Freedom of Information request 028-2022

Trust HQ
Edward Jenner Court
1010 Pioneer Avenue
Brockworth
Gloucester
GL3 4AW
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E-mail: freedomofinformation@ghc.nhs.uk Website: www.ghc.nhs.uk
DATE: 11/03/2022
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Freedom of Information Request – Ref: FOI 028-2022
Thank you for your recent Freedom of Information request. Please find our response below.
1. A structure chart showing the job titles and banding of staff in the medical device
EBME. team/function for the trust see below
2. Does the trust provide training in the use of medical devices? 2a. If yes, what software or system does it record this training in? The suppliers of the equipment provide the training. Training is recorded on the users personal training record. 3. Approximately how many medical devices/EBME devices does the trust own? Approximately 10,000
4. Does the trust subcontract the maintenance of medical/EMBCE devices to a outside provider or does it maintain the devices using internal engineers? 4a. If an external provider is used, what is the name of the company? The maintenance of all devices is sub contracted. The Medical Engineering Department of Gloucester Managed Services a subsidiary company of Gloucestershire Hospitals NHSFT..
5. A copy of your medical devices/EBME policy Please see attached.
6. If the trust has a medical device management committee, please provide the terms of reference Please see attached.
7. Please provide the name, email address and job description of the role responsible for managing medical devices within the trust Several people are involved in the management of medical devices but ultimately it’s Kevin Adams, AD of Estates, Facilities & Medical Equipment.
Please email us on contactus@ghc.nhs.uk who will redirect your email accordingly. Should you have any queries in relation to our response in this letter, please do not hesitate to contact me. If you are unhappy with the response you have received in relation to your request and wish to ask us to review our response, you should write to:-
– Head of Legal Services / Associate Director of Corporate Governance Gloucestershire Health and Care NHS Foundation Trust
Edward Jenner Court
1010 Pioneer Avenue
Gloucester Business Park
Brockworth
GLOUCESTER GL3 4AW
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E-mail: —
If you are not content with the outcome of any review, you may apply directly to the Information Commissioner’s Office ICO. for further advice/guidance. Generally, the ICO will not consider your case unless you have exhausted your enquiries with the Trust which should include considering the use of the Trust’s formal complaints procedure. The ICO can be contacted at: The Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF.
Yours sincerely,
Freedom of Information Officer
On behalf of Gloucestershire Health & Care NHS Foundation Trust
DRAFT TERMS OF REFERENCE
. Constitution
The Associate Director of Estates, Facilities and Medical Equipment as the Chair of the Buildings Environment and Medical Equipment BEME. Group hereby resolves to establish a sub committee to be known as the Medical Devices Group.
The Medical Devices Group covers all aspects of medical devices management to deliver structure, process, outcome and assurance as defined by the Medicines and Healthcare products Regulatory Agency MHRA.
. Membership
Group Members
Title Name
Head of Estates & Facilities Professional Services Chair. Michael Banks
Assoc Dir of Estates, Facilities & Med. Equipment Deputy Chair. Kevin Adams
Deputy Director of Nursing and Quality Deputy Chair. Hannah Williams
Medical Equipment Manager Alison Hartless
Interim Manager Patient Safety Team Sally King
Deputy Service Director – MH & LD Inpatients Amy Alexander
Deputy Service Director – Physical Health Inpatients Juliette Richardson
Deputy Service Director – ICT Steven Holmes
Service Director – UCASS Helen Mee
Theatre Manager Severine Ryder
Health and Safety Compliance Officer Carol Sefton
Senior Contracts & Procurement Manager Sefton Clyan Andrews
Service Director, Integrated CYPS Directorate Mel Harrison
Estates & Facilities Administrator minute/notes taking. Chelsea Jones
Members must ensure representation if they are unable to attend.
Non-Members may be invited at the request of the chair for specific issues and to deputise in the event of absence of any of the above.
