The following terms have been defined for the purpose of the bulletin:-

User organisation; A device owner, which either uses devices (e.g. a hospital trust) or loans them to end-users (e.g. a community store).

Service provider; Any organisation or individual providing repair or maintenance on a medical device.

DB2000(02) is aimed at those within user organisations with responsibility for device and equipment repair and maintenance. This will include managerial, technical and clinical staff. It covers the management of the repair and maintenance process, and sets out good practice for the organisation that carries it out.

• The guidance and recommendations in the bulletin supplement the duties of user organisations and service providers under health and safety legislation to ensure that equipment is adequately maintained. Failure to comply with health and safety law is a criminal offence.

• Whoever is carrying out the repair or maintenance activity, the service provider should always use the written service documentation from the manufacturer. The onus is on the service provider to demonstrate to the satisfaction of the user organisation that they meet the general recommendations of the bulletin.

• If any organisations or individuals other than the manufacturer undertake repair or maintenance work, they should ensure that it is done in accordance with the manufacturer’s instructions.

• The user organisation should ensure that its chosen service provider has the capability to carry out the work. It is the responsibility of the user organisation to ensure, as far as possible, that equipment continues to operate in accordance with its original specification after repair.

• User organisations and service providers are reminded of their duties under health and safety legislation to ensure that repairs and maintenance are only done by those who are competent to do the work.

A medical device service provider may be:-

• Manufacturer service organisation

• Authorised service agents

• Multi-vendor service providers

• Third party service providers

• In-house service providers: - A user organisation which undertakes repair and maintenance on its own devices, and usually on its own premises. However, if a clinical engineering department (or similar, biomedical engineering, medical physics department, etc.) undertakes repair and maintenance activities for another organisation, such as a nearby trust or medical school (outside its own legal entity) then it does so as a third party service provider.
• All those undertaking repair and maintenance should be able to produce written evidence of appropriate training, possibly as part of the documentation required by a quality system They should also be able to demonstrate that they are being kept up-to-date on new maintenance techniques, consistent with the devices they are servicing.

The user organisation needs an appropriate strategy for repair and maintenance. The choice may include one or a combination of the following:-

• The device manufacturer.
  An in-house department.
  An independent service provider.
  A managed service provider.

• User organisations should only use a service provider which can demonstrate compliance with relevant quality system standards, for example, BS EN 46002 or BS EN ISO 9002.

• The user organisation should ensure that the service provider has adequate insurance in place.

The contractual agreement with the service provider should clearly describe the level and type of service required by the user organisation and should include, where appropriate:-

• reference to manufacturer’s written instructions;
• availability, source and traceability of spare parts;
• notification of any changes, including the use of alternative spare parts or methods;
• training of personnel;
• quality assurance systems in place;
• requirement for adequate record keeping;
• use of sub-contractors.
• The user organisation should take all reasonable steps to ensure that a device is repaired and maintained appropriately.
• A user organisation could be held responsible under health and safety law and civil liability in the event that a patient or member of personnel died or suffered personal injury or damage as a result of a user inappropriately repairing or maintaining a device.

Particular types of devices and equipment are covered by legislation, which may impact on their repair. Health and safety legislation usually refers to responsibilities of the employer, rather than ‘user organisation’ which is used in the bulletin.

Health and Safety at Work This Order covers the general duty of care of an employer to his employees. If the employer allows the poor repair or maintenance of a device, he may be in breach of health and safety law. The Order also refers to the responsibilities of the employer to non-employees, e.g. the patient and the general public.

Control of Substances Hazardous to Health Regulations Exposure to certain hazardous substances (including biological agents which may cause infection) is covered by these regulations. The user organisation/employer is required to undertake a risk assessment to determine, amongst other requirements, the precautions necessary to prevent or control exposure of users, patients and others to the substance. User organisations therefore need to ensure that the repairer is not exposed to these substances when carrying out repair or maintenance.

• Other Legal Devices should be safe to handle by any personnel that may come into contact with them during the course of repair or maintenance.

Appendix 1. brings together some of the key points raised in the bulletin by providing a list of questions to which the user organisation should seek satisfactory responses, before entering into an agreement with any service provider.

The responses to the questions should be supported by documentary evidence and site visits, where appropriate.

Appendix 1. - Questionnaire on repair methods, process and standards of operation.

• The user organisation should seek satisfactory responses to the following key questions from all those being considered for maintenance and repair activities.

• The responses to the questions should be supported by documentary evidence and site visits, where appropriate.

