POLICY FOR THE MANAGEMENT, USE AND DISPOSAL OF MEDICAL DEVICES

Transcription

1 POLICY FOR THE MANAGEMENT, USE AND DISPOSAL OF MEDICAL DEVICES Amendments Date Page(s) Comments Approved by Re-naming of Management and Use of to include the Disposal of February 2007 February 2007 December 2010 December 2013 All All All Complete Revision Review of policy to comply with NHSLA standards Minor changes e.g. titles Non-Clinical Risk Committee Non-Clinical Risk Committee Chairman s action Safety and Risk Committee Chairman s action By: Paul Cooper, Head of Estates & Facilities Infrastructure Review date: Ratified by: Safety and Risk Committee (previously Non Clinical Risk Committee) Next Review Due: December 2016 Target Audience: All healthcare staff Equality Impact Assessment Carried Out By: Contact name for comments: Paul Cooper, Head of Estates & Facilities Infrastructure Paul Cooper, Head of Estates & Facilities Infrastructure Issue 4 Page 1 of 18

2 ASHFORD & ST PETER S HOSPITAL FOUNDATION NHS TRUST POLICY FOR THE MANAGEMENT USE AND DISPOSAL OF MEDICAL DEVICES See also: Health and Safety Policy Incident Reporting Policy Supplier Representatives Policy Trust Standing Financial Instructions Training for Clinical Staff Policy Cleaning and Disinfection Policy Supplier Representative Policy Single Use, Single Patient Use and Limited Use Policy Point of Care Testing Policy. 1. INTRODUCTION The purpose of this policy is to outline the systems and processes that will ensure medical equipment used within the Trust can be used safely. Equipment used within Imaging, Pathology and Pharmacy Departments have their own service arrangements and operational policies as these are specialist units. The MHRA Bulletin Managing - Guidance for Healthcare and Social Services Organisations (DB2006 (05)) November 2006 makes recommendations about the need for effective medical equipment management systems to be implemented in all healthcare premises. The Trust accepts the recommendations contained within the bulletin. 2. DEFINITION OF MEDICAL DEVICES The term medical device covers a broad range of products including those used every day in most healthcare settings and can be defined as any instrument, apparatus, appliance, material or healthcare product, excluding drugs, used for a patient or a client for the purpose of: Diagnosis, prevention, monitoring, treatment or alleviation of a 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 conception. This policy applies primarily to electro-medical equipment, although many of the principles apply to other equipment such as beds and wheelchairs. 3. POLICY AIMS The aims of the policy are: To increase staff awareness of the principles and importance of equipment management. To ensure that managers and individual members of staff are aware of their responsibilities in relation to the use of medical devices. To ensure that all medical devices are: suitable for intended purpose maintained in a safe and reliable condition used only be competent staff To reduce incidents involving medical devices. 4. RESPONSIBILITIES Issue 4 Page 2 of 18

