MEDICAL DEVICES

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					         POLICY TITLE                         Medical Devices Policy


POLICY REFERENCE NUMBER                                  M7


        DATE OF ISSUE                              December 2006


 DATE OF IMPLEMENTATION                            February 2007


 DEVELOPED / REVIEWED BY                 Associate Director of Patient Safety


         REVIEW DATE                                February 2008
                                                   (February 2009)

  RESPONSIBLE DIRECTOR                           Director of Nursing


   MAY BE DISCLOSED TO                                  YES
        PATIENTS


Equality & Diversity statement

The NHS can no longer be reactive in its response to demographic changes within society.
There is now a positive duty to be proactive and ensure that it provides services and
develops policies that are accessible and appropriate to all sections of the community.

The development/review of this policy has undergone an Equality Impact Assessment
[EIA], as per the guidance in the Trust Policy Development Monitoring & Review [P3].




WEST LONDON MENTAL HEALTH NHS TRUST
Policy Date: February 2007                                 May be disclosed to patients
M7

MEDICAL DEVICES



INDEX



1.    Introduction
2.    Aim
3.    Objectives
4.    Definitions
5.    Responsibilities
6.    Incident Reporting
7.    Medical Equipment Condemning
8.    Training
9.    Medical Device Inventory

Appendix A - Type of Medical Device and Training

Appendix B - Medical Devices and Resuscitation Competency Verification
             Form




WEST LONDON MENTAL HEALTH NHS TRUST
Policy Date: February 2007                         May be disclosed to patients
M7

MEDICAL DEVICES


1. CONTEXT


1.    Introduction

      Medical devices are an integral part of the diagnosis, treatment, support and
      care of service users within West London Mental Health NHS Trust. As part
      of an overall strategy for Risk management the Trust has an obligation to
      make certain that it minimises the risks of using medical devices to as low a
      level as practicable by ensuring that it buys the most appropriate equipment
      for purpose, trains staff how to use them competently and safely, cleans and
      maintains them correctly, and disposes of them in an appropriate manner.

2.    Aim

      The Trust recognises the risks to service users, staff and others created by
      the use of medical devices. It therefore intends to ensure that there is a
      suitable and operational system in place to manage the procurement,
      usage, maintenance and disposal of medical equipment, to meet the
      requirements of national legislation and NHS guidance, and to make sure
      that equipment is used safely, competently and effectively for the care of
      patients.

3.    Objectives

      To ensure that:

3.1   A register of medical devices is established and maintained within the Trust

3.2   A system for identifying the risks associated with the procurement and use
      and disposal of medical devices within the Trust is established

3.3   A system to ensure the compliance of the Trust with all external risk
      standards is established

3.4   A training programme for staff to ensure competence in using medical
      devices is established

3.5   A system for reporting incidents and disseminating information which
      concerns the use of medical devices is established


WEST LONDON MENTAL HEALTH NHS TRUST
Policy Date: February 2007                             May be disclosed to patients
3.6     All staff are conversant with the systems put in place.


4.      Definitions

        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:

4.1     Diagnosis, prevention, monitoring, treatment or alleviation of disease

4.2     Diagnosis, monitoring, treatment, or alleviation of, or compensation for an
        injury or handicap

4.3     Investigation, replacement or modification of the anatomy or of a
        physiological process.

4.4     Control of conception

5.      Responsibilities

5.1     Chief Executive

        The Chief Executive has overall responsibility for the safety and welfare of
        all Trust staff, service users and visitors. This includes overall responsibility
        for the use of Medical Devices within the Trust.

5.2     Estates and Facilities Department

5.2.1 Advise on the negotiation and monitoring of any maintenance contracts

5.2.2 Ensure medical devices/equipment are disposed of appropriately


5.3     Head of Procurement

5.3.1   Purchase of all medical devices within the Trust.

5.3.2 Receiving of all purchased equipment.

5.3.3 Checking that the items are as ordered and arrive undamaged.

5.4     Service Directors/Service Managers

5.4.1 Ensure that all equipment is maintained as appropriate. For example,
      Automatic External Defibrillators receive specialist services as appropriate.