• If the responses received are not ideal then you must assess the response in light of potential risk to patients and users.

This questionnaire applies to the following device(s):- e.g. Infusion pumps, Electrosurgical units (surgical diathermy), Anaesthetic machines, Patient Ventilators, Medical Gas Cylinder Regulators/flowmeter, Defibrillators, Suction pumps & Controllers, External Pacemakers, Dialysis machines, Physiotherapy, Automatic Tourniquets, Endoscopic, By-pass Pumps, IAB Pumps, Imaging, Physiological Monitoring, Patient maneuvering and tissue care

1. Information on repair and maintenance methods
   • What is the source of your repair and maintenance instructions ?
   • What arrangements do you have for obtaining these instructions ?
   • How do you ensure that you are kept up-to-date with the latest instructions from the manufacturer ?
   • What level of detail is the information provided by the manufacturer and is this sufficiently detailed to enable repair and maintenance tasks to be carried out effectively ?
   • What is the experience and training of the repair and maintenance personnel ?
   • What evidence do you have of individual personnel training ?
   • How do you ensure that the personnel are kept up to date with training ?
   • How do you propose to manage advisory notices [such as Hazard and Safety Notices] sent to you by the user organisation and implement their advice where relevant ?
   • How do you propose to manage advisory notices received by the manufacturer and implement their advice where relevant ?
2. Repair and maintenance process
   • What is your liability for repair and maintenance ?
   • What repair and maintenance instructions are used ?
   • If using repair and maintenance methods not specified by the manufacturer, how have you demonstrated its suitability ?
   • What spare parts are being used ?
   • Where do you source your spare parts ?
   • Where do you source your spare parts if they are not available from that specified above ?
   • If using spare parts not specified by the manufacturer, how have you demonstrated their suitability?
   • What evidence do you have of the arrangements for obtaining spare parts ?
   • Do you ever use refurbished parts, if so under what circumstances ?
   • How do you document the repair and maintenance process ?
   • What records do you keep and for how long ?
   • How would you notify the user organisation of any changes in spare parts or repair and maintenance methods ?
   • When would you notify the user organisation of proposed changes in spare parts or methods ?
   • When would you implement a change in spare parts or method ?
   • Do you sub-contract any aspect of the repair or maintenance process, if how is this controlled ?
   • What tools and test equipment do you have to undertake repair and maintenance ?
   • What consumables do you use in the repair or maintenance process ?
   • Where do you source the consumables used in the repair method ?
   • How do you maintain the repair tools and test equipment ?
3. Quality systems
   • What quality system do you operate ?
   • Has the system been independently assessed and if so by whom ?
   • How do you ensure that the service provider reports conditions which have the potential to cause a device failure or otherwise compromise the clinical outcome ?
4. Contractual agreements
   • Do you fully understand the requirements of the user organisation ?

Appendix 2 – Questionnaire on service provision issues

• The user organisation might also consider the following service related questions, which may or may not be relevant or critical depending on the level of service required.

Question

1. Provide details of other user organisations that you provide a service to [include name of organisation, address, contact name, device type].
2. What is the experience of other user organisations named above ?
3. Do you provide a loan service to replace equipment that is undergoing repair or maintenance?
4. If a loan service is provided, how do you demonstrate the loan device is safe and fit for purpose ?
5. Do you operate an emergency call out service for fixed installation equipment ?
6. How do you handle broken devices or equipment that cannot be repaired immediately ? For example, where the fault might not be easily identifiable.
7. Do you keep supplies of all spare parts on site ? If not, what is the expected delivery time for spare parts ?
8. Do you operate 24-hour service, if not, how would you handle out of hours repairs ?
9. What is the response time for both off-site and on-site repairs ?
10. What other service options can you provide ?
11. Provide a summary of the history of the repairer and the current personnel structure.
12. Are any IT systems used in managing the repair process. If so, provide details.
13. Do you offer a help desk facility ?
14. What is the procedure for obtaining a repair ?
15. Do you offer a remote diagnostic support service ? If so, how is this operated and supported ?
16. Do you provide software for fault finding ?
17. What documentary information can you provide on the repair or maintenance that has been undertaken and in what format is this delivered [e.g. computer print-out, worksheet] ?
18. Is there any equipment specified that you cannot repair or maintain ?
19. Can the user organisation have access to your facility at any time for inspection or audit ?
20. What contracts do you have with other organisations ?
21. Do you supply upgrades for software-driven devices free of charge ?

WOM Davis I.Eng. FIEE
June 2002