3 4.1 TRUST BOARD The Chief Executive has overall responsibility for the management of medical devices and implementation of this policy within the Trust. 4.2 THE MEDICAL DEVICES GROUP The Group will oversee and coordinate the management of medical devices. These Groups will be broad based and include representatives from all Divisions and services departments such as estates, Procurement, clinical skills education, Health & Safety and Point of Care Testing (Pathology Services). 4.3 DIVISIONAL DIRECTORS AND HEADS OF DEPARTMENT Divisional General Managers and Heads of Department are responsible for ensuring compliance of this policy within their own Divisions and Departments. This includes: Systems are in place for adherence to this policy. There are adequate measures and resources to enable the provision of training. There are systems in place to ensure that staff are competent to use the medical devices. The procurement of medical devices is in accordance with Trust Policies. 4.4 WARD MANAGERS Ward managers will: Maintain and upkeep the ward medical equipment inventory. Authorise and be accountable for users of the equipment Assist and facilitate with training needs and maintain appropriate training records. Control the loan and use of medical devices 4.5 HEALTH & SAFETY ADVISOR The Health & Safety Advisor is responsible for assisting with reporting of incidents involving medical devices to the MHRA. 4.6 MEDICAL ENGINEERING MANAGER The Medical Engineering Manager is responsible for the dissemination of medical device alerts from the MHRA website. 4.7 EQUIPMENT USERS All equipment users are accountable for ensuring that they use medical devices safely. Equipment users must undertake training as required by the Trust for the training of staff on medical devices and every ward or department must keep its own record of the training. Users must not use or connect to patients any item of medical equipment on which they have not been trained. Users must also ensure that all defects and malfunctions are immediately reported to the Medical Engineering Team (through the Facilities Helpdesk) or the Point of Care Testing Team where appropriate and the equipment is withdrawn from service suitably labelled and decontaminated correctly. 4.8 MEDICAL ENGINEERING SERVICE The Medical Engineering Service and Point of Care Testing Team must: Undertake maintenance of medical devices Maintain a maintenance log Produce reports on medical devices reported as faulty Promote standardisation of medical devices Carry out acceptance tests and condemning procedures in accordance with MHRA recommendations Through the equipment library staff will: Provide medical devices to pre-defined clinical areas fit for purpose, clean and maintained Issue 4 Page 3 of 18

4 Provide, in conjunction with the Clinical Skills Education Manager, training in the safe and effective use of medical devices within their remit. The Point of Care Testing Team will: Provide point of care testing devices for which business cases have been approved by the Point of Care Testing Committee. These devices will have been evaluated and deemed to provide clinically acceptable results. Point of Care Testing devices will undergo verification checks by the POCT team before release for use. The Point of Care Team will provide training and manage competency in conjunction with the device users 5.0 PROCUREMENT OF MEDICAL EQUIPMENT 5.1 INTRODUCTION The aim is to ensure that: All medical equipment purchased by the Trust represents best value for money. All costs of purchase are considered, both the initial cost of the product and the ongoing costs of maintenance and consumables. All equipment meets relevant safety standards. Any agreed standardisation of particular brands of equipment is complied with. The Trust complies with guidance issued by the MHRA in the form of Safety Notices, Alerts and Bulletins. All prospective purchases must be discussed with the relevant budget holder at an early stage. Capital purchases (single items costing 5000 or more) have to be submitted on a Equipment Capital Bid Proforma for approval by the Medical Equipment Group (MEG). The purchase of any Point of Care Testing device must be approved by the Point of Care Testing Committee and budget allocated before procurement This policy applies to all purchases, whatever the source of funding, including charitable and research fund purchases. 5.2 STANDARDISATION The Trust uses local contractors, NHS Supply Chain and NHS Commercial Solutions. There are several; categories of equipment where the Trust aims to standardise by selecting a particular manufacturer s product. These include Infusion devices Dynamic mattresses Blood pressure/vital signs monitoring Defibrillators Tympanic thermometers Blood glucose monitoring devices Blood gas analysers Managers should check with the Procurement Department or Point of Care Testing Dept if appropriate before proceeding with a purchase to see if the equipment is included in the standardisation programme 5.3 SPECIFICATION Following business case approval. The first stage in the procurement process is to write a specification for the equipment, which includes user specific requirements, compatibility, safety and reliability, manuals and training, running costs (maintenance, consumables), availability of spare parts, ease of decontamination and installation costs. For more detail on factors to consider before acquisition refer to MHRA DB 2006(05) section 3.3. The Procurement Department can offer advice and templates to support you in this process. Issue 4 Page 4 of 18

