DECONTAMINATION OF REUSABLE MEDICAL DEVICES
TRUST POLICY
Version
3
Name of responsible (ratifying) committee
Decontamination Committee
Date ratified
28 January 2015
Document Manager (job title)
HSDU Manager / Decontamination Lead
Date issued
03 February 2015
Review date
01 February 2017
Electronic location
Infection Control Policies
Related Procedural Documents
Hand Hygiene, Standard Precautions
Key Words (to aid with searching)
Decontamination of medical devices, cleaning,
sterilisation, disinfection
Version Tracking
Version
Date Ratified
Brief Summary of Changes
Author
3
28 January 15
Minor revision and review
IPCT
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 1 of 22
CONTENTS
1.
Introduction
2.
Purpose
3.
Scope
4.
Definitions
5.
Duties and responsibilities
6.
Process
-
Risk Assessment and Choice of decontamination methods
-
Compatibility
-
Regulatory framework for medical device decontamination
-
Decontamination Committee and the Management of Decontamination
Services
-
Decontamination of invasive medical devices
-
Decontamination of non-invasive medical devices
-
Decontamination of Endoscopes
-
Record Keeping
-
Devices suspected of contamination with prions
-
Single Use medical devices
-
Decontamination of Equipment Prior to Service or Repair
-
Loan/Lease devices
7.
Training Requirements
8.
References and associated documentation
9.
Equality Impact Statement
10.
Monitoring compliance with procedural documents
11.
Appendix A: Approved list of cleaning agents
12.
Appendix B: Example of a Decontamination Certificate
13.
Appendix C: Decontamination Committee Terms of Reference
14.
Appendix D: Regulatory Framework for Medical Device Decontamination
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 2 of 22
QUICK REFERENCE GUIDE
This policy must be followed in full when developing or reviewing and amending Trust procedural
documents.
For quick reference the guide below is a summary of actions required. This does not negate the need
for the document author and others involved in the process to be aware of and follow the detail of this
policy. The quick reference can take the form of a list or a flow chart, if the latter would more easily
explain the key issues within the body of the document
1. Decontamination is a combination of processes (cleaning, disinfection and/or sterilisation)
which removes or destroys contamination so that infectious agents cannot reach a
susceptible site in sufficient quantities to cause harm to a patient or device user. Differing
levels of decontamination are used depending on the device and the procedure involved.
2. The choice of the decontamination method (cleaning, disinfection and/or sterilisation) centres
around the infection risk associated with the use of the device, the type of device, the nature
of the contamination, the organisms involved, the risk to patients and staff.
3. Medical devices must be checked for compatibility with the proposed decontamination
method.
4. Invasive medical devices, such as surgical instruments, must be decontaminated in a
compliant environment with validated processes such as the Hospital Sterilisation and
Disinfection Unit (HSDU)
5. Non-invasive medical devices must be subjected to a suitable level of decontamination based
on the use and type of device involved.
6. The decontamination of flexible endoscopes is to include cleaning and disinfection. These
processes must be undertaken in dedicated Endoscope Decontamination Areas within the
Trust.
7. If equipment is believed to be contaminated with prions then the equipment should not be
decontaminated and should be quarantined. Seek advice from the Consultant
Microbiologist, Decontamination Lead or the Infection Control Team
8. The reuse of ‘single-use’ devices has legal implications. It is the policy of the Portsmouth
Hospitals NHS Trust that medical devices designated for a single episode of use are not to be
reused under any circumstances
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 3 of 22
1. INTRODUCTION
High standards of cleanliness and hygiene related to equipment and medical devices are
essential for the prevention of cross infection in the healthcare environment. The cleanliness of
the environment and equipment used in patient care is the responsibility of all staff.
The Health and Social Care Act 2008 requires the Trust to ensure that appropriate standards
are maintained for the decontamination of equipment and reusable medical devices. This policy
provides an explanation of the processes, responsibilities and requirements relating to the
decontamination of medical devices.
Whilst the advice contained within this policy relates particularly to microbiological hazards,
equipment may also become contaminated with hazardous chemicals. The same requirements
of decontamination to provide safe equipment apply and should be included in safe systems of
work.
