Medical Devices Policy - May 2021
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Medical Devices Policy
May 2021
This policy supersedes all previous policies and procedures for Medical Devices
Page 1 of 30Policy title Medical Devices Policy
Policy reference RM04
Policy category Clinical/Risk Management
Relevant to All staff using medical devices on and off Trust premises when delivering services
on behalf of C&I
Date published March
2021
Implementation date March
2021
Date last reviewed Supersedes all previous policies
Next review date September
2021
Policy lead Nurse Consultant Physical Health
Contact details Christina.Amin@Candi.nhs.uk
0203 317 7090
Accountable director Director of Nursing & Governance
Approved by Physical Health & Nutrition Group
(Group):
Approved by Clinical Risk and Governance Committee
(Committee):
Document history Date Version Summary of amendments
Added Procurement Process
Added links to policies
March 2021 5
Updated equipment list
Updated document format
Updated contacts and links
Document formatting and inclusion of revised
processes
May 2019 4
Incorporate OT Equipment /Patient Handling
Equipment
Comprehensive review to align with Trust
Jan 2018 3 current practices
Aug 2010 2 Matrix reviewed and updated
Membership of the
policy development/ Christina Amin, Consultant Nurse Physical Health and Infection Prevention and
review team Control (Lead for Medical Devices and Resuscitation)
Consultation
Members of Physical Health and Nutrition Group, Divisional Associate Directors,
Clinical Directors, Service/Team Managers and Matrons
DO NOT AMEND THIS DOCUMENT
Further copies of this document can be found on the Foundation Trust intranet.
Page 2 of 30Contents:
1. INTRODUCTION........................................................................................................ 4
2. POLICY STATEMENT ................................................................................................ 4
3. SCOPE....................................................................................................................... 5
3.2 Objectives ................................................................................................................ 5
3.3 Definitions ................................................................................................................ 5
4. DUTIES ...................................................................................................................... 6
5. TRAINING .................................................................................................................. 8
6. MEDICAL DEVICES MANAGEMENT AND PROCEDURES....................................... 9
6.1 Procurement and Purchasing ................................................................................... 9
6.2 Acceptance of Equipment....................................................................................... 10
6.3 Procedure for the receipt of a new medical device .................................................. 10
6.4 Pre-Purchase Questionnaire (PPQ)........................................................................ 10
6.5 Assessment Testing ............................................................................................... 11
6.6 Planned Preventative Maintenance (PPM) and Electrical Testing ........................... 11
6.7 Repairs and Process .............................................................................................. 11
6.8 Decontamination and Destruction........................................................................... 11
6.9 Single Use Devices ................................................................................................ 12
6.10 Cleaning and Medical Devices Audit .................................................................... 12
6.11 Medical Devices Asset Register ........................................................................... 12
6.12 Competence......................................................................................................... 13
6.13 Incident reporting ................................................................................................. 13
6.14 Medical Device Alerts ........................................................................................... 13
7. REVIEW AND MONITORING ARRANGEMENTS .................................................... 13
8. PROCESS FOR MONITORING AND COMPLIANCE ............................................... 14
9. DISSEMINATION ..................................................................................................... 15
Appendix 1 Medical Devices (Standardised Items and Asset).......................................... 17
Appendix 2 Medical Devices Pre-Procurement Questionnaire… ....................................... 20
Appendix 3 Procurement of Medical Devices .....................................................................24
Appendix 4 Process for the Repair of Medical Devices ...................................................... 25
Appendix 5 Decontamination Label… ...............................................................................26
Appendix 6 Medical Device Competencies… .................................................................... 27
Appendix 7 Medical Device Competency Training History ................................................. 29
Page 3 of 301. INTRODUCTION
1.1 The appropriate management and control of medical devices within Camden& Islington
NHS Foundation Trust (C&I) is acknowledged at the highest level as being a
fundamental component in ensuring the safety, health and wellbeing of both patients
and staff.
1.2 The use of medical devices is an essential part of being able to provide safe care. The
Care Quality Commission (CQC) and National Health Service Resolutions (NHSR)
require Trusts to reduce risks associated with medical devices and equipment in order
to protect patients and staff from any harm. Training is integral to reducing risk and the
competencies required for devices used within C&I are attached to the policy as
appendices.
1.3 This policy applies to all wards, teams and departments that use or loan medical
equipment and devices on or off the Camden & Islington Trust premises. This includes
devices given to service users as part of their care in the home.
1.4 Camden and Islington NHS Foundation Trust requires that all ward and team managers
for inpatient and community services take responsibility for the medical devices used in,
and loaned from, their area and for the relevant training for competency.
1.5 Correct management of medical devices and assignment of responsibilities plays an
essential part in fulfilling our obligations under the Health and Safety at Work Act (1974),
the Provision and Use of Work Equipment Regulations (1998) and the relevant NHS
Care Standards.
1.6 This policy sets out the systems for managing the use of medical devices in directly
managed Trust services within the operational Directorates. Management of medical
devices encompasses the whole life cycle of the device, from pre-procurement issues,
maintenance and safe disposal. The standards set out in this policy should be
incorporated into all subcontracts for the provision of services by other organisations.
1.7 Although not directly applicable to independent contractors and their staff, the standards
set out in this policy should be regarded as good practice for these services. Services
provided for users of the Trust by other NHS Trusts should follow their own Trust’s
policy relating to medical devices. Integrated services providing social services
equipment should follow social services policies in managing this equipment.
1.8 The principles, policy and procedures relating to the management of medical devices
is over seen by the Physical Health & Nutrition Group; with a report to the Clinical
Quality and Risk Committee on a six-monthly basis.
2. POLICY STATEMENT
2.1 The Trust has an obligation to protect service users, staff and visitors who enter their
premises and is committed to ensure that the regulations/guidance informing this policy
are fully implemented.
Page 4 of 302.2 The Trust also expects staff members to uphold the Trust Values while carrying out their
responsibilities to ensure compliance with the policy.
2.3 The Trust is committed to maintaining a high standard of quality and patient safety in
delivering its services and is steadfast in implementing the guidance set out by the
Medicines and Healthcare Products Regulatory Agency (MHRA) through the policy’s
aims and objectives.