5 5.4 PRE PURCHASE QUESTIONNAIRE (PPQ) (Appendix 1) incorporating decontamination requirements For electrical and electronic equipment a PPQ form is sent by the Procurement Department to the manufacturer which specifies British and International standards to which equipment must comply. The Estates Department and Sterile Services Department will undertake a technical assessment of this form and their approval is required before a purchase order can be raised. 5.5 COMPLIANCE WITH STANDING FINANCIAL INSTRUCTIONS (SFI) All orders/requisitions/quotations/tenders must be raised in line with the Trust s Standing Financial Instruction (SFI). In addition EU procurement legislation requires purchases over 111,676 + vat (Jan 2014) to be competitively tendered via Official Journal of the European Union (OJEU). 5.6 ACCEPTANCE CHECKS When equipment is first delivered, the Medical Engineering Service (MES) or The Point of Care Testing team will perform verification checks before any device is released for use. Checks will be carried out as outlined in the MHRA DB 2006(05) section MEDICAL EQUIPMENT LOANS 6.1 There are several different routes by which equipment may be loaned to, or between departments within the Trust. These include: Equipment loaned by suppliers (see 6.3) Equipment loaned temporarily from another hospital site (see 6.4). Loans within departments in the same hospital (see 6.2). Equipment owned by another organisation but on long term loan to the Trust (see 6.4). Equipment owned by the Trust but loaned for use outside Trust premises. Refer to Appendix 3 Loan of Checklist. 6.2 Wards and Departments loaning equipment to each other should maintain records of these loans so that the location of equipment is known. This record should include the make, model and serial number of the equipment. The manager of the department receiving loaned equipment should ensure that staff are competent to operate the equipment safely (see Training for Clinical Staff Policy). 6.3 Any equipment provided on loan or as a free issue by a supplier must be discussed with Procurement who will check to see if the supplier is registered on the Master Indemnity Agreement (MIA) If the supplier is not included on the MIA Register then the Procurement Department will arrange for the standard indemnity forms to be completed. Indemnity forms are required for equipment loaned for any purpose, including equipment on trial or replacement for faulty equipment. This avoids liability for loss or damage. Also refer to MHRA DB 2006(05)section With reference to MHRA DB 2006 Section Equipment on loan from organisations with a quality assurance system for device management is likely to be safer and more reliable than from an uncontrolled system. The medical device may require a unique local reference number, so that it can be recorded and traced on the local equipment management system. Any local reference number must be traceable back through to the supplier s and manufacturer s records for each device in case of future recalls or updates made by the manufacturer. Manufacturers instructions must accompany any piece of medical equipment on loan. 6.5 Any equipment that requires sterilisation or decontamination by use of an Automated Endoscopy Reprosessor (AER) should be supplied with manufacturers instructions for decontamination and the Sterile Services Department contacted prior to use. 7. EQUIPMENT INVENTORY Issue 4 Page 5 of 18

6 7.1 An equipment inventory is held within the Medical Engineering Service, a separate inventory is held by the Point of Care Testing department for Point of Care Testing devices. These databases records such information as: Make Model Serial Number Site and location Date of purchase Company Maintenance interval (schedule of maintenance) Lifespan Next service date Last service date Status Ownership 8. PROCESS FOR MAINTENANCE AND REPAIR 8.1 Maintenance of medical equipment is required to be undertaken as per the relevant equipment service schedule. All equipment will be registered on the equipment inventory database which includes the last service date and the next service date. 8.2 The routine maintenance and monitoring of equipment will be co-ordinated and managed by the Estates & Facilities Department through the Medical Engineering Service (MES) and in the case of point of care testing devices, by the Point of Care Testing Team (POCT). Equipment maintenance including calibration is the responsibility of MES or the POCT team (where appropriate) in conjunction with manufacturer or the service engineers where the device is covered by a service contract. 8.3 Where backlog maintenance is identified this work will be prioritised and dealt with accordingly. 8.4 An annual co-ordinated equipment audit will be undertaken. This is to ensure that areas identify equipment that is in their areas and to confirm service and maintenance is up to date. This will be initiated and planned by the Medical Engineering Service and POCT undertaken by ward and departmental managers. 8.5 Staff are responsible for noting when malfunction or damage has occurred, ceasing the use of the equipment and contacting the appropriate servicing department. 8.6 Equipment for repair should be clearly labelled identifying the suspected fault using the Trust Yellow tags (available from the medical equipment library) and removed from use. The user must contact the Facilities Help Desk or POCT where appropriate requesting that the item be repaired. In the case of the Facilities Helpdesk request a unique identifier will be given to aid tracking of repair. 8.7 Wards and departments should maintain accurate records of equipment sent for repair. Repeated malfunction of very old equipment may indicate a need for replacement. Point of care testing equipment downtime is collated daily by the POCT team and funding sought where equipment replacement is deemed necessary to ensure continuous service. 8.8 It is essential that medical equipment is cleaned and, where relevant, decontaminated prior to being despatched for service or repair (see Appendix 2). Advice may be sought from the Cleaning and Disinfection Policy (Infection Control team), Medical Engineering (Equipment Library staff)or POCT team. Issue 4 Page 6 of 18