2. PURPOSE
The purpose of this policy is
 To provide staff with the necessary information to decontaminate patient equipment
safely in order to protect patients, public, members of staff from infection, injury or harm
whilst maintaining the integrity and purpose for which each item of equipment was
intended
 To promote the safest possible environment for patients through the identification and
application of best practice in the decontamination of re-usable medical devices.
 To provide compliant guidance to all staff who undertake the decontamination of medical
devices within Portsmouth Hospitals NHS Trust.
 To promote consistency in Decontamination practices across the Trust incorporating
essential quality requirements and best practice.
The principles of this policy are:
 That the Trust will continually review and develop practices in order to comply with all
present and future medical device legislation within resources available.
 That equipment will be adequately cleaned, disinfected or sterilised according to its
function so as to protect as far as reasonably practical the health, safety and welfare of its
staff, patients and those recipients who are involved in inspection, service, repair or
transportation of medical devices or equipment.
 That the Trust will ensure adequate provision of disinfectants, cleaning agents and
equipment necessary to achieve the required standard of decontamination.
3. SCOPE
This policy applies to direct employees of Portsmouth Hospitals NHS Trust and employees of
other organizations managed by the Trust.
‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises
that it may not be possible to adhere to all aspects of this document. In such circumstances,
staff should take advice from their manager and all possible action must be taken to
maintain ongoing patient and staff safety’
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 4 of 22
4. DEFINITIONS
Decontamination;
The decontamination of re-usable medical devices is the combination of processes, which if not
correctly undertaken, individually or collectively, may increase the likelihood of microorganisms
being transferred to patients or staff. Decontamination is a process, which removes or destroys
contamination and thereby prevents microorganisms or other contaminants reaching a
susceptible site in sufficient quantities to initiate infection or any other harmful response. Three
processes of decontamination are commonly used;
- Cleaning
- Disinfection
- Sterilisation
Cleaning;
Cleaning is the mechanical process which physically removes soiling 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 micro-organisms and the organic material on which
they thrive.
Disinfection;
Disinfection is a process intended to kill, reduce or remove, pathogenic micro-organisms 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;
Sterilisation is the process of rendering an article completely free from all living microorganisms
including viruses. Standard sterilisation methods will not destroy abnormal prion proteins
thought to be the causative agents of Creutzfeldt-Jakob disease (CJD).
Bioburden;
The population of viable infectious agents contaminating a medical device
Single-use device;
A medical device which is intended to be used on an individual patient during a single
procedure and then discarded. It is not intended to be used on another patient. Staff who
disregard this information and allow further use of these items, will transfer legal liability for
the safe performance of the product from the manufacturer to themselves, or to the Trust
HSDU;
The Hospital Sterilisation and Disinfection Unit (HSDU) is a centralized department specifically
designed and equipped to reprocess reusable medical devices. The department uses a range
of decontamination equipment such as ultrasonic washers, washer-disinfectors and sterilisers
to achieve medical device decontamination.
CJD and vCJD;
Creutzfeldt–Jakob disease and variant Creutzfeldt–Jakob disease (vCJD) are degenerative
neurological disorders that are incurable and invariably fatal. Brain tissue develops holes and
takes on a sponge-like texture. This is due to a type of infectious protein called a prion. Prions
are misfolded proteins which replicate by converting their properly folded counterparts.
Standard sterilisation methods will not destroy these abnormal prion proteins.
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 5 of 22
5. DUTIES AND RESPONSIBILITIES
The Chief Executive
The Chief Executive is ultimately accountable for ensuring that there are effective
arrangements in place for the decontamination of medical devices, including the provision of
adequate decontamination facilities.
The Chief Executive has authorized the delegation of these responsibilities to the Director of
Infection Prevention and Control (DIPC) and the Trust Decontamination Lead.
Director of Infection Prevention and Control (DIPC)
The Director of Infection Prevention and Control (DIPC) is responsible for overseeing local
control of infection policies (including decontamination) and their implementation. The DIPC
nominates a Decontamination Lead to be responsible for the implementation of an operational
policy for decontamination.
