Velindre NHS Trust Medical Devices and Equipment Management Policy
Trust Policy Policy Lead: T Harrison-Risk/Health and Safety Manager
Velindre NHS Trust
Black 94
Trust Policy
MEDICAL DEVICES AND EQUIPMENT MANAGEMENT POLICY
Policy Lead: T Harrison-Risk/Health and Safety Manager
CONTENTS
1. Policy Statement Page 3
2. Definitions and Examples Page 3
3. Policy Aim Page 4
4. Trust Accountability Page 5
5. Procurement Page 7
6. Training Page 8
7. Infection Control Page 9
8. Prescription of Devices Page 9
9. Maintenance and Repair of Medical Devices Page 9
10. Loan Equipment Procedures Page 10
11. Adverse Incidents-Device Related Page 10
12. Replacement Criteria Page 11
13. Disposal/Transfer of Ownership of Equipment Page 11
14. References Page 12
Appendices:
Appendix 1 Pre Purchase Questionnaire Page 13-15
Ref: Black 94 Page 1 of 15
Approved by: Executive Board Issue No.1
Approval Date: 8th February 2006 Next Review Date: February 2009
Velindre NHS Trust Medical Devices and Equipment Management Policy
Trust Policy Policy Lead: T Harrison-Risk/Health and Safety Manager
1. Policy Statement
Velindre NHS Trust attaches great importance to the health, safety and wellbeing of its staff, patients and visitors whilst fulfilling its statutory obligations within Health and Safety law.
The purpose of this Policy is to put systems in place which ensure that all risks associated with the acquisition and use of Medical Devices and Equipment are controlled and minimised, that medical devices and equipment purchased are suitable for intended use and offer best value.
2. Definition and Examples
Medical devices play an increasingly important role in the assessment and management of patients in clinical practice today. The term “medical device” covers a broad range of products and are used for: diagnosis or treatment of disease; monitoring of patients and assistive technology.
Examples are given below but these are not exhaustive lists.
Anaesthetic equipment / Patient monitoring equipment e.g. cardiac monitors)Blood warming cabinets / Physiotherapy equipment
Catheters (e.g. urinary) / Radiotherapy equipment (brachytherapy, external beam)
Chiropody equipment / Surgical instruments and equipment
Dressings / Syringes and needles
Examination gloves / Thermometers
IV administration sets and pumps / Radiology and Nuclear Medicine imaging systems
For Patient transportation or moving:
Carry chairs / Lifting aids (e.g. hoists)
Stretchers and trolleys
For critical care:
Defibrillators / Resuscitators
Ventilators
People with a disability:
Orthotic and prosthetic appliances / Patient hoists
Pressure relieving equipment / Walking aids
Wheelchairs and special support seating
For daily living:
Bathing and showering equipment / Commodes
Hearing aids / Incontinence products
Prescriptive footwear / Urine drainage systems
Diagnostic Equipment:
Blood gas analysers / Devices for blood glucose measurement
Hepatitis and HIV test kits / Specimen collection tubes
Urine test strips
Products used in conjunction with medical devices including:
Bench top sterilisers / Blood and tissue storage systems
Disinfecting and sterilising equipment
Within the Trust, there are many pieces of equipment that fall within the above equipment type. Usage is commonplace and very often training is part of an employees education. The Trust expects all staff to adhere to the following principles before using ANY medical device:
· Always visually check the piece of equipment for cleanliness and signs of damage or incorrect settings before each use
· Ensure equipment has been serviced where appropriate by checking service label
· If the equipment requires disposables, ensure they are correct for the device and for its current settings
· Do not use the piece of equipment unless you have been trained to do so
· Do not be afraid to ask for advice
3. Policy Aim
The aim of this policy is to ensure that whenever a medical device is used it is:
· Suitable for its intended purpose
· Properly understood by the professional user
· Maintained in a safe and reliable condition
The main topics covered are:
· Responsibility of identified personnel
· Purchase of the most appropriate device
· Acceptance testing for newly delivered devices
· Adequacy of instructions
· Decontamination and cleaning of devices
· Ensuring the appropriate medical device is used
· Maintenance and servicing
· Record keeping
· Training
· Reporting adverse events
This policy is based on statutory requirements produced by the Health and Safety Commission including the:
Health and Safety at Work etc Act 1974
Electricity at Work Regulations1989
Management of Health and Safety at Work Regulations 1999
Provision and use of Work Equipment Regulations 1998
And mandatory requirements produced by:
Department of Health
Medicines and Healthcare Products Regulatory Agency
And will have review dates clearly identified and will be reviewed on a regular basis.