7 9. EDUCATION AND TRAINING 9.1 Managers are responsible for ensuring that manufacturers instructions are available to staff and that their staff have the appropriate knowledge and skills to use any medical devices required. They should also, as part of individual staff development appraisals, identify any training needs. The POCT team are responsible for ensuring that standard operating procedures are available and staff are trained and deemed competent before being enabled to use a POCT device. 9.2 Individual members of staff are responsible for ensuring that they have received written and oral instructions and that they are competent to use any item of medical equipment before they attempt to operate it. If there is any doubt the individual concerned should consult their manager and report the training needs. 9.3 Where possible wards and departments should aim to standardise the makes of equipment used so staff are familiar and safe in using the equipment. It is the responsibility of the manager to ensure that adequate training is given to staff when new equipment is purchased or loaned. 9.4 Every department will hold their own training records. 10. REPORTING ADVERSE INCIDENTS RELATING TO MEDICAL DEVICES 10.1 An adverse incident is an event which gives rise to, or has the potential to produce, unexpected or unwanted effects involving the safety or wellbeing of patients, users or others. Adverse incidents involving medical devices may arise from various causes: A fault in the device itself Shortcomings in the instructions for use Lack of servicing or maintenance Locally initiated modifications or adjustments Shortcomings in user practice or training Environmental factors such as electromagnetic interference Any adverse incident relating to the use of medical devices must be reported via the Trust s Incident Report process (Datix) An adverse incident involving a device must be reported to the MHRA through the Trust s Health & Safety Advisor if the incident has led or could have led to: A death A life threatening Deterioration in health Temporary or permanent impairment of a body function or body structure Necessity of medical or surgical intervention to prevent permanent impairment or damage Unreliable test results leading to inappropriate diagnosis or treatment 10.3 The Trust Health and Safety Officer will act as the Trust s MHRA liaison officer. The liaison officer will ensure that device related adverse incidents are reported to the MHRA It is the responsibility of every member of staff who is aware of an adverse incident involving a medical device to report the occurrence. All incidents must be reported in line with the Trust s Incident Reporting Policy. In addition any incident involving a medical device must be reported immediately to the MHRA liaison officer. Issue 4 Page 7 of 18

