HSPOL26 MEDICAL DEVICES POLICY V6 by Provide Community

Medical Devices Management Policy & Procedures

Version: V6

Ratified by: Finance and Investment Committee (FIC)

Date ratified: 25/05/2022

Job Title of author:

Reviewed by Committee or Expert Group

Health, Safety, Fire and Security Manager

Property Health and Safety Steering Group

Equality Impact Assessed by: Health, Safety, Fire and Security Manager

1. Introduction

Provide is committed to ensuring that there are robust processes in place for effective device management for the whole life cycle of the device, from determining the justification of the need to purchase a device through to its ultimate disposal.

This policy has been developed to set out the essential key aspects of a systematic approach required to ensure that Provide services use safe medical devices and that Provide meets all its statutory legal requirements.

It is expected that employees of Provide will abide by the requirements of the following guidance and legislation affecting the management and use of medical devices:

• Health & Safety at Work etc. Act 1974

• Provision and Use of Work Equipment Regulations 1998 (PUWER)

• Electricity at Work Regulations 1998

• Control of Substances Hazardous to Health Regulations (2004)

• Management of Health & Safety Regulations 1999

• Managin Medical Devices 2015 – Devices in practice a guide for health and social care professionals.

• MHRA DB2006(04) – Single Use Devices – Implications and consequences of use

• MHRA DB2007(01) – Reporting adverese incidents and disseminating device alerts

• Managing Medical Devices 2015 – Management of medical devices prior to repair, service or investigation

• Care Quality Commission, Outcome 11- Safety, availability and suitability of equipment

• Health & Social Care Act (Section 20 – Regulation 16)

• Waste Electrical and Electronic Equipment (WEEE) Regulations 2013

• Lifting Operations and Lifting Equipment Regulations 1998

• Manual Handling (Operations) Regulation 1992

• Medical Devices Regulations 2002

• Pressure Systems and Transportable Gas Containers Regulations 1989

2. Purpose

The aim of this policy is to ensure that all medical devices in use within Provide are suitable for their intended purpose; staff are properly trained and competent in their use; devices are procured and selected in accordance with legislation and regulations, maintained in safe and reliable condition and they are recorded on a medical devices asset register at service level and a central database held by MEMS (Medical Equipment Management Services).

This policy will provide guidance to all staff regarding their roles and responsibilities in ensuring the safe use of medical devices, in order to safeguard the health and welfare of our patients / staff, the benefits are maximised and the risks minimised.

3. Definitions

Medical devices are used widely by Provide for diagnosis, monitoring and treatment. It is essential that new and reused devices meet relevant safety and quality standards, are suitable for purpose and represent value for money over their whole life cycle.

Devices in use must be maintained in a safe working condition and operated competently in accordance with required standards and procedures. Old devices must be replaced when worn out or obsolete.

This policy outlines a systematic framework for the training and training needs of all users of medical devices, and the procurement, deployment maintenance and repair, and subsequent disposal of medical devices within Provide.

The organisation expects all staff, including temporary staff working for Provide to adhere to the following principles before using any medical device:

• To been trained according to organisational standards competent in use of the device

• Know where the user manual or instructions are located

• Always visually inspect the equipment for signs of damage prior to use

• Be aware of the organisation’s incident reporting procedure

The policy also aims to promote the requirement for procedures, which will instil a safer, more efficient, and high quality management of all medical devices.

4. Duties

The following reporting structure shows lines of accountability throughout the organisation:

Group Chief Executive

The Group Chief Executive has the overall accountability for the management of medical devices.

CEO, Health and Chief Nurse and Chief Medical Officer Have overall responsibility for the management of medical devices within Provide.

Medical Devices Safety Officer (MDSO) In line with the Medicines and Healthcare products Regulatory Agency (MHRA) the organisation has an appointed Medical Device Safety Officer (MDSO) and has a medical device task and finish group in place.

The Health, Safety, Fire and Security Manager is the nominated Medical Devices Safety Officer for Provide. The key purpose of the role is to promote learning and safe use of medical devices across the organisation and provide expert clinical resource. The role will be report to the Safety & Quality Committee

Head of Quality and Safety

Head of Quality and Safety oversees all clinical and practice risks within Provide and will incorporate any issues relating to medical devices management into the bi-monthly report to the Quality & Safety Committee.

Head of Quality and Safety is the nominated MHRA / CAS officer and is responsible for dissemination and co-ordination of and maintaining the local inventory for all MHRA / CAS alerts and local action responses. The Head of Quality and Safety will report CAS status updates to the Quality and Safety Committee, detailing alerts received, alerts relevant to Provide, alerts sent out and responses.