. Quorum
Chair or Deputy Chair
Medical Equipment Manager or representation
A minimum of 2 Deputy Service Directors
Senior Contracts & Procurement Manager
. Frequency of Meetings
The Medical Devices Group will meet monthly.
Notwithstanding the need for an emergency meeting, it will be the responsibility of the Chief Executive, Director of Finance and/or Chief Operating Officer to identify and implement any action necessary to deal with a critical safety issue.
All papers for meeting will be circulated 7 days in advance of the date of the meeting and the Chair will reserve the right to additional business on the day of the meeting if appropriate
. Authority
The Medical Devices Group is authorised by the Buildings Environment and Medical Equipment Group to review and consider any activity within its terms of reference
including:
Seek any information it requires from any employee and all employees are directed to cooperate with any request made by the group.
If required, obtain outside legal or other independent professional advice and to secure the attendance of outsiders with relevant experience and expertise if it considers this necessary.
The group is authorised to review, comment and ratify local policies, procedures and plans
that relate to its areas of responsibility.
In addition to the formal escalation I governance procedures above, the group will also maintain a direct link to the Chief Executive in order to ensure that urgent matters relating to health and safety & security can be addressed where circumstances require.
. Purpose
The purpose of the group is to provide assurance and oversight regarding Medical Devices activity across Gloucestershire Health and Care Services NHS Foundation Trust GHC.. This oversight and assurance will include and not be limited to; policy guidelines and activity regarding resuscitation process & procedures.
Monitor operational plans for safe and effective acquisition and use of medical devices; to deliver structure, process, outcomes and assurance for all aspects of medical devices. The group will monitor incidents and set standards and review compliancy.
The group will ensure that the Trust meets the standards established by and alerts issued by the relevant national bodies e.g. Medicines and Healthcare products Regulatory Agency MHRA. and any others, updating policies and procedures as and when appropriate. The group will direct and receive reporting and subsequently report into the Trust governance structure in line with the Trust Quality Governance Framework Document. The Medical Devices Group will ensure it provides onward assurance on all aspects of its work as set in:
. The Health & Safety at Work Act 1974.
. Medicines & Healthcare products Regulatory Agency MHRA.
. Provision and Use of Work Equipment Regulations PUWER1998.
. Lifting Operations and Lifting Equipment Regulations LOLER1998.
. Ionising Operations Medical Exposure. Regulations IRMER 2000.
. NHS Litigation Authority Risk Management Standards
. Waste Electrical & Electronic Equipment Directive 2006.
. Care Quality Commission
. Public Health England
. Clinical Commissioning Groups CCGs.
. Duties To work on the establishment, development and oversight of the medical equipment replacement programme for capital and non-capital investment items.
To provide assurance of an open, responsive and documented approach to current guidelines and activity regarding medical devices across the Trust.
To receive and review assurance reports from Medical Engineers and Specialist Technology on the maintenance of all medical devices in use across the Trust, including those under contracted maintenance arrangements.
To endorse maintenance and servicing arrangements of new medical equipment, ensuring such arrangements are adequate, safe and resourced.
To authorise and enter device-related risks onto the Trust-wide corporate risk register, underwriting or escalating as deemed necessary, and providing ongoing oversight of such risks.
To authorise and review the Medical Devices Management Policy.
To review medical device decontamination and infection control issues, escalating as necessary.
To review and advise on medical devices procurement and trials issues, as well as capital.
investment.
To review and implement measures and actions arising from Medical Device Alerts MDAs. issued via the Central Alerting System CAS.
To monitor and review medical equipment training requirements. . Standing Agenda Items
1. Welcome/Introductions/Apologies
2. Previous Minutes/notes
3. Medical Device Alerts
4. Health & Safety Incidents
5. Medical Device Incidents
6. Rolling Replacement Programme
7. Med Eq Capital Scheme Updates
8. Capital Management Group bids historic/current/future.
9. Medical Equipment Purchase updates
10. AOB
. Future Review
The terms of reference of this meeting will be formally reviewed, updated and agreed in November 2022CLINICAL POLICY
Medical Devices Policy Number CLP040
Version: V5
Purpose: This policy sets out the standards required by providers in relation
to medical devices, ensuring they are fit for purpose, properly
decontaminated and that colleagues have been trained and are
competent to use.
