SOUTH STAFFORDSHIRE AND SHROPSHIRE HEALTHCARE NHS FOUNDATION TRUST

Transcription

1 SOUTH STAFFORDSHIRE AND SHROPSHIRE HEALTHCARE NHS FOUNDATION TRUST Document Version Control Document Type and Title: Authorised Document Folder: New or Replacing: Document Reference: Version No. v4.0 Medical Devices Policy YELLOW - Clinical Replacing C/YEL/gen/02 v3.0 (March 2009) C/YEL/gen/02 Implementation Date: Policy Owner: Approving body: Kevyn Ingram Senior Estates Manager Quality Governance Committee Approval Date: 13 th February 2014 Ratifying body: Board of Directors Ratified Date: 27 th February 2014 Committee, Group or Individual Monitoring the Document: Medical Devices Group Review Date: February 2017

2 CONTENTS 1 KEY WORDS 2 2 ASSOCIATED TRUST DOCUMENTS 2 3 INTRODUCTION Background Principles Purpose Scope Roles and Responsibilities Legislation 6 4 DEFINITIONS 4.1 Medical Devices and Equipment Single- use Medical Devices Single Patient Use Medical Devices Limited Use Re-usable 8 5 PROCEDURE/COURSE OF ACTION REQUIRED Central Alerts System (CAS) Adverse Incident Reporting (Medical Devices) Training Staff Training End-user Training Procurement of Medical Devices Standard List of Medical Equipment Devices Containing Mercury Prescribing of Equipment Written Instructions Summary Legal Requirements Instructions for the End-user End-users with Particular Problems Suitability of Manufacturer s Instructions Evidence of Giving Instructions Providing Instructions with Loan Equipment When a New Device is Delivered Receipt of Devices Acceptance Checks Acceptance Procedures Checking and Testing of a New or Recently Repaired Device Storage of Medical Equipment, Devices and Associated Consumables Procedure for Starting to Use a New Device Maintenance and Repair Introduction Periodic Planned Preventative Maintenance 20

3 5.8.3 Routine Maintenance Cleaning and Decontamination Breakdowns Device Replacement Regular Planned Maintenance of Major Items of Equipment Checks and Inspections Responsibilities for Maintaining Equipment Indemnity Agreements Responsibilities of Staff Repair of Equipment Whilst Still in Use Decontamination Condemning and Safe Disposal Key Indicators 26 6 IMPLEMENTATION PLAN Dissemination Training/Awareness Audit, Monitoring and Evaluation Breach of this Policy 27 7 REFERENCES 27 APPENDIX A - Medical Devices Group Terms of Reference 29 APPENDIX B - Procedures for Planned Preventative Maintenance (PPM) 322 APPENDIX C - Guidance for Routine (User) Maintenance 34 APPENDIX D - Sample Declaration of Decontamination Status Certificate 36 APPENDIX E - Medical Devices Policy Definitions 37 APPENDIX F - Examples of: Medical Devices/Equipment 39 APPENDIX G - Medical Devices Accountability Arrangements 40 APPENDIX H - Example of Department Inventory and Training Record 41 APPENDIX I - Disposal of Equipment Guidance 42 1 KEY WORDS Adverse incident reporting; Condemning equipment; Decontamination; Deliveries; Device alerts; Device co-ordinators; Disposal; Equipment; Maintenance; Medical devices; Medical equipment; Medical Devices group; Mercury; Pre-purchase questionnaire; PPQ; Procurement; Safe disposal; CAS, Medicines and Healthcare Products Agency, QGC, CQC. 2 ASSOCIATED TRUST DOCUMENTS This document should be read in conjunction with the following Trust documents: Risk Management Strategy Health & Safety Policy Safe Load Movement Policy 2

4 Management of Adverse Events, Serious Incidents and Near Misses Infection Control Policy Management of Healthcare Waste Policy Decontamination Policy Asset Management Policy Mandatory Training Policy Verification of competencies and safe use of medical devices 3 INTRODUCTION 3.1 Background The Trust aims to continually review its medical devices management procedures. To this end, it has appointed a Medical Devices Group to identify risk and equipment management issues. The Medical Devices Group has representatives from each of the Trust s Directorates and partner organisations. The group considers issues raised in the Department of Health s device bulletin regarding Medicines and Healthcare Products Agency Managing Medical Devices DB2006(05) entitled Guidance for healthcare and social services organisations. This document supersedes the previous MDA DB9801 guidance. 3.2 Principles The Trust s policy is to provide and maintain safe and healthy working conditions, equipment and safe systems of work for all employees and to provide such information, training and supervision as they need for this purpose. The Trust also accepts responsibility for the health and safety of other people who use services and may be affected by Trust activities. 3.3 Purpose This policy has been prepared and developed in order to consolidate good practice methods and to reduce risk when prescribing, procuring, checking, using, testing, maintaining, borrowing and loaning, decontaminating and disposing of medical devices and equipment. The overall aim of the policy is to ensure that whenever a medical device is used it is:- Suitable for its intended purpose; Properly understood by all users; Used correctly and safely; Available for use; Comfortable to use; Maintained in a safe and reliable condition; Independence-promoting 3.4 Scope This document has been written for all Trust employees who have responsibility for the purchasing, deployment, use, maintenance and repair of medical devices in Hospitals and in the Community. The term Medical Device covers any product, other than 3