Directors / Assistant Directors / Service Managers

All Directors, Assistant Directors and Service Managers are responsible for ensuring that their services have:

• All instructions for medical devices made available at point of use of that device

• All appropriate clinical policies and risk assessments associated with the use of medical devices in place within each ward / department / clinic and community team

• Actively participated in the dissemination of information and any relevant action of medical device alerts published by MRHA and in reporting adverse or potentially adverse incidents

• All medical devices are appropriately maintained, tested and properly stored

• All proper procurement processes as set out in this policy are adhered to

Annual updates of medical devices must be undertaken by services.

All Staff / Medical device users

A member of staff using a medical device is known as ‘the user’. The user is ultimately responsible for ensuring that:

• The device is safe to use within service date and that any deficits are reported promptly and where appropriate the medical device is taken out of use and quarantined until service / repair or replacement has been completed

• The user must have sufficient knowledge and training to operate the device safely

• All staff have a responsibility with regard to adverse incident reporting and should follow the incident reporting policy in respect of medical devices and report via ‘DATIX’

• They have complete and up-to-date training records in line with professional registration competency requirements

• If they don’t know how to use a piece of equipment, they ASK how to use it and become competent in its use

Under Health and Safety Regulations, staff must also take reasonable care for their own health and safety and for patients / staff / visitors who may be affected by their acts or omissions.

Medical Devices Group

The group is responsible for:

• Review and update of medical devices policy

• Identifying, developing and promoting activities that serve to minimise risk associated with the acquisition, use, decontamination and disposal of medical devices

• Reviewing MRHA alerts and other safety data to identify, prioritise and address medical device risk and minimise harm to patients

• Discussing complex medical device alerts and will propose and co-ordinate processes and system changes that will reduce the likelihood of occurrence of harm and never events resulting from medical device use (i.e. needle-free devices/safety devices

• Procurement and deployment of medical devices

5. Consultation and Communication

All staff shall comply with the Health and Safety at Work Act 1974 and the Provision and Use of Work Equipment Regulations 1999 (PUWER), which places a statutory requirement on employers and employees to ensure that they are trained to use any work based equipment.

6. Monitoring

Compliance with the medical devices policy and associated procedure will be monitored to ensure that the aims and objectives of this policy are met in accordance with CQC fundamental standard 11: Safety, availability and suitability of equipment:

Compliance with the medical devices policy and associated procedure will be monitored to ensure that the aims and objectives of this policy are met. The following mechanisms will be used.

• Annual Report from the Assistant Director of Estates to the Board

• Regular reports to the reports to the Quality & Safety Committee

• Regular reports (in accordance with the terms of the contract) to the organisation’s MDSO from external contactor (MEMS)

• It is the responsibility of MEMS to maintain effectively and ensure that reusable medical devices and/or equipment is properly maintained, repaired within agreed time frames in accordance with the contractual arrangements

• Incidents reported involving medical equipment will be reviewed by the Health, Safety, Fire and Security Manager

• Implementation of suitable training programmes

• In conjunction with MEMS, audits of locally held records for Medical Equipment Training of staff will be the responsibility of Assistant Directors

7. Training

All staff have a professional duty to ensure their own skills and training remains up to date, that they are confident / competent to use the equipment and seek assistance from colleagues if unsure how to use.

Medical device training shall provide the user of the device with the skills to utilise it safely within their clinical setting, encompassing the practical knowledge and the theory of its functions.

It is the responsibility of the Ward / Service manager to ensure that their area has an up to date medical devices asset register of all equipment and devices used within that area. This training should be pertinent to both single-use and re-usable medical devices.

This inventory should be reviewed annually to ensure it is up to date.

Staff shall be given full instruction, written, verbal and demonstration of the equipment, with time to practice and demonstrate understanding and practical application. Staff should sign that they have read the manufacturer’s instructions, received training, are able to comply with the safe use of the equipment / device and have self-assessed themselves as competent to use the medical device by signing a self-competency assessment form (Appendix 1).

For existing staff, (employed prior to June 2018) completed self-competency assessment forms shall be kept in the personal professional development folder of the staff members as evidence of competency; this must be presented when requested.

For new clinical staff (employed post June 2018) competency will be ascertain by Service Manager and form part of the local induction.

Only staff whose training and competence has been established shall use any medical device. No member of staff may operate any piece of equipment unless they and their immediate managers are confident that they are completely competent in its use. This applies to temporary (bank, agency and locum) staff, as well as permanent members of staff.

Update training shall be planned as necessary to maintain a high standard of performance. This is especially important for staff who use a device infrequently, or

have a break in the use of a device (e.g. long term sickness or maternity leave). The frequency of updates of training varies between equipment type and frequency of use by the operator.