The Decontamination Lead
The Decontamination Lead reports to board level through the DIPC. The Decontamination Lead
is responsible for the effective, and technically compliant, provision of decontamination
services. The Decontamination Lead is responsible for the implementation of an operational
policy for decontamination. He/she will ensure that the operational policy clearly defines the
roles and responsibilities of all personnel who may be involved in the use, installation and
maintenance of decontamination equipment. The Decontamination Lead is also responsible for
monitoring the implementation of the policy and will form and chair a Decontamination
Committee.
The Decontamination Committee
The Decontamination Committee is chaired by the Decontamination Lead. The Committee’s
function is to provide direction to the Clinical Service Centres of the Trust. Representation on
this committee includes the operational leads of those departments involved in decontamination
of medical devises (i.e. HSDU, Endoscopy, Clinical Engineering).
Authorising Engineer (Decontamination) - AE(D)
The role of the AE(D) is fully independent of the healthcare facilities’ structure for maintenance,
testing and management of the decontamination equipment. The AE(D) is defined as a person
designated by Management to provide independent auditing and technical advice on
decontamination procedures, washer-disinfectors, sterilisers and sterilisation and to review and
witness documentation on validation.
The AE(D) is appointed under the authorisation and direction of the Decontamination Lead. The
AE(D) must be IHEEM registered and offer impartial advice to the Trust Management on all
matters relating to medical device decontamination.
Senior Operational Manager (Estates)
The Senior Operational Manager is technically, professionally and managerially responsible
(and accountable to the Decontamination Lead) for the engineering aspects of decontamination
plant and environment. This function includes the management of the maintenance and testing
programmes for decontamination machinery and physical environments. The Senior
Operational Manager (Estates) has defined Competent Persons (Decontamination) to
undertake repairs, maintenance, validation and testing of washers, sterilisers and associated
decontamination equipment.
Authorised Person (Decontamination) AP(D)
An internally appointed person who has undertaken specialist training and possesses technical
knowledge relating to the engineering aspects of decontamination. The person will manage the
practical implementation of policy and procedure.
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 6 of 22
Competent Person(s)
Designated by management to carry our maintenance, validation and periodic testing of
decontamination plant and equipment.
Users
The User is defined as the person designated by Management to be responsible for the
management of decontamination processes. The User is also responsible for the Operators.
Within Portsmouth Hospitals NHS Trust the User includes the HSDU Manager, Endoscopy
Manager and Lead Clinical Engineer.
The principal responsibilities of the User are as follows:
 to certify that the decontamination equipment is fit for use;
 to hold all documentation relating to the decontamination equipment, including the names
of other key personnel;
 to ensure that decontamination equipment is subject to periodic testing
 and maintenance;
 to appoint operators where required and ensure that they are adequately trained;
 to maintain production records;
 to establish procedures for product release in line with the quality management system;
 to ensure that procedures for production, quality control and safe working are documented
and adhered to in the light of statutory requirements and accepted best practice.
The User may seek the advice of the Decontamination Lead, infection control teams, AE(D) or
Microbiologist (Decontamination).
Operators
The Operator is defined as any person with the authority to operate decontamination
equipment, including the noting of instrument readings and simple housekeeping duties.
Operators have their tasks clearly defined in their job description. Operators have documented
training records to demonstrate that they are competent at undertaking their assigned tasks.
HSDU
The HSDU provides a decontamination service to all operating theatres, wards, outpatients,
clinics etc. and some external customers. The principle responsibilities of the HSDU are to;
 Provide decontamination which will comply with current legislation and guidelines
processing surgical instrument sets, supplementary instruments, loan instrument sets,
anaesthetic devices and rigid endoscopes.
 Provide specialist advice on decontamination and sterilisation as appropriate.
 Report any significant or major decontamination incidents to the Decontamination Lead,
liaise with Infection Prevention and Control, and where appropriate Health and Safety.
Endoscopy Decontamination Areas
These areas are responsible for the safe and effective decontamination of flexible endoscopes
to support the clinical activity of endoscopy units. The responsibility of these areas are to
undertake endoscope reprocessing in accordance with Department of Health guidance.
Infection Prevention and Control Team
The IPC Team will provide specialist advice for the decontamination of equipment prior to
purchase and during use.
General Managers, Heads of Nursing, Department Managers
Ensure that this policy and its associated procedures are fully adhered to within their area of
responsibility.
Employees
Employees are expected to co-operate and assist with the implementation of this Policy,
and its associated procedures.