5 4 Medical Devices Policy/C/YEL/gen/02/v4.0 medicines, which is used for the diagnosis, prevention, monitoring or treatment of illness or injury. The range of products is very wide, including: contact lenses and condoms, heart valves and hospital beds, resuscitators and radiotherapy machines, surgical instruments and syringes and wheelchairs and walking frames. 3.5 Roles and Responsibilities The Trust Board has the corporate responsibility to ensure that this policy is implemented and complied with. The Board will regularly review performance in this respect through the established committee structure, assurance process and audit arrangements. Chief Operating Officer / Director of Nursing - will ensure that a system is in place to co-ordinate the effective reporting of adverse incidents involving medical equipment and devices within the Trust. The Director will also have executive responsibility for the implementation of this policy and the monitoring of its effectiveness. Senior Estates Manager - will undertake the role of Medical Devices Liaison Officer. The Manager will ensure that defect and failure reports are communicated to the Medicines and Healthcare Products Agency and provide technical support and guidance to managers in all aspects of device procurement, maintenance and management, in conjunction with the Procurement Department and other relevant departments. The Manager will also ensure that all significant adverse incidents reported in the Trust that involve medical devices, are promptly reported to the Medicines and Healthcare Products Agency when appropriate to do so. Risk and Claims Manager - will undertake the role of Central Alerting System officer for the Trust. The Manager is responsible for ensuring that safety alerts are appropriately disseminated throughout the organisation and will ensure that remedial action is taken as required and suitable records of such action are maintained. Managers - any manager who agrees the purchase of any new type or make of diagnostic or therapeutic medical device should ensure that the equipment is added to their locally held equipment register and training plan. They should also ensure that all medical equipment under their control is suitable for its purpose, properly stored and maintained and that staff are adequately trained in its correct use. Healthcare Professionals and Support Workers - should be aware at all times that they are personally and professionally accountable for ensuring that they are adequately trained and that they use medical devices safely. They are also personally and professionally accountable for ensuring that the medical equipment that they use is safe, correctly maintained and prescribed, and that it is used correctly and in accordance with the manufacturer s instructions. They will only use equipment for which they have received formal, recorded training and therefore which they are competent to use correctly and safely. Where patients are provided with equipment it will be the responsibility of staff providing the equipment to ensure that patients are given adequate instructions in its correct operation. Where necessary, specialist or technical advice will be provided either directly through the Facilities and Estates Department, EBME provider or by the supplier/manufacturer. In the application of this policy, reference should be made to relevant clinical guidelines, policies, procedures and protocols.

6 5 Medical Devices Policy/C/YEL/gen/02/v4.0 For further information and advice, all staff connected in any way with the management, purchase or use of medical devices should read: a current copy of the Medicines and Healthcare Products Agency Managing Medical Devices DB2006(05) the Medical Devices Agency booklet entitled Equipped to care the safe use of medical devices in the 21 st century published by the Medical Devices Agency in ISBN Devices in Practice a guide for professionals in health and social care Medicines and Healthcare Products Agency August 2008 If staff have difficulty in obtaining any of the above documents, they are advised to contact the Trust s Medicines and Healthcare Products Agency Liaison Officer on Infection Prevention and Control Nurse Team - will set and monitor the standards of decontamination of medical devices and that they are decontaminated and stored in line with legislation and best practice requirements including standard infection prevention and control precautions. Purchasing Officers - will ensure that the Heads of EBME services at Good Hope Hospital and Royal Shrewsbury Hospital receive copies of all PPQs for approval prior to raising orders for new equipment. Purchasing Officers will also pass copies of device orders to the Heads of EBME for information only when appropriate to do so. The Procurement Service, in conjunction with the Senior Estates Manager, will provide support and guidance to managers during the procurement process. After-sales service requirements will be managed by the Senior Estates Manager with support from the Procurement Service as necessary. This will include follow-up actions with suppliers (where appropriate) regarding defects and failures or other related matters. Director of Facilities and Estates - will ensure that there is an effective maintenance system in place for all medical equipment. This may include a combination of in-house maintenance teams, partner trust services (EBME), manufacturers (or their appointed agents), specialist contractors and consultants. The Director of Facilities and Estates is also responsible for ensuring that a library of users instructions from equipment manufacturers is maintained and that staff are able to access this when necessary. The Director will hold, update and manage the Trust s medical equipment inventory, equipment history database and medical equipment user-instructions library. Medical Device Co-ordinators - appointed from each Directorate throughout the Trust to represent equipment users and to act as the point of contact between various staff groups (medical equipment users) and the Medical Devices Group, the Director of Facilities and Estates, and others. Device co-ordinators will assist in: ensuring that medical equipment is used properly and safely within their area of responsibility, arranging training of staff, assisting when device recall is necessary and informing staff groups about the existence of this policy and safety information and how they may obtain advice or information regarding any aspects of medical equipment and devices. Medical Devices Group - will raise and discuss medical equipment and device management issues. The group will take steps to minimize risks associated with the