4. Trust Accountability
The Executive Director of Nursing and Quality is the Trust Board’s nominated Director who is responsible for ensuring compliance with this policy.
The Trust Risk/ Health and Safety Manager is the Trusts nominated Medical Devices Liaison Person and is accountable to the Executive Director of Nursing and Quality, for ensuring the effective reporting of adverse incidents involving medical devices to the Medicines and Healthcare Regulatory Agency (MHRA) and Health and Safety Executive (HSE), if appropriate, and the dissemination of advice and recommendations issued by them, including medical device alert notices throughout the Trust. The Trust Risk/ Health and Safety Manager is also the Trust Lead Manager for the Welsh Risk Management Standard 30 – Medical Devices and Equipment and chairs the Trust’s Medical Device Working Group.
Role of Medical Device Liaison Officer
With the advent of the MHRA’s Safety Alert Broadcast System (SABS) the primary role of the medical device liaison officer is to encourage the effective reporting of adverse incidents and this is being achieved in line with the Trusts Incident Reporting Policies. The liaison officer is responsible for disseminating medical device alertsand this is undertaken via the Risk/Health and Safety Department.
The Trust Procurement Manager liaises with the Trust Risk/Health and Safety Manager in relation to adverse incidents involving medical devices. The Procurement Manager also informs the Welsh Health Supplies where appropriate of any adverse incident involving medical devices as well as reporting to the MHRA and Surgical Materials Testing Laboratory (SMTL). When reporting adverse incidents involving medical devices and equipment the Trust Incident Reporting Policy should be followed.
Medical Devices & Equipment Working Group
The Medical Devices and Equipment Working Group consists of wide ranging representation from each division who will be responsible for co-ordinating the division’s responses/actions and communications.
The purpose of the group is primarily to ensure that the Welsh Risk Management Standard is appropriately complied with, the group monitors progress against the Risk Management action plans in order that improvements in the use and maintenance of medical devices and equipment is achieved.
Terms of reference for the group include:
· To lead and co-ordinate policy development that ensures the Trust is compliant with health and safety/other legislation and is fulfilling it’s responsibilities to promote safe and proper use of medical devices and equipment
· To formulate strategies for deploying, monitoring and controlling medical devices and equipment, making recommendations to Trust Board and Management Executive for action
· To advise on the purchase of selected equipment, e.g. high volume, high-risk equipment, such as infusion devices, taking into account efficacy, safety, reliability, whole life costs and ease of maintenance
· To develop systems that monitor and record the management, maintenance and repair of medical devices and equipment
· To promote safe practice in the use of medical devices and equipment by identifying what equipment requires user training, standardising and co-ordinating training programmes, where appropriate, and ensuring contemporaneous records of training updates are maintained
· To ensure that the purchasing and acquisition process offers best value
Divisional Level Responsibilities
Divisional Service Directors should ensure equipment management structures are in place and that systems are developed to ensure all staff are aware and take ownership of their responsibilities concerning the management of equipment in accordance with national guidelines including MDA DB9801 and Welsh Risk Management Standards.
Departmental Managers should:
· Identify individuals for specific tasks and responsibilities
· Set objectives, standards and timescales and monitor performance in relation to equipment management in their areas of work
· Report problems/areas of concern to senior managers
· Implement the policy for equipment management and monitor compliance with the Medical Devices and Equipment Management Policy in their area
· Take part in the business planning process relating to equipment
· Check competence of all staff upon induction and monitor/review competence of all staff as part of appraisal and risk management processes
· Identify training and support for department leads. Ensure all training and competence is documented
Professional users should:
· Work only within sphere of professional/personal competence
· Use equipment in a safe authorised manner, only for its intended or designated purpose, following manufacturers guidelines and local policies
· Work to all Trust policies and procedures relating to the procurement, use and disposal of equipment.
· Report any adverse incidents and concerns relating to the use of equipment to line manager.
· Equipment must not be used or maintained without appropriate training and staff have a responsibility to identify and report any training needs to their line manager.