It is the service manager’s responsibility to monitor any competency lapse of their staff annually and shall do so at appraisal and ensure that any member of staff who is not competent is provided with further training as defined in their personal development plan.

All areas where medical devices are used shall have a readily accessible (electronic or paper) information available containing manuals and instruction sheets for medical devices used in that area.

The manager will ensure that all staff in the Ward or department have received training in the requirements of incident reporting as it relates to medical devices.

It is the organisation’s intention to review the training for medical devices as part of the Medical Device Project to strengthen the training, develop a trust wide training needs analysis and develop a medical devices standard operating procedure (SOP).

The level and frequency of training required can be determined through risk assessment.

The table in Appendix 2 will assist managers and their staff in determining the training required.

Where high risk equipment is to be used (risk defined by Service Manager) specific training will be provided and competency assured / documented prior to use.

Training for Patient / Carer

Where a medical device is loaned to a patient or carer, staff shall ensure that this end user has all the training necessary to ensure a level of safety and operation similar to that which would be expected with service staff in accordance with the Loan of Medical Device standard operating procedure (SOP) – Appendix 3. Staff shall ensure that any instructions sent with the medical device are adequate for the knowledge level of the end user and that user and/or carers have signed a receipt confirming their understanding. This record shall be documented in the patient’s records.

8. Selection of Medical Devices (Procurement)

Identification of Need

All medical devices and equipment should be chosen in accordance with the Medicines and Healthcare Products Regulatory Agency and the National Audit Office recommendations. When considering purchasing medical devices the following should be taken into account in the justifying the need for the device:

• Clinical need

• Risk management

• Equipment replacement

• Changes in design, technology, or clinical practice

• Patient specific needs.

Funding

Prior to purchase resources (capital or service budget) must be sufficient with adequate provision for installation, user training, on-going maintenance, consumables and final disposal. In addition service manuals must be purchased with re-usable medical devices.

Budget holders must confirm with their AD / Service Manager / Finance Business Partners that any on-going costs such as consumables and maintenance are affordable and within budget.

The case for standardisation and variety reduction

Standardisation on medical devices MUST be considered in order to achieve best value for money, to minimise the amount of training as staff move between areas of work and, ultimately, to reduce clinical risk.

The Procurement Team must be involved, at an early stage, in any decision to purchase medical devices.

Procurement and Selection of Medical Devices (Pre purchase)

Prior to purchasing, all new medical devices must be evaluated for technical and clinical performance as well as their economic suitability. Before an order is placed, prospective suppliers of medical devices to the organisation may be required to demonstrate that their equipment is safe and suitable for its intended purpose and that it can be cleaned and decontaminated adequately.

Information on compliance with relevant technical standards, EEC directives and decontamination methods must be requested. This process will also ensure that the supplier is able to provide continued technical support following purchase. Medical equipment supplied to the organisation must meet the essential requirements of the Medical Devices Directive (93/42/EEC).

All medical devices are legally required to comply with EU directives and the relevant UK legislation for performance and safety.

MEMS MUST APPROVE ALL MEDICAL DEVICES, agree to maintain the medical device during its lifecycle and include it on the organisation’s asset register.

If a medical device requires software or access to the Provide network, IT must be contacted to give advice to ensure the medical device is compatible with the IT systems.

The selection of any medical device that involves drug delivery must be undertaken in conjunction with the organisation’s Medicines Management Team.

Selection

Best practice suggests that all medical devices should be standardised, and chosen from a list of devices approved by the organisation. This would ensure interchangeability, ease of staff training, availability of spare parts, and more cost effective contracts. It is the organisations intention to standardise medical devices purchased in the future and work is in progress to achieve this as part of the Medical Devices Group.

Until standardisation is achieved when a medical device is required, the reason and choice must be justified and account taken of all relevant issues (function, compatibility, cost and compliance with directives). Compatibility with existing medical devices and facilities should be achieved wherever possible. When ordering medical devices staff should discuss their selection for information on current standard models with the Procurement Team and from MEMS, if required.

Final selection of a medical device should be made in close consultation with those responsible for its use, taking into account relevant technical and financial information, Infection, prevention and control and value for money. This will include lifetime costs (e.g. training, maintenance and consumables) warranty provision and the availability of technical support and service manuals.

The purchaser may set other specific performance criteria with the supplier against which the medical device will be judged before it is accepted, for example, reusable devices must be capable of being decontaminated using available facilities. Only CE marked devices should be purchased. The CE (European Conformity) mark is a declaration by the manufacturer that the device meets the essential requirements of all relevant European Directives.