8 Local action must be taken to ensure the safety of patients, users and others. The device must be taken out of use but otherwise left exactly as it was at the time of the incident. The equipment 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. In serious cases this record should be witnessed and the witness should also make a personal written record. The MHRA liaison officer or person authorised by the Trust MHRA liaison officer will take appropriate action and will quarantine the equipment pending investigation. Quarantining of small items may be achieved by the MHRA liaison officer or authorised person removing the equipment from the ward or department but larger items will be taped off and clearly signed DO NOT USE. Incidents will be reported to the MHRA via the online website It is the responsibility of staff at all levels to be aware of the procedures to be followed in reporting incidents and the isolation and retention of the equipment involved. The MHRA liaison officer will retain and collate copies of reports sent to the MHRA. The outcomes will be reported to the Trust s Group. 11. MHRA MEDICAL DEVICE ALERTS (MDA) AND THE CENTRAL ALERTING SYSTEM (CAS) 11.1 Safety alerts from the MHRA are sent to the Trust electronically via the Central Alerting System CAS. These are then distributed internally throughout the Trust via to relevant individuals for action. The Trust CAS liaison Officer is responsible for ensuring that alerts are dealt with appropriately within given timescales or deadlines and for reporting back through CAS. 12. DISPOSALS 12.1 Managers should consult the Medical Engineering Service about safe disposal of obsolete equipment. The Point of Care Testing Team will take responsibility for the disposal of point of care testing equipment according to the POCT Policy. Medical equipment may be considered for disposal as a result of its natural obsolescence, failure to meet current treatment standards, uneconomic or poor serviceability etc. Decommissioning and decontamination should be carried out prior to final disposal. For the decontamination of medical equipment, users should refer to the Trust s Cleaning and Disinfection Policy. A Declaration of Decontamination Status form should be completed (Appendix 2) The purpose of decommissioning is to make sure that the equipment is electrically and environmentally safe. A suitably qualified person must carry out decommissioning. As a minimum requirement the following steps must be taken:- Remove any mains power cord and external protection fuses and carriers. Open the unit, remove internal fuses and disable the power supply by clipping out key components e.g. smoothing choke, rectifiers, etc. Remove any supply back-up batteries. Remove other environmentally sensitive components. (If in doubt check with manufacturer) The removal of prosthesis in theatre are to be placed in a sharps bin and sent for incineration for disposal. The Manufacturer, Model and Serial Number of the equipment must be recorded and details passed to the buyer/scientific/technical items for disposal, to ensure accurate Asset Register records. The equipment must be labelled (a suitable example is shown below) and disposed of in accordance with the Trust s Management of Waste Policy. Issue 4 Page 8 of 18

9 DECOMMISSIONED & DECONTAMINATED READY FOR DISPOSAL 13. MONITORING The policy will be monitored by the Group. This is achieved through the quarterly meetings and the receipt of relevant reports. These include Product and Equipment Performance Monitoring Trust Incidents relating to Safety Alerts report Medical Engineering Services reports New devices introduced into the Trust. Membership of the Group includes representatives from Divisions to enable feedback to areas when required. 14. EQUALITY AND DIVERSITY This policy has been impact assessed in accordance with statutory requirements and a copy of the assessment is attached to the policy. 15. ARCHIVING This is a Trust wide document and archiving arrangements will be made by the quality department. 16. IMPLEMENTATION AND TRAINING This policy and associated procedures will be available to all staff via the Intranet. Hard copies of this document should be kept locally for easy reference. Managers are responsible for ensuring that their staff are aware of this policy and are kept informed of any changes or additions. The contents of this policy will be included in mandatory training and induction. 17. REFERENCES Standards for Better Health, Healthcare Commission, November 2006 Managing, guidance for healthcare and social services organisations, DB2006 (05) November 2006 Reporting adverse incidents and disseminating medical device alerts, DB2007 (01) January 2007 Medical Device Alert MDA/2007/01, January 2007 Equality Impact Assessment Summary Background Description of the aims of the policy Issue 4 Page 9 of 18

10 Context in which the policy operates Who was involved in the Equality Impact Assessment This policy has been developed to comply with the requirements of the Medical and Healthcare Products Regulatory Agency (MHRA) to ensure that all staff are aware of the procedures for dealing with medical equipment. Methodology A brief account of how the likely effects of the policy was assessed (to include race and ethnic origin, disability, gender, culture, religion or belief, sexual orientation, age) The data sources and any other information used The consultation that was carried out (who, why and how?) The policy is based on guidance provided by the MHRA and is not likely to have any Equality or Diversity implications. Key Findings Describe the results of the assessment Identify if there is adverse or a potentially adverse impacts for any equalities groups The policy is based on current legislation and there are no potential impacts for any equality groups. Conclusion Provide a summary of the overall conclusions The policy provides fair, consistent guidance on managing medical equipment. Recommendations State recommended changes to the proposed policy as a result of the impact assessment Where it has not been possible to amend the policy, provide the detail of any actions that have been identified Describe the plans for reviewing the assessment No changes recommended. Guidance on Equalities Groups Race and Ethnic origin (includes gypsies and travellers) (consider communication, access to information on services and employment, and ease of access to services and employment) Disability (consider communication issues, access to employment and services, whether individual care needs are being met and whether the policy promotes the involvement of disabled people) Religion or belief (include dress, individual care needs, family relationships, dietary requirements and spiritual needs for consideration) Sexual orientation including lesbian, gay and bisexual people (consider whether the policy/service promotes a culture of openness and takes account of individual needs Issue 4 Page 10 of 18