Consultation: Clinical Policy Group, Buildings, Environment and Medical Equipment Group BEME.
Approved by: Clinical Policy Group Date approved: 13th July 2021
Author: Alison Hartless – Medical Equipment Manager
Date issued: 15th July 2021
Review date: July 2024
Audience: All staff within GHC
Dissemination: The policy will be communicated with colleagues via line
managers following the approved process. The policy will be made
available on the Trust’s Intranet.
Impact
Assessments:
This policy has been subjected to an Equality Impact Assessment. This concluded that this policy will not create any adverse effect or discrimination on any individual or particular group and will not negatively impact upon the quality of services provided by the Trust.
Version History
Version Date Reason for Change
V September 2018
Building and Environment Group Membership comments
V4 November 2018
Put into latest format, minor amendments and
reviewed until January 2020
V4.1 April 2019 Appendix 6 added
V4.2 October 2019
Transferred to new Trust Template and updated Trust Name and details following merger of trusts, GHT amended to GMS, links updated
V4.3 March 2020
Extension to review date as advised by Director of Nursing, Therapies & Quality during Trust Prioritisation of Services for Covid19
V4.4 July 2020 Extension to review date whilst the process of merging the physical and mental health policy
information takes place
CLP040 Medical Devices Policy Page 2 of 12 15th July 2021
V5 June 2021 Full Review for merged Trust
SUMMARY
This policy aims to ensure that recommended safety standards and legislation is adhered to in the use of medical devices and that it is the Trust’s intention to adopt best practice standards in the management of medical devices.
ABBREVIATIONS
Abbreviation Full Description
GHC Gloucestershire Health and Care NHS Foundation Trust
MHRA Medicines and Healthcare Products Regulatory Agency
GIS Gloucestershire Industrial Services
GMS Gloucestershire Managed Services wholly owned subsidiary company of Gloucestershire Hospitals NHSFT.
NHSR National Health Service Resolution formerly NHSLA.
CQC Care Quality Commission
SABS Safety Alert Broadcast System
NICE National Institute for Health and Care Excellence
SFI Standing Financial Instructions
ESR Electronic Staff Record
KPI Key Performance Indicator
NPSA National Patient Safety Agency
DOH Department of Health
MDSO Medical Devices Safety Officer
PUWER Provision and Use of Work Equipment Regulations 1998 PUWER.
MEMS Medical Equipment Management System – OPTIM
MEM Medical Equipment Manager
FSN Field Safety Notice
LOLER Lifting Operations and Lifting Equipment Regulations 1998
CAS Central Alerts System
CLP040 Medical Devices Policy Page 3 of 12 15th July 2021
1. INTRODUCTION 1.1 Gloucestershire Heath and Care NHS Foundation Trust GHC. is committed to providing services that are excellent, of high quality and safe for patient care and colleagues. The Trust provides a wide range of health-related services to the people in and around Gloucestershire. The Trust recognises its duties and legal responsibilities to ensure, as far as reasonably practicable, the health, safety and welfare of its patients and employees. This also incorporates the procurement and maintenance of equipment and the training of the staff to use the equipment in a safe and appropriate way.
1.2 The following organisational documents may be used in conjunction with this policy:
. Health Records and Clinical Record Keeping Policy
. Decontamination of Equipment Policy
. Central Alert CAS. Policy
. Equipment Maintenance Policy
. Health and Safety Policy
. Incidents Policy
. A to Z of Decontamination Policy
. Bed Rail Assessment and Safe Use Policy
. Moving and Handling Policy
. Health & Safety Policy
. Lifting Operations and Lifting Equipment Regulations LOLER. Management Policy
. Provision and Use of Work Equipment Regulations PUWER. Management Policy
2. PURPOSE
2.1 The Trust owns and relies upon a large stock of clinical and diagnostic medical devices in order to carry out its function of patient care.
