Version: 4.0. Reporting Defects and Failures Policy. Name of Policy: Effective From: 24/10/2012

Transcription

1 Policy No: RM05 Version: 4.0 Name of Policy: Reporting Defects and Failures Policy Effective From: 24/10/2012 Date Ratified 19/06/2012 Ratified Medical Device Management Group Review Date 01/06/2014 Sponsor Director of Estates and Facilities Expiry Date 18/06/2015 Withdrawn Date This policy supersedes all previous issues.

2 Version Control Version Release Author/Reviewer Ratified by/authorised by 1.0 Oct 2002 Risk Management Committee Date 04/10/2012 Changes (Please identify page no.) 2.0 November Central Team November /08/2009 PQRS 17/07/ /10/2012 J Edwards MDMG 19/06/2012 Reporting Defects and Failures Policy v5 2

3 REPORTING OF DEFECTS & FAILURES POLICY CONTENTS PAGE No 1 Introduction Policy Scope Aim of the policy Roles & Responsibilities Definition of terms Reportable Defects Defects and failures of the following non-medical equipment categories are reportable Defects and failures relating to the following Medicines and Healthcare product categories are reportable Classification of incidents involving the above listed medical & non-medical equipment categories Reporting is required to external agencies Procedure or actions required following an incident / discovery of fault Training Equality & Diversity Monitoring Compliance of this policy Consultation and review Implementation of policy References Associated documents Appendix 1 Internal reporting Appendix 2 How to report pathway Appendix 3 External Agencies Reporting Defects and Failures Policy v5 3

4 REPORTING OF DEFECTS AND FAILURES POLICY 1 Introduction The policy for reporting defects and failures describes the occurrences and processes to guide staff following such events for medical and non-medical equipment. The policy details the types of reportable defects, and agencies to which we are reportable externally and those requiring information locally. All staff working in a Healthcare environment has a responsibility to report defects and failures that occur at work. HSG (93) 13 outlines the Trusts responsibilities to promptly report adverse incidents and reactions to enable the investigation and prevention of similar occurrences both locally and nationally, and advises that the failure to report such incidents endangers the safety of employees and patients. This is backed up by a Medicine and Healthcare products Regulatory Agency annual publication in the form of a device bulletin Reporting of Medical device Adverse Incidents and Disseminating Medical Device Alerts (March 11) and a Department of Health, Estates and Facilities Division Alert Reporting Defects and Failures and Disseminating Estates & Facilities Alerts (Feb 2012). This policy makes reference to the above stated documents and will be updated as required in the light of additional guidance from the Department of Health, the Medicines and Healthcare products Regulatory Agency. Gateshead Health NHS Foundation Trust attaches the greatest importance to safety and care of its patients and therefore considers it essential to provide effective safe medical devices. There are however unforeseen occasions when equipment develops a defect or fails, we therefore need to ensure prompt effective address to maintain reliable safe provision or care in such circumstances. With the implementation of this guidance the Trust should be able to confidently show effective reporting of defects and failures. 2 Policy scope This Policy relates to all medical and non-medical equipment, supplies, buildings and plant. If an event gives rise to, or has the potential to produce unexpected or unwanted effects involving the safety of patients, staff, visitors contractors or others it must be reported 3 Aim of the Policy The aim of the policy is to ensure staff have the necessary guidance to deal with situations that arise from a defect of failure of equipment / items either medical or non-medical, the policy details reportable agencies however internal to the trust an identified person involved in the investigation will take responsibility for ensuring necessary reporting has been undertaken Reporting Defects and Failures Policy v5 4