11 APPENDIX 1 PRE-PURCHASE DECONTAMINATION QUESTIONNAIRE PART 1 This form is intended to supply our organisation with information about your equipment prior to purchase. It is intended principally for pre-purchase information on all equipment, medical, non-medical including non-electrical items, and to give information prior to equipment being supplied on loan. Answer all sections, if a section is not appropriate indicate with N/A. Failure to do so may lead to your product not being purchased. Purchaser PPQ Master Reference: A. Product Details 1 Supplier Name 2 Supplier reference No 3 Tel No 4 Fax No 5 6 Generic Device Type 7 Device Model 8 Country of Origin 9 Manufacturer B. CE Marking (Tick or Circle as appropriate) 10 Does the product carry the CE mark? Yes No 11 Which Directive(s) does your device comply too? 12 Is the product a custom-made device (93/42/EEC)? Yes No 13 Is the product intended for clinical investigation (93/42/EEC) or performance evaluation Yes No (98/79/EC)? 14 If intended for clinical investigation provide evidence of risk assessment/management eg ISO C. Management System Standards 15 Is the manufacturer currently registered to any management system standards (eg ISO 9001, ISO 14001, ISO 13485, ISO 14971)? 16 If YES, please state the standard(s) certification body and frequency of audits: 17 If NO, further investigation is required. 18 Is the supplier's service / repair organisation currently registered to any management system standards? 19 If YES, please state the standard(s) and certification body: 20 If NO, further investigation is required. D. Other Standards Yes Yes No No 21 Other than management system standards which standard(s) does the product comply? If equivalency is claimed please supply appropriate evidence. Standard Test House Certificate Number Date Issue 4 Page 11 of 18

12 E. Hazards 22 Does the product contain a source of ionising radiation or is it capable of emitting ionising Yes No radiation? 23 Are there any specific hazards linked with the device? Yes No 24 If YES, describe: F. Decontamination / Reprocessing 25 Is the item intended to be processed / reprocessed? If NO, do not reprocess. Yes No What designation is the device Clean Yes Disinfected Yes Sterile Yes 26 intended to be prior to use? No No No 27 Is there a recommended maximum number of uses / reprocesses? Yes No 28 If YES, describe: 29 Are decontamination/reprocessing instructions supplied? Yes No 30 If YES, do manufacturer s instructions meet ISO 17664? Yes No 31 Is the device uniquely marked to allow tracking? Yes No 32 Are there any contra indications when used with other materials? Yes No 33 Are instructions available for safe disposal? Yes No 34 Is manual cleaning the ONLY cleaning method specified before disinfection or sterilization? Yes No 35 If YES, has this validation been carried out in operational use? Evidence will be required Yes No 36 If YES, how is the device disinfected to allow safe handling prior to sterilization? Describe: 37 During the manual and /or automatic cleaning process what are the minimum and maximum temperature and time that can be used for washing/cleaning, thermal disinfection, rinsing and drying? Time (Minutes) Minimum Maximum Temp ( 0 C) 38 Are there any restrictions on chemistries e.g. detergents, disinfectants and sterilants? Yes No 39 If YES, describe: Where chemical disinfection is to be used Time (minutes) Temp ( 0 C) Dosage (mls) 40 give the minimum/maximum time / temp / Min: Min: Min: dosage parameters. Max: Max: Max: 41 Can the device withstand autoclaving at o C for mins? Yes No 42 Has validation been carried out for UK routine steam under pressure sterilization parameters 134 Yes No o C for mins? 43 Is the item compatible with other sterilization methods? Yes No 44 If YES, describe: Yes No 45 Does reprocessing require the use of specified equipment? Yes No 46 If YES, please state equipment type (e.g. containers, processors, etc) and, where appropriate, parameters of operation (e.g. temp, pressure, etc): 47 Are tools required to aid dismantling/reassembly? Yes No 48 If YES, are they supplied with the device, describe : 49 Are lubricants required? Yes No 50 If Yes, describe: Issue 4 Page 12 of 18

