Medical Devices Policy
Version
Ver. 2.0 Replacing Medical Devices Policy Ver. 1
(2012)
Name of responsible (ratifying)
committee
Medical Devices Management Committee (MDMC)
Date ratified
16 October 2012
Document Manager (job title)
Dr Matthew Wood (Chair of MDMC)
Date issued
08 November 2012
Review date
January 2015 (unless requirements change)
Electronic location
Management Policies
Standing Financial Instructions Policy;
Decontamination Policy;
Procurement; record keeping; prescribing;
maintenance; decontamination; storage;
Key Words (to aid with searching)
replacement; disposal; loan; single-use; adverse
incident
In the case of hard copies of this policy the content can only be assured to be accurate on the
date of issue marked on the document.
For assurance that the most up to date policy is being used, staff should refer to the version held
on the intranet
Related Procedural Documents
Medical Devices Version 2.0
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CONTENTS
1.
PURPOSE ................................................................................................................................... 3
2.
SCOPE ........................................................................................................................................ 3
3.
DEFINITIONS .............................................................................................................................. 3
4.
DUTIES AND RESPONSIBILITIES ............................................................................................. 4
5.
PROCESS ................................................................................................................................... 5
6.
7.
5.1.
PROCUREMENT ...................................................................................................................... 5
5.2.
RECORD-KEEPING .................................................................................................................. 6
5.3.
ACCEPTANCE OF MEDICAL DEVICES ........................................................................................ 6
5.4.
CLOCK SETTING ..................................................................................................................... 7
5.5.
MONITORING, DEPLOYMENT AND CONTROL.............................................................................. 7
5.6.
PROCEDURES ........................................................................................................................ 8
5.7.
PRESCRIBING ......................................................................................................................... 8
5.8.
MAINTENANCE AND REPAIR ..................................................................................................... 8
5.9.
DECONTAMINATION ................................................................................................................. 9
5.10.
STORAGE ........................................................................................................................... 9
5.11.
REPLACEMENT PLANNING .................................................................................................. 10
5.12.
DISPOSAL ......................................................................................................................... 10
5.13.
LOAN EQUIPMENT ............................................................................................................. 10
5.14.
SINGLE-USE EQUIPMENT ................................................................................................... 11
5.15.
MANUFACTURING AND MODIFICATIONS OF MEDICAL DEVICES .............................................. 12
5.16.
ADVERSE INCIDENTS AND MANAGEMENT OF SAFETY NOTICES ............................................. 12
TRAINING ................................................................................................................................. 13
6.1.
RESPONSIBILITIES ................................................................................................................ 13
6.2.
PROCESS ............................................................................................................................. 13
REFERENCES AND ASSOCIATED DOCUMENTATION ......................................................... 15
7.1.
INTERNAL ............................................................................................................................. 15
7.2.
EXTERNAL ............................................................................................................................ 15
7.3.
CARE QUALITY COMMISSION’S SCHEDULE OF APPLICABLE PUBLICATIONS ............................... 15
APPENDIX A.
SUBGROUPS ...................................................................................................... 20
APPENDIX B.
PURCHASE OF A NEW MEDICAL DEVICE ........................................................ 21
APPENDIX C.
GUIDANCE TO FOLLOW IN A MEDICAL DEVICE ADVERSE INCIDENT ......... 23
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INTRODUCTION
The term “medical device” covers a broad range of products, used every day throughout the Trust to
support the diagnosis treatment and care of patients. These devices have a direct impact on the
quality of care and can also be a source of risks to the patients and the staff. Regulations and safety
of medical devices are guided by national legislations [6].
Care Quality Commission Outcome 11 [8] requires NHS Trusts to ensure that there is a system in
place to manage risks associated with the use of medical devices.
This policy, when read in conjunction with other relevant policies and procedures, ensures that
whenever a medical device is used throughout the Portsmouth Hospitals NHS Trust (PHT), it is:
 Suitable and available for its intended purpose
 Properly understood by the user
 Used in accordance with the manufacturer’s instructions
 Maintained in a safe and reliable condition
 Disposed of safely and legally
1. PURPOSE
This policy is written to enable the safe, efficient and effective deployment, monitoring and control of
medical devices throughout the Trust. If in exceptional circumstances it is necessary to contravene
any part of this policy, approval must be sought from the most senior manager on duty and the
details recorded as an adverse incident.
2. SCOPE
This policy applies to all permanent, locum, agency, bank and voluntary staff of Portsmouth Hospitals
NHS Trust and the MDHU (Portsmouth) who have involvement in evaluation, selection, purchasing,
commissioning, training, storage, maintenance, prescribing and disposal of medical devices owned
wholly, in part, or loaned to the Trust, whilst acknowledging that for staff other than those directly
employed by the Trust the appropriate line management or chain of command will be taken into
account.