3. SCOPE
3.1 This policy applies to Trust staff and any staff providing services under contract in both
hospital and community services who are involved in any aspect of medical devices use
and management. It applies to medical devices which are used in In-Patient services, in
the community and in patients’ own homes.
3.2 Objectives
• To ensure that all the Trust’s medical devices are managed in a way that maximises
safety, performance, efficiency, value, correct use and minimises risk.
• To recognise the possible risks to service users, staff and the Trust, of the failure to
meet suitable standards of safety and performance in the application and use of
medical devices.
• To ensure all staff are competent in the use of medical devices that they are
reasonably expected to use in their clinical area and operated in accordance with the
manufacturer’s instruction by users and professionals who have obtained and
maintained the correct level of knowledge and competency necessary. The Trust will
support the staff to fulfil the aims of this policy by providing the necessary resources,
training and IT systems.
• To ensure correct processes are followed for decommissioning and disposed at the
end of the devices useful life and decontaminated in accordance with the Infection
Control Guidance – Cleaning and Decontamination.
3.3 Definitions
• Medical devices can be defined as all products except medicines. They are used in
healthcare for screening, diagnosis, prevention and monitoring of treatment. This
includes the alleviation, or compensation for an injury or handicap, the investigation,
replacement or modification of the anatomy or of a physiological process and the
control of conception.
Under the amended European Commission Directive 2007 the term Medical Device
now includes software products, and not only software required for the normal
functioning of a device.
For examples of medical devices please see Appendix 1
• National Health Service Resolutions (NHSR) Has a statutory duty to manage and
raise the standards of risk management throughout the NHS
Page 5 of 30• Medicines and Healthcare Products Regulatory Agency (MHRA) is the agency
charged with protecting and promoting public health and patient’s safety in relation
to medical devices and the use of medicines
• Reusable equipment is equipment designed to be used more than once,
appropriately decontaminated between patient usage.
• Single Patient Use - All items marked by the manufacturer as single patient use
must only be used by a single named patient. All the manufacturers‟ usage
guidelines must be adhered to.
• Decontamination is a combination of processes, which removes or destroys
contamination and thereby prevents microorganisms or other contaminants reaching
a susceptible site in enough quantities to initiate infection or any other harmful
response. This is achieved by cleaning, disinfection and/ or sterilisation.
• MDA - Medical Device Alerts.
• Competence is a specific range of skills, knowledge or ability at a enough level to
be able to perform effectively in an appropriate setting.
• Avensys is the contracted company that provide C&I with medical physics services,
this includes, but is not exclusive to:
o Repairs
o Assessment Testing
o Maintenance
4. DUTIES
4.1 The Chief Executive has ultimate responsibility for ensuring that mechanisms are in
place for the overall implementation, monitoring and revision of policy.
4.2 The Head of Governance and Quality Assurance, via the Clinical and Corporate
Policy Manager, is responsible for ensuring:
• In conjunction with the Policy Lead identifies resource implications to facilitate
implementation and compliance
• Training and monitoring systems are in place
• Regular review of the policy takes place
4.3 Divisional Directors are responsible for implementation of the policy within their own
spheres of management and must ensure that:
• All new and existing staff have access to and are informed of the policy
• Ensure that local written procedures support and comply with the policy
• Ensure the policy is reviewed regularly
• Staff training needs are identified and met to enable implementation of the policy
4.4 The Director of Nursing has Board level responsibility for the use of medical devices.
The Director is responsible for ensuring that the Trust has safe systems for managing
Page 6 of 30medical devices and that the Board can fulfil its governance role in relation to their use.
4.5 The Operational Directors through their service managers ensure that those services
directly managed by the Trust adhere to the standards set out in Section 6 of this policy.
Additionally, they ensure that these standards are incorporated in subcontracts for the
provision of services by other organisations.
4.6 Occupational Therapists maintain an asset list for OT equipment available for use in
the in-patient setting. Maintenance and decontamination of equipment is aligned to this
policy and the infection control policy. Initial training is required by OTs to assess and
prescribe specific equipment e.g. bath boards, raised toilet seats etc. This is achieved
by attending a one day commissioned Occupational Therapy Aids and Equipment
Course. Refresher training is undertaken as minimum every three years. Refer to OT
Equipment Guidelines
4.7 Ward/Team Managers are aware of their responsibilities for procedures set out in
Section 6. These may be delegated under a locally agreed and signed policy. Overall
responsibility, however, remains with the manager of the ward or clinical department.
4.8 The Procurement Department is responsible for ordering stock and non-stock medical
devices as requested by the ward/team managers. The department will where
necessary send out pre-purchase questionnaires to manufacturers, seek approval from
medical physics, arrange delivery and where appropriate acceptance checking by
Medical Physics.
4.9 Consultant Nurse Physical Health lead on Medical Devices and Resuscitation is the
nominated Trust Medical Devices Safety Officer and is responsible for disseminating
alerts, advice and recommendations of the Medical and Healthcare Products Regulatory
Agency (MHRA). In addition, all medical device failures must be reported by Trust staff
on Datix as an incident. The Medical Devices and Resuscitation Lead is part of the
Clinical Governance Team managed within the Nursing Directorate and has the
responsibility for the development, maintenance, review and ratification of this document
lies with the Consultant Nurse Physical Health.
4.10 Estates and Facilities are responsible for undertaking annual Portable Appliance
Testing (PAT) with the exception of medical and laboratory electrical equipment.
4.11 The Clinical Engineering and Medical Physics Departments (is contracted by C&I
to Avensys) are responsible for the management, maintenance (including repairs and
destruction), procurement advice, regulatory compliance and standardisation in
accordance with the relevant company, national and international guidance.
4.12 The Physical Health and Nutrition Group are responsible for the following areas and
report any concerns to the Health, Safety and Fire Committee.
• Improve communication about medical devices within the organisation
• Ensure involvement of clinicians, technical staff and users in relation to any proposed
changes, including large scale purchasing relating to devices, where appropriate
• Define persons responsible for device management tasks, training and safe device
operation
• Define and review the device management policy
Page 7 of 30• Review incidents including governance issues relating to medical device
management
4.13 All Trust staff:
• Are familiar with the content of the relevant policy and follow its requirements
• Work within, and do not exceed, their own sphere of competence
• Fully implement this policy and bring to the immediate attention of Managers any
issues affecting the effective implementation of this policy.