7 acquisition and use of medical equipment and devices and will ensure that best practice, new guidance, information and equipment and device developments are brought to the attention of all relevant staff groups, professional users and managers as appropriate. Primarily, the group considers risks and management issues in connection with mains and battery driven equipment. Terms of reference for the MDG can be found in Appendix A. The Trust s accountability arrangements chart can be found in Appendix G of this Policy. For the definition of the term medical device refer to Appendix F of this Policy. Further definitions of terms used in this document may be found in Appendix E. 3.6 Legislation EU Directives 90/269/EEC Directive concerning Manual Handling of Loads 90/385/EEC Directive concerning Active Implantable Medical Devices 92/59/EEC Directive concerning general Product Safety 93/42/EEC Directive concerning Medical Devices Acts of Parliament Employers Liability (Defective Equipment) Act 1969 Health & Safety at Work Act 1974 Consumer Protection Act 1987 {Part 1) Sale of Goods Act 1979 Statutory Instruments Control of Substances Hazardous to Health (COSHH) Regulations 1994 Electrical Equipment (Safety) Regulations 1994 Electricity at Work Regulations 1989 The General Product Safety Regulations 1994 The Medical Device Regulations 1994 The Active implantable Medical Device Regulations 1995 Display Screen Regulations 1992 Management of Health & Safety at Work Regulations 1999 Provision & Use of Work Equipment Regulations 1998 Personal Protective Equipment Regulations 1992 Workplace (Health, Safety & Welfare) Regulations 1992 Ionizing Radiation Regulations 1985 Ionizing Radiation (Protection of Persons undergoing Medical Treatment) Regulations 1998 Nursing Home (Lasers) Regulations 1984 Manual Handling Operations Regulations 1992 Supply of Machinery (Safety) Regulations 1992 Pressure Systems & Transportable Gas Containers Regulations 1989 Reporting of Injuries, Diseases & Dangerous Occurrences (RIDDOR) Regulations

8 4 DEFINITIONS 4.1 Medical Devices and Equipment Any instrument, apparatus, appliance, material or health care product (excluding drugs) used for a patient or client for the purpose of: Diagnosis, prevention, monitoring, treatment or alleviation of disease; Diagnosis, monitoring, treatment, or alleviation of, or compensation for, an injury or handicap; Investigation, replacement or modification of the anatomy or of a physiological process; Control of contraception. 4.2 Single-use Medical Devices - A Medical Device that is intended to be used on an individual patient during a single procedure and then discarded. The expression single-use on the packing of a medical device means that the manufacturer: Intends that the device be used once and then discarded; and Considers that the device is not suitable for use on more than one occasion; and Has evidence to confirm that re-use would be unsafe. This symbol, which indicates Do Not Re-use, appears on the packaging of single-use medical devices and may replace any wording: DB2006(04) also clearly states the following key points: Devices designated for single-use must not be re-used under any circumstances. The re-use of single-use devices can affect their safety, performance and effectiveness, exposing patients and staff to unnecessary risk. Single-use devices are not designed to allow thorough decontamination and resterilisation processes. 7

9 Reprocessing single-use devices may alter the nature of the materials from which the device is made and therefore its performance to an extent that makes it unsafe to re-use. The re-use of single-use devices has legal implications. Reprocessing may expose both staff and patients to health and safety and infection control risks and result in civil liability for any injury caused by the device. Bulletin DB2005(01) provides a list of examples of medical devices, which includes the following items that are or may be single use: catheters, dressings, examination gloves, IV administration sets, syringes and needles, vaginal specula and intra-uterine devices. Also many pieces of equipment, including patient monitoring equipment and nebulisers, have single use attachments. Patients may also use items that are single-use or single patient use. These include contact lenses, hearing aids, incontinence products and urine drainage systems. 4.3 Single Patient Use Medical Devices - A Medical Device that may be used for more than one episode on one patient only which may undergo some form of reprocessing between each use. Devices marked for single patient use must not be used for more than one patient. 4.4 Limited Use - A medical device that is intended only for a specific number of uses and can be reprocessed using an appropriate method. The number of times each individual item can be, and is, reprocessed is documented and appropriate records of re-use are maintained. Controls and monitoring arrangements are in place to ensure that the agreed number of reprocessing episodes is not exceeded. 4.5 Re-usable - A medical device that can be used for repeated episodes on different patients, but will need to be decontaminated appropriately between each episode of use, according to the manufacturer s advice. 5 PROCEDURE/COURSE OF ACTION REQUIRED 5.1 Central Alerting System (CAS) Central Alerting System is an electronic system used for the dissemination of safety alert notices. The system was developed by the Department of Health with the Medicines and Healthcare Products Regulatory Agency, NHS Estates and the National Patient Safety Agency. Safety alerts are broadcast to NHS Trusts, Primary Care Trusts, Ambulance Service Trusts, Health Authorities and Social Services for information and/or action. The urgency of each alert is determined by categories: a) Immediate action b) Action c) Update d) Information request 8

