to specification. Consideration
must be given to the ongoing costs of consumables, such as water
and energy, which may be high. However, automated washers might
enable a higher turnover of equipment and reduced operative hours.
The use of an automated system can increase the level of quality
assurance and reduce the risk to operatives. Loan stores should give
serious consideration to whether an automated system would be
appropriate for the equipment routinely being decontaminated and its
cost-effectiveness.
If you plan to use high-pressure jet washers and steam cleaners, an
assessment of the risks to operators and staff should be undertaken
beforehand. Splashes of water and aerosols (spray) could carry
particles of soil from the device into the air, which could pose a risk to
operators and staff in the vicinity. The risk assessment should identify
any personal protective equipment necessary, including respiratory
protective equipment.
Equipment that cannot be immersed may be decontaminated by
wiping with a cleaning cloth soaked in detergent solution and wrung
out. Wipe all the surfaces of the equipment. The cloth should be reimmersed periodically and the detergent solution changed frequently.
Disposable cloths should be used and discarded at the end of the
shift or earlier if necessary. The detergent should be rinsed or wiped
off using clean disposable cloths that have been immersed in clean
water and wrung out.
Equipment that has been cleaned should be dried prior to
disinfection, inspection, maintenance, repair or storage.
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4.2 Disinfection
Equipment should first be cleaned using a method suggested above
and then disinfected using either (a) moist heat (e.g. hot water or
steam) or (b) a liquid chemical disinfectant.
When using moist heat, the equipment should be held at 80oC for a
minimum of 1 minute in order to achieve disinfection. Other
time/temperature relationships can also be used to achieve
disinfection and the advice of the local infection control team should
be sought on this issue. This can be more easily achieved using an
automated processor where the water can be in continuous contact
with the device.
For equipment that cannot tolerate immersion in solution or exposure
to high temperatures, manual disinfection using a clean cloth and a
compatible liquid chemical disinfectant should be used. The solution
should be wiped over the equipment's surface using a clean
disposable cloth. When using a liquid chemical disinfectant, it is
important to ensure that the disinfectant is at the correct
concentration and is in contact with the device for the specified
minimum contact time. The disinfectant solution should be removed
from the equipment with clean water and the item dried prior to
storage.
Equipment that has been disinfected should be dried.
Disinfectants should be used and stored in accordance with the
manufacturer's instructions. The use of personal protective equipment
when handling chemicals may be required.
5 Legal and other requirements
The Health and Safety at Work etc. Act (1974) places a number of
duties on employers and employees concerning the requirements of
safe working practices [4].
The Management of Health and Safety at Work Regulations (1999)
place a statutory duty of co-operation between employers and
employees to provide each other with clear communication in health
and safety matters including any hazards associated with their
activities e.g. decontamination, transfer of material or equipment etc.
[5].
In addition, the Control of Substances Hazardous to Health (COSHH)
Regulations (2002) is applicable to both chemical hazards and
biohazards [6].
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The Controls Assurance Standards programme was established in
1999 to ensure that boards of strategic health authorities, NHS trusts
and primary care trusts have systems in place to ensure that risks are
assessed and properly managed. Of the published Controls
Assurance Standards several are relevant to this area: in particular
‘Decontamination of medical devices’, ‘Infection control’ and ‘Medical
devices management’ [7].
6 Antibiotic resistant bacteria and other infectious
agents
Some vegetative bacteria are resistant to antibiotics, but there is no
evidence to suggest resistance to chemical or thermal disinfection.
Organisms such as methicillin-resistant Staphylococcus aureus
(MRSA) do not pose specific problems for loan store activities.
The proper cleaning of equipment, even as the only method of
decontamination, can minimise the risk of spreading infection via
equipment to new hosts (people). Hand hygiene (regular washing and
drying) is a key factor in the minimisation of transfer of infection from
equipment to staff in the loan store.
Further advice on antibiotic resistant bacteria and other infectious
agents should be sought from the infection control team at your local
NHS trust or primary care trust.
7 Glossary
Cleaning – A process which physically removes infectious agents
and the organic matter on which they thrive but does not necessarily
destroy all infectious agents. Cleaning is an essential prerequisite to
ensure effective disinfection or sterilization.
Contamination – The soiling or pollution of inanimate objects or
living material with harmful, potentially infectious or other unwanted
material. Such contamination may have an adverse effect on the
function of a medical device and may be transferred to a person
during use and storage.
Decontamination – A process which removes or destroys
contamination so that infectious agents or other contaminants cannot
reach a susceptible site in sufficient quantities to initiate infection or
any other harmful response. Differing levels of decontamination are
used depending on the device and its intended use. The levels of
decontamination are:
• Cleaning,
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•
•
Cleaning followed by disinfection, and
Cleaning followed by sterilization.