Some types of medical devices include standard computing devices or have a requirement for network connections or data storage. Proposals to buy suchequipment should be referred to the IT Department to ensure that these requirements can be met and that the equipment is compatible with existing IT equipment.

Medical Devices which may consume significant electrical power or require connection to other mains services such as water or medical gases, or require environmental control (e.g. air conditioning) must be referred to the Health, Safety, Fire and Security Manager and Estates Team.

Post Purchase

To comply with Managing Medical Devices 2015 responsible organisations must ensure that all medical devices are appropriately checked before being placed into clinical use.

All items of medical equipment entering the organisation (howsoever acquired –including loan equipment) shall undergo acceptance tests by MEMS in accordance with Managing Medical Devices 2015 before being put into use.

This acceptance test is designed to check the delivery against the order, confirm compliance with current legislation, ensure that equipment is functioning correctly, electrically and functionally safe, calibrated (as per manufacturers requirements) and recorded on the computerised equipment inventory.

Acceptance checks will be carried out by MEMS on all medical devices that are new to the organisation and medical device details will be entered in the equipment database (asset register). It is the responsibility of the first time user to ensure that acceptance checks have been carried out.

Service managers must ensure that, where equipment is installed by a third party (the manufacturer or supplier) in situ, it is appropriately acceptance tested by MEMS before being put into use. Service managers who allow the use of medical devices that have not been appropriately checked and calibrated (as per manufacturer’s requirements) may be made personally liable in the event of an accident involving that equipment

Users should consult MEMS in the first instance for guidance where electrically active medical devices are involved. All equipment should be delivered to the relevant clinical area but area MUST be quarantined until acceptance testing has been carried out by MEMS and NOT USED until an authorised work sheet has been issued by them.

New or Replacement of Medical Devices

Budget holders must justify the purchase or replacement of medical devices taking into account all relevant cost which will include items such as specialist installation, alteration to premises, training costs, running cost and annual maintenance costs. In incidents where it is not possible to purchase ESSENTIAL new or replacement equipment, due to funding issues, Managers should record this on the relevant risk register (See Risk Management Policy for further details).

9. Acceptance & Installation of Medical Devices

MEMS shall attach labels to all medical devices that have been through this process to indicate maintenance arrangements and the inventory/asset number.

Service Managers shall ensure that, where equipment is installed by a third party (the manufacturer or supplier) in situ, it is appropriately acceptance tested by MEMS before being put into use.

Checking and/or Modifying Instructions

All professional and patients must have access to manufacturer’s instructions and should sign a statement to the effect that they have received instructions on the safe use of devices or equipment. All devices coming into Provide, whether they are purchased, leased, rented, on loan or on trial, should be treated in the same way.

Storage

Inappropriate storage of items affects their subsequent safe use. Manufacturer’s information and instructions both on storage conditions and shelf life should be followed.

10.Decontamination

It is the responsibility of Provide to ensure that all medical devices do not carry a biological or chemical hazard. Provide has a duty to ensure that decontamination of any device is applied before re-use, submission to maintenance, repair or before being transported to another location. A suitable identification should indicate the state of decontamination.

Reference should be made to the Provide Infection Prevention and Control guidelines and the Decontamination of Medical Equipment policy.

Handling of Surgical Instruments on Loan from another Organisation

Instrumentation may be loaned to the organisation so that a particular procedure can be performed. Instruments may be loaned both from manufacturers and other trusts and then returned after use. This practice increases the risks associated with

decontamination and reprocessing of such devices because Provide staff may not be familiar with them. Decontaminate all loan instrumentation both before and after use in accordance with the manufacturer’s instructions.

Cleaning

All medical devices fall into specific categories on how to clean and disinfect that particular device. The cleaning agent will be dependent upon the category to which the device belongs. Manufacturer’s instructions or specialist advice should be sought, if in any doubt when cleaning or disinfecting devices the IPPOL9 - Decontamination of Medical Equipment Policy should be followed.

11.Maintenance, Service & Repair

Medical devices shall be maintained, serviced and repaired and / or calibrated following the manufacturers recommendations. Users should ensure that before using a device that it is full working condition. Medical devices shall be maintained, serviced and repaired in accordance with the Provide Maintenance, Service and Repair Standard Operating Procedure – Appendix 5.

In accordance with the requirements of the CQC fundamental standard 15: Premises and equipment the organisation is responsible for ensuring that medical devices are maintained and serviced. This will be undertaken by Provide’s appointed external contactor (MEMS) and will be performed in accordance with the agreed contract.

Servicing and maintenance arrangements for medical devices within the organisation are provided by MEMS. No user is allowed to enter into any external service or maintenance contract agreement without prior discussion and agreement with their Service Manager, the budget holder, Procurement Team and our Contracts Department.