10 9 Medical Devices Policy/C/YEL/gen/02/v4.0 All alerts issued by the agencies are transmitted nationally and are received electronically. The appointed Central Alerting System Liaison Officer evaluates each alert and disseminates these as appropriate throughout the Trust to relevant staff groups through Directorate Risk Co-ordinators. It is the responsibility of the Liaison Officer to ensure that comprehensive records of safety alerts issued by Department of Health and other agencies are properly managed and maintained and records kept of dissemination, action taken by recipients and their comments. Directors and senior managers are informed of the dissemination of each alert and are invited to comment should they not be in total agreement with the Liaison Officer s choice of distribution. Electronic records are maintained by the Liaison Officer who is based in the Facilities and Estates office, St Georges Hospital, Stafford. The role of the Central Alerting System Liaison Officer is to: maintain contact information with the Department of Health and other agencies; nominate a deputy to receive incoming alerts; cascade alerts to relevant managers for action and forward transmission to staff groups as applicable; collate responses from those taking action following an alert; complete responses and ensure the Central Alerting System website is accurate and up to date. 5.2 Adverse Incident Reporting (Medical Devices) MDA (YEAR) (01) is the Medicines and Healthcare Products Regulatory Agency s most recent published guidance on the reporting of adverse incidents involving medical devices. This notice is updated and re-issued by the Medicines and Healthcare Products Agency on the 1st of January each year. The Trust s Medicines and Healthcare Products Agency Liaison Officer will ensure that an electronic copy of this notice is forwarded early in January of each year to all relevant members of staff for their information. An adverse incident is an event that gives rise to- or has the potential to produceunexpected or unwanted effects involving the safety of patients, users or other persons. Maintaining the implementation of the Trust s Management of Adverse Events, Serious Incidents and Near Misses Policy is the responsibility of the Risk and Claims Manager. However, all staff are responsible for reporting adverse incidents and near-misses involving any medical device or medicinal product through the Trust s Incident Reporting System. In addition to the appropriate management of the incident and completion of an adverse incident form, the Medicines and Healthcare Products Agency Liaison Officer should be notified immediately on , if any adverse incident or near-miss involves a medical device. The Medicines and Healthcare Products Agency Liaison Officer is responsible for investigating and reporting any medical devices incidents that indicate

11 adverse reactions or defective products or user errors to the Medicines and Healthcare Products Agency within twenty-four hours to facilitate the raising of alerts to the entire NHS if appropriate. A copy of the completed incident form should subsequently be sent to the Medicines and Healthcare Products Agency Liaison Officer, St Georges Hospital, Stafford. In any event, the senior line manager must be informed of the incident at the earliest opportunity. Any equipment or medical device involved in an incident, together with other material evidence (e.g. packaging of a single use device), should be taken out of use immediately, clearly identified and labelled and stored safely in a place where it is secure and cannot be interfered with by the person reporting the incident until further investigation by the Medicines and Healthcare Products Agency Liaison Officer or others has been completed. The serial number, type of equipment and other details regarding the equipment, including the follow-up action taken, must be recorded on the incident form. Adverse incidents in medical devices may arise due to shortcomings in: the device itself; the instructions for use; servicing and maintenance; locally initiated modifications or adjustments; user practices, user error, inadequate training; management procedures; the environment in which it is used or stored; incorrect prescription. All staff at all levels (including contractors) are to be made aware of their personal and professional responsibilities and of the procedures to be used to report adverse incidents and to isolate and retain defective items as necessary. For further information on the reporting of adverse incidents, refer to the latest Medicines and Healthcare Products Agency guidance issued on 1 st of January each year. [Medicines and Healthcare Products Agency YEAR (01)]. 5.3 Training Staff Training Training is a key element in device safety. Managers are required to formulate training programmes for new members of staff and arrange for ongoing training as necessary for existing staff. Training of staff on designated items of equipment is to follow the guidance laid out in document Verification of competencies and safe use of medical devices Nov A competency framework is being developed and will be in place for all areas by the end of Some manufacturers offer free training, others may charge for the service. All training given must be recorded and records held both locally by the service manager and corporately by the Training department. Training takes many forms and includes: training for professional users; instructions supplemented with training; 10