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 7 of 22
6. PROCESS
6.1
Risk Assessment and choice of decontamination method
The choice of the decontamination method centres around the infection risk associated with
the use of the device. Table 1 categorises the risk associated with the use of the device and
the required level of decontamination for that device.
Table 1: Decontamination requirements based on device use and risk
Items in close contact with a break in skin or
mucous membrane or introduced into a
DEFINITION
normally sterile body area.
Surgical instruments
EXAMPLES
Syringes and needles
HIGH RISK
Intrauterine devices
Cleaning and disinfection followed by
SUITABLE
Sterilisation.
METHODS
Use disposable, single use items where
possible
Items in contact with mucous membranes or
other items contaminated with particularly
DEFINITION
virulent or readily transmissible organisms or
items to be used on highly susceptible people.
INTERMEDIATE
Respiratory equipment
RISK
EXAMPLES
Endoscopes, vaginal and rectal ultrasound
probes
SUITABLE
Cleaning and disinfection required. Sterilisation
METHODS
preferred if the device is compatible.
Items in contact with normal and intact skin.
DEFINITION
LOW RISK
EXAMPLES
SUITABLE
METHOD
Commodes, infusion pumps, syringe drivers
Cleaning using a suitable detergent
Other factors which may need to be considered when choosing an appropriate
decontamination method will include:
o The type of device
o The nature of the contamination
o The organisms involved
o The risk to patients and staff
o The heat, pressure, moisture and chemical tolerance of the medical device
o The quality and risk associated with the decontamination method
o The manufacturers guidance
6.2
Compatibility
Personnel responsible for reprocessing reusable medical devices should:
o Ensure that the decontamination agents used are compatible with both devices
and reprocessing equipment.
o Consult the medical device and reprocessing equipment manufacturer/supplier
before changing any decontamination process and obtain their written approval
for the change in decontamination process.
o Decontaminate reusable medical devices in accordance with the instructions
provided by the device manufacturer.
o Ensure that appropriate decontamination facilities and compatible agents are
available before purchasing new devices.
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 8 of 22
o
6.3
Follow the instructions for use supplied by the manufacturer of the
decontamination agent.
Regulatory framework for medical device decontamination
When undertaking decontamination activities Portsmouth Hospitals NHS Trust is required to
demonstrate compliance with the following legislation:
- European Medical Device Directive
- Health and Safety at Work Act
- Consumer Protection Act
- Health and Social Care Act
This legislation is supplemented by various regulations that require compliance. For further
details refer to Appendix D.
The Care Quality Commission (CQC) regulates all providers of healthcare activities in
England through the Health and Social Care Act 2008. This includes requirements related to
cleanliness, infection control, safety, availability and suitability of equipment. This includes
requirements directly relating to the decontamination of medical devices.
The Department of Health also provides specific guidance on the Management and
Decontamination of Medical Devices in the form of HTM and CFPP documents. Portsmouth
Hospitals NHS Trust are required to incorporate this guidance, where practicable.
Enforcement and regulation of the legislation and standards falls within the remit of the
following regulatory bodies:
- Care Quality Commission (CQC)
- Medicines and Healthcare products Regulatory Agency (MHRA)
- Notified Bodies (i.e. BSI)
The Trust will cooperate with these regulatory bodies to ensure compliance with essential
requirements and best practice.
6.4
Decontamination Committee and the Management of Decontamination Services
A Decontamination Committee is formed to ensure the Trust operates safely with respect to
the management and decontamination of reusable medical devices. The committee will act as
a management group ensuring that:
- decontamination options are assessed to improve patient outcomes
- decontamination procedures undertaken within the Trust encompass all statutory and
regulatory requirements
- benefits, efficiencies and risks are evaluated specifically relating to medical device
decontamination
- essential quality requirements with regards to medical device decontamination (as
detailed in the standards) are attained and a plan is in place to work towards best practice
- a risk register is maintained for medical device decontamination
- a decontamination policy is defined and continues to be fit for purpose
- representatives from each department/specialty undertaking medical device
decontamination attend regularly
- decontamination processes are monitored and audited regularly to demonstrate
compliance
The Decontamination Committee consists of the Trust Decontamination Lead (as designated
by the DIPC) and representation from Infection Control, HSDU, Endoscopy, Clinical
Engineering, Estates Management, Clinical Departments undertaking medical device
decontamination and Clinical users.