• Deliver personalised care using medical devices in a way that has regard to the
dignity, comfort and safety of patients and which promotes their independence
and well-being.
• Use best interest provisions where required.
• Take account of the training needs of patients/carers regarding any equipment
the patient/carer is given to use.
• Report incidents and near misses involving medical devices via DATIX electronic
incident reporting system.
• Address any concerns in a timely manner where they identify problems around the
safety or suitability of equipment in a patients’ own home.
• Use medical devices safely and in the prescribed manner including ensuring that any
safety checks required by manufacturers‟ instructions or procedures/guidance are
carried out prior to use of medical devices including safe decontamination.
• Individual staff members must ensure they have received sufficient training i.e. verbal
and/or written instructions and hence are competent to use a medical device before
attempting to operate it. If there is any doubt, the member of staff should consult their
Manager and the manufacturers‟ instructions.
• All prescribing decisions involving medical devices will be made by staff with
appropriate professional qualifications and suitable experience.
• Preserve the Trust’s assets and keep unnecessary expenditure to a minimum.
• Every member of staff must have ownership and responsibility for minimising the
impact of risk.
4.14 Independent contractors:
All independent contractors are wholly responsible for the management of risks within
their practice. To support Independent Contractors in satisfying this duty the Trust
recommends full compliance with this policy. The provision of directly managed Trust
services within an Independent Contractor’s practice may be dependent on full
compliance with all the Trust’s Medical Devices Policy, governance policies and
procedures. Failure to provide evidence of compliance may result in the withdrawal of
direct Trust services.
4.15 The Clinical Governance and Risk Committee
4.16.1 The Clinical Governance and Risk Committee will be notified when this policy has
been approved by the Physical Health and Nutrition Group and be made aware of
any amendments.
5. TRAINING
Training of medical devices should be completed locally at team level in the
form of a competence assessment. All team managers are required to keep a
record of staff competencies. See “Medical Device Competency Training
History” (Appendix 7) as evidence of the competencies being completed.
Page 8 of 305.1 Training is an essential element in ensuring the medical device is used, maintained and
managed correctly. The Trust has a responsibility to provide, by whatever means most
appropriate, any necessary training relating to the management of medical devices.
5.2 The Trust will ensure that staff have access to appropriate levels of training.
5.3 Managers are responsible to maintain, promote and develop skills that ensure the safe
use of medical devices. It is important that staff work within their ‘Scope of Practice’.
Staff should only use, maintain or manage equipment that they can demonstrate
competency in through specific training or through professional knowledge and skills.
5.4 Staff are responsible for ensuring they access training appropriate to their role in
providing safe and quality care.
5.5 Training on all medical devices must include appreciation of corresponding readings,
values and device indicators to inform safe and quality care and interventions.
5.6 Managers must ensure the provision of supervision for all staff at appropriate levels for
assessment of practical skills using medical devices.
5.7 Where staff are not employed by the Trust but use, maintain or manage the equipment,
some confirmation of competency should be sought by Service Level Agreement (SLA).
5.8 Competency assessments will be kept locally to form part of supervision and the
appraisal induction / process and will include:
• Medical Device
• Date training was received
• Training delivered by
5.9 Levels of training are identified as part of the competencies.
6. MEDICAL DEVICES MANAGEMENT AND PROCEEDURES
6.1 Procurement and Purchasing
6.1.1 The Trust supports the identification and standardisation of medical devices wherever
practicable but is fully committed to ensuring the needs of the individual/clinical areas
are considered.
6.1.2 All medical devices that have been through the Pre-Purchase Questionnaire (PPQ)
(Appendix 2) process and approved by the Medical Devices Lead will be added to
the standardised medical devices list. This is a fluid list of devices that will change
ona regular basis; this is to accommodate for devices going out of production or
unavailability from suppliers, for the most up to date list of standardised medical
devices contact medical.devices@candi.nhs.uk.
Page 9 of 306.1.3 All medical devices must be purchased via the Agresso Catalogue or via the CANDI
Procurement system at Candi.Procurement@nelft.nhs.uk . This allows the
procurement department to identify any medical devices that have been purchased
requiring assessment testing, and then direct them to the contracted medical physical
department (Avensys).
For the pre-procurement of non standard Medical Devices please see Appendix 2
For the procurement of standard Medical Devices please see Appendix 3
6.2 Acceptance of Equipment
6.2.1 The process for accepting medical devices into a clinical environment should only
be carried out by designated Trust staff or people identified and approved by
Matrons /Team Managers. Details of how to complete the process is listed in
Section 6.3.
6.2.2 Equipment MUST not be used until the acceptance process is completed
satisfactorily. Where possible, appropriate documentation will be made available to
Matrons/Managers via the Medical Devices email Medical.Devices@Candi.nhs.uk
6.2.3 Avensys Medical Physics will complete all acceptance checks and records will be
kept by the medical devices’ administrator. All new items will be added to the
Avensys database. You can request a list of your equipment via
Medical.Devices@Candi.nhs.uk
6.3 Procedure for the Receipt of a new Medical Device
6.3.1 Managers/delegated member of staff will adhere to the following procedure when
taking receipt of new medical devices: -
i) Check that the correct product, complete with operating manuals and
maintenance instructions has been supplied.
ii) Complete and retain the delivery checklist.
iii) Ensure that product items have been delivered in good condition and in
working order.
iv) Record the details of the device (product no., serial no., etc.).
v) Comply with safety legislation
vi) A written decontamination procedure is made available and stored with
the records for each piece of equipment.
vii) Determine the correct training requirements for the use and maintenance
of each piece of equipment and retain evidence of all training together
with the Medical Devices lead.
6.4 Pre-Purchase Questionnaire (PPQ)
6.4.1 All medical devices not previously used or on the pre-approved items list in the Trust
must be presented to the Medical Devices lead prior to purchase, this will be
reviewed before being purchased.
Page 10 of 306.4.2 All devices that have been approved will be added the standardised equipment list.
6.5 Assessment Testing
6.5.1 A medical device prior to its first use in a clinical area is required to be tested by the
Medical Physics Department. This does not include all devices and in most cases
refers to electrical medical devices (e.g. Pulse Oximeter), or medical devices that
require a moving mechanism to function (e.g. wheelchairs).