The maintenance schedule for medical devices will be managed by MEMS on behalf of the organisation who will advise when equipment is due for service. All medical devices should be serviced in accordance with manufacturer’s instructions.

The planned maintenance schedules and details of maintenance, repairs and calibrations performed by MEMS are recorded in an equipment database. Information from this data base including performance against the key performance indicators (KPIs) of the MEMS contract which will be sent to the organisations Medical Devices Safety Officer (MDSO) monthly and will be reviewed and discussed at the monthly MEMS contact and performance monitoring meeting chaired by the MDSO.

The user MUST check the medical device before every use to ensure it is working correctly. The Service Manager MUST ensure servicing and maintenance on all medical devices used within the service is carried out on a routine basis in accordance with the training or instructions given by the manufacturer. Logs of such service and maintenance MUST be kept by the Service Manager and any daily checks where required.

All users MUST make medical devices available for the external maintenance contractor upon request when clinically possible and appropriate for servicing and maintenance

Modification of Devices

The Medical devices regulations stipulate that the manufacturer of a device is responsible for establishing that the device is safe and that it is suitable for its intended purpose.

Staff should on no account modify devices or use them for purposes for which they are not designed: to do so may put patients at risk and may make the health professional liable for any consequences. This would include:

• used off-label (e.g. urinary catheters as enteral feeding tubes)

• modified by the user

• not intended for medical use (e.g. non-medical LED torches used for patient neurological observations, when the packaging warns against shining the torch into a person’s eyes)

As well as the risks to the patient and user, liability for the performance and safety of products could be transferred to the user. Healthcare professionals should also be aware that following modification of a CE-marked (European Conformity) medical device, the healthcare organisation and/or professional could be deemed to be the manufacturer of a new device and may therefore be subject to the requirements of the Medical Devices Regulations.

12.Disposal of Medical Devices and Equipment

All medical devices which are deemed to be worn out, broken or damaged beyond safe and economical repair shall be removed from the organisation in accordance with the Decommissioning and Disposal SOP – See Appendix 6.

This procedure provides guidance to all staff regarding their roles and responsibilities in decommissioning and disposing of medical devices in order to comply with relevant Health and Safety legislation, European Union Directives and Waste Electrical and Electronic Equipment (WEEE) legislation.

13.Asset Management

All services shall have an up to date asset register with all medical devices recorded with the following information:

• Name of medical device (e.g. Omron)

• Type of medical device (e.g. Blood pressure monitor)

• Serial number

• Asset number

• Date of last service

• Name of staff member or patient who is in receipt of this (if applicable)

To comply with Managing Medical Devices 2015 MEMS has delegated responsibility to maintain a computerised inventory of all medical equipment within the organisation.

It’s Provide’s intention to develop a central computerised database in the future for all services to record their medical devices and to allow for full oversight of all medical devices within the organisation. Work is in progress to achieve this as part of the Medical Devices Project.

All clinical users must notify MEMS of all medical devices acquired (howsoever funded, including loan devices and free of charge devices) and all decommissioning of medical devices. Clinical users must also notify MEMS of any changeto the status of equipment such as long-term relocation.

14.Adverse Incidents / Near Misses

An adverse incident is an event that causes, or has the potential to cause unexpected or unwanted effects involving the safety of patients, users or other persons. All such incidents or near misses should be dealt with appropriately and reported on the organisation’s Incident Reporting system (Datix web). Any medical device incidents that require reporting to the MHRA will be carried out by Health, Safety, Fire and Security Manager.

Reference should be made to Provide IGPOL44 - Risk Management Policy, IGPOL10 Health & Safety at Work Policy and the IGPOL19 - Incident Reporting and Management Policy.

Defective items should initially be quarantined and should not be repaired (either inhouse or by a third party) or returned to the manufacturer/supplier or discarded before an investigation.

All material evidence should be labelled and kept secure. This includes the products themselves and, where appropriate packaging material or other means of batch identification. The evidence should not be interfered with in any way except for safety reasons or to prevent its loss. If necessary a record should be made of all readings, settings and positions of switches, valves, dials, gauges and indicators, together with any photographic evidence and eyewitness reports.

15.Medical Devices on Loan to Patients

When devices are loaned by the organisation, the procedure outlined in the Loan of Medical Device Standard Operating Procedure should be followed to ensure that the organisation discharges its duty of care to the device users and patients – See Appendix 7.

When devices are loaned to the organisation, this procedure shall also be followed to ensure that Provide is indemnified against any claims for injury resulting from their use and that the device is appropriately managed as set out in Managing Medical Devices 2015, MDA SN 2002(17) and MDA SN 2000(18).