2.2 The purpose of the policy is to provide a clear understanding of the Trust’s principles regarding the management and decontamination of medical devices and set out the standards and guidance to ensure systems are in place to provide assurance for safe acquisition, use, storage, decommissioning and disposal of all medical devices.
2.3 The term medical device or medical equipment covers all products, except medicines, used in health care for diagnosis, prevention, monitoring or treatment of illness or disability. According to the Medical Devices Regulations 2002 SI 2002 No 618, as amended. UK MDR 2002., a medical device is described as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap investigation, replacement or modification of the anatomy or of a physiological process, or control of conception. A medical device does not achieve its main intended action by pharmacological, immunological or metabolic means although it can be assisted by these.
CLP040 Medical Devices Policy Page 4 of 12 15th July 2021
2.4 This policy sets out the arrangements for the management of these devices throughout the Trust based upon the requirements of legislation and good practice as defined in the following documents.
. Health and Social Care Act 2008 Regulated Activities. Regulations 2014: Regulation 15 Premises and Equipment.
. Bulletins issued by the Medicines and Healthcare products Regulatory Agency MHRA. Device Bulletin DB 2006
. Managing Medical Devices January 2021
. Care Quality Commission CQC.
. National Patient Safety Agency NPSA.
. Health and Social Care Act 2008
. Regulation 12 Provision and Use of Work Equipment Regulations 1998 PUWER.
. Lifting Operations and Lifting Equipment Regulations 1998 LOLER.
. Department of Health DOH. and other relevant national and international standards
3. SCOPE
3.1 This Policy should be followed by all Staff in Gloucestershire Health and Care NHS Foundation Trust and applies to all medical devices used in the Trust irrespective of whether the equipment has been purchased, loaned or received as a gift.
3.2 The management of medical devices is to ensure that the correct equipment is available when required, in a safe and serviceable condition and at a reasonable cost.
4. DUTIES 4.1 The Chief Executive and Directors have overall responsibility for medical devices throughout the Trust and ensuring that safe standards and procedures are maintained as far as reasonably practicable.
4.2 Associate Director of Patient Safety and Learning will ensure the effectiveness of the medical devices and equipment management system and that risk exceptions in the medical devices policy and procedural devices are reported to MHRA and or other external agencies, using approved and recognised reporting systems.
4.3 Associate Director of Estates, Facilities & Medical Equipment is responsible for service and maintenance contracts for medical devices; Accountable for effective monitoring and liaison with Gloucester Managed Services Medical Engineers and their contracted responsibilities for this policy.
4.4 Medical Equipment Manager is responsible for providing effective management of medical devices and equipment procedures from acquisition to disposal.
4.5 Ward and Clinical Managers are responsible for maintaining an updated electronic inventory of medical devices to provide accurate statements to support acquisition, use, storage, decommissioning and disposal; supporting the need for action following MHRA alerts and manufacturers modification recalls.
4.6 Infection Prevention and Control Team are responsible for auditing and advising CLP040 Medical Devices Policy Page 5 of 12 15th July 2021
services using reusable and single use medical devices. In addition, advising and supporting acquisitions, training needs and decontamination processes through the effective monitoring of compliance.
4.7 All staff are responsible for ensuring their own health and safety, and also that of others who may be affected by their actions or inactions in the safe use of medical equipment.
4.8 Medical Devices Safety Officer MDSO. key roles include promoting the safe use of medical devices across the Trust. The MDSO is the essential link to implementing national initiatives by providing local actions to improve medical device safety. In addition to being the nominated representative for the Trust, should act as a point of contact for manufacturers and support local actions on Field Safety Notices FSN.,
disseminate and co-ordination of the local inventories for MHRA/CAS alerts and local action responses of the DATIX system. They will provide CAS status update reports to the Medical Devices Management Group detailing alerts received, sent out and responses.