6.5.2 The Procurement Department will ensure that all devices that require assessment
testing will be sent to the medical physics department (Avensys) directly from the
supplier. Once testing has been completed the device/s will be forwarded to a
nominated member of staff.
6.5.3 The standardised equipment list (Appendix 1) Identifies devices requiring assessment
testing, if a device arrives in your service and does not display the assessment tested
sticker from Avensys, you must contact the Medical Devices lead for advice via
Medical.Devices@Candi.nhs.uk
6.6 Planned Preventative Maintenance (PPM) and Electrical Testing
6.6.1 Medical devices must be tested on an annual basis in order to assure functionality
and calibration for safety.
6.6.2 A member of your team identified by the manager/matron will receive notification via
Medical.Devices@Candi.nhs.uk of equipment which is due for service, no less than
one week before it is due. It is the responsibility of the team manager or delegated
member of staff to ensure that all equipment and associated parts for servicing is
made available for the attending engineer. Equipment not presented in full will NOT
be tested this may impede patient care and/or incur unnecessary additional costs.
6.6.3 A concise report will be presented to the area and to the Physical Health and Nutrition
Group on a quarterly basis.
6.7 Repairs and Process
6.7.1 If a medical device is not functioning correctly you should contact the Medical Devices
lead immediately via Medical.Devices@Candi.nhs.uk. Advise will be offered to the
service as to whether the device will be repaired or if it is more economically viable to
replace the device.
6.7.2 If a device is going to be repaired the medical physics department will send an
engineer as soon as possible to repair the device. Depending on the urgency,this will
be done either within 24 – 48 hours or 3 - 7 days.
6.7.3 The first visit by the engineer is to diagnose and potentially repair the device. If
replacement parts are required, the engineer will make a second visit once they
have obtained the parts and complete the repair.
To request an engineer visit please see Appendix 4
6.8 Decontamination and Destruction
Page 11 of 306.8.1 If a device is considered beyond economic repair, then it must be labelled as
cleaned and ready for destruction. Inform the Medical Devices Lead via
Medical.Devices@Candi.nhs.uk that disposal is required.
i) Medical devices no longer required will be disposed of in a safe manner, in
compliance with required legislation.
ii) Disposal of redundant medical devices will be by, transfer of ownership,
decommissioning or disposal in line with the Trust policy for waste disposal.
iii) In cases of transfer of ownership - decontamination certificates, maintenance records
and operating instructions, will be transferred with the device at the time of transfer.
iv) When devices are decommissioned - decontamination certificates, maintenance
records and operating instructions will be retained within departments.
v) Advice and guidance to be followed as per Trusts Waste Management Policy.
6.9 Single Use Devices
6.9.1 All single use devices must only be used once regardless if it is the same patient; they
must be disposed of in line with the Infection Control Policy.
6.9.2 Some medical devices have single use components (e.g. Glucometers) it is important
to know what components are for single use and what part of the medical device is for
repeated use.
6.10 Cleaning and Medical Devices Audit
6.10.1 All medical devices must be cleaned in line with the infection control policy, this is
predominately after every use, it should also be additionally cleaned once a week
and checked that it is in good working order.
6.10.2 The weekly cleaning and checking of medical devices should be documented using
the Meridian Medical Devices Audit.
6.11 Medical Devices Asset Register / Database
6.11.1 All medical devices that require PPM will now be logged on the Trusts Asset Register.
This is a third party database that is held by the medical physics department and you
can request a report via Medical.Devices@Candi.nhs.uk
6.11.2 All service managers will have access to the system where they can view the assets
that are currently registered under their service. Please request access via
Medical.Devices@Candi.nhs.uk
6.11.3 The asset register will be updated on a monthly basis by the medical physics
department for the following reasons:
Purchase of devices that have been assessment tested
Repairs of devices
Decommissioning and destruction of devices
Page 12 of 306.11.4 Service managers are responsible for ensuring that their asset register is correct and
contacts the medical physics department if the status of the devices has changed
(devices added / removed).
6.12 Competence
6.12.1 All staff are expected to be competent in the medical devices they use for practice in
clinical areas, this will vary based on roles and service areas.
6.12.2 Service managers/matrons are required to provide assurance staff are safe to use
medical devices appropriate for care in clinical areas. This can be achieved by using
the medical devices competency tool.
6.13 Incident reporting
6.13.1 Any failure or adverse incidents of medical devices should be reported via the Datix
reporting system in line with the Trusts ‘Management of Serious Incidents
Policy’ found here
6.13.2 The Trusts Medical Devices lead will investigate all Datix related to medical device
incidents and if necessary report them to the MHRA using the yellow care system on
the following web address: https://yellowcard.mhra.gov.uk/
6.14 Medical Device Alerts
6.14.1 The process by which the Trust deals with Medical Device Alerts is outlined in the
‘Central Alert System (CAS) Policy’ found here
7. REVIEW AND MONITORING ARRANGEMENTS
7.1 The policy will be reviewed every 2 years in line with the Trusts Policy review guidelines
to ensure that it is contemporaneous to modern mental health practice and research. All
policies are subject to earlier review if significant changes in legislation or national best
practice indicate.
Page 13 of 308. PROCESS FOR MONITORING AND COMPLIANANCE
Elements to be Lead Reporting Frequency How Trust will monitor Reporting and Implementation of
monitored compliance Monitoring Lessons Learnt
These elements are to e.g. Audit, checklist, Which committee or How will changes be
be linked to the purpose dashboard group will be responsible implemented and
/ objectives of the for scutinising reports lessons learnt / shared?
document and monitoring outcomes
Reported to the Trust
by the Medical Physics Divisional Directors
Consultant Nurse
All medical devices that Department Physical Health and informed of any
Physical Health
require annual PPM 6 Monthly (contracted service Nutrition Group changes/action
(Medical Devices
Avensys) plans and
Lead)
cascaded down.
Divisional Directors
Medical Devices Reported to the Trust informed of any
Infection Control Infection Control
Cleaning Audit 3 Monthly by the Infection changes/action plans
Lead Group
Control lead and cascaded down.