Disinfectant – A chemical agent that, under defined conditions, is
capable of disinfection.
Disinfection – A process used to reduce the number of viable
infectious agents but which may not necessarily inactivate some
microbial agents, such as certain viruses and bacterial spores.
Disinfection does not achieve the same reduction in microbial
contamination levels as sterilization. Moist heat under defined
conditions will also disinfect.
Infectious agents – The term includes micro-organisms and other
transmissible agents, with the potential to cause an infection.
Sterilization – A process used to render an object free from viable
infectious agents including viruses and bacterial spores [8].
8 References and bibliography
Website addresses and links correct at time of publishing.
1 Department of Health (2001) Integrating Community Equipment
Services (ICES) http://www.icesdoh.org
2 Sterilization, disinfection and cleaning of medical equipment:
guidance on decontamination from the Microbiology Advisory
Committee to Department of Health Medical Devices Agency
(MAC manual)
Part 1 Principles (published 1993, updated 2002)
Part 2 Protocols (published 1996)
Part 3 Procedures (published 1999, updated 2000 and 2002).
3 MHRA Device Bulletin DB 2003(05) Management of medical
devices prior to repair, service or investigation. Web only publication:
http://www.mhra.gov.uk
4 Health and Safety at Work etc. Act 1974. HMSO; 1974.
5 Statutory Instrument 1999 No. 3242 The Management of Health
and Safety at Work Regulations 1999. The Stationery Office.
6 Statutory Instrument 2002 No. 2677 The Control of Substances
Hazardous to Health (COSHH) Regulations 2002. The Stationery
Office.
7 Controls Assurance Standards (Department of Health):
http://www.doh.gov.uk/riskman.htm
DB2003(06) September 2003
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•
•
•
•
•
•
•
Decontamination of medical devices
Health and safety
Infection control
Medical devices management
Risk management system (core standard)
Transport
Waste management
8 BSI. BS EN 556-1: 2001 Sterilization of medical devices.
Requirements for medical devices to be designated "STERILE".
Requirements for terminally sterilized medical devices.
Department of Health
National Minimum Standards (National Care Standards Commission)
[http://www.carestandards.org.uk] provide requirements for independent
health and social care providers.
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 1998.
Available at: http://www.doh.gov.uk/chcguid1.htm
PL CO(95)5 Advisory Committee on Dangerous Pathogens: Guidance
on Protection Against Blood-Borne Infections In The Workplace: HIV and
Hepatitis; 1995.
Health Service Circular HSC2000/032 Decontamination of medical
devices; 2000.
Medicines and Healthcare products Regulatory Agency (MHRA)
(Formerly Medical Devices Agency)
Device Bulletin DB 9801 Medical device and equipment management for
hospital and community-based organisations; 1998.
Device Bulletin DB 2000(04) Single-use medical devices: Implications
and consequences of reuse; 2000.
Safety Notice SN 2001(28) Compatibility of medical devices and
reprocessing equipment with decontamination agents; 2001.
Medical Device Alert MDA/2003/001 Medical devices – reporting
adverse incidents and disseminating medical device alerts; 2003.
Health and Safety Executive
The publications below are on the HSE website: http://www.hse.gov.uk
Five Steps to Risk Assessment.
COSHH Essentials – Easy Steps to Control Chemicals.
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Appendix 1
Certificate of Decontamination
Type of equipment
Model
Manufacturer
Serial no
Loan store inventory number
Method of decontamination
Please tick appropriate box
Cleaning
Cleaning followed by disinfection
Other (please specify)
Decontaminated by
on
Inspected & packaged by
on
Store location
Notes
This item has been prepared to ensure safe handling & transportation
Name
Position
Signature
Tel
Date
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DISTRIBUTION
This device bulletin should be brought to the attention of staff working with community equipment in loan
stores. It may also be of interest to infection control doctors, infection control nurses and consultant
microbiologists.
TECHNICAL ENQUIRIES
Enquiries concerning the content of this device bulletin should be addressed to:
Nathan Moore
MHRA
Hannibal House
Elephant & Castle
London
SE1 6TQ
Jonathan Plumb
MHRA
Hannibal House
Elephant & Castle
London
SE1 6TQ
Tel: 020 7972 8263
Fax: 020 7972 8106
E-mail: [email protected]
Tel: 020 7972 8128
Fax: 020 7972 8103
E-mail: [email protected]
© CROWN COPYRIGHT 2003
Medicines and Healthcare products Regulatory Agency
An executive agency of the Department of Health
ISBN 1 84182 766 5
Sept 03 500