The terms of reference for the committee are defined in Appendix C.
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 9 of 22
6.5
Decontamination of invasive medical devices
As stated in Table 1 invasive medical devices entering the sterile body cavities or breaking
the skin or mucous membranes (such as surgical instruments) require a decontamination
process that includes cleaning, disinfection and sterilisation. Figure 1 represents the
decontamination cycle that is applied to invasive medical devices.
The Decontamination of surgical instruments is undertaken in the HSDU of Portsmouth
Hospitals NHS Trust. The processes employed are as follows;
o Cleaning: the removal of all organic debris is achieved through the use of water and
detergent. A combination of manual cleaning and ultrasonic cleaning is used prior to
devices being placed into an automated washer-disinfector. Automated washing is
preferred to manual cleaning due to the ability of washer-disinfectors to achieve a
reproducible process that can be validated.
o Disinfection: is achieved by heat within the thermal disinfection stage of the automated
washer-disinfector cycle.
o Sterilisation: is achieved using moist heat (steam) vacuum sterilisers. These use a
sterilisation stage at 134-137°C or alternatively 121-124°C. For devices that are heat
sensitive Gas Plasma (Hydrogen Peroxide) sterilisation is available.
The decontamination machinery used in the HSDU is subject to a testing and validation
programme in accordance with Department of Health Guidelines (CFPP 01-01), British,
European and International Standards.
The Decontamination Services undertaken in the HSDU are monitored against the essential
requirements of the Medical Device Directive (MDD) and the unit is subject to regular external
auditing by a notified body (BSI). The HSDU is required to operate a Quality Management
System that meets the standards of the MDD (Portsmouth Hospitals NHS Trust has opted to
comply with BS EN ISO 13485). The Quality Management System is a documented system
that is applied to all areas of the decontamination cycle.
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 10 of 22
The HSDU ensures that its decontamination processes (Cleaning, disinfection and sterilisation)
are validated and that the production of instrument packs is subject to internal quality control in
a controlled environment.
6.6
Decontamination of non-invasive medical devices
Non-invasive medical devices can become contaminated and present a risk of cross infection
to patients, users and staff. This category of medical device includes diagnostic and
therapeutic equipment such as syringe pumps, feeding pumps, suction pumps, resuscitation
equipment, patient monitors, nebulisers etc.
The following principles must be applied to these devices;
 Cleaning of the equipment must be performed immediately following patient use
by the user of the equipment
 Clean the device using disposable detergent wipes or water and detergent with a
disposable cloth (see appendix A for approved list of cleaning agents)
 Following cleaning use an approved disinfectant if the equipment has been used
on a patient with a suspected or confirmed infection/colonization (see appendix A
for approved list of disinfection agents).
 Store cleaned equipment separately from used equipment and away from areas
where cleaning of devices is being undertaken to reduce the risk of
recontamination
 Check manufacturers instructions for cleaning guidance
 Use a top down approach to cleaning
 Wear PPE (gloves and apron) when performing cleaning and disinfection
 Replace damaged or worn equipment as it may not be possible to clean this
equipment effectively
 Following cleaning/disinfection the device may need to be checked by Clinical
Engineering or be returned to the Medical Equipment Library
Other types of non-invasive equipment
There is a wide range of medical equipment located in the patient environment that may not
be traditionally considered as a medical device. This includes items such as drip stands,
commodes, bed pans, dressing trolleys, hoists, frames, standing/sitting aids etc.
The principles detailed above must also be applied to this type of equipment as they can
become contaminated and hence present a risk to patients, users and support staff.
In addition to regular cleaning of this equipment by the users an additional deep clean of the
items may be necessary and available via the HSDU service of the hospital. The HSDU
provides an automated washing and disinfection service for this type of medical equipment.
Contact the HSDU for further information on availability and compatibility of the equipment
with this type of service.
6.7
Decontamination of Flexible Endoscopes
As stated in Table 1 the decontamination of flexible endoscopes is to include cleaning and
disinfection. These processes take place in dedicated Endoscope Decontamination Areas
within the Trust.