Divisional Directors
Monitored by Heads of Reported to Physical
Medical Devices Matrons /Service informed of any
3 Monthly Nursing/Service Health & Nutrition
Competencies Managers changes/action plans
Managers Group and cascaded down
Register of Medical Matrons/Service 3 Monthly Divisional Directors
Monitored by Heads of Reported to Physical
Devices assets Managers informed of any
Nursing/Service Health & Nutrition
changes/action plans
Managers Group and cascaded down
Page 14 of 309. DISSEMINATION
9.1 The issue of this policy will be communicated to all staff via the Communications Digest.
Local managers are responsible for implementing this policy within their own teams.
9.2 This policy will be available to all staff via the Intranet.
9.3 The previous version will be removed from the Intranet and Trust website and archived.
Microsoft Word and pdf. copies of the current and the previous version of this policy are
available via the Governance Team. Any printed copies of the previous version should
be destroyed and if a hard copy is required, it should be replaced with this version.
10. REFERENCES
Care Quality Commission (2015) Guidance for Providers on Meeting the Regulations.
London http://www.cqc.org.uk/content/regulations-service-providers-and-managers
Department of Health (2009) Competencies for Recognising and Responding to Acutely ill
Patients in hospital London
Houses of Parliament (2002) Medical Device Regulations, No. 618 London
http://www.legislation.gov.uk/uksi/2002/618
Houses of Parliament (2008) Health and Social Care Act (Regulated Activities) Regulations
2014 (Part 3), No: 2936. London. The Health and Social Care Act 2008 (Regulated
Activities) Regulations 2014
Medical Device and Equipment Management for Hospital and Community-based
Organisations www.mhra.gov.uk/
MDA DB2000 (02) - Medical Device Agency Device Bulletin2000 (02) - medical device and
equipment: repair and maintenance provision. www.mhra.gov.uk/
Medical Devices Agency (2002) Devices in Practice, DOH London www.mhra.gov.uk/
MDA DB2000 (04) - Medical Device Agency Device Bulletin2000 (04)-single-use Medical
Devices: implications and consequences of reuse. www.mhra.gov.uk/
MDA DB2000 (04) - Supplement 2. Guidance on the sale, transfer of, ownership and
disposal of used medical devices. www.mhra.gov.uk/
MDA DB 9801- Medical Device Agency Device Bulletin 9801-Medical Device and
equipment management for hospital and community-based organisations www.mhra.gov.uk/
Medical Devices Agency (2002) Devices in Practice, DOH London www.mhra.gov.uk/
Medicines and Healthcare Regulatory Agency Annual Report 2004. www.mhra.gov.uk/
Medicines and Healthcare Products Regulatory Agency (2015) Managing Medical Devices:
Guidance for healthcare and social services organisations. London.
https://www.gov.uk/government/publications/managing-medical-devices
Page 15 of 30National Institute of Clinical Excellence (2007) Acutely ill patients in hospital. Recognition of
and response to acute illness in adult hospitals London
http://www.nice.org.uk/guidance/CG50
Nursing and Midwifery Council (2015) The Code: Professional standards of practice and
behaviour for nurses and midwives. London. http://www.nmc.org.uk/standards/code
Resuscitation Council (UK) (2014) Quality standards for cardiopulmonary resuscitation
practice and training London Available at: https://www.resus.org.uk/quality-
standards/mental-health-inpatient-care-quality-standards/
Royal Marsden Manual On-line 9th edition http://www.rmmonline.co.uk/
Medicines and Healthcare products Regulatory Agency 2005 (MHRA DB2005 (01) Reporting
Adverse Incidents and Disseminating Medical devices Alerts
Waste Electrical and Electronic Equipment (WEEE) Directive (2002/96/EC)
11. ASSOCIATED POLICIES
Physical HealthCare & Wellbeing
Management of Serious Incidents
Infection Control / Decontamination & Waste
Page 16 of 30Appendix 1 Medical Devices Standardised Items and Assets
Device Type Supplier Product Product Requires How To Order
Code Description Testing
Tympanic Procurement to FWH157 Tympanic Ear Email
Thermometer source Thermometer Pro 6000 Yes Procurement
With Small Cradle
Tympanic Device NHS Supply Chain FWH040 Single Use Probe Order throughNHS
Disposable Covers For Tympanic No Supply Chain via
Covers Device Models Pro ‘Agresso’
4000 & 6000
Infrared Procurement to FWH122 Non-Contact Infrared Email
Thermometer source Temporal Artery Yes Procurement
Thermometer
Thermfinder FS-700
Room/Fridge Denward TMM111C Dual Display Order Through
Thermometer Calibrated No Denward Through
Thermometer Agresso
Digital Portable Williams Medical M-420 Marsden 220kgC3 Yes Email
Scales Portable Scale Procurement
Digital Portable Marsden CC-420 Marsden CC-420 Carry Email
Scales Carry Case Case For Personal No Procurement
Scales
Test Strips NHS Supply Chain HHH1851 10 Parameter Urinalysis Order throughNHS
Regent Test Strips 5 No Supply Chain via
Tubs Of 100 ‘Agresso’
Blood Pressure Williams Medical W57228 Welch Allyn DuraShock Email
Sphygmomano meter DS54 Thumbscrew No Procurement
Aneroid
Sphygmomanometer
Blood Pressure Cuff - Williams Medical W6519 Welch Allyn Email
Sphygmomano Flexiport System No Procurement
meter Small 20-26cm
Blood Pressure Cuff - Williams Medical W6524 Welch Allyn Email
Sphygmomano Flexiport System No Procurement
meter Large 32-42cm
Blood Pressure K-Med KSP097 Omron M6 AC Auto Email
Monitor Upper Arm BP Monitor Yes Procurement
With Easy Cuff (22-
42cm)
Blood PressureCuff K-Med KSP005 Omron Small Cuff – No Email
(17-22 cm) Procurement
Blood Pressure Cuff K-Med KSP004.2 Omron Easy Cuff M-L No Email