5 4 Roles and Responsibilities The Chief Executive The Trust Board Divisional Managers Specialist Service Manager - Medical Devices Engineering Supplies Manager General Ward or Dept Managers Trust employees/ users of equipment/ products Clinical Risk Manager and Medical Equipment Library Manager Infection Control Is responsible for ensuring that the trust complies with all health and safety regulations and approved guidance. In practice the tasks and responsibilities for ensuring compliance with regulations and guidance relating to defect and failures of medical and non-medical equipment, supplies, buildings and plant are delegated to senior managers but overall responsibility will remain with the Chief Executive. Is overall responsible for formally reviewing the systems and processes for ensuring failures and defects are reported and managed according to guidance from external agencies to maximise patient, staff and visitor safety. This will be achieved by the presentation of reports indicating achievements and incidents to the board for updates and actions. Are responsible for ensuring reporting and investigation processes are carried out within their own area according to guidelines. Will review incident forms and ensure any follow up processes are completed e.g. removal of batches Coordinate investigations of electronic defects and failures both internal and external to the organisation Report outcome of investigation. Accompany external agencies including manufacturer during investigation phase Liaise with manufacturers over the defects and failures Ensure patients staff visitors are treated accordingly if involved in the incident Responsible for ensuring staff follow guidelines in the event of a defect or failure Ensuring equipment involved in the incident is removed from use Ensuring all details are included on the incident reporting form Ensuring all the relevant personnel are informed If an item is found to be defective or fails in use, the user must take the initial steps to assess the safety of the environment, patients, staff or visitors in the immediate area. Report the defect of fault to the ward or department manager Assist in removal of the item from use Complete an incident reporting form with all details of the incident, defect or near miss To assist in the investigation and external reporting of clinical incidents involving defects and failures of medical devices. Escalate to Head of Risk Management if incidents result in patient injury Responsible for providing advise and feedback on the cleaning, disinfection, decontamination and if required the sterilization of equipment prior to commencement of investigation. Reporting Defects and Failures Policy v5 5

6 Health and Safety, Manager Medical Engineering Dept Point of Care Dept Blood Transfusion Nurse Specialist / on call haematologist Pharmacy Incidents occurring as a consequence of a defect or failure of equipment, which lead to patient safety issues are to be reported to the H&S manager. The H&S Manager will then assist during the investigation phase of the incident. Assist in the collection of evidence Report to the Health and Safety Executive as required Document findings of investigation Advise the reporting as stated in the Ionising Radiation Regulations Carry out maintenance duties as required, including a 24-hour on-call for emergency breakdowns. Advise users of common faults and assists with defect and failure reports. Identify defective parts in equipment Identify equipment beyond economic repair, following damage, ware & tear. Safely decommission or dispose of unusable devices. Only attempt to repair or investigate equipment/items of which the Medical Engineering Department has been trained to deal with Carry out maintenance duties as required Advise users of common faults and assists with defect and failure reports. Identify defective parts in equipment Identify equipment beyond economic repair, following damage, ware & tear. Safely decommission or dispose of unusable devices. Only attempt to repair or investigate equipment/items of which the Point of Care Department have been trained to deal with Respond to calls / incidents and coordinate an investigation following a suspected Serious Adverse Blood Reaction and event. Ensure all equipment and consumables are appropriately stored for investigation Advise and report events to the MHRA and SHOT as necessary Guide staff on the completion of appropriate documentation Make arrangements to withdrawal medicines concerned Inform MHRA as necessary Complete documentation of actions take 5 Definition of terms Defect a physical problem in a machine, structure, or system, especially one that prevents it from functioning correctly Failure- something that falls short of what is required or expected 6 Reportable Defects see below 6.1 Defects and failures of the following non-medical equipment categories are reportable Buildings, building components and lifts Demolitions and construction, including plant Reporting Defects and Failures Policy v5 6

7 Engineering plant and services of all types e.g. boilers, generators, heating, ventilation, water, drainage, electrical instillations & other fixed plant equipment excluding medical devices Fire protection installations and equipment Permanently installed sterilizers, bedpan washers and disposable units Equipment in laundries, catering departments, workshops and other plant or equipment used for maintenance and cleaning Piped medical gas and vacuum systems, cryogenic liquid systems vacuum insulated evaporators and anaesthetic gas scavenging Fixed luminaries including examination lights Communications equipment Lightning protection and electrostatic discharge systems Clinical waste treatment or storage compounds / equipment Environmental aspects of Controls of Substances Hazardous to Health Regulations Installation of fume cupboards and microbiology safety cabinets, including ductwork and their interaction with ventilation systems Ambulances and similar vehicles excluding those for disabled persons, leased & goods vehicles. 6.2 Defects and failures relating to the following Medicines and Healthcare product categories are reportable: Medical Devices i.e. Equipment used for diagnosis, treatment, monitoring, prevention and alleviation of disease, illness or injury. This includes Assistive technology Equipment for moving or transporting patients Equipment for people with disabilities In vitro diagnostic equipment and accessories Equipment for critical care Equipment used for daily living Also see Medical devices policies Medicinal Products with suspected adverse reactions or suspected defects in Prescription Medicines Herbal Remedies Over the Counter Medicines Also see Trust Drugs Policy DP1 Section Blood and blood products Also See MHRA publications:- Background guidance on Reporting Serious Adverse Events and serious Reactions Reporting Defects and Failures Policy v5 7