Endoscope decontamination is undertaken in compliance with the following standards:
CFPP 01-06

BSG Guidelines

JAG Guidelines
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 11 of 22
6.8
Record keeping
All decontamination facilities must have in place a record keeping regime to ensure the
decontamination process is documented and medical device reprocessing is recorded. The
records must show that the decontamination parameters have been met and the device is
rendered safe for reuse.
This is particularly important for sterile products whose records must detail process
parameters used and achieved during the sterilisation of a device.
Validation records for decontamination machinery (washers and sterilisers) must be held by
the decontamination facilities.
For surgical instruments and endoscopes records must be maintained and retained to enable
devices to be traced to an individual patient.
6.9
Devices suspected of contamination with prions
Prions are an abnormal protein thought to be the causative agent of Transmissible
Spongiform Encephalopathies (TSE) e.g. Creutzfelt-Jacob Disease (CJD). The protein is
highly resistant to conventional methods of disinfection and sterilisation.
If equipment is believed to be contaminated with prions then the equipment should not be
decontaminated and should be quarantined. Seek advice from the Consultant
Microbiologist, Decontamination Lead or the Infection Control Team.
Please refer to the Trust CJD Policy for further guidance
6.10 Single Use medical devices
Single use refers to the medical device that is intended for use on an individual patient during
a single procedure and then discarded after use (MDA DB2000:04). Single use devices are
not intended to be reprocessed and used on another patient. If a device is reprocessed and it
is not fit for its intended purpose, both the re-processor and the professional user may be
committing an offence.
The reuse of ‘single-use’ devices has legal implications. It is the policy of the Portsmouth
Hospitals NHS Trust that medical devices designated for a single episode of use are not to be
reused under any circumstances
Single use devices will have the following symbol on either the packaging or the device itself;
6.11 Decontamination of Equipment Prior to Service or Repair
Anyone who inspects services repairs or transports medical devices and equipment has a
right to expect that they have been appropriately treated so as to remove or minimise the risk
of infection or other hazards e.g. chemical or radiation.
Medical devices should be decontaminated and all devices presented for service or repair
must be provided with a decontamination certificate according to the Trusts procedure (see
Appendix B).
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 12 of 22
6.12 Loan/Lease Equipment
Instrumentation or equipment may be loaned/leased to an organisation so that a particular
procedure can be performed. The instruments are loaned both from manufacturers and other
hospitals and are returned after use. This practice increases the risks associated with the
decontamination and reprocessing of such devices because the organisation may not be
familiar with them.
Decontaminate all loan instrumentation both before and after use in accordance with the
manufacturer’s instructions. Where appropriate they should be decontaminated in the HSDU.
Ensure that loaned instrumentation is accompanied by relevant reprocessing instructions and
a comprehensive list of contents. If these are missing or if you do not have the facilities to
follow them (e.g. inappropriate sterilisation time/temperature relationships are quoted) the
instruments should not be used.
Ensure that adequate time is allowed to carry out effective decontamination both prior to and
after use.
Ensure that systems are in place to allow instrumentation to be tracked through the
decontamination processes and to the patient upon which it is used.
Check that indemnity forms have been completed and that responsibilities for the
instrumentation have been identified and documented.
6.13 Transport of used medical devices
Used non-invasive medical devices such as syringe pumps, feeding pumps, suction pumps,
resuscitation equipment, patient monitors, nebulisers, drip stands, commodes, bed pans,
dressing trolleys, hoists, frames, standing/sitting aids etc must be decontaminated
immediately following patient use by the user of the equipment (in accordance with Section
6.6). If any items are being sent to Clinical Engineering for service, repair of checking then the
items must be decontaminated prior to them being sent.
The transport of used invasive medical devices must be undertaken to minimize the risk of
cross infection during transport. The decontamination of invasive medical devices is to be
undertaken in authorized units specifically designed for this purpose (i.e. HSDU, Endoscope
Decontamination Areas). The transport of used medical devices to these units is to be
undertaken using sealed leak proof containers (approved transport boxes or enclosed
trolleys). These containers should carry a biohazard warning label.
7. TRAINING REQUIREMENTS
The Trust understands the issues surrounding decontamination including its responsibilities to
inform instruct and train employees in the safe effective decontamination practices including
the use and disposal of chemical disinfectants.