Size for all BPMS (22- Procurement
42cm)
Blood Pressure Omron 907 Professional Yes Email
Monitor Medisave BP Monitor With 3 Cuff Procurement
Sizes
Blood Glucose Meter Williams Medical W710 Accu-Chek Performa Yes Email
Glucometer Procurement
Page 17 of 30Blood Glucose Meter Williams Medical D256 Accu-Check Safe-T-Pro Email
Lancets Plus Lancets – Pack of No Procurement
2000
Blood Glucose Williams Medical D215 Accu-Check Email
Meter Control Performa Control Solution No Procurement
Solution
Blood Glucose Meter Williams Medical D213 Accu-Chek Inform II& Email
Test Strips Performa Strips x50 No Procurement
Tape Measure NHS Supply VWR007 Tape Measure Paper No Order through NHS
Chain 150cm Long Metric And Supply Chain via
Imperial Latex Free ‘Agresso’
Disposable
Height Measure Williams Medical W7732 Seca 213 Height Measure No Email
Procurement
Pulse Oximeter Williams Medical W4372 Choice Med Finger Pulse Email
Oximeter With Carry Yes Procurement
Case
Stethoscope Williams Medical W3293B 3M Littmann Lightweight II Email
K S.E. Stethoscope No Procurement
Peak FlowMeter Williams Medical W10015 Micro Peak Peak Flow Email
Meter Yes Procurement
Peak Flow Mouth Williams Medical W33591 Carefusion Adult Email Procurement
Pieces Disposable Mouthpieces No
x 500
Portable ECG Health Care HCE203 Welch Allyn Cardio Email
Machine Equipment PerfectPC Based ECG Yes Procurement
System
ECG Machine Williams Medical W56793 Welch Allyn CP 150 ECG Yes Email
Machine with Procurement
Interpretation
ECG MachineTrolley Williams Medical W56800 Trolley For CP 150 ECG No Email
Machine Procurement
ECG Trolley Arm Williams Medical W56801 Cable Arm And Tray No Email
and Tray For CP150 Trolley Procurement
ECG Paper Williams Medical ECG679 Welch Allyn ECG No Email
1 Paper Pack 5 x 200 Procurement
Sheets
ECG Electrodes Tabs NHS Supply FDK129 ECG Electrodes No Order through
Chain Accessories Universal NHS Supply
Snap Clip Adaptors
For Chain via
Tab Electrodes 3-4mm ‘Agresso’
ECG Electrodes NHS Supply Chain FDK536 ECG Electrodes No Order through
Accessories Micropore NHS Supply
ECG cablesecuring
system for fixation of Chain via
electrode lead wires on ‘Agresso’
patients
Medical Fridge 15Litre Glen Dimplex PSR151 15 Litre Under Counter Yes Email Procurement
UK Lec Medical Fridge
Medical Fridge45 Glen Dimplex PE190C 45 Litre Under Yes Email
Litre Counter LEC Procurement
Medical
Fridge
Medical Fridge82 Glen Dimplex PE207C 82 Litre Under Counter Yes Email Procurement
Litre LEC Medical Fridge
Hypodermic NHS Supply FWD048 Safety Hypodermic No Order through
Needle3ml Chain Needle& Syringe 21G NHS Supply
Green 38mm (1.5 inch)
Chain via Agresso
Page 18 of 30With 3ml Concentric
Syringe Sterile
Hypodermic NHS Supply Chain FWD047 Safety Hypodermic No Order Through
Needle 3ml Needle & Syringe 23G NHS Supply
Blue x 25.4mm(1 inch) Chain Through
With 3ml Concentric Agresso
Syringe Sterile
Hypodermic NHS Supply Chain FWD049 Safety Hypodermic No Order Through
Needle 5ml Needle & Syringe 21G NHS Supply
Green x 38mm (1.5 Chain Through
inch) With 5ml Agresso
Concentric Syringe
Sterile
Hypodermic NHS Supply Chain FWD050 Safety Hypodermic No Order Through
Needle 10ml Needle & Syringe 21G NHS Supply
Green x 38mm (1.5 Chain Through
inch) With 10ml Agresso
Concentric Syringe
Sterile
Insulin Needle 1ml NHS Supply Chain FWD044 Safety Insulin Needle& No Order Through
Syringe 29G Red x NHS Supply
12.7mm (0.5 inch) With Chain Through
1ml Concentric Syringe Agresso
Sterile U100
Insulin Pen NHS Supply Chain FTR1834 Safety Insulin Pen Needle No Order Through
Needle 29G x 8mm ForPre Filled NHS Supply
Reusable Pen Injectors Chain Through
Autoprotect Agresso
Nebuliser Williams Medical W559 Medix AC2000 Yes Email
Nebuliser Procurement
Nebuliser Outlet Williams Medical W5012 Medix AC2000 No Email
Filter Nebuliser Outlet Procurement
Filter
Nebuliser Inlet Filter Williams Medical W5013 Medix AC2000 No Email
Nebuliser Inlet Filter Procurement
Ophthalmoscope Williams Medical W57540 Keeler Standard Yes Email
Ophthalmoscope Procurement
Otoscope Williams Medical W57534 Keeler Standard Yes Email
Otoscope Procurement
COPD Screening 40200 Vitalograph COPD-6 Yes Email
Device Medisave COPD Screening Procurement
Device
COPD Screening 20242 Vitalograph SafeTway No Email
Device Mouth Pieces Medisave One- Way Valve Procurement
Mouthpieces x 200
Alcohol HHH375 AL6000 Digital Yes – To be Order Through
Breathalyser NHS Supply Chain Alcohol Breathalyser assessed on NHS Supply
site Chain Through
Agresso
Alcohol HHH378 100 x AL6000/AL7000 No Order Through
Breathalyser NHS Supply Chain Replacement NHS Supply
Mouth Pieces Mouthpieces Chain Through
Agresso
Page 19 of 30Appendix 2 Medical Devices PPQ 2018
The PAQ is endorsed by NHS Business Services Authority (NHSBSA), NHS Supply Chain (NHSSC), Health Care Supply Association (HCSA),
Association of British Healthcare Industries (ABHI), and Association of Healthcare Technology Providers for Imaging, Radiotherapy & Care (AXREM).
PRE-PURCHASE QUESTIONNAIRE (PPQ Form)
The purpose of this Form is to provide information about a Medical Device(s) which we shall then use to inform pre- purchase planning and approval of proposals
to procure such Medical Device(s) – whether by purchase, exchange, rental, lease, loan, donation or other agreement. (Note: The term ‘Device’ as used here includes
equipment, systems and accessories. In the case of systems the requirements below apply both to the individual constituent Devices and to the configured system as
a whole. Accessories within the scope of this Form need to be identified under 1(d).)