8 SABRE A User Guide Trust policies:- Blood Transfusion Policies RM Classification of incidents involving the above listed medical & nonmedical equipment categories are: Those which cause or have the potential to cause unexpected effects involving the safety of patients, staff or others. Those which contribute to incidents via incorrect use, inappropriate modifications or adjustments, or inadequate servicing and maintenance procedures. Those which cause or have the potential unexpected effects due to deficiencies in the technical or economical performance of the equipment Defects in the product, product instructions identified locally or nationally or failures in critical services e.g. electricity, water gas communications etc Adverse reactions observed during or after transfusion which may be attributable to the quality or safety of blood or components- Issued for transfusion by the hospital blood bank Collected, Tested, Processed, Stored, Or distributed by blood establishment Suspected adverse drug reactions and suspected defects in medicinal products Actual Incidents & Near misses are reportable using the Trust incident reporting system See Incident Reporting Policy RM Reporting is required to external agencies should a device or product:- Cause a fatal accident or serious injury RIDDOR 95 Cause an incident related to equipment use Cause an explosion or sudden fracture of any pressurised vessel, system or high pressure water main Cause any runaway or crash of a passenger lift Be a suspected adverse drug reactions Be a suspected defects in medicinal products Cause a serious adverse events and serious reactions related to blood and blood products. Reporting to external agencies shall be done by a member of the local investigation team, i.e. a staff member from either Estates, Pharmacy, Blood transfusion, Medical Engineering, Point of Care Department or Supplies (see appendix 1). External agencies include:- DoH Estates and Facilities Division Medicines and Healthcare products Regulatory Agency Health & Safety Executive National Patient Safety Agency Reporting Defects and Failures Policy v5 8

9 Most external reporting can now be done on line by accessing the relevant agency web site See appendix Procedure or actions required following an incident / discovery of fault Where a defect /failure has been identified, the manager or person responsible for the ward/ department must take the following action once the environment, persons involved are safe:- Report the incident verbally to the appropriate local department this will be Electronics Department, Estates Department, Supplies Department, Blood Transfusion Nurse Specialist Point of Care Department or Pharmacy (See appendix 1). Incidents occurring as a consequence of a defect or failure of equipment, which lead to patient safety issues are to be reported to the Health and Safety, Risk and Assurance Manager. Remove the defective item to prevent further use. This includes all materials/items attached or involved when the incident, such as disposables etc Decontaminate the defective item/s if necessary, provided this process does not interfere with the investigation or evidence (processes for decontamination are outlined in the infection control policy), complete decontamination form to indicate this has been done (appendix 3) Clearly label the item/s as potentially hazardous if it is not possible to decontaminate it. If possible photographs should be taken of the incident scene and / or damage caused Defective / failed items should not be interfered with in any way except for safety reasons or to prevent injury or loss Store the item/s securely, within the ward/department. N.B. never release equipment /products to manufacturers until all investigations have been completed. Where appropriate a record should be kept of all readings, settings, and positions of switches, valves, dials, gauges and indicators etc, this record should be included with the incident form and available to investigating teams. If the item is part of a batch, the head of the department must ensure the withdrawal of all products of the same batch number, they should be labelled as potentially hazardous and stored securely, within the ward/department. As soon as is practical to do so an incident form should be completed giving full details of equipment involved and concise details of the incident. Following review by heads of service, a copy of the incident form must be forwarded to the appropriate department i.e. Electronics, Estates, Supplies, Pharmacy Point of Care Department or Blood transfusion (Appendix 1) It is the responsibility of Electronics, Estates, Supplies, Pharmacy Point of Care Department or Blood Transfusion Nurse Specialist to undertake investigation, if necessary inform the appropriate national Reporting Defects and Failures Policy v5 9