Managers must ensure that staff are aware of current decontamination methods and in the
principles of Infection Prevention and Control, and that they have received approved and
documented training in those methods and systems.
.
Designated Users and Operators (see Section 5; Duties and Responsibilities) are required to
ensure they have undertaken the appropriate technical training and certified courses to equip
them with the skills and knowledge to undertake the task. Guidance from the
Decontamination Lead as to the relevant training to be undertaken should be sought.
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 13 of 22
8. REFERENCES AND ASSOCIATED DOCUMENTATION



CFPP 01-01: Management and decontamination of surgical instruments
Health and Social Care Act 2008 ‘Code of Practice on the prevention and control of
infection and related guidance’
CFPP 01-06: Decontamination of flexible endoscopes
9. EQUALITY IMPACT STATEMENT
Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably
practicable, the way we provide services to the public and the way we treat our staff reflects
their individual needs and does not discriminate against individuals or groups on any grounds.
This policy has been assessed accordingly
All policies must include this standard equality impact statement. However, when sending for
ratification and publication, this must be accompanied by the full equality screening
assessment tool. The assessment tool can be found on the Trust Intranet -> Policies -> Policy
Documentation
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 14 of 22
10. MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS
This document will be monitored to ensure it is effective and to assurance compliance.
Minimum requirement
to be monitored
Lead
Tool
Frequency of
Report of
Compliance
Reporting
arrangements
Lead(s) for acting on
Recommendations
Decontamination
Policy
Quarterly
Decontamination
Committee
CSC leads
Regular meetings to
monitor effectiveness of
Policy
Decontamination
Lead
Protocols and
procedures defined
Decontamination
Lead
Decontamination
audits
Annually
Decontamination
Committee
CSC leads
Register of activities
Decontamination
Lead
Decontamination
audits and risk
register
Quarterly
Decontamination
Committee
CSC leads
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 15 of 22
APPENDIX A:
Approved list of cleaning agents;
TYPE OF CLEANING
CATEGORY
APPROVED LIST
Equipment
Disposable wipe
Clinell detergent wipe (yellow packet)
Work Surfaces
Detergent + Chlorine
Actichlor plus
General environment
Detergent + Chlorine
Actichlor plus
Approved list of disinfectants;
Type of
Disinfection
Environment
Equipment
Categories
Approved List
Comment
NaDCC (Chlorine)
Haz-tab tablets
Haz-tab granules
Actichlor
Chlorine dioxide
Difficil-S
Chlorhexidine & Cetrimide
Travasept
Pharmacy
Phenolics
Hycolin
For use in Mortuary and
laboratory.
Alcohol
70% IPA Spray, Azo-wipes, Alcowipes
Pharmacy only
Peracetic acid
Aperlan,
For use in Endoscopy suite
Chlorine dioxide
Tristel wipes
Nasendoscopes, TOE and
invasive probes only
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
For use on Blood spillages
Page 16 of 22
APPENDIX B:
Example of a Decontamination Certificate that must accompany any medical device leaving the
hospital site for service, repair or loan purposes.
Page 1 Certificate of Decontamination
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 17 of 22
APPENDIX B (continued):
Page 2: Certificate of Decontamination
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 18 of 22
APPENDIX C:
Decontamination Committee Terms of Reference
Purpose
A Decontamination Committee is formed to ensure the Trust operates safely with respect to the
management and decontamination of reusable medical devices. The committee will act as a
management group ensuring that decontamination procedures undertaken within the Trust
encompass all statutory and regulatory requirements and the benefits, efficiencies and risks are
evaluated to improve patient outcomes.
Functions of the Group
 To receive and review reports from those responsible for, or involved in, medical device
decontamination within the Trust;
 As a result of the point above, to monitor decontamination issues and update the
decontamination risk register;
 To provide guidance to the Trust on purchases of decontamination equipment;
 To be responsible for keeping up-to-date with all decontamination regulations, standards
and guidance and to disseminate information to members of the group regarding changes in
decontamination practice, regulation, standards or guidance;
 To recommend, review and implement policies or procedures that comply with current
decontamination regulations, standards and guidelines;
 To monitor the Trust’s compliance with the decontamination aspects of Care Quality
Commission Outcomes
 To ensure essential quality requirements with regards to medical device decontamination
(as detailed in the standards) are attained and a plan is in place to work towards best
practice
 To maintain and review where necessary the Trust decontamination policy for medical
devices and ensure it continues to be fit for purpose
 To form any sub-groups as necessary to conduct the business of the Group.