4.9 Buildings, Environment and Medical Equipment Group BEME. has responsibility for the development and implementation of the Medical Devices Policy, associated procedures and guidelines; ensuring compliance with relevant legislation when reviewing and monitoring medical devices related reports. BEME presents exception
reports to the Quality and Performance committee six monthly.
5. POLICY DETAIL
5.1 Use of Medical Equipment
The use of medical equipment for non–designated purpose; any modification or use of equipment other than it’s intended use is a clear breach of the terms of the manufacturer’s warranty.
5.2 Incidents which occur that involve medical devices can have the potential to produce unexpected or unwanted outcomes that may affect the safety of patients, service users, staff and visitors:
a. Injuries as a result medical device failure or misuse
b. Treatment is interrupted or compromised
c. Risk of infection from contaminated device if not handled, collected and transported in a manner that avoids risk and decontaminated in accordance to best practice. d. Decontaminated equipment is subject to validation, calibration and monitoring by qualified personnel.
e. The procedure for monitoring and reporting incidents/events should be followed and all near misses or incidents must be escalated using the DATIX system.
5.3 Loan Equipment
Loaned medical equipment agreements have different maintenance and servicing contractual agreements. The person responsible for arranging the loan should ensure that all indemnity, legal and liability checks are completed, and ensure that manufacturers quality control inspections have been completed prior to use within the Trust.
CLP040 Medical Devices Policy Page 6 of 12 15th July 2021
5.4 Trialling Medical Devices
All suggestions for medical device trials need to be presented at the Physical Health Group for consideration followed by agreement at the Medical Devices group meeting. All trials must be Procurement led once agreed.
6. PROCESS FOR THE PROCUREMENT OF MEDICAL DEVICES
6.1 All potential purchase of medical equipment, new or replacement must be agreed by the clinical lead or team manager; regardless of the value or quantity. It must follow
the process with consideration given to income, risk and the profitability of the service where possible; as outlined in the flow chart: appendix 1.
6.2 The Medical Equipment Manager MEM. must be notified of all intended purchases,
presented to the Physical Health Group and/or Medical Devices Group. If it’s new
equipment with a purchase cost exceeding £5k then a business case must be prepared for presentation to the Capital Management Group.
6.3 All medical devices must be purchased through the Procurement Medical Equipment
Specialist. Team to ensure that the equipment is a nationally recognised and approved framework agreement; the details of the equipment required is submitted using a procurement Statement of Requirement SOR. form obtained from Procurement. All
new equipment is subject to completion of a pre-requisition form to ensure that any service and maintenance contracts are established and all new medical equipment is recorded on OPTIM, the medical equipment management system MEMS..
6.4 All new medical devices or enabling works for new medical devices is subject to completion of a “Check list for Infection Control approval for the purchase of new items”. Appendix 2.. The IPC Team must be contacted and confirm agreement.
7. NEW MEDICAL DEVICES
7.1 All new medical devices must be acceptance tested on arrival and should be complete with user manuals. Maintenance instructions should be followed in accordance with the manufacturer’s detailed information; medical devices should be selected and acquired in accordance with the MHRA “Managing Medical Devices” January 2021 document and all other relevant recommendations with regard to the following:
a. Technical specifications regulatory compliance
b. Maintenance, disposal and replacement costs
c. Standardisation to single models where possible
d. Monitoring and manufacturing advice for training and support where needed
e. Record of pre-requisition questions f. Medical devices on loan or trial must have been through the procurement process with all risks and safety checks evidence documented
g. Compliance with MHRA guidelines and supplier indemnity agreement documents.
h. Asset registered, recorded, labelled and checked by Medical Engineers before use
i. Subject to calibration if required
j. Decontaminated before patient use.
k. Recorded on local inventory
CLP040 Medical Devices Policy Page 7 of 12 15th July 2021
8. OPTIM, PLANNED PREVENTATIVE MAINTENANCE AND REPAIRS
8.1 The OPTIM database is used to record all medical devices within the Trust; the database is owned and managed by Gloucester Managed Services GMS. who are responsible for updating and maintaining accurate records and providing reports for medical devices, service, maintenance, contractual arrangements, obsolescence, risk and manufacturers alerts. 8.2 Planned preventative maintenance PPM. should be carried out by following the manufacturers guidance by appropriately trained technicians ensuring safe practice and use of equipment.