5.4.2 Ensure that service contracts are in place as required.


WEST LONDON MENTAL HEALTH NHS TRUST
Policy Date: February 2007                                  May be disclosed to patients
5.5    Managers/Team leaders

       It is the responsibility of all Managers/Team leaders to:

5.5.1 Liaise with the Head of Procurement when purchasing medical devices.

5.5.2 Ensure that medical devices are only purchased through the Head of
      Procurement and/or their team.

5.5.3 Ensure that all new equipment is received from the Purchasing and
      Supplies department.

5.5.4 Maintain an up to date register of all medical equipment used by staff in
      their area of responsibility.

5.5.5 Ensure that a system is established to regularly check all equipment for
      working order. This may be done by allocating a member of the team to be
      responsible for regularly checking each piece of equipment.

5.5.6 Ensure all staff are competent to use the equipment (Appendix B)

5.5.7 Ensure that no new equipment is used before being received and checked
      by the goods-in department.

5.5.8 Ensure all equipment is suitably decontaminated where appropriate

5.5.9 Ensure all equipment is safely stored and maintained when in use

5.5.10 Ensure all equipment is disposed of in the required manner

5.5.11 Ensure all incidents involving medical devices are reported

5.5.12 Ensure all safety alerts and bulletins are brought to the attention of staff in
       their area

5.5.13 Ensure that instruction manuals are available to all staff


5.6    Staff

       It is the responsibility of Trust staff to ensure that they:

5.6.1 Only use medical equipment if they are competent and authorised to do so

5.6.2 Follow procedures and policies regarding the management and use of
      equipment




WEST LONDON MENTAL HEALTH NHS TRUST
Policy Date: February 2007                                   May be disclosed to patients
5.6.3 Report any defects or faults with equipment immediately to the Facilities and
      Estates Department and either clearly label defective devices or ensure they
      are taken out of commission

5.6.4 Report any untoward incidents as soon as possible



5.7    Infection Control Advisor

5.7.1 Provide advice on the cleaning, disinfection, decontamination and where
      appropriate the method of sterilisation of the device taking account of
      manufacturer’s instructions

5.7.2 Ensure all relevant policies are reviewed within agreed time limits.

5.8   Committees

       The Medical Devices and Safety Alert Broadcasts Committee is chaired by
       the Associate Director of Patient Safety and meet on a quarterly basis. The
       terms of reference are:

5.8.1 Develop a Trust wide approach to the management of medical devices,
      ensuring that all aspects of procurement, usage, training, maintenance,
      decontamination and disposal are considered and assessed to ensure the
      safe and most effective use is made of every piece of equipment;

5.8.2 Develop a Trust wide register of all medical devices across the Trust and
      identify those that represent a significant risk to patient care or staff safety;

5.8.3 Monitor service contracts across the Trust.

5.8.4 Liaise with the Supplies Department to ensure that only reputable suppliers
      are used, and that consideration has been given to the maintenance,
      decontamination and eventual disposal of these devices as part of the
      purchasing procedure

5.8.5 Monitor the reporting of incidents to the Medical Healthcare products
      Regulatory Agency (MHRA), and ensure that all MHRA notices are
      distributed and actioned appropriately

5.9    Risk Department

5.9.1 The Risk Department will monitor the maintenance of medical devices by
       conducting yearly audits on service contracts to ensure that appropriate
       checks are carried out.

5.9.2 Responsible for the onward transmission of all notifications to the MHRA. In
      addition, will be responsible for the distribution of medical Device alerts to
      the Medical Devices Liaison Officer (Associate Director of Patient Safety).