16.Glossary

The following terms may be used in this document and are therefore explained below:

Asset register/database

An inventory of all items considered to be an asset of the organisation (including medical devices)

Care Quality Commission (CQC)

The independent regulator of health and social care in England

CE Mark

The CE (European conformity) mark is a declaration by the manufacturer that the device meets the essential requirements of all relevant European Directives.

Decommissioning

Removing a device which has been deemed unsafe and or un-usable from use.

Medical Device

Medical Devices encompass both re-usable and single use items. The Medicines and Healthcare products Regulatory Agency (MHRA) define a medical device as any instrument, apparatus, appliance, material or healthcare product, excluding drugs, used on a patient or client for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease.

Any medical device used for the assessment, diagnosis, treatment or monitoring of patients under medical/clinical supervision include any device which:

• Makes physical or electrical contact with the patient, and/or:

• Transfers energy, medication or gases to or from the patient, and/or;

• Detects such energy transfer, or is used in a laboratory setting as a diagnostic analyser of patient samples

Medical Equipment Management Services (MEMS)

The external service provider contracted by Provide to carry out maintenance, repair, modification and disposal of all medical devices across the organisation.

Medicines and Healthcare products Regulatory Agency (MHRA)

Enhances and safeguards the health of the public by ensuring medicines and medical devices work and are acceptably safe.

Medical Devices Safety Officer (MDSO)

As part of the MHRA Managing Medical Devices guidance healthcare organisations should appoint a Medical Device Safety Officer (MDSO). This role includes reporting adverse incidents in relation to medical devices to the MHRA and other official agencies. The appointed MDSO within the organisation is the Health, Safety, Fire and Security Manager.

Re-Usable Device

The medical device can be used on more than one patient on multiple occasions. The device must undergo some form of decontamination and may require reprocessing between each use.

Single Patient Use Device

The medical device may be used for more than one episode on one patient only. The device may undergo some form of decontamination and/or reprocessing between each use but must never be used on more than one patient

Single Use Device

The medical device is intended to be used on an individual patient during a single procedure and then discarded. The item will carry “single use” marking on its packaging.

SOP Standard Operating Procedure are the documented processes that the organisation has in place to ensure services and/or products are delivered consistently every time in accordance with regulations, laws and/or Provide standards

Waste Electrical and Electronic Equipment (WEEE) Recycling

The Waste Electric and Electronic Equipment (WEEE) recycling regulations 2013 became law in the UK on the 1st of January 2014 and replaced the 2006 regulations. The new regulations transpose the main provisions of Directive 2012/19/EU on WEEE which recasts the previous Directive 2002/96/EC.

These regulations also provide for a wider range of products to be covered by the Directive with effect from 1st January 2019.The regulations apply to all Electrical and Electronic Equipment (EEE) placed on the market in the UK covered by the scope of the Regulations.

Appendix 1: Self-Competency Assessment Form

Medical Device Competency Self-Assessment Form

Medical Device (more than one device can be listed below:

Surname:

Forename(s)

Title(Mr/Mrs/Miss/Dr): Personal Number (on wage slip)

Job Title:

Line Manager:

Dept. / Team / Unit:

Extension No:

Self-Verification of competence is undertaken by assessment against the following statements: These statements are designed to indicate competence to use this item. Responsibility for the use remains with the user, so if you are in any doubt regarding your competence to use the item, you should seek advice and support to bring about improvement.

Carry out an initial assessment. You must answer yes to all questions before considering yourself to be competent. If you are not competent instigate learning and then repeat assessment. Items to achieve: Initial Assessment Date: / / Second Assessment Date: / /

Are you safe using this device? Can you / Do you:

1. Check the device is clean, in working order and has been serviced within the last 12 months?

2. Identify what the device is used for and any contraindications in using the device.

3. Operate the device correctly as per the manufacturers manual / instructions

4. Know how to clean / decontaminate the device

5. Know the location of the operators manual

6. Know the process for reporting faults

7. Know how to report an adverse incident involving a medical device.

8. Have access to MDA Device bulletins of relevance to your area of practice.

I require further training before I can use this device in a competent manner:

Signature:

Indicate how you plan to meet your learning needs:

1. Yes / No 2. Yes / No

3. Yes / No 4. Yes / No

Yes / No

Date:

User Statement: I certify that I am aware of my professional responsibility for continuing professional development and I realise that I am accountable for my actions. With this in mind I make the following statement:

I am competent to use this medical device without further training:

Signature:

Date:

Keep this form in your personal folder. Ensure that your manager receives a copy of the form.

