Standard Operating Procedure 12 (SOP 12) Dissemination of Alerts within the Trust for Reusable Medical Devices Why we have a procedure? This procedure sets out the steps to be followed to ensure that a clear process is in place for disseminating/actioning MDA s and FSN s relating to re-usable medical devices. Implementation of the procedure will contribute to the safety of patients, users and others. This procedure is in compliance with CQC Fundamental Standards- section B and E of Regulation 12: Safe Care and Treatment and sections C and E of Regulation 15: Premises and Equipment. The intention of regulation 12 is to ensure that the equipment used by the service provider for providing care or treatment to a service user is safe for such use and used in a safe way. The intention of regulation 15 is to ensure equipment used by the service provider is suitable for the purpose for which it is being used and properly maintained. What overarching policy the procedure links to? Medical Devices Policy Which services of the trust does this apply to? Where is it in operation? Group Inpatients Community Locations Mental Health Services all Learning Disabilities Services all Children and Young People Services all Who does the procedure apply to? Governance Assurance Unit Medical Device Managers Ward/Department Managers When should the procedure be applied? When GAU receive MDA and FSN alerts relating to re-usable medical devices Dissemination of Alerts Within BCPFT for Reusable Medical Devices Page 1 of 7 Version 1.0 December 2015
When wards/departments are responding to GAU alerts relating to re-useable medical devices How to carry out this procedure All alerts relevant to the service identified are received by GAU Reusable medical equipment related device alerts emailed to Lead Managers of EBME Department at New Cross Hospital, Wolverhampton to identify if the affected devices are located within the BCPFT by checking the F2 Database If the alert is not relevant EBME Manager completes feedback form and returns it to GAU within two working days and enters data on their MHRA Monitor spreadsheet If the alert is relevant EBME Manager will identify departments/sites where the affected devices are located by completing the feedback form within two working days and upload alert into F2 database Relevant Alerts are sent to nominated Medical Device & Governance leads in each Group within one working day for actioning/awareness. They will include a deadline for completion Responses are collated by leads and one response sent to GAU identifying actions taken within agreed timescales. Withdrawal of affected devices alert GAU to alert the relevant Groups of the need to withdraw from service the affected devices and place in secure location and arrange collection in accordance with the alert recommendations Local action plans and any withdrawal of devices should be highlighted on the response form to GAU with a copy of all action plans On completion GAU to make EBME Managers aware to close the alert on their MHRA Monitor spreadsheet Modification of device part alert Where recommendations for parts to be replaced i.e. new battery/upgraded internal circuit board etc., EBME Managers will upload alert into F2 database and log work requests for all relevant individual devices for the relevant work to be carried out by EBME staff EBME Managers will