‘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.
3. DEFINITIONS
Medical Device
According to Medical Devices Directive [10], any instrument, apparatus, appliance, material or health
care product (excluding drugs), used for a patient or client for the purpose of:
 Diagnosis, prevention, monitoring, treatment or alleviation of disease
 Diagnosis, monitoring, treatment or alleviation of or compensation for, an injury or Handicap
 Investigation, replacement or modification of the anatomy or of a physiological process
 Control of Conception
Prescriber
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A person who decides which is an appropriate device for a given patient or client.
Professional users
Those appropriately trained and qualified to operate medical devices for the benefit of a patient.
User
Qualified person using devices as tools.
End User
A patient or client who uses a medical device unsupervised at home (e.g. wheelchair user).
4. DUTIES AND RESPONSIBILITIES
Medical Devices Management Committee (MDMC) is responsible for monitoring the implementation
of this policy throughout the organisation. This will be achieved through monitoring and ensuring
adherence to this policy by the Clinical Service Centres (CSC). MDMC will have responsibility for
managing all pieces of medical devices owned by or used within the Trust and for monitoring training
implementation to ensure the safety of staff, visitors and others.
Subgroups will be chaired by clinicians and be responsible for ensuring good governance in relation
to the management of disposable and non-disposable medical devices governed by their subgroup.
This will be achieved through:
 Safe use of devices by promoting responsibility of the CSCs and individual clinicians ensuring
users are appropriately and adequately trained in the use of medical devices
 Record keeping of: lifecycle history, maintenance and repair, utilisation, training of users
 Responding to alerts from various sources: internal adverse incident reports; MHRA alerts
and manufacturer recalls/alerts.
 Analysis of technical and clinical evaluations of medical devices
 Ensuring appropriate procurement of medical devices
The Chair has responsibility for ensuring the appropriate membership and meetings of the subgroup
and providing leadership to the subgroup. They will ensure minutes of meetings are produced and
kept.
The Chair of the subgroup will:
 Advise the CSCs and the MDMC on the priorities for the annual replacement of existing
equipment to assist the CSCs in developing their annual business plans (see flow chart for
purchase of replacement medical devices).
 Advise the MDMC and the Trust Planning Committee (TPC) or equivalent on whether new
medical devices should be introduced into clinical practice in the Trust
 Be standing members of MDMC and will be expected to attend meetings as required or to
ensure appropriate deputies attend in their place. The Chairs will report to the Chair of
MDMC and will on occasion be asked to deputise for them.
The structure of subgroups can be found in APPENDIX A.
Clinical Service Centre Management Teams, Department and Line Managers are responsible for
ensuring this policy is implemented in their areas. They must also ensure necessary resources are
available to enable staff to attend appropriate training.
Professional users are those appropriately trained and qualified to operate medical devices for the
benefit of a patient. They have a duty of care to the patient and others to ensure they understand the
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purpose, operation, and limitations of devices together with measures to minimise risks. Those who
are competent to decide on the appropriateness of a device for use with a specific patient, may act
as prescribers.
Clinical Engineering Department (ClinEng)
 Is responsible for providing an in-house maintenance and repair facility to the Trust for
Medical devices agreed at purchase. They are responsible for accepting medical devices to
the Trust and disposing of equipment at the end of their life cycle. Acceptance and disposal
is in line with recommendations made in DB2006 (05) [7].
 Is in charge of the medical devices management database and central inventory.
 Provides assistance and advice to all Trust members on procuring, selecting devices,
selecting maintenance, co-ordinating training and investigating adverse incidents.
Procurement Department will lead tender / quotation exercises and place purchase order(s) after
Medical Equipment forms and pre purchase questionnaires have been approved.
All staff involved directly or indirectly in healthcare are responsible for following the procedures laid
down in this policy and for ensuring that they have the skills and knowledge required to work safely
with any medical device.
5. PROCESS
5.1. Procurement
A flowchart that details the steps to be taken during a procurement procedure can be found in
APPENDIX A. This flowchart is a guidance tool and must be used in conjunction with the Trust’s
Standing Financial Instructions Policy. Medical Equipment Procurement (MEP) form and relevant
documents can be found on the MDMC page on the Trust’s Intranet. Any specific standards or
guidance that needs to be met will be considered prior to writing suitable specifications. Following the
instructions and guidance will ensure that these issues will be appropriately considered:
 Life cycle / replacement
 Fitness for intended applications
 Guarantee/Warranty
 Safety
 Reliability
 Service Support
 Maintenance Requirements
 Technical Support
 Training (including on site training if appropriate)
 Decontamination
 Standardisation
Once the need for the device and the source of funding are identified, a risk assessment procedure
and full consideration of relevant standards and guidelines will results in technical specifications for
the device.