Appendix 2: Medical Devices Training Needs Analysis

Template can be found on the intranet

Appendix 3: Loan of Medical Device SOP

Provide staff to assess patient as requiring a loan of a medical device, suitability of the loan and identify medical device for loan

Provide staff to check medical device is working correctly and has been serviced within last 12 months by MEMS

Provide staff to instruct and demonstrate to the patient / carer the correct use of the medical device and give written instructions for future reference

Provide staff to confirm patient / carer understands the safe & correct use of medical device

Provide staff to confirm with user the timeframe of the loan and the patient / carer responsibilities during this loan including servicing, providing consumables and what to do if the medical device is not working.

Provide staff ask patient / carer to sign loan form (see Appendix 3b) giving a copy to the patient and scanning the original into the patients records (keep paper copy if paper patient records

Provide staff to arrange with MEMS to attend the service to check the medical device prior to reuse

Appendix 3a: Loan of Medical Device Pro-forma

USER MEDICAL DEVICE LONE AGREEMENT FORM

Patient / Carer Details

Name:

Address:

Contact Number:

PATIENT / USER COPY SERVICE COPY ____

Name of Medical Device Make:

Serial No: __________________________ MEMS Asset Tag No.

The above medical device is on loan for ___________ weeks from the ______________ Service. If there are any problems with the working condition of the equipment please do not hesitate to contact us on the above number. Our working hours are …………………………...

Please complete the following section:

1. I have been shown and understand how use the medical device and have been given written instructions

2. I acknowledge the safe receipt of the medical device described above.

3. I shall advise the Service of any change of address or telephone number whilst the medical device is on loan to me.

4. If the medical device is damaged or lost, whilst on loan to me, I undertake to meet the cost of repair/replacement.

5. I agree to make this medical device available for collection on or before the due date and accept that I will be charged a replacement cost if I fail to return the equipment.

Patient/Carer Signature: ___________________ Date:_____________________

Patient/Carer Name: ______________________

Staff Signature: __________________________ Date: _____________________

Returned by (signature):____________________ Date: _____________________

Staff Signature: ___________________________ Date: ______________________

Appendix 4: Maintenance, Service and Repair SOP

When a medical device is not working correctly or ceases to function, the following procedure should be followed:

Provide staff identifies or suspects a medical device is not working correctly or has ceased to function

Provide staff remove medical device from service and attach label to identify that the medical device should not be used. If the medical device has caused or contributed to an incident, staff must complete the incident reporting system (Datix)

Provide staff decontaminates the medical device as per the Decontamination policy

Staff to inform MEMS Helpdesk via Telephone on: 01702 385131 or via email at: memshelpdesk@southend.nhs.uk providing the following information:

• Service contact details

• Location

• Medical Device details

• Asset Number

• The details of what is wrong with the device

MEMS will provide the Provide staff member with a service request reference number

MEMS staff arranges to attend, remove the medical device and transport to the central store

YES

MEMS staff able to repair medical device on site NO

MEMS staff repair medical device on site and update Asset Database

MEMS staff remove the medical device and transport to their base for repair/decommissioning

MEMS staff return medical device to Provide service or inform Service medical device beyond repair & recommend decommissioning

Staff following Decommissioning & Disposal SOP

Appendix 5: Decommissioning and Disposal SOP

If a medical device is deemed worn out, broken or damaged beyond safe and economical repair the following procedure must be followed:

Provide staff identify medical device to be decommissioned

Staff remove medical device from service and attach label to identify that the medical device should not be used. Staff updates the Service asset register to identify the medical device is being decommissioned

Provide staff decontaminates the medical device as per the decontamination policy

Staff to inform MEMS Helpdesk via Telephone on: 01702 385131 or via email at: memshelpdesk@southend.nhs.uk providing the following information:

• Service contact details

• Location

• Medical Device details

• Asset Number

MEMS will provide the staff member with a service request reference number.

MEMS staff arrange to attend, remove the medical device and transport to the central store.

MEMS issue a decommissioning form to the appropriate service lead for authorisation.

Provide Service Lead authorises decommissioning form and returns to MEMS.

MEMS dispose of medical device in accordance with WEEE regulation

EQUALITY IMPACT ASSESSMENT TEMPLATE: Stage 1: ‘Screening’

Name of project/policy/strategy (hereafter referred to as “initiative”):

Medical Devices Management Policy

Provide a brief summary (bullet points) of the aims of the initiative and main activities:

Project/Policy Manager: Health, Safety, Fire and Security Manger Date: May 2022

This stage establishes whether a proposed initiative will have an impact from an equality perspective on any particular group of people or community – i.e. on the grounds of race (incl. religion/faith), gender (incl. sexual orientation), age, disability, or whether it is “equality neutral” (i.e. have no effect either positive or negative). In the case of gender, consider whether men and women are affected differently.