Chair
The Group shall be chaired by the Trust Decontamination Lead. The Lead may temporarily delegate
chairmanship to a nominated deputy during times of absence.
Membership
The membership shall include:
 The Trust Decontamination Lead;
 Director of Infection, Prevention & Control (DIPC) or nominated representative
 Representative of Infection Prevention and Control
 Clinical Engineering Representative
 The Estates Engineering Manager (Trust)
 Senior Operational Manager (Carillion)
 The Trust’s appointed Authorising Engineer (Decontamination);
 Those responsible for providing/managing directly or indirectly the decontamination
services across the Trust (Users and department representatives) including but not limited
to:
- HSDU Manager;
- Endoscopy manager;
- Representation from Operating Theatres;
- Representation from wards and departments as applicable;
Advice and attendance from other representatives, such as the Trust’s appointed Authorising
Engineer (Decontamination), may be required when undertaking specific projects.
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 19 of 22
APPENDIX C (continued):
Decontamination Committee Terms of Reference
Reporting Arrangements
The Decontamination Group is responsible to the Trust Infection Prevention & Control Committee
and with respect to the Decontamination Risk Register, the Trust Risk Management Group.
Minutes of the Group can be made available on the Trust intranet if requested.
Decisions made by the Group and policies and procedures which are reviewed and updated shall be
put on the agenda of the Trust Infection Prevention & Control Group for final approval.
Quorum
Attendees must include the Group’s Chair (usually the Decontamination Lead) and at least three
other members for the meeting to be quorate.
Majority
A course of action requires support from the Group chair, the representative of Infection Prevention
and Control and more than 50% of group members who attend the meeting.
Meeting Frequency
The Group shall meet at quarterly intervals.
Agenda, Minutes and documentation
A package will be prepared and sent to members of the Group a minimum of three business days in
advance of a meeting. This package will include the following:
- Agenda for the upcoming meeting;
- Minutes of the previous meeting;
- The decontamination risk register;
- Any other documents/information to be considered at the meeting
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 20 of 22
APPENDIX D:
Regulatory Framework for Medical Device Decontamination
Overview of the interaction between the different structures within the English legislative system
[Source: Choice Framework for local Policy and Procedures 01-01: Management and decontamination of
surgical instruments (medical devices) used in acute care. Part A: the formulation of local policy and choices
manual, (May 2012), DH Estates & Facilities Policy Division, Leeds.]
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 21 of 22
APPENDIX D (continued):
Regulatory Framework for Medical Device Decontamination
European Harmonised Standards relevant to decontamination processes and equipment:
- BS EN ISO 11737. Sterilisation of medical devices.
- BS EN ISO 14937. Sterilisation of health care products.
- BS EN ISO 17665. Sterilisation of health care products. Moist heat.
- BS EN 285:2006 Sterilisation. Steam sterilisers.
- BS EN 13060. Small steam sterilisers.
- BS EN ISO 15883 Washer-disinfectors.
European Harmonised Standards relevant to decontamination management
- BS EN ISO 13485. Medical devices. Quality managements systems.
European Harmonised Standards relevant to safety requirements for decontamination equipment
- BS EN 61010-2-040. Safety requirements for electrical equipment for particular
requirements for sterilisers and washer-disinfectors used to treat medical materials.
- BS EN ISO 13849-2. Safety machinery.
European Harmonised Standards relevant to medical devices
- BS EN 556 Sterilisation of medical devices.
- BS EN 1041. Information supplied by the manufacturer of medical devices.
- BS EN ISO 17664. Sterilisation of medical devices. Information to be provided by the
manufacturer for the processing of re-sterilisable medical devices.
- BS EN ISO 14971. Application of risk management to medical devices
Decontamination of Reusable Medical Devices Policy
Version: 3
Issue Date: 03 February 2015
Review date: 01 February 2017 (unless requirements change)
Page 22 of 22