Procurement and Disposals should:
· Ensure all purchases are made in accordance with MDA Guidance DB9801
· Ensure that equipment matches the planned level of service.
· Carry out condition appraisals – e.g. age/state of repair/maintenance histories
· Ensure equipment is disposed of in accordance with the appropriate Trust Policies, manufacturer’s guidance and relevant legislation.
· Develop strategies to ensure that the Trust learns from any purchasing mistakes and identify any training needs concerning procurement & disposals of equipment.
Maintenance
Divisions must ensure that there is adequate maintenance provision for medical devices and equipment and appropriate maintenance schedules are put in place. This should include planned preventative maintenance programmes. The following should be considered where appropriate:
· Ensure service contracts are in place and set up follow-up systems to ensure contracts are reviewed well before renewal date to ensure best value is achieved.
· Devise systems to ensure equipment which is loaned to patients / other departments etc is regularly tested for safety and appropriately maintained.
· Set up systems to ensure maintenance contractors carry out a thorough job.
5. Procurement
Various parties in the Trust are responsible for the procurement process.
The Trust process for the selection and acquisition of medical devices/equipment will ensure:
Value for money
Equipment that meets the needs of it’s professional and end users
Compliance with Standing Financial Instructions
To comply with the Trust’s Standing Financial Instructions, competitive tendering or quotes will be necessary and indeed it is considered good practice wherever possible. There will be a need for a device / equipment specification
This process covers both new and replacement devices whether purchased (including lease) or non-purchase acquisitions of medical devices such as renting, borrowing, in-house manufacture, modification of in-house devices, refurbishment or ‘cannibalising’. Cannibalising is NOT to be considered a method of equipment procurement, merely a short term reaction to given changes in circumstance.
Procurement Checklist
A procurement checklist should be drawn up and followed in the specification /quotation / tendering stages of the procurement process. This will often be needed in addition to an equipment specification where that specification looks only at the primary functions and capabilities of a device.
Some examples of questions likely to be asked could include:-
Will this replace existing equipment?Will it meet department’s requirements? (as per business case)
Are there installation costs? (E.g. electrical sockets, workbenches, communication cables etc.)
Have all accessories been requested? (E.g. stands, trolleys etc.)
Have running costs been considered? (Disposables, extra staff, capital charges)
Are there any training costs involved?
Is regular maintenance required?
If yes is funding available (on average 10% of purchase cost)
Will the equipment be in contact with intact skin, non intact skin, mucous membranes?
What are manufacturer guidelines for cleaning, decontamination and sterilisation?
Does equipment comply with relevant standards
Overall is equipment considered satisfactory?
The Trust Procurement Department will send a Pre-Purchase Questionnaire (PPQ) form to the prospective supplier; the form includes information relating to safety and infection control to enable the purchaser to make an informed decision as to whether to proceed with the particular purchase. A copy of the PPQ form can be found in Appendix 1.
6. Training of Staff in the Use of Clinical Equipment.
Introduction
Training of staff in the use of diagnostic or therapeutic equipment is essential if the Trust is to ensure that the health care workers it employs are competent to undertake the duties for which they are employed and to ensure that the potential risk of harm to patients is reduced to a minimum.
This section applies to all grades and disciplines of staff that are employed directly or indirectly within relevant Trust divisions.
Identification of Equipment
All departments will identify equipment within their areas for which staff will require specialist training; Department managers will identify which staff are able to use each device following successful completion of a programme of training. This may include setting up a device, preparing for its use and or checking the device.
Training
Upon local induction ensure all appropriate staff, including bank and agency staff, receive appropriate training before using equipment.
Ensure competence is measured, documentation maintained and training recorded and reviewed as part of staff’s individual performance review (IPR).
Ensure designated storage place for manufacturer’s instruction manuals.
Review training plans and organise regular refresher training when necessary
Ensure training / induction includes an understanding of relationships with other departments (e.g. Maintenance Department, Prevention and Control of Infection etc)
Individuals are responsible for ensuring they are competent for any equipment they use. Anyone who does not feel competent must not use equipment until they have undertaken the appropriate training and assessment.
Competence will be monitored and reviewed through staff appraisal and risk management processes or when staff have not used a piece of equipment for 12 months or earlier if indicated by clinical practice