Q1. Who will benefit from this initiative? Is there likely to be a positive impact on specific groups/communities (whether or not they are the intended beneficiaries), and if so, how? Or is it clear at this stage that it will be equality “neutral”? i.e. will have no particular effect on any group.

Neutral

Q2. Is there likely to be an adverse impact on one or more minority/under-represented or community groups as a result of this initiative? If so, who may be affected and why? Or is it clear at this stage that it will be equality “neutral”?

Neutral

Q3. Is the impact of the initiative – whether positive or negative - significant enough to warrant a more detailed assessment (Stage 2 – see guidance)? If not, will there be monitoring and review to assess the impact over a period time? Briefly (bullet points) give reasons for your answer and any steps you are taking to address particular issues, including any consultation with staff or external groups/agencies.

Neutral

Guidelines: Things to consider

Equality impact assessments at Provide take account of relevant equality legislation and include age, (i.e. young and old,); race and ethnicity, gender, disability, religion and faith, and sexual orientation.

The initiative may have a positive, negative or neutral impact, i.e. have no particular effect on the group/community.

Where a negative (i.e. adverse) impact is identified, it may be appropriate to make a more detailed EIA (see Stage 2), or, as important, take early action to redress this – e.g. by abandoning or modifying the initiative. NB: If the initiative contravenes equality legislation, it must be abandoned or modified.

Where an initiative has a positive impact on groups/community relations, the EIA should make this explicit, to enable the outcomes to be monitored over its lifespan.

Where there is a positive impact on particular groups does this mean there could be an adverse impact on others, and if so can this be justified? - e.g. are there other existing or planned initiatives which redress this?

It may not be possible to provide detailed answers to some of these questions at the start of the initiative. The EIA may identify a lack of relevant data, and that data-gathering is a specific action required to inform the initiative as it develops, and also to form part of a continuing evaluation and review process.

It is envisaged that it will be relatively rare for full impact assessments to be carried out at Provide. Usually, where there are particular problems identified in the screening stage, it is envisaged that the approach will be amended at this stage, and/or setting up a monitoring/evaluation system to review a policy’s impact over time.

EQUALITY IMPACT ASSESSMENT TEMPLATE: Stage 2:

(To be used where the ‘screening phase has identified a substantial problem/concern)

This stage examines the initiative in more detail in order to obtain further information where required about its potential adverse or positive impact from an equality perspective. It will help inform whether any action needs to be taken and may form part of a continuing assessment framework as the initiative develops.

Q1. What data/information is there on the target beneficiary groups/communities? Are any of these groups under- or over-represented? Do they have access to the same resources? What are your sources of data and are there any gaps?

N/A

Q2. Is there a potential for this initiative to have a positive impact, such as tackling discrimination, promoting equality of opportunity and good community relations? If yes, how? Which are the main groups it will have an impact on?

N/A

Q3. Will the initiative have an adverse impact on any particular group or community/community relations? If yes, in what way? Will the impact be different for different groups – e.g. men and women?

N/A

Q4. Has there been consultation/is consultation planned with stakeholders/ beneficiaries/ staff who will be affected by the initiative? Summarise (bullet points) any important issues arising from the consultation.

N/A

Q5. Given your answers to the previous questions, how will your plans be revised to reduce/eliminate negative impact or enhance positive impact? Are there specific factors which need to be taken into account?

N/A

Q6. How will the initiative continue to be monitored and evaluated, including its impact on particular groups/ improving community relations? Where appropriate, identify any additional data that will be required.

N/A

Guidelines: Things to consider

An initiative may have a positive impact on some sectors of the community but leave others excluded or feeling they are excluded. Consideration should be given to how this can be tackled or minimised. It is important to ensure that relevant groups/communities are identified who should be consulted. This may require taking positive action to engage with those groups who are traditionally less likely to respond to consultations, and could form a specific part of the initiative. The consultation process should form a meaningful part of the initiative as it develops, and help inform any future action.

If the EIA shows an adverse impact, is this because it contravenes any equality legislation? If so, the initiative must be modified or abandoned. There may be another way to meet the objective(s) of the initiative.

Further information:

Useful Websites www.equalityhumanrights.com Website for new Equality agency www.employers-forum.co.uk – Employers forum on disability www.disabilitynow.org.uk – online disability related newspaper www.womenandequalityunit.gov.uk – Gender issues in more depth www.opportunitynow.org.uk - Employer member organisation (gender) www.efa.org.uk – Employers forum on age www.agepositive.gov.uk – Age issues in more depth