8.3 All staff are responsible for following safe working practices and reporting any problems that may be associated with medical devices using normal reporting procedures. As well as maintenance, staff are responsible for ensuring medical devices are available for scheduled calibration and safety checks.
8.4 Any medical device that is found to be faulty must be removed from service, suitably decontaminated and labelled to await repair. Once returned, the medical device must be decontaminated before use. Repairs can be arranged by contacting GMS Medical Engineering team via the following link:
http://ghtmejr.glos.nhs.uk/MedEng/en/Customer/index.asp
8.5 Procedures should be in place for regular routine, performance or maintenance checks
conducted by Medical Engineering GMS. as indicated in the manufacturer’s instruction manual and recorded to provide monthly reports for assurance to the BEME Group.
PPM and KPI reports should be presented at the Medical Devices Group meeting to provide assurance to the BEME Group.
9. ADVERSE INCIDENT REPORTING
9.1 The Trust MDSO will ensure that arrangements are in place to receive and disseminate safety warnings and bulletins issued by the MHRA. Refer to the Central Alerts System CAS. Policy. and other expert and professional bodies i.e. NICE.
9.2 Managers will be responsible for ensuring that all device users are aware of local procedures for reporting incidents. Any adverse incident involving a medical device will be reported to the MHRA as soon as possible after the event and the Health and Safety Compliance Officer via the Trust intranet using the Incident Reporting to GHC DatixWeb. 10. DECONTAMINATION OF MEDICAL DEVICES
10.1 All reusable medical devices must follow a decontamination process to ensure the equipment is safe to use and it is essential that adequate information demonstrates
and evidences a complete record of the decontamination process. This must be held locally in order to provide assurance that the equipment has been decontaminated in accordance with legislation and guidance.
10.2 Manufacturers of medical devices are required to provide advice on how the equipment is required to be decontaminated and this should always be followed. The CE mark on CLP040 Medical Devices Policy Page 8 of 12 15th July 2021
reusable devices provides the appropriate process to follow for decontamination and is the declaration the device meets the requirement of the medical device’s directive. 10.3 It is illegal to transport contaminated medical devices. Do not send contaminated equipment elsewhere as it must not be transported without a declaration stating the method of decontamination used; if it is impossible to decontaminate before transportation the equipment should be wrapped and labelled declaring the status.
Refer to the Trusts Infection Control Policy and Guidelines for further details.
A-Z Decontamination of Medical Equipment infection Control Policy CLP077.
11. SINGLE USE ITEMS
11.1 Single use items can be defined as “a device that is intended to be used on an individual service user/patient during a single procedure and then discarded.”
Therefore, the practice of reusing medical devices labelled by the manufacturer ‘for single use only’ will not be permitted.
Single use items are identified by the symbol:
11.2 The Consumer Protection Act 1978 will hold a person liable if a single use item is reused against the manufacturers recommendations and the Trust would be liable in the event of an adverse outcome. The Medical Devices Agency 2000 04. states the hazards and risks associated with using single use items. 12. DECOMMISSIONING AND DISPOSAL
12.1 Any reusable medical device which is no longer serviceable should be decommissioned. Decommissioning of a medical device must include decontamination, making safe and unusable unless to be sold, donated or auctioned..
12.2 Decommissioned medical equipment should be disposed of following the correct procedure for disposal or condemnation of medical equipment.