Please ensure that all relevant sections have been completed and that all supplementary information requested has been provided, (shaded boxes indicate that
supplementary information is required); questions for which the only available response is ‘YES’ indicate that this response is a requirement, if the question applies.
PART I - PRODUCT INFORMATION
to be completed by the device Manufacturer or Authorised Representative
PRODUCT DETAILS:
UDI Device Identifier: (GS1-GTIN)
Device Description:
(GMDN Code / Group if available)
Make:
Type:
Model:
Manufacturer:
Supplier:
Authorised Representative:
1 a) When was this Model first placed upon the market ?
b) Is this Model still in production ? NO YES if NO, when did production cease ?
c) Does this Form cover a range of Model variants ? NO YES if YES, list of Models attached to this Form ? YES
d) Does this Form cover Accessories ? NO YES if YES, list of Accessories attached to this Form ? YES
e) Has a Device brochure and specification been attached to this Form ? YES
REGULATORY COMPLIANCE:
2 a) Is the Device CE-marked, for its intended use, to all currently applicable EC Directives ? NO YES
b) - if YES, have the EC Declaration/s of Conformity been attached to this Form ? YES
c) Which EC Directive/s apply ?
Medical Devices Directive Classification? (1, 1-m, 1-s / IIa / IIb / III)
Active Implantable Devices Directive
In-Vitro Diagnostics Medical Device Directive Category? (general / self-test / List-A / List-B)
Other/s
- which Directive/s?
c) Has this included Notified Body conformity assessment ? NO YES
- Notified Body identification number & name:
d) Is the manufacturer currently certified to any management / quality sys tem Standards ? NO YES
- which Standard/s ? (eg: EN-ISO-9001, 13485, 14001, etc.)
- Certification Body:
3 If not CE-marked, (or if ‘off-label’ use is proposed for a CE-marked Device), then -
a) Is this a Medical Device for ‘Clinical Investigation’ ? NO YES
- if YES, quote the MHRA ‘no objection’ reference
- if YES, has a copy of the MHRA’s notice of ‘no objection’ been attached to this Form ? YES
b) Is this an In-Vitro Diagnostic Medical Device for ‘Performance Evaluation’ ? NO YES
- if YES, has a copy of notification to MHRA been attached ? YES
c) Is this a ‘custom-made’ Medical Device ? NO YES
- if YES, name the prescribing Medical Practitioner:
d) - if NO to 2(a), and to 3(a) (b) and (c), then provide justification of the Device’s status (e.g.: MHRA-approved humanitarian grounds)-
Page 20 of 30Page 1 of 4
Page 21 of 30PRODUCT COMMITMENT:
4 a) To what date is manufacturer support for this Model guaranteed ?
- does this include availability of parts and supply of consumables / accessories ? YES
- does this include product support, as detailed below, (training, maintenance, repair, etc.) ? YES
b) What is the Device warranty period? Have warranty details been attached to this Form ? YES
c) What is the recommended working lifetime for this Device? (‘not applicable’ for disposable Devices)
d) Have details for end-of-life waste management of the Device been attached to this Form ? YES
e) Does the manufacturer / supplier have a robust system for notification of Device alerts / upgrades to a named hospital representative ? YES
PRODUCT SUPPORT:
5 a) Can an additional User Manual be provided (electronic format) ? YES
b) Can a Technical Manual be provided (electronic format) ? NO YES
c) Is identical loan equipment normally available in the event of equipment failure ? NO YES
(Any conditions or costs associated with 5(b) or 5(c) should be included in the response to 7(b))
Commissioning & Deployment
6 a) Has a protocol for post-delivery inspection and acceptance testing of Device function and safety been attached to this Form ? YES
b) Does the Device have particular installation requirements and / or require ancillary services or other prerequisite arrangements ? NO YES
- if YES, then have details of all installation requirements been attached to this Form ? YES
Technical Support
7 a) Is this a disposable non-serviceable device ? (- if YES, proceed to Section 8) YES
b) Does the manufacturer or an authorised servicing agent provide a maintenance / repair and technical support service ? NO YES
- if YES, then have details of all service contract options been detailed, fully costed and attached to this Form ? YES
- where is the servicing facility located ?
- are all servicing staff verifiably trained and competency assessed for the servicing tasks that they perform ? YES
- are qualification / competency records of servicing staff available upon request ? YES
c) Is the servicing organisation currently certified to any management system Standards ? NO YES
- which Standard/s ? (eg: EN-ISO-9001, 13485, 17025, etc.)
- Certification Body:
d) Do the contract alternatives offered in 7(b) include an option for in-house equipment servicing by hospital staff ? NO YES
- if YES, have details of the availability of spare / replacement parts to support equipment servicing been attached to this Form ? YES
- if YES, have details of information / test equipment / tooling / software required for equipment servicing been attached to this Form ? YES
Decontamination
8 a) What level of Device decontamination is required ? - (for multi-component systems identify all applicable levels)
none cleaning disinfection sterilisation
- if answer is not ‘none’, have validated decontamination instructions been attached to this Form? YES
- for sterilisable Devices, do these instructions meet the requirements of EN-ISO-17664 ? YES
b) Does the device require processing / reprocessing before / between uses ? NO YES
- if YES, have all decontamination process requirements for special equipment, tools and materials been detailed in attached information ? YES
- if YES, have any special post-processing Device storage requirements been detailed in the attached information ? YES
- is there a limit to the number of Device reprocessing cycles ? NO YES if YES, what is the limit ?
- are Devices uniquely identifiable ? NO YES state if ‘Single-Use’
- is this an implantable Device ? NO YES
Data Security
9 a) Does the Device store or transmit patient information that will require information governance measures ? NO YES
- if YES, then have details of information capture / encryption / storage / transmission / deletion been attached to this Form ? YES
b) Does the Device interface, by wired or wireless connection, with Information technology (IT) equipment or network systems ? NO YES
- if YES, then have details of Device IT software / hardware compatibility requirements been attached to this Form ? YES
- if YES, then have details of provisions made for Device IT cybersecurity been attached to this Form ? YES
Particular Requirements
10 a) Does the Device present particular hazards that require special safety management measures ? NO YES
(eg: ionising / non-ionising radiation; contamination / infection; hazardous materials; hazardous mechanical / electrical energy; etc.)