13 51 Will lubricants affect the cleaning, disinfection or sterilization of the product Yes No 52 Do you provide decontamination / reprocessing training for your device? Yes No 53 If YES, is this free of charge? Describe: 54 Are the trainers you provide appropriately qualified and hold evidence of this? Yes No 55 If YES, describe: 56 Are reprocessing instructions available on the Web? Yes No 57 If Yes, give web address: 58 Is the item single use but can be processed multiple times within a pack/tray until used? E.g Yes No orthopaedic implants 59 If YES, how many times can it be reprocessed and how was this validated? Describe: 60 What is the total weight of the product including any containers that are supplied? Kg 61 Are there any specific storage conditions before and after processing? Yes No 62 Has the device been involved in any adverse incidents? Yes No 63 If YES, describe: G. Warranty 64 Please confirm that a copy of the warranty is provided on a separate sheet. Yes 65 Does the packaging of equipment meet the standardized packaging of instrument for sterilisation according to ISO and EN 868 H. Declaration When reference is made to this form and its attachments within the process of obtaining the item, we agree that the purchaser will be entitled to rely upon the contents and subsequent non-compliance with the statements contained herein will entitle the purchaser to seek redress. Name: Position: Date: Company / Address: Decontamination instruction review is required for any new purchase or loan devices that require decontamination. No purchases or loans should be accepted without the approval of the Trust nominated person for this purpose e.g. Sterile Services Manager. Issue 4 Page 13 of 18

14 PART 2 I. Other Information SERVICE / SPARES / INSTALLATION 5. Is service/repair information available? YES NO If NOT f.o.c. please state current price Indicate contents below: (Please state YES, NO or N/A) Full circuit diagrams Fault finding procedure Preventative maintenance Repair information Spare parts listing Are special tools/test equipment/etc required. If so supply separate list If YES, please state whether also available on: Disk Website If Web, please state address 6. a) In addition to the service/repair information/manual, will training be required before competent technical personnel can provide: (Please state YES, NO or N/A) First-line maintenance Planned preventative maintenance Calibration Repair b) Is the supplier able to provide this training for the purchaser s or a third party s technical personnel? YES NO If YES, will this be free of charge? Or chargeable? Indicate cost If NO, please indicate if details of an organisation that is able to provide this training are available on request? Supplier's Reference: YES NO c) Is the provision of service/repair information conditional upon completion of training? YES NO d) In order to undertake maintenance/repair/calibration, is any special software/test equipment/tooling required? YES NO If YES, please indicate that details of special software/test equipment/tooling are provided on a separate sheet: YES 7. a) Is the supplier able to provide an 'as required' repair/maintenance service in the UK? YES NO b) Is the supplier able to provide a contract repair/maintenance service? YES NO c) i) If YES, please confirm that details of repair/maintenance contracts are provided on a separate sheet. ii) If repairs are normally performed by the supplier on the purchaser's site, please state typical response time: If repairs are performed off-site, where will these be carried out? Company: Location: Typical turnaround time: iii) Is free of charge loan equipment normally available? YES NO YES 8. Please state if repair parts will be available to the purchaser s or a third party s suitably trained and equipped personnel: If YES, is the supply of repair parts conditional upon acquisition of repair information? YES NO YES Or training? YES NO 9. Please indicate when this model was first placed on the market: 10. a) For how many years from the date of last manufacture is the supply of spare parts guaranteed? b) Is the product still in current production? YES NO If NO, indicate year of last manufacture: 11. Is installation necessary? YES NO 12. If YES, please confirm that details of all services required are provided on a separate sheet: Will software upgrades be notified? Will this be supplied FOC? YES N/A YES NO Issue 4 Page 14 of 18