The medical device subgroup determines if the device should be considered as a Trust Medical
Device Standard (MDS). If identified as an MDS it will generally remain current for the term
negotiated by the Procurement Department with the supplier, typically 5 years. This period may be
extended if the device remains suitable beyond the end of the initial contract.
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Prior to any purchase, a multidisciplinary team will evaluate the available medical devices that meet
the clinical need. The relevant Subgroup of MDMC is in charge to design and carry out the technical
and clinical appraisals. Ideally a minimum of three alternative suppliers should be considered to
ensure compliance with EU procurement legislation and the Trust’s Standing Financial Instructions.
Completed NHS Pre-Purchase Questionnaire form (PPQ) will be obtained from each candidate
supplier and reviewed by ClinEng to verify compliance with national standards.
Using a scoring system, devices will be evaluated against the following criteria:
 Compliance with national legislation
 Minimisation of all risks
 Ability to provide essential clinical function
 Reliability and availability of technical and user support
The subgroup will report the results together with full lifetime costs to MDMC who will inform the
relevant CSC for items costing under £25000 or the Trust’s Planning Committee (TPC) or equivalent
for items costing over £25000. Maintenance arrangements must also be considered at this stage.
Next, the signed ME form will be sent to ClinEng who will pass the form to the Procurement team for
placing the order.
Further guidance and advice can be sought from MDMC, DB2006 (05) [7] and Trust’s Standing
Financial Instructions. A flowchart in PURCHASE OF A NEW MEDICAL DEVICE will be used to
assist with the procurement process.
5.2. Record-keeping
ClinEng keep a record of all medical devices in the Trust, which provides evidence of:
 A unique identifier for the device, where appropriate
 A full history, including date of purchase and where appropriate when it was put into use,
deployed or installed
 Any specific legal requirements and whether these have been met
 Proper installation
 Where it was deployed and utilisation
 Scheduled maintenance
 Maintenance and repairs
 The end-of-life date.
The records will also show that users:
 Know how to use the device safely
 Can carry out routine checks and maintenance
 Have been trained and had relevant refresher training.
5.3. Acceptance of Medical Devices
When a new medical device is delivered to ClinEng, a series of tests will be carried out to ensure
safety and verify the performance of the device, before it is deployed in service.
Delivery checks will include:
 Checking that the correct product, complete with usage and maintenance information and any
relevant accessories, has been supplied
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 Ensuring that devices have been delivered in good condition and, where relevant, in good
working order.
The details of the tests can be found in DB2006 (05) [7]. Assembly of the device and performance
checks will be performed in line with manufacturer’s recommendations to ensure the accuracy prior
to clinical use.
The manufacturer’s user instructions will be supplied at purchase and delivered with the equipment.
A signature will be obtained from the recipient user. A maintenance manual must be requested if not
already provided, logged and filed.
According to DB2006 (05) [7], some devices must be risk assessed before first use. See the table
below for details:
Category
Examples
Medical devices manufactured outside
the scope of the Medical Devices
Regulations.
Purchased by an individual outside
EU.
In-house manufacture.
Bought second-hand.
Lent by another responsible
organization.
Equipment re-issued to second or
subsequent users.
Equipment which has, or may have,
been used before.
Devices within scope of Medical
Devices Regulations, but not CE
marked.
Custom-made for a named patient.
Under clinical investigation.
The Medical Device Training Team will be informed of all new equipment purchases and they will
decide the level of training required for staff, organise the training and record the user training.
5.4. Clock Setting
The clock on all medical devices must be set to the correct time by the user. In some equipment the
clock is not user settable and will be left at Greenwich Mean Time (GMT) and these devices will carry
a label to that effect.
5.5. Monitoring, Deployment and Control
Clinical Engineering Department (ClinEng) must ensure an inventory of all medical device is
maintained.
This will enable the organisation to take appropriate action following manufacturer’s recall or the
issue of hazard warning notice. The inventory will ensure that medical devices are examined annually
for electrical safety, calibrated and/or serviced as necessary and that scheduled maintenance takes
place.
All inventories must include the following:
 Order Number
 Date of purchase
 Unique asset number
 Supplier
 Manufacturer, Model, Manufacturer’s serial number, serial numbers of components modules
 Nominated team of ClinEng in charge of the device
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 Results of acceptance test
 Warrant details
 Identified Maintenance/repair Organisation
 Date of first service and subsequent service dates (to include calibration)
 Information about/instructions relating to application e.g. safe working load, cleaning and
decontamination etc.
5.6. Procedures
ClinEng holds an inventory and service log of all diagnostic and therapeutic equipment used within
the organization. Medical Devices Training Team (MDTT) will use separate matrices of “equipment
vs. members of staff” for every ward and department within the Trust. Twice a month ClinEng will
provide reports of newly purchased equipment to MDTT who will add them to the relevant matrices
and ensure that appropriate training is arranged in advance. This will be supported and managed by
MDMC to ensure that information is cascaded to ClinEng and MDTT to facilitate training at the
earliest point.