WEST LONDON MENTAL HEALTH NHS TRUST
Policy Date: February 2007                                May be disclosed to patients
5.9.3 Chair the Medical Devices and SABS group, reporting 6 monthly to WLMHT
      Risk Committee.

5.9.4 Distribution of Hazard and Safety Notices from MHRA – Medical and
      Healthcare Product Regulatory Agency and NPSA National Patient Safety
      Agency. Implementation of actions required by information received from
      Hazard or Safety Notices.

6.    Incident Reporting
6.1   If an incident occurs to a patient, member of staff, contractor or member of
      the public, which involves a medical device, it is the responsibility of staff to
      report the event in line with the Trust Incident Reporting Policy.

6.2   The person reporting the incident should record details of the equipment
      involved, including manufacturer, registration number, batch number, date
      of manufacture etc. and retain the equipment in a secure environment until
      further notice.

6.3   If the device cannot be moved a notice should be placed on it warning
      against using it.

6.4   Those incidents where the medical device contributed to the incident will be
      reported to the MHRA, and the Risk Management department will assist in
      assessing which need notification, and in completing the report form.

7     Medical Equipment Condemning


7.1   An item of medical equipment can be condemned for one or more of the
      following reasons:
     Worn out beyond economical repair
     Damaged beyond economical repair
     Unreliable
     Clinically or technically obsolete
     Spare parts no longer available
     More cost or clinically effective devices are now available
     Unable to be cleaned effectively prior to disinfection and/or sterilisation


7.2   Medical equipment/devices can only be condemned by the Trust Estates
      and Facilities Dept or qualified individual or company commissioned to carry
      out the role by the Trust


WEST LONDON MENTAL HEALTH NHS TRUST
Policy Date: February 2007                                May be disclosed to patients
8     Training


8.1    Training in the general risk management of medical devices will be included
      in the corporate induction programme, and as part of the general risk
      management training for managers.

8.2   Each department should ensure that medical device management is
      included in their local induction programme including procedures for
      acquisition, training requirements, decontamination and disposal.

8.3   Training in the use of equipment should be provided in house by staff who
      are competent to do so, or via specialist training, either through the Trust or
      via external providers. (Please see Appendices A and B)
8.4   Each ward/department should maintain a record of all equipment/devices
      for which training is required and keep records of training given to staff, this
      should include when the next training update is required. Records of training
      and verification of competency where appropriate should be kept by line
      managers (Please see Appendices A and B), this will include: -
                ECT and anaesthetic equipment
                Resuscitation equipment

8.5    No medical equipment shall be used clinically unless the operators (staff,
      and in some cases patients, who use the device[s]) have received
      appropriate training.

9.    Medical Device Inventory

9.1   The manager for each area will maintain a local inventory, which will identify
      the various types of medical device held within the department, and the
      training needs for each member of staff.

9.2   The inventory should be reviewed on a quarterly basis with new equipment
      added, and a record of when old equipment is removed and disposed of.

9.3   The register does not need to include smaller individual items such as
      dressings and tongue depressors, although a manager may include them as
      a generic group.

9.4   The local inventory will be checked 6 monthly by the Risk Department as
      part of the Audit process.




WEST LONDON MENTAL HEALTH NHS TRUST
Policy Date: February 2007                               May be disclosed to patients
Appendix A

TYPE OF MEDICAL DEVICE          TRAINING                    FREQUENCY OF              IDENTIFIED TRAINER              UPDATE
                              REQUIRED FOR                TRAINING DELIVERY                                          REQUIRED

                                               DIAGNOSTIC EQUIPMENT


     Glucometer                 Nursing Staff of              Manufacturer to            Manufacturer        Whenever staff
                                  all bands                      train when new              Re: specific        move to a new site
     Sphygmomanometer           Bank Staff                     equipment                   equipment           using different
                                 Medical Staff                  purchased by                initially.          equipment
     Thermometers                                               ward /unit                 Line Manager to
                                                                On local                    ensure ongoing
                                                                 induction                   competency, and
                                                                                             to train on local
                                                                                             induction