12 consideration of training needs when a new device is introduced; generic and specific training for technical staff; training needs for effective maintenance work and access to manufacturer s training courses; training for end-users; training for carers. Training in the safe use of equipment for lifting and handling must also be considered. Managers of staff groups are to regularly remind staff of their personal and professional responsibilities regarding the safe use of medical devices and adverse incident reporting. This information must be conveyed to new staff as part of their induction training. Regular reviews must be undertaken to ensure that the procedures are effective and are being followed. Professional users are regarded as being trained persons who operate a device for the benefit of a patient or client. The patient or client who uses the device is regarded as being the end-user, if the end-user has a responsibility to use a device for their own treatment, it must be ensured that adequate instruction has been given and documented. The patient or client ability to use the equipment must be considered as should the environment. It is expected that professional users will understand the normal operation of all devices they use. Where relevant they should: be aware of differences between models of a given device, where these affect safety or device function; be able to re-assemble the device if it needs dis-assembling for cleaning, and fit relevant accessories; be able to set the controls appropriately; be able to link the device to a patient effectively, and cause the minimum of discomfort; be able to show and explain to the patient/client how to use the device safely and effectively. If the device malfunctions, staff should be able to: recognise malfunctions; correct them, or withdraw the device from service; contact appropriate personnel for advice or assistance (if necessary); ensure that an Incident Form is completed and the adverse incident reporting procedure is followed when necessary (see section 5.2). When the device is removed from service, or prior to it being transferred to another patient, professional users should know how to clean it and how to organise the effective decontamination of it in accordance with Medicines and Healthcare Products Agency DB2003(05). (For further information, refer to 5.9 and Appendix D.) The National Audit Office recommends that NHS Trusts consider how to make best use of medical engineering departments and other expertise in user training. Contact the Estates Department for advice or assistance if necessary. 11

13 5.3.2 End user Training Patients / clients or their carers who use devices are deemed to be the end-user. Clinical supervisors need to ensure that training for end-users enables them to use a device safely and effectively, and to perform any necessary routine maintenance tasks. For example, end-users of ambulatory infusion pumps should be aware of how the device works, including special features such as bolus delivery, and the risks of siphoning if a syringe is removed from a driver. It is also essential that end-users be provided with information contained in manufacturers instructions and that it is explained and, where necessary, expanded upon. When equipment is loaned to a patient, it is essential that the patient be provided with instructions and that they have been understood. It is equally important to ensure that the provision of such instructions is suitably documented and that patients sign for their receipt. When instructions are not returned with loaned equipment, managers should ensure that copies are maintained and a new set issued as required. User instructions or labels may be attached directly to certain types of equipment. In such cases managers should check that these are current and intact before re-issuing equipment. Details of advice, training and information given to the end-user should be clearly documented by the member of staff giving the advice, in the patient / client s health or care record. 5.4 Procurement of Medical Devices Standard List of Medical Equipment When appropriate, all new equipment should be chosen from the Trust s Standard List of Medical Equipment which will be compiled and maintained by the Trust s Medical Devices Group (MDG) with input from suitably qualified professionals, technical specialists, device co-ordinators, end-users and others. The list will be compiled with respect to guidance given by the Medicines and Healthcare Products Agency in consideration of their evaluation programmes, information relative to safety, consideration of CNST issues, compatibility with existing equipment, value for money, cost-in-use, consumables, maintenance, availability of technical support, staff training needs, reliability of equipment, clear and concise instructions, ease of use, reliability, etc. The Medical Devices Group will regularly review and update the list. The Trust s purchasing department will inform the Medical Devices Group of any equipment that is requisitioned but does NOT appear on the Standard List of Medical Equipment prior to purchase and/or use. The Trust s Procurement Service will analyse each request for a new medical device and check to ensure that it is included on the Standard List of Medical Equipment. If the equipment has not been purchased in the recent past, the purchasing officer will ask the supplier to complete a Pre-Purchase Questionnaire form. The EBME departments (Good Hope Hospital, Royal Shrewsbury Hospital) and Infection Control leads will check that the information given on the Pre-Purchase Questionnaire is acceptable, and will inform the Purchasing officer of the decision to proceed or otherwise and will raise any 12