Training can be arranged in clinical areas or in the Training and Education Department. This can be
facilitated in a number of ways and can include workshops, one to one training; ad hoc training can
also be arranged.
Once the training is provided, records of this training will be uploaded onto ESR. A completed
competency statement will form evidence of competence.
5.7. Prescribing
The prescription of medical devices must be made by healthcare professionals who are suitably
qualified and experienced to understand the function of the device and its application.
Those responsible for selection need to have been trained and need ready access to information
about the device, including:
 The manufacturer’s description of the intended user, usage and the instructions for use
 Safety issues and any limitations on use
 Pre-use set up or testing requirements
 Maintenance and cleaning or decontamination requirements.
Devices are chosen to best meet the requirements of the intended medical procedure or needs of the
end user. Any short-term loan/issue of a device should be considered to provide benefit to end users
until the most appropriate device is available. The needs of the carer should be taken into account
where appropriate.
In some instances devices remain with patients for periods extending beyond original episode (e.g.
patient taking a device from acute to secondary care or patient with an implanted device) crossboundary prescribing may exist. In such cases the prescribing professional must clarify where
professional and legal responsibility for prescription lies and where continuing responsibility lies to
monitor the device and the condition of the end-user.
5.8. Maintenance and Repair
All medical devices require routine maintenance and/or calibration at a frequency recommended by
the manufacturer whether it be checks by the user, maintenance by ClinEng or maintenance by the
manufacturer. It is a requirement of NHSLA standard 5 – criterion 4 [9] that the Trust has an
approved documented process for managing the maintenance of reusable diagnostic and therapeutic
equipment. Guidance is taken from DB2006 (05) [7].
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Maintenance may be provided by the manufacturer or supplier, in-house organisation, third party
provider or partnership arrangements between any of these. Accurate detailed records of all
maintenance and repair work must be provided by the maintenance provider and kept by the ClinEng
on the equipment management database with copies readily available to user manager if required.
Labels are affixed to devices to show when next maintenance is due. The equipment management
database will also hold details on the servicer, service schedule and contract reference.
It is the responsibility of each individual to ensure the equipment they use is in a serviceable state
prior to clinical use. Serviceable state would mean there is no visible damage to the equipment, the
equipment passes pre use checks, the equipment has not been reported as faulty and that the
service due date hasn’t expired.
All reusable medical devices must be scheduled for Planned Safety and Performance Testing
(PSPT). Medical devices are retrieved from their location by ClinEng with the agreement of the user
and returned to service after the completion of the PSPT. The level and frequency of maintenance is
decided based on manufacturer’s recommendation but may be adjusted to take account of local
factors and experience.
All faulty medical devices must be removed from service immediately. For all faults occurring on
medical devices ClinEng should be contacted by email or on the phone: 02392286000 (7700) 6101.
ClinEng will then initiate the process to resolve the problem depending on how the maintenance
support is provided i.e. in-house or by external contract.
All medical devices must be decontaminated by the user prior to release for maintenance or repair.
Any spare parts used will be supplied by the manufacturer or to the same specification. Pre-used
parts will only be used under exceptional circumstances for example to replace a faulty part that is no
longer available from the manufacturer. A record of spare parts replaced during maintenance or
repair will be kept by ClinEng with traceability of critical parts back to the manufacturer.
5.9. Decontamination
Most medical devices can become contaminated and hence present a risk to patients, users and
support staff. Contamination may be chemical, biological, or radiological in nature. Specific guidance
on decontamination can be found in the Trust Decontamination Policy. However the following basic
principles must be followed:
 All medical devices must be free from contamination and if necessary sterile prior to use.
 A medical device must be decontaminated as soon as practicable after use.
 If it is not possible to decontaminate a device it must be isolated, e.g. bagged and labeled,
with the nature of contamination and date.
 Medical devices must be decontaminated prior to service.
 Medical devices must be decontaminated before loan to other organisations or end users.
 Decontamination must be performed according to procedures specified in Trust policy.
 Manufacturers are required to provide information regarding suitable methods of
decontamination.
5.10. Storage
Poor storage conditions prior to deployment can adversely affect medical devices. Ward and
Department managers who have responsibility for use of medical devices must operate systems to
avoid the following:
 Dirty or wet storage conditions
 Inappropriate temperature or humidity
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 Physical damage due to poor stacking
 Mix of contaminated and decontaminated items due to inadequate space or zone
demarcation.
 Failure to maintain charge and capacity of device batteries
The Medical Equipment Library (MEL) provides a central repository of widely used medical devices.
This will be the preferred storage location for many common devices.