10 7 Training agency (i.e. Medicines and Healthcare Products Regulatory Agency, Estates an Facilities Division, Health & Safety Executive) and inform service managers or department heads of any further actions required The manufacturer should be notified promptly and shall be allowed accompanied access with responsible member of the investigating team to inspect the equipment. care must be taken to ensure the manufacturer does not exchange, interfere or remove any part as this may influence subsequent investigations the manufacturer should be informed by the investigating department The equipment should not be handed over to the supplier, repairer or be discarded before Estates & Facilities have had an option to investigate and agree a course of action. Where there is a clinical need for the equipment to be kept in use, any defective parts must be clearly identified. Following agreement of the local investigation team, defective parts can be removed, and the equipment repaired for re-use the defective parts must then be securely stored for inspection future inspection. No formal training is required in relation to this policy, staff reporting formally to external agencies will be made aware of the process as part of their role 8 Equality & Diversity The Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds. 9 Monitoring Compliance /Effectiveness of the Policy Incident investigations will provide information on the effectiveness of this policy Incident review of the Datix system relating to medical device defects & failures will form the basis of reports and action plans, presented at each MDMG meeting and consequently annually to the PRQS. Annual audit focusing on the process required for reporting of defects and failures of medical devices shall also demonstrate the level of compliance the applicable policy section. Failures relating to blood & blood products shall form the basis of reports and action plans presented at hospital transfusion committee meeting. Adverse transfusion incidents, events, are entered into the quality management system as a corrective and preventative action and good learning points will be fed back through the pathology safe care sessions. Annual audits shall inform compliance to external reporting, audit reports will provide relevant information to assist in the development of recommendations or action plans required for practice development or change Reporting Defects and Failures Policy v5 10

11 10 Consultation and Review This policy has been reviewed in consultation with the safe care, estates, blood transfusion, pharmacy, and PoC 11 Implementation Strategy Following ratification of the policies they will become available to all clinical staff via the Trust Intranet. An will be sent to individuals informing them of the updated policy 12 References See appendix 3 Reporting adverse incidents and disseminating medical device alerts DB2011(01) March 2011 alert EFA 2012/001 Reporting of defects and failures and disseminating Estates and Facilities Alert 13 Associated documentation OP 31 Operational Policy Medical Device Engineering and Library RM45 Training Policy For Medical Devices Medical Devices Strategy RM 44 Local Policy for Authorised users of Medical Devices RM 30 Policy for the Procurement Management and Use of Medical Devices Reporting Defects and Failures Policy v5 11

12 Appendix 1 Verbal reports and completed defects and incident forms should be forwarded to the local departments identified below 1 = District Supplies Manager, Local Supplies Department, Queen Elizabeth Hospital. Tel No: = Specialist Services Manager, Electronics Department, Queen Elizabeth Hospital. Tel No: = Estates Department, Queen Elizabeth Hospital Tel No: / = Pharmacy Department, Queen Elizabeth Hospital Tel No: = Blood Transfusion, Haematology Tel No: / = Point of Care Department, Pathology Tel No: / 3548 MEDICAL All equipment used in the treatment and monitoring of patients, in diagnosis of disease, in dentistry, in surgery, in life support Orthotic and prosthetic appliances, aids for the disabled, wheelchairs, patient hoists and patient lifting/transfer equipment Surgical implants, e.g. heart valves, pacemakers Single use devices, e.g. syringes, administration sets, catheters, dressings. N.B. Medical Dressings should be reported in accordance with defective or hazardous medicines Hospital laboratory equipment such as blood analysers, centrifuges, automatic stirrers, wax baths, microbiological safety cabinets, the chemical reagents, consumables and in-vitro diagnostic products used in hospital laboratories (but not general workshop equipment such as power tools and machine tools Transportable device washing disinfecting and sterilising equipment warming cabinets, blood storage refrigerators and chemical biological indicators used in sterilisation processes Point of Care devices such as Blood gas analysers, Hemocue (Hb), Inform meters (blood glucose), Coaguchek (INR), HbA1c, Urinalysis and Pregnancy Testing, the reagents and consumables Medical Textiles, mattresses and covers Reporting Defects and Failures Policy v5 12

13 MEDICAL Hospital beds Bloods & blood products Prescription, herbal, over the counter medicines NON-MEDICAL Buildings and building components and plant used in maintenance and construction Engineering plant and services of all types, e.g. boilers, generators, heating, ventilating, water, drainage and electrical instillations and any other fixed plant (but not fixed medical equipment) Fire protection installations and equipment Permanently installed sterilisers, bedpan washers and disposal units Laundry, catering, cleaning, workshop and domestic equipment Piped medical gas and vacuum installations VIE s and anaesthetic gas scavenging systems Fixed luminaries, including operating and examination lamps Communications equipment, e.g. telephone, paging, radio Communications equipment e.g. Nurse call, alarms Installation aspects of fume cupboards and microbiological safety cabinets, including ductwork and their interaction with ventilation systems 4 5 Reporting Defects and Failures Policy v5 13