- identified hazards:
- if YES, then have details of the nature of identified hazards been attached to this Form ? YES
Page 2 of 4
Page 21 of 30b) Does the Device require particular performance quality assurance measures ? (eg: calibration, qualification, PoCT controls, etc.) NO YES
- QA measures:
- if YES, then have details of quality assurance requirements been attached to this Form ? YES
IMPLEMENTATION SUPPORT:
11 a) Is competency-based user training available from the manufacturer or an authorised provider ? NO YES
- if YES, have details of user training offered (amount / content / assessment / duration / location / cost / etc.) been attached ? YES
b) Is competency-based technical (equipment servicing) training available from the manufacturer or an authorised provider ? NO YES
- if YES, have details of technical training offered (amount / content / assessment / duration / location / cost / etc.) been attached ? YES
c) Is competency-based decontamination / reprocessing training available from the manufacturer or an authorised provider ? NO YES
- if YES, have details of decontamination training offered (amount / content / assessment / duration / location / cost / etc.) been attached ? YES
d) Are qualification / competency records of training providers available upon request ? YES
e) If other additional support facilities are available, (eg: helpdesk, literature, website resources, etc.), have details of these been attached ? YES
DECLARATION:
Please ensure that all necessary supplementary information, (as indicated by shaded boxes in the Form above) accompanies this Form.
1.c) List of all Model variants covered by this Form ATTACHED NOT APPLICABLE
1.d) List of all Accessories covered by this Form ATTACHED NOT APPLICABLE
1.e) Device brochure / specification ATTACHED
2.b) EC Declaration/s of Conformity ATTACHED
3.a) MHRA’s notice of ‘no objection’ for Medical Device ‘Clinical Investigation’ ATTACHED NOT APPLICABLE
3.b) Notification to MHRA for In-Vitro Diagnostic Medical Device ‘Performance Evaluation’ ATTACHED NOT APPLICABLE
4.b) Warranty details ATTACHED
4.d) Details for end-of-life waste management of the Device ATTACHED
6.a) Protocol for post-delivery Device inspection / acceptance testing ATTACHED
6.b) Details of installation requirements ATTACHED NOT APPLICABLE
7.b) Service support contract options for maintenance / repair ATTACHED NOT APPLICABLE
7.d) Availability of spare / replacement parts ATTACHED NOT APPLICABLE
Information / test equipment / tooling / software required for Device servicing ATTACHED NOT APPLICABLE
8.a) Validated decontamination instructions / protocols ATTACHED NOT APPLICABLE
8.b) Requirements for special reprocessing equipment, tools and materials ATTACHED NOT APPLICABLE
Details of special post-processing Device storage requirements ATTACHED NOT APPLICABLE
9.a) Details of patient information capture / encryption / storage / transmission / deletion ATTACHED NOT APPLICABLE
9.b) Details of Device IT software / hardware compatibility requirements ATTACHED NOT APPLICABLE
Details of provisions made for Device IT cybersecurity ATTACHED NOT APPLICABLE
10.a) Details of particular hazards that require special safety management ATTACHED NOT APPLICABLE
10.b) Details of particular performance quality assurance measures required ATTACHED NOT APPLICABLE
11.a) Details of user training offered ATTACHED
11.b) Details of technical training offered ATTACHED NOT APPLICABLE
11.c) Details of decontamination training offered ATTACHED NOT APPLICABLE
11.e) Details of any additional support facilities offered ATTACHED NOT APPLICABLE
We agree that the NHS organisation will be entitled to rely upon the contents of this Form and its attachments, and that subsequent non-compliance with the
statements contained herein will entitle the NHS organisation to seek redress.
Name:
Position:
Company:
Address:
Website:
Email: Telephone:
Signature: Date:
PAQ Form (Part-I) – Declaration Reference No.:
Page 3 of 4
Page 22 of 30PART II – TRANSACTION DETAILS
for completion by the device Supplier
(eg: Manufacturer, Authorised Representative or other)
Previous sections in PART I provided general product information; this PART II addendum provides details specific to particul ar transaction/s for
supply of the product:-
PRODUCT INFORMATION:
This statement is to be read in conjunction with product information provided in PAQ FORM (Part-I) Declaration Reference No.:
Dated:
TRANSACTIONAL:
14 a) On what basis will the product be supplied, (including Devices for clinical investigation / research) ?
purchase ? exchange ? rental / lease ? loan ? donation ?
b) For supply by loan or donation, other than Devices for clinical investigation / research -
Is the Supplier on the Department of Health & Social Care (DHSC) Master Indemnity Agreement (MIA) Register ? NO YES
(Note: unregistered Suppliers are advised to register for the MIA Overarching Agreement with the DHSC)
- if YES, has a Department of Health & Social Care (DHSC) MIA Call-Off Agreement Form been attached ? YES
DHSC MIA registration number:
- if NO, has an Indemnity Insurance Certificate (for local indemnity agreement with the customer) been attached ? YES
c) For supply by loan or donation of Devices for clinical investigation / research -
Has confirmation of Health Research Authority (HRA) approval, including indemnity arrangements, been attached ? YES
d) Is the particular item to be supplied a pre-used product ? NO YES
- if YES, has usage and full service history been attached to this Form ? YES
15 a) Are there any outstanding Field Safety Corrective Actions / Field Safety Notices relating to this product? NO YES
- if YES, are issued Notices / Alerts attached to this Form ? YES
Name:
Position:
Company:
Address:
Email: Telephone:
Signature: Date:
Page 4 of 4
Page 23 of 30Appendix 3 Procurement of Medical Devices
Do you know where to order your item from?
Yes
No
Complete the appropriate Please review our procurement
procurement request or email process which can be found
candi.procurement@candi.nhs. here
uk if not listed https://intranet.candi.nhs.uk/sit
es/default/files/2020-
08/The%20Procurement%20Pro
cess%20and%20Specifications
.pdf
Please ensure you
refer to 6.2 and 6.3 of
this policy when Review product needed in
Appendix 1 and order
accepting and appropriately, if not listed email
receipting new candi.procurement@candi.nhs.
equipment or devices uk
If you require further advice, contact the medical devices team via:
Page 24 of 30
Email: medical.devices@candi.nhs.ukYou can also read