The Supply Chain team within the Procurement Department is responsible for ensuring the majority
of disposable or single use medical devices are: Available when required
 Stored with appropriate stock rotation
 Use by and sterilisation dates are not exceeded.
Storage records will be maintained and periodic audit of the above factors will be undertaken. Stock
takes of all library equipment, verifying locations within the hospital, should be performed on a
quarterly basis.
5.11. Replacement Planning
A device will not be considered serviceable if any of the following criteria apply:
 Worn / damaged beyond economical repair
 Unreliable (poor service history)
 Clinically or technically obsolete
 Spare parts no longer available
 If because of design, wear and tear or damage the equipment cannot be cleaned effectively
prior to disinfection / sterilisation
 Subject to MHRA Issued Medical Device Alert/ Safety Notice/Manufacturer recommended
removal from use / service
It is the responsibility of the CSCs to secure funds for medical devices either through revenue
monies, capital, Trust funds or charitable funds.
The Trust Planning Committee (TPC) or equivalent are responsible for monitoring and authorising
capital bid purchases. MDMC is responsible for monitoring and authorising all medical device
purchases although responsibility for routine purchase is delegated to the ClinEng. The flowchart in
APPENDIX B, is an assistive tool for this procedure.
5.12. Disposal
The reuse, resale and disposal of medical devices is described DB2006 (05) [7]. Prior to disposal the
device will be removed from any maintenance schedule and be marked as disposed on the
equipment management database.
5.13. Loan Equipment
5.13.1. Medical Devices loaned to the Trust for Trials, Evaluation or Clinical Use
Prior to any agreements/arrangements for delivery of such equipment to the Trust,
members of staff must liaise with the general manager of the relevant CSC who will contact
Solent Supplies Team for the advice on the appropriate procedure (Solent Supplies Suppliers Representative Policy). Solent Supplies Team will then contact the MDMC
Subgroup chair. All such equipment is subject to acceptance checks and procedures as
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described in section 5.3 above. Appropriate indemnity forms and delivery notes must be
completed prior to clinical use.
All users must be given instruction in the safe use of the equipment prior to the equipment
being put into service.
All guidelines relating to the cleaning and decontamination of medical devices must be
applied to any equipment on loan to the Trust. Full certification must be provided
confirming that the equipment is fully traceable and has been effectively decontaminated
prior to delivery. Equipment and devices (including surgical instruments) loaned to the
Trust must be accompanied by appropriate reprocessing instructions (if relevant) and a
comprehensive inventory detailing all contents.
All surgical instruments loaned to the Trust will be processed in HSDU prior to and
following use.
Loan equipment must be collected promptly when no longer required or when the date on
the indemnity expires.
5.13.2. Medical Devices Loaned to Other (Third Party) Organisations
Medical Devices (including surgical Instruments) that are the property of the Trust must not
be loaned to any third party unless the borrower can guarantee full systems of traceability,
safe transport, competency of users and effective decontamination. The duration of the
loan can be realistically forecast.
This process will be managed by ClinEng under MDMC’s guidance.
5.14. Single-use Equipment
Some medical devices are designated by the manufacturer as “single use” and are identified with the
symbol shown above either on the device or the packaging. Devices with this designation may be
either, unsuitable for sterilisation or decontamination due to their materials or construction or be
insufficiently robust to withstand more than one use. Governance arrangements of these devices will
come under the relevant MDMC Subgroup (APPENDIX A)
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Under the Medical Device Directive (93/42/EEC) [10], if a device has been reprocessed for reuse, it
is no longer the original manufacturer but the reprocessor who must ensure that they comply with the
requirements of the Medical Device Directive.
When reprocessing single use devices, whether for in-house reuse or for reprocessing to supply to
others, if the device causes damage or injury during reuse, the reprocessor and the user may
become personally liable.
The MHRA published advice on this matter in DB 2006(04). In almost all circumstances the MHRA
advice is pertinent to medical device use within PHT. As a default requirement, no medical device
designated as single use by the manufacturer shall be reused or reprocessed.
In exceptional circumstances, where there could be higher probability of other risks, the Trust may
authorise re-use of single use devices after a full risk assessment by MDMC.
5.15. Manufacturing and Modifications of Medical Devices
PHT policy is not to modify medical devices.
All plans to manufacture or modify medical devices locally within the Trust must be reported to the
MDMC via the appropriate subgroup.
Whilst the Medical Devices Regulations [6] do not apply to devices manufactured “in-house” provided
they are used only within the same legal entity, the standards of manufacture must be equivalent.
Adequate documentation must be produced for all devices manufactured in-house and of
modifications to commercial devices. The documentation must include details of risk assessment in
accordance with BS EN 14971 [11].
In-house manufactured devices must comply with the principles of this policy.