15 APPENDIX 2 DECLARATION OF DECONTAMINATION STATUS Where appropriate all equipment should be sent to Sterile Services for decontamination Description of equipment... Quantity... Please complete all sections deleting * as appropriate. A. Has this equipment /item been used in an invasive procedure or been in contact with blood, other body fluids or pathological samples? *YES / NO / UNKOWN B. This equipment / item could not be decontaminated. The nature of the risk and safety precautions to be adopted are:- C. This equipment has been suitably prepared to ensure safe handling / transport. *YES / NO / UNKOWN I declare that I have taken all reasonable steps to ensure the accuracy of the above information Department.. Contact Name... Signature... Position... Date... Issue 4 Page 15 of 18

16 APPENDIX 3: LOAN OF MEDICAL DEVICES FOR HOME USE CHECK LIST Attach patient Label: Equipment Loaned by: Does the patient/carer know the name of the device and the reason it is being loaned? Does the patient/carer know how to set up the device in the home? Has the patient/carer been trained in the use and functions of the device? Has the patient/carer been trained in how to deal with fail safe features e.g. alarms. If appropriate have the alarm limits been set? Does the patient/ carer require accessories? If so, do they know where to obtain these and how often? When was the equipment last serviced? When will it need to be brought back to the hospital for servicing? Does the patient/carer have a point of contact in the Trust for any queries? If relevant does the patient/carer have a contact point in case of emergency? If appropriate, equipment instruction leaflet given to parent/carer Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No Yes / No / NA Can the equipment be used abroad? Yes / No HV/Community Nurse/GP notified Comments Details Details Date Date Yes / No Who: Name and signature of Member of Staff Return of Equipment Anticipated date of Details return Yes / No Does patient/carer know where to return the device once the treatment is complete? Signature and details of Parent/ Carer: Address (if different to that of patient): Issue 4 Page 16 of 18

17 MEDICAL DEVICE LOAN AGREEMENT Medical equipment for use in the home is expensive and very often bought with charity money please look after it carefully. For equipment used out in public places we suggest you consider third party liability cover in case of accident. Check with your insurance company to see if you are already covered by any existing insurance. Name of borrower: DOB (if applicable) Address: Telephone No. GP Tel No. Primary Nurse: Tel No. Nurse/Dr Authorising Equipment: Signed: Equipment Type: Equipment Serial Number: Date of Review or Return: Date of Next Service: Date of Loan: PLEASE READ CAREFULLY THE FOLLOWING I acknowledge receipt of the above mentioned medical equipment and accept the designated method of decontamination. I understand that it is on loan to me. I have been given instruction on how to use and maintain the equipment and I agree to keep the equipment in a clean condition and to only use it for its intended purpose. The device will not be adapted for any use outside that identified by the manufacturer as defined in the instructions for use. Devices intended for single use must not be re-used. I agree to ensure that the equipment is serviced by the Ashford & St. Peter s Hospitals NHS Foundation Trust on the date stated. I understand that I will return the equipment to the Hospital and notify them of any known malfunction or accidental damage. I understand that the loan will be for an initial period of, following which the situation will be reviewed. I have been advised and understand what needs to happen in the event of an adverse incident involving the device * Appropriate Declaration of Contamination Status Certificates must accompany equipment loaned out and before any period of re-issue Name: Signature: Date: (or by the Parent /Guardian) Issue 4 Page 17 of 18

18 Name of Healthcare Professional /or on behalf of the borrower: Name: Signature: Date Designation: Name: Signature: Date: (on behalf of the Trust) Issue 4 Page 18 of 18