     Pulse Oximeter       Nursing staff of all          Contained in CPR/AED         Trust’s resuscitation      Whenever staff
                           bands and medical             training.                    trainer or Accredited      move to a new site
                           staff in acute in-patient                                  External Trainer           using different
                           wards and PICUs               On local induction to                                   equipment
                                                         ward/unit


     Laryngoscope         Medical Staff                 Competency acquired                                     Whenever staff
                                                         during medical training       RMO/CONSULTANT            move to a new site
     Ophthalmoscope                                                                      TO ENSURE              using different
                                                                                           ONGOING               equipment.
     Auroscope                                                                          COMPETENCY


WEST LONDON MENTAL HEALTH NHS TRUST
Policy Date: February 2007                             May be disclosed to patients
TYPE OF MEDICAL DEVICE           TRAINING                FREQUENCY OF              IDENTIFIED TRAINER             UPDATE
                               REQUIRED FOR            TRAINING DELIVERY                                         REQUIRED

                          EQUIPMENT RELATED TO THE ADMINISTRATION OF TREATMENT:

     Syringes                    All in-patient     Competency acquired          Ward/Line Manager to      Whenever staff
     Needles                      qualified          during nursing/medical       ensure ongoing            move to a new site
                                   nursing staff      training                     competency                using different
                                  Medical staff                                                             equipment
     Nebulisers                  All in-patient     Manufacturer to train        Manufacturer Re:          Whenever staff
                                   qualified          when new nebuliser           specific nebuliser        move to a new site
                                   nursing staff      used on ward/unit            initially. Ward/Line      using different
                                  Medical staff                                   Manager to ensure         nebuliser
                                                      On local induction           ongoing competency.
     ECT equipment               ECT Lead           Please refer to WLMHT        Please refer to WLMHT     Whenever staff
                                   Nurse and          ECT Policy                   ECT Policy                move to a new site
                                   identified                                                                using different
                                   deputies                                                                  equipment
                                  Medical staff

                                      EQUIPMENT RELATED TO LIFE SUPPORT

     Automated External          In-patient         As soon as possible          Trust’s designated        12 months.
      Defibrillators               nursing staff      after induction (within 3    Resuscitation trainer,
     Ambu Bag                     (including         months                       including training
     Airways                      HCA/Support                                     delivered by accredited
     Endotracheal Tube            staff)                                          external trainers
     Hand-pump Suction           Bleep holders
      machine                     Medical Staff,
     O2 cylinders/masks and       including
      tubing                       Consultant/RM
     Pulse Oximeter               O
WEST LONDON MENTAL HEALTH NHS TRUST
Policy Date: February 2007                          May be disclosed to patients
TYPE OF MEDICAL DEVICE                   TRAINING                 FREQUENCY OF              IDENTIFIED TRAINER    UPDATE
                                       REQUIRED FOR             TRAINING DELIVERY                                REQUIRED
                                        Bank staff

                                                                                                                   Appendix B
MEDICAL DEVICES VERIFICATION OF COMPETENCY (SAFE USE) OF MEDICAL EQUIPMENT
& RESUSCITATION TRAINING

Name of WARD/UNIT/Dept__________________

Name/s of Competency Assessor & Sample of signatures & Initials

Sign and date each cell as verification is completed.
Complete verification checklists dated & signed for each item of equipment




Names of Staff & Designation 




Blood Glucometer

Oxygen Cylinders

Pulse Oximeter

Non-mercury
Sphygmomanometer

Suction machine

Thermometer


WEST LONDON MENTAL HEALTH NHS TRUST
Policy Date: February 2007                                   May be disclosed to patients
Basic Life Support Equipment




WEST LONDON MENTAL HEALTH NHS TRUST
Policy Date: February 2007            May be disclosed to patients

				
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