5.16. Adverse Incidents and Management of Safety Notices
An adverse incident is any event or circumstances arising during NHS care that could have or did
lead to unintended or unexpected harm, loss or damage.
All adverse incidents involving medical devices must be reported according to the Trust Adverse
Incident Reporting Policy. A flowchart providing guidance is shown in APPENDIX A.
The Risk Management Department (RMD) will notify the MHRA via the Medical Devices Liaison
Officer (MDLO) if appropriate. According to Central Alert System (CAS) Policy, head of Risk
Management and Legal Services is the Trust’s nominated CAS officer.
Users are requested not to contact MHRA direct except in the case of incidents where there is
extreme and immediate danger of reoccurrence. Devices involved in an adverse incident together
with other material evidence (e.g. packaging of single use device) must be clearly labeled and where
practicable kept in quarantine until the incident investigation is complete. If this is not practical, the
identification and state of the device at the time of the incident must be recorded. Any clearly
dangerous device must be effectively disabled to prevent it being used.
The RMD will send copies of adverse incidents involving medical devices to the relevant Subgroup.
Adverse incidents will be considered at each Subgroup meeting.
If the RMD has considered it necessary to report to MHRA the subgroup will be required to
communicate with RMD all measures taken to prevent reoccurrence.
Receipt and distribution and response to MHRA and manufacturer safety notices on medical devices
is managed by the MDLO.
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6. TRAINING
Training is a key element in medical device safety. It is a requirement of NHSLA standard 5 –
criterion 5 [9] that the Trust has an approved document which sets out the training requirements of all
permanent staff in relation to the use of diagnostic and therapeutic equipment.
6.1. Responsibilities
MDMC has the responsibility to ensure that the training of medical devices is provided to all the users
of medical devices and the service personnel. They will promote the safe and appropriate use of
medical devices available in the Trust and ensure members of staff have access to training which
provides them with the necessary knowledge and skills to operate medical devices they may be
required to use.
Line Managers at all levels have a duty to ensure that their staff required to use medical devices are
competent and supporting records exist, e.g. training and assessment. They must also support the
medical device training program and allow staff time for adequate and appropriate training.
Medical Device Training Team (MDTT), Specialist Technical/ Clinical Advisers & Practice
Educators act as a source of expert information and, where appropriate, training for other staff. Such
advisers must ensure that their own competence is continually updated, verified and recorded.
Medical Device Training Section can be contacted via telephone extension (7700) 3786 or email.
Users
Department managers are responsible for identifying training needs within their areas of
responsibility and organising appropriate training. Healthcare professionals working for the
organisation, as employees or contractors, have a professional duty to ensure their own skills and
training are appropriate and remain up to date.
End User
The Prescriber is responsible for ensuring that the End Users receives training for the prescribed
device and is competent in its use prior to release.
Technical Staff
The ClinEng Section Head is responsible for identifying training needs of technical staff maintaining
and repairing medical devices and for arranging appropriate training as described in local quality
procedures.
6.2. Process
6.2.1.
Medical Device Training information is included in mandatory corporate induction; this
provides all new staff with awareness of the existence and role of the MDTT.
6.2.2.
Permanent staff are identified through the Electronic Staff Record (ESR).
6.2.3.
These self-assessment documents and associated questions are available from the MDTT
or can be accessed on the Intranet. They are validated every two years or when new
equipment is added to the inventory. The statements are completed by staff and returned
to the MDTT. This information is then recorded on ESR and staff will receive automatic
notification on ESR before their competency expires. The competency statement identifies
whether the user is currently competent, requires training or does not use any items of the
listed equipment.
6.2.4.
Staff who require training complete the relevant box on the form giving details of their
availability for training in the next month. If the member of staff does not give suitable dates
for training or does not attend, they, and their ward manager, receive a reminder email and
have two weeks to respond. This ensures that staff absence does not compromise receipt
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MEDICAL DEVICES POLICY
of required training. If there is no response after this period it is assumed that training is no
longer required and their form will be updated to indicate that they no longer require
training.
6.2.5.
During the yearly Appraisal and Personal Development Review (APDR) process, Line
Managers go through the training records of each permanent member of staff to verify that
their training is up-to-date on all the Medical Devices they use as part of their role.
6.2.6.
Training is delivered in a variety of ways: ward based; attendance at specialty training
days; ad hoc and on a one to one basis. This ensures all staff can receive appropriate
training. In addition, E-learning refresher courses and user instruction manuals for Medical
Devices are available to all members of staff on Medical Devices Training Intranet page.
This ensures all staff can receive appropriate training.
6.2.7.
Staff verification of competence for each item of equipment are recorded on ESR. Line
Managers can access this information in ESR under Manager Self-service, Manage Staff
Careers heading, the Competence section. This allows the Line Managers to ensure that
any member of staff who does not complete and return the Medical Devices Group
Competency Statement form can be followed up.