12.3 In the first instance; contact the Medical Equipment Manager MEM., emailing GHCEstates@ghc.nhs.uk detailing:
a. ME number
b. serial number
c. site and location of device
d. confirmation of decontamination status
e. reason for disposal
f. replacement consideration
Following this request and complete a Medical Equipment Condemnation and Disposal Form, obtained by emailing GMS. These are individually serial numbered and therefore they need to be obtained directly by emailing Medical Engineering. ghntr.medeng@nhs.net.
12.4 Notification of decommissioning and disposal must follow this process to ensure CLP040 Medical Devices Policy Page 9 of 12 15th July 2021
records are updated and equipment is removed from the asset database Optim.
12.5 The Transfer of Ownership must adhere to the correct legislation with proof of decontamination before removal from site following no the decision when sold, donated, added to WARPIT, or auctioned.
At all costs DO NOT dispose of any medical device in a skip or other waste streams without consultation with the MEM.
Adhere to the European Waste Directive, Control of Substances Hazardous to
Health Regulation 2002, HTM 07-01 Safe Management of Healthcare Waste and Waste from Electrical and Electronic Equipment WEEE. 2013.
13. CANNIBALISATION AND MODIFICATIONS
13.1 Cannibalising is the process of replacing parts which have failed in service with ones taken from other broken devices. This practice must NOT be undertaken within the Trust due to the risk of claims of negligence. 14. PROCESS FOR MONITORING COMPLIANCE
14.1 The Trust will undertake annual audits that involve medical devices as and when appropriate. The Trust will also undertake “observational” spot checks of medical devices and equipment.
15. TRAINING AND SUPPORT
15.1 Staff, service users/patients and carers, where appropriate will be trained in the safe operation of medical devices.
15.2 It is the responsibility of the department lead to ensure staff have access to training and manufacturer’s updates and instructions.
15.3 Training records should be evidence that staff have been trained on the safe use and function of the equipment; understand how equipment works and recognise malfunctions and when to withdraw equipment from service; decontamination requirements and fault reporting.
15.4 Patients/service users and carers must be provided where appropriate with the same standard of equipment training and checklist of use, following the contractual agreement of the third-party supplier of medical devices.
16. ASSESSING RISK
16.1 Risk is identified by several means including the review of adverse incident, review of CAS, Datix Incidents and near misses, medical device inspections, testing and PPMs.
16.2 The MDSO will be informed of any risk relating to medical devices.
17. REFERENCES
Medical Devices Agency 2000. Single use medical devices: implications and consequences of re-use MDA DB 200004. Medical Devices Agency, London.
CLP040 Medical Devices Policy Page 10 of 12 15th July 2021
Medical Devices Agency 1998. Medical Devices and Equipment Management for Hospitals and Community-based Organisations MDA DB 9801 Medical Devices Agency, London. www.mhra.gov.uk/Publications/Safetyguidance/DeviceBulletins/CON202 5142
MHRA, Managing Medical Devices – Guidance for healthcare and social services organisations – April 2014
Department of Health and Social Care 2018. NHS long term to reduce carbon footprint to promote a greener NHS by reuse or recycling.
https://www.gov.uk/government/news/nhs-to-reuse-more-medical-equipment
17/10/2018
Health and Social Care Act 2008 Regulated Activities. Regulations 2014: Regulation 15 Premises and Equipment.
Health Act 2008, Code of Practice for health & social care on the prevention and control of infections and related guidance
Health & Safety at Work Act 1974
Medical Devices Agency 200004. Single Use Medical Devices: Implications & Consequences of Reuse
HTM01-05 Decontamination in PC Dental Practices 2013
HTM01-01Part A-D Management & Decontamination of Surgical Instruments, Medical Devices in Acute Care 2016
DH 2006 Sterilisation, Disinfection & Cleaning of Medical Equipment: Microbiology Advisory Committee.
Medical Devices Regulations 2002 SI 2002 No 618, as amended. UK MDR 2002.