14 Appendix 2 How to report Defect or Failure discovered Patients, staff, environment assessed for safety Defect / failures resulting in patient safety issues to be reported to Clinical Risk Manager Ward / dept manager or person in-charge informed Defect/ failure incident reported to relevant internal team for investigation Defective item removed from use, record all settings Defective item decontaminated, provided this process does not interfere with the investigation, Contact Infection control for advice Point of Care Team Estates Medical engineering Supplies Pharmacy Blood transfusion Incident form completed Health & Safety advisor contacted as required to advise and assist investigations carried out by internal teams, evidence collected, photographs, statements, copy of incident forms Defective item stored securely labelled as potentially hazardous awaiting investigation Manufacturer contacted by investigating team, manufacturer accompanied during inspection of equipment by local teams Equipment must not be sent to manufacturer before Local investigation teams will contact external agencies as appropriate, i.e. MHRA, DoH Estates & Facilities Division HSE Reporting Defects and Failures Policy v5 14

15 Appendix 3 Contact details for external agencies Following an internal investigation a member of the internal investigation team will contact the necessary external agency as required or refer to the trusts' appropriate person 1. Medicines and Healthcare products Regulatory Agency, MHRA REPORTING OF MEDICAL DEVICES DEFECTS AND FAILURES Online reporting preferred option by the MHRA User Reporting online E mail aic@mhra.gsi.gov.uk Fax/Mail - Adverse Incident Centre, Medicines & Healthcare products Regulatory Agency, 2/2 G Market Towers, 1 Nine Elms Lane, London, SW8 5NQ Fax No Telephone , must be followed up by written report REPORTING OF SUSPECTED ADVERSE DRUG REACTIONS Health professionals are encouraged to used the electronic Yellow Card. It offers a quick and easy way to report, without having to worry about finding a postbox. Alternatively Yellow Cards are also available: By downloading a pdf copy to print out: Healthcare professional Yellow Card By writing to: MHRA, CSM Freepost, London. SW8 5BR. From the 'British National Formulary' (BNF). From the 'Nurse Prescribers' Formulary' (NPF). From the 'ABPI Compendium of Data Sheets and Summaries of Product Characteristics'. From the 'MIMS Companion'. or by writing to one of the Commission on Human Medicine's Yellow Card Centres: Yellow Card Centre Mersey, Freepost, Liverpool. L3 3AB. Yellow Card Centre Wales, Freepost, Cardiff. CF4 1ZZ. Yellow Card Centre Scotland, 51 Little France Crescent, Old Dalkeith Road, Edinburgh. EH16 4SA. Yellow Card Centre Northern and Yorkshire, Freepost,Newcastle-upon-Tyne. NE1 1BR. Yellow Card Centre West Midlands, Freepost, Birmingham. B18 7BR. REPORTING SUSPECTED DEFECTS IN MEDICINES Suspected defects can be reported by telephone, fax, or letter or using our online form. Telephone: (during office hours Monday to Friday , (urgent calls outside of normal working hours, at weekends or on public holidays). Fax: info@mhra.gsi.gov.uk Online form: Suspected defect reporting form 2. Department of Health, DoH REPORTING OF DEFECTS AND FAILURES OF NON MEDICAL DEVICES, ESTATES AND FACILITIES On-line reporting (preferred option) Reporting Defects and Failures Policy v5 15

16 Further information is available from the efm-information Helpdesk, telephone number Paper based reports The form D&F 01 is available on the Department of Health website. The form can be completed electronically and ed to Estates & Facilities or printed and sent by mail or fax to: Rachael Whitaker Tel: Defect & Failure Project Officer Fax: Estates & Facilities Department of Health 3N 34A Quarry House Leeds LS2 7UE Emergency reporting During an emergency verbal reports can be made to the Department of Health s Duty Officer on RIDDOR REPORTING PROCEDURES, HSE 1. HSE has put in place a facility to report RIDDOR-reportable incidents to a single point, the Incident Contact Centre (ICC) based at Caerphilly. 2. Reports can be made by telephone, post, , Internet and fax as follows: By phone: , available from Monday to Friday from 8.30 am to 5.00 pm and charged at local call rate. By post: The Incident Contact Centre Caerphilly Business Park Caerphilly CF83 3GG By riddor@natbrit.com There is also an option to provide Internet reports via or alternatively by a link via the HSE website: By fax (charged at local call rate): Reporting Defects and Failures Policy v5 16