6.2.8.
Once training is completed in a Department, information on staff competence is sent to the
Department Managers and Heads of Nursing.
6.2.9.
The Learning and Development Team provide a monthly heat map from ESR to each CSC,
to enable monitoring of competence. ???
6.2.10. Compliance is further monitored through the CSC performance reviews with the Executive
Team.
6.2.11. Once trained, the member of staff is deemed competent for the following two years, when
a further self-assessment Medical Devices Group Competency Statement form must be
completed.
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MEDICAL DEVICES POLICY
7. REFERENCES AND ASSOCIATED DOCUMENTATION
7.1. Internal
[1]. Policy for the Management of Adverse Incidents and Near Misses
[2]. Policy for the Management of Serious Incidents Requiring Investigation
[3]. Central Alert System Policy
[4]. Decontamination Policy
[5]. Standing Financial Instructions
7.2. External
[6]. Medical Device Regulations, 2002
[7]. Device Bulletin DB2006 (05), Managing Medical Devices - Guidance for healthcare and social
services organisations: MHRA, Nov 2006. www.mhra.gov.uk/Publications
[8]. The Essential Standards of Quality and Safety: Care Quality Commission, 2009
[9]. NHSLA Risk Management Standards 2012-13 Version 1. NHS Litigation Authority (NHSLA),
January 2012
[10]. Medical Devices Directive: The Council of the European Communities, Directive 93/42/EEC,
1993
[11]. The Application of Risk Management to Medical Devices: EN 14971:2009 Standard, British
Standards Institution
[12]. The Electricity at Work Regulations. Statutory Instrument 1989 No. 635. ISBN 011096635X.
http://www.opsi.gov.uk/si/si1989/Uksi_19890635_en_1.htm
[13]. Health and Safety at Work etc. Act 1974. London: HMSO, 1974. ISBN 0105437743
7.3. Care Quality Commission’s Schedule of Applicable Publications
[14]. MHRA DB2008(03) Guidance on the safe use of lasers, IPL systems and LEDs
[15]. MHRA DB 2006 (4) Single-use Medical Devices: Implications and Consequences of Reuse
(MHRA, 2006)
[16]. MHRA DB 2006(5) Managing Medical Devices: Guidance for health care and social care
organisations (MHRA, 2006)
[17]. Safety alerts, rapid response alerts, guidance and directives relating to equipment published
by expert and professional bodies including:
 National Institute of Clinical Excellence
 National Patient Safety Agency
 Medicines and Healthcare products Regulatory Agency
 Royal Pharmaceutical Society of Great Britain
 DH
 Product manufacturers
[18]. DH IRMER Guidance and Good Practice Notes
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MEDICAL DEVICES POLICY
[19]. Mental Health Act 1983 and Mental Health Act Code of Practice (DH, 2008 relating to
seclusion facilities)
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MEDICAL DEVICES POLICY
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.
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MONITORING COMPLIANCE
As a minimum the following elements will be monitored to demonstrate compliance.
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MEDICAL DEVICES POLICY
Minimum requirement to
Lead
be monitored
Process for ensuring
Head of
that all reusable medical
Clinical
devices and equipment
Engineering
are maintained: 95%
maintained within
designated timescales
Process for ensuring
Head of
that all reusable medical
Clinical
devices and equipment
Engineering
are repaired: 95%
repaired within
designated timescales
Process for identifying
Medical
which permanent staff
Devices
are authorized to use the
Training
equipment identified on
Team
the inventory: 95% of
staff identified
Process for determining
Medical
the training required to
Devices
use the equipment
Training
identified on the
Team
inventory and the
frequency of updates
required: 100%
Process for ensuring
Medical
that the identified
Devices
training needs of all
Training
permanent
staff
are
met:
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85%
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Tool
Frequency
of Report
Annually
Reporting
arrangements
Policy audit report to:
Medical Devices
Management
Committee
Lead(s) for acting on
recommendations
Chair of Medical
Devices Management
Committee
Audit of
Clinical
Engineering
Dashboard
Annually
Policy audit report to:
Medical Devices
Management
Committee
Chair of Medical
Devices Management
Committee
Medical
Devices
Training
Database
Annually
Policy audit report to:
Medical Devices
Management
Committee
Chair of Medical
Devices Management
Committee
Medical
Devices
Training
Database
Annually
Policy audit report to:
Medical Devices
Management
Committee
Chair of Medical
Devices Management
Committee
ESR
Annually
Policy audit report to:
Medical Devices
Management
Committee
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Chair of Medical
Devices Management
Committee
Audit of
Clinical
Engineering
Dashboard
APPENDIX A.