14 issues which need to be brought to the attention of the purchaser, requisitioner or maintenance department. Consideration of the following list of actions prior to purchasing a medical device will help in minimising the risk of an adverse incident. Should a prescriber or device purchaser wish to obtain and use a device that is not on the standard equipment list, they must consider the following criteria: Has the device or equipment specified been selected and acquired in accordance with this policy and the recommendations of the Medicines and Healthcare Products Agency and National Audit Office? Has the Medicines and Healthcare Products Agency produced a device evaluation publication relative to the device required? If so, has the publication been referred to by the prescriber and are they still satisfied with the specification of the device? Which safety and performance standards have been complied with? Do Medicines and Healthcare Products Agency publications reveal persistent problems? Reliability have other users experienced problems or failures? Service support are spare parts readily available and is service support guaranteed? For how long? Is response time guaranteed and acceptable? What are the recommended service intervals, frequency of checks and need for calibration during operation of device? The purchaser/prescriber must make allowances in their budgets for ongoing maintenance of each device. Does the manufacturer/supplier offer free access to technical advice for professional users and technical staff? Is there a 24-hour helpline available? Are staff that will use the device familiar with it? Have they had formal recorded training and are therefore competent to use it? Is there a device competency format in place? Diversity will this choice of device increase the number of types of device is use, and could this be to the detriment of equipment standardization and/or staff training needs? Does the device required appear on the Trust s standard list of equipment that is compiled and maintained by the medical devices group? Has the manufacturer/supplier confirmed that the device carries a CE mark? Has a Pre-Purchase Questionnaire form been submitted by the manufacturer/supplier and has this been approved by the EBME department? Has the device been prescribed by staff with appropriate professional qualifications and suitable experience, backed by appropriate administrative and technical support? Have the total costs of purchase (including maintenance/servicing, training and running costs) been taken into account when purchasing and do the department budgets allow for future costs? Do the likely benefits outweigh these costs? Life cycle/replacement (how long will the device last?) Fitness for intended application? The device must meet the user organisation s performance specification. Unnecessary features may be a disadvantage, e.g. complicated devices may break down more frequently or may be more difficult to use and/or understand. 13

15 Guarantee/warranty are these negotiable? Can the device be decontaminated easily using equipment that is available within the Trust? (Please contact the Infection Prevention and control team for advice if required.) Any device which is borrowed from another organisation must go through the formal acceptance procedure described in [Refer to MDA SN 2002(17) and SDHSN 2003(02)]. Consideration should be given to the appropriateness of devices owned and used by patients. The Trust is not responsible for the maintenance of equipment owned by the patient, but advice on correct use and maintenance should be given when appropriate. Staff who modify existing devices, or use them for purposes not intended by the manufacturer, can be considered as being the device manufacturer under the Medical Devices Regulations and such actions have significant safety and legal implications. This practice is therefore not permitted under any circumstance Devices containing mercury Many items of hospital equipment such as manometers, thermometers, sphygmomanometers and electrical controls, may contain metallic mercury. The superficially inert appearance of mercury is misleading. If handled, mercury is easily absorbed through the skin. It is volatile and mercury vapour is much more toxic than is generally appreciated. Evaporation of spilt mercury in poorly ventilated areas may rapidly lead to concentrations in the air above the recommended threshold levels that may safely be breathed. Continued exposure may lead to neurological or psychiatric disease. Human disease is usually associated with using large quantities of mercury industrially or in laboratories. However, the effects of mercury vapour over prolonged periods are cumulative. All spillages should be cleared up as soon as is practically possible. When purchasing devices, consideration should be given to using alternative electronic devices that do not contain mercury. Electronic devices are competitively priced when compared to the equivalent mercury tube devices. 5.5 Prescribing of Equipment All equipment-selection decisions made by the Trust are to be made only by staff with appropriate professional qualifications who have suitable experience. When appropriate, all new equipment shall be selected from the Trust s Standard List of Medical Equipment. Decisions to purchase are to be backed by administrative and technical support. If necessary, risk assessments should be in place. In addition, where joint working arrangements are put in place and involve the crossing of professional boundaries in prescribing, providers should clarify and record where professional and legal responsibility for prescription lies. In all cases the patient/client s ability to use the device safely and comfortably must be assured. The environment must also be considered when prescribing. 14

16 5.6 Written Instructions Summary Good clear instructions have a crucial role in the safe and effective use of medical devices. The Medical Devices Regulations make the manufacturer responsible for supplying appropriate instructions with all new devices. The Trust will ensure that professional users and end-users have access to manufacturers instructions and that, when necessary, the information in the instructions is explained and expanded upon during training. Staff may need to consider adding to or replacing manufacturers instructions in cases where a) they are regarded as being inadequate because of the context in which the device is being used, b) the instructions are lost, have deteriorated or been defaced or c) because users have cognitive or other problems. Where loan equipment needs a new set of instructions each time it is issued, end-users will be given a set of written instructions and will be made aware of their importance. When manufacturers update instructions they will be requested to send these to a nominated person within the Trust (i.e. Medicines and Healthcare Products Agency Liaison Officer or EBME department) Legal Requirements Manufacturers instructions, as well as being practically helpful, make an important contribution: to patient and professional user safety; from a legal point of view. Instructions may be either part of the labelling of a device, or given in a separate manual. The Medical Devices Regulations have requirements covering the provision of adequate instructions and labels. Every device must have instructions to ensure it can be used safely and to indicate the training needs of potential users. (There are exceptions for some low and moderate risk devices). Manufacturers are legally bound to supply information about the nature and frequency of the maintenance and calibration needed to ensure that devices operate properly and safely at all times. In accordance with regulations, manufacturers affix permanent labels to new equipment to indicate any special storage or handling conditions. Safety issues do not stop with the device itself. Professional and end-users awareness of relevant information is a crucial and possibly a legally decisive factor. Professional users should refer to manufacturers instructions when prescribing devices. Instructions should give indications for and against the use of a device, including the type of use intended and categories of patient/client for whom the device is suitable. They should describe risks and side-effects to the patient, allowing prescribers to weigh these against expected benefits. 15