SUBGROUPS
There are 5 subgroups of the Medical Devices Management Committee (MDMC):
 General Medical Technology
 Patient Handling and Mobility
 Specialist Surgical Devices
 Imaging and Radiotherapy
 Pathology Subgroups.
Pathology
Autoclaves (Laboratory)
ACT monitors
Blood gas, Haemoglobin and other Point Of Care
Testing analysers
Blood glucose & HbA1C measuring devices
Cholesterol test kits
Fridge & Freezers (non domestic)
Fume cabinets
Microscopes (Laboratory)
Other IVDs
Pharmacy devices
Pregnancy test kits
Specimen collection receptacles, syringes, swabs
Urine test strips
Imaging & Radiotherapy
CT scanners
Gamma Cameras
Linacs & RT devices
MR scanners
Nuclear medicine equipment
Radiation monitors
Ultrasound imaging systems
X ray imaging systems
X ray therapy systems
Specialist Surgical
Autoclaves and other HSDU
Cryosurgical Equipment
Cardiac Pacemakers (implantable)
Dental equipment and materials
Implants e.g. orthopaedic prostheses
Incontinence aids
Insulin injectors
Lasers
Operating and diagnostic microscopes
Operating tables
Ophthalmology devices
Powered implants e.g. pacemakers
Plaster saws
Rigid Endoscopes & video systems
Surgical and dental instruments
Surgical diathermy
Patient handling & mobility
Bathing equipment
Chiropody and podiatry equip
Commodes
Clinical chairs
Dental chairs
Medical Devices Version 2.0
Hospital beds & mattresses
Patient hoists
Pat slides
Prescribable footwear
Pressure relief equipment
Prostheses
Stretchers and trolleys
Walking aids
Wheelchairs
General Medical Technology
Anaesthesia machines
Audiometers
Blood warmers
Continuous passive motion devices (CPM)
Defibrillators
Dialysis equipment
Domiciliary O2 therapy equip
Drip stands
ECT devices
EEG EMG analysis systems
Flexible Endoscopes & video systems
Endoscope washers
Electrocardiographs
Humidifiers Respiratory
Infusion control devices
Laryngoscopes etc
Illuminating Light Sources
Light therapy sources
Medical gas equip. regulators suction controllers
cylinder holders etc
Nebuliser compressors
Nebuliser ultrasonic
Patient monitoring NIBP, SpO2 ECG etc
Patient warming / cooling devices
Peak flow meters
Physio. electro-therapy
Pulse oximeters
Respiratory lung function analysis
Resp. support devices, domiciliary vents.
Resuscitation equipment
Sphygmomanometers
Stress test systems
Suction equipment
Thermometers
Ultrasound Doppler
Ventilators ICU & Anaesthesia
Weighing scales
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MEDICAL DEVICES POLICY
APPENDIX B.
PURCHASE OF A NEW MEDICAL DEVICE
On the following Page
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MEDICAL DEVICES POLICY
Identify source of funding in principle
Seek advice from chair of Subgroup
Yes
New
Technology?
Prepare proposal
for evaluation
Proposal
approved
by
subgroup
?
Yes
No
No
Clinical and technical evaluation –
report result to Subgroup
Prepare proposal for purchase
Proposal for purchase
approved by subgroup?
No
Yes
No
< £25000?
Submit to TPC or
equivalent for approval
Yes
Send MEP form to Clinical Engineering
Purchase by Procurement Team
Delivery to MED
Training of users
Commissioning the equipment
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APPENDIX C.
GUIDANCE TO FOLLOW IN A MEDICAL DEVICE ADVERSE
INCIDENT
On the following Page
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MEDICAL DEVICES POLICY
Incident Occurs
PATIENT HARM?
YES
NO
Respond to patient and carer need
Alert all relevant clinical
staff
Mark all devices clearly as potentially faulty
Quarantine device and accessories (e.g. infusion pump AND disposable item
including packaging) Do not send to supplier
Identify “lead” staff member to act as contact/liaison
Grade incident and follow procedure as detailed in Adverse Event Reporting
policy. Complete Adverse Incident Report form
In case of extreme and immediate
danger of reoccurrence, contact MRHA
directly via link ‘report incidents’
http://www.mhra.gov.uk/Safetyinformation/Reportingsafety
problems/Devices/index.htm
Advise Trust
Liaison Officer of
incident via email
sheena.king@portho
sp.nhs.uk
Contact Clinical
Engineering or other
specialist technical
department for advice
Advise other areas/users of potential problem if
appropriate.
Notify Manufacturer or Supplier
Staff “Lead” review incident with Liaison Officer re further action/roles i.e. incident
investigation, contact with MRHA, Clinical Engineering, Manufacturer etc.
Staff “Lead” to feedback results of investigation/incident to staff (including Risk
Management) highlighting any lessons learned
Report results of investigation/incident to Chair of appropriate Medical Device Subgroup
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