17 Particular care and diligence is necessary when prescribing bed rails. A number of fatalities have occurred in recent years. Risk assessments should be in place if bed rails are prescribed. For further guidance, refer to publications MDA/2004/007 Bed rails: twin bar design and DB2001(04) Advice on the safe use of Bed Rails. Both publications are available on the Medicines and Healthcare Products Agency website. In case of difficulty, contact the Trust s Medicines and Healthcare Products Agency Liaison Officer Instructions for the end-user Extra care is needed in the case when the end-user is a patient for whom the device has been prescribed. Providers of equipment for end-users should be aware of the legal provisions under which they may incur liability, corporately or individually. Prescribers and providers should be aware that failure to pass on the manufacturer s original instructions on how to use a device to the end-user may not only compromise the end-user s ability to use the device safely, but may also lay the provider open to legal liability. For example, failure to pass on the manufacturer s instructions about safe use of a product could be seen to be the cause of an accident or incident - which could lay the Trust open to legal liability End-users with particular problems Some users with particular disabilities or medical conditions will need special instructions and training from their prescriber and/or clinical supervisor. Basic safety and maintenance information will also need to be supplied to all users by administrative or stores staff. Thus, the manufacturers instructions about safe use and maintenance should be passed on to all end-users. However, in addition, the prescriber and/or clinical supervisor may give additional specific information to the user and the carer in the light of their particular needs and daily routines. Sometimes the basic information may go beyond aspects of the hardware itself and its basic use and indicate generally who might or might not use it safely Suitability of manufacturer s instructions Prescribers and/or clinical supervisors need to be aware that some end-users (for example people who are blind or confused) will not have access to the information in the basic instructions and will need special training. In such cases, the Trust may supply its own instructions, though it will need to do so carefully since defensive legal advice might suggest that this invites legal liability. Equally, however, the provider and/or clinical supervisors may be inviting liability if they knowingly pass on inadequate instructions supplied by the manufacturer. The Trust may wish to impose- as a contractual condition when operating a tendering process for purchase of the items of equipment- that the manufacturer must supply adequate instructions; the adequacy to be determined by the purchaser, who must review the instructions and agree their content. 16

18 If Trust staff draft their own instructions, they should submit them to the manufacturer or the Medicines and Healthcare Products Agency Liaison Officer for approval prior to using them Evidence of Giving Instructions In the event of litigation, the Trust will need to be able to call on evidence that instructions were given to end-users in respect of certain types of equipment. To this end, reference should be made in the patient s notes or users of equipment should be requested to sign statements to the effect that they have received written or oral instructions and understood them Providing Instructions with Loan Equipment Manufacturers will provide good quality user instructions with all new devices. A copy of these should be passed on to the end-user of the equipment. Often, the instructions will not be returned with the equipment, thus when the provider comes to reissue the equipment, staff will need to adopt one of more of the following options: Strategy Keep master copy and photocopy. Request additional sets from manufacturer or contact the Estates Department. Attach instructions rigidly to device. Some manufacturers screen print onto instrument cases (e.g. infusion pumps). Comments May need manufacturer s permission. Instructions must be for the relevant model. Attached instructions must survive cleaning, decontamination, wear and tear. Manufacturers sometimes issue revised instructions, incorporating safer methods of using devices and clearer guidance. They will be requested to forward copies of these to the relevant equipment co-ordinators who will have a procedure for keeping track of all the sets of instructions for equipment used in their departments, and for replacing them with revised versions when necessary. 5.7 When a New Device is Delivered Receipt of devices On receipt of new equipment, acceptance checks aim to identify faults with any product or goods that have been damaged in transit. Tests to discover whether a device is suitable for its intended application or whether it complies with standards are inappropriate after delivery, therefore this information must be considered before a device is ordered. The Medicines and Healthcare Products Agency encourages manufacturers to include a list of suitable acceptance checks in the maintenance manual provided with each device. On receipt of all new medical equipment, the EBME department technician will carry out checks for visible damage and will perform all necessary acceptance, calibration and 17

19 performance checks. Functional checks should be carried out by the professional user or the end-user each time a device is used. Periodic calibration checks and safety tests should only be performed by staff that have been trained to do so. On delivery, the EBME department will establish if there is a need for the device to be periodically recalled for maintenance or testing. If it requires periodic maintenance, a suitable asset label with text will be attached to the device giving the date due for the next service. Large complex devices need specialists to install and commission them. The Estates Department will organize this on behalf of Trust staff/managers. All new, portable, electrically-powered medical devices are delivered to the EBME department. On delivery, each device is given a unique asset number. Other details such as make, model and serial number are recorded and entered onto a database. This information is held until the device is eventually taken out of service at the end of its useful life. Life-cycle history- including maintenance records- is added to the database. All such records are maintained by the EBME department. When a new device is first put into service, records need updating, planned preventative maintenance put in place and staff may need additional training. Professional users should be aware when they are the first person to use a new device Acceptance Checks Acceptance checks are carried out to ensure that goods: have not been damaged in transit, are as specified on the purchase order, perform correctly and accurately and pass electrical and other safety tests. They also serve to identify faulty product items that have slipped through the manufacturer s quality assurance processes. New medical devices must not be used until they have had the appropriate acceptance check/test undertaken Acceptance Procedures Comprehensive acceptance checks must be carried out on complex medical equipment some of which may need to be assembled, installed and commissioned on site. In these cases, installation, commissioning and performance validation will need to be carried out by qualified persons and/or the manufacturer. For portable equipment, a variety of acceptance testing procedures may be necessary - electrical safety tests for example. Manufacturers may recommend certain forms of acceptance testing in the maintenance manual supplied with the device. Some medical devices that are not mains electrical or battery-driven may be delivered directly to the requisitioner or end-user. However, all equipment new to the organisation (on loan as well as newly purchased devices) should be thoroughly checked before being issued to users. 18

20 5.7.4 Checking and testing of a new or recently repaired device Medical Devices Policy/C/YEL/gen/02/v4.0 Before using a new or recently repaired device for the first time, the end-user, carer or professional user should check it for correct functionality and performance. Persons carrying out checks should be adequately trained and competent to do so Storage of Medical Equipment, devices and associated consumables Apart from possible dangers to the end-users of the equipment, poor storage conditions also put the organisation at legal risk. When storing equipment the following checklist should be observed: TOPIC Physical Conditions Storage system Separation of equipment for decontamination (and/or repair) from equipment ready to issue Stock Control CONSIDERATIONS Avoid dirty or wet storage conditions. Avoid excessive temperature or humidity. Labels or symbols on packaging should indicate appropriate storage conditions. Avoid stacking material too high- fragile equipment stored too far off the ground is likely to be damaged should it fall. Ensure adequate space and separation for isolation/quarantine purposes. Ensure adequate labelling. Ensure effective stock control procedures are in place so that earliest deliveries are not issued first. Avoid excessive storage times which can cause rubber components to set in position and lubricants to migrate in motor- driven devices. Shelf life of batteries and sterile products must be closely monitored and controlled. Rechargeable batteries may be irreparably damaged if not subjected to regular charge/discharge cycles Procedure for Starting to Use a New Device The following procedures must be followed: Check that the device has a label on it that states that the device has been tested. Observe the next service due date (for maintainable equipment only). Read the manufacturer s instruction manual. Take a copy for record purposes, as these manuals/booklets are easily lost. Become familiar with the controls and indicators. Note any requirements for end-user periodic maintenance checks and ensure that this is brought to the attention of the end user. Where applicable, ensure that stocks of consumables are readily available. 19

21 20 Medical Devices Policy/C/YEL/gen/02/v4.0 Consider any additional staff or user training needs. Update training records and the locally held equipment-training list. Do not allow the use of any device if appropriate end-user training has not been given. Ensure that the end-user has been given a copy of the manufacturer s user instructions. 5.8 Maintenance and Repair Introduction Prior to the purchasing of equipment, managers need to make a decision regarding the most appropriate strategy for repairs and planned preventative maintenance: to use an in-house engineering department, a third party servicing organisation or manufacturers servicing facilities. The Estates Department are able to offer advice if required. Maintenance of equipment may be carried out either by trained in-house engineering staff, EBME technicians employed by another NHS Trust or specialist contractors/ suppliers. Refer to Appendix B for further guidance Periodic Planned preventative maintenance Manufacturers guidance will be followed concerning the frequency of planned preventative maintenance and the checks and operations to be carried out. Following periodic maintenance, the maintenance organisation will attach a label to indicate the next service date due. It is the clinical supervisor or end-user s responsibility to ensure that equipment is within its maintenance period. An Estates Department recall system is in place, but this is limited in its effectiveness as users rarely inform the department when equipment is moved from place to place, making the tracing of equipment extremely difficult. Staff are advised and encouraged to inform the Estates department when devices are transferred from place to place. Refer to Appendix C for detailed procedures regarding planned preventative maintenance for users Routine Maintenance Routine maintenance is the responsibility of professional users and end-users and may involve regular cleaning, preparation for use, filter changing (if appropriate), and the regular performance checking of devices. It includes inspection and device care operations performed by end-users and professional users, as distinct from planned preventative maintenance operations and/or recalibration procedures carried out by engineers or technicians. End-users in the community will perform a limited set of operations such as: Simple day-to-day equipment care, including cleaning. Periodic battery replacement or battery re-charging. Noting when malfunctions or obvious damage has occurred, and withdrawing the device from service (adverse incident). Contacting the servicing organisation. Ensuring that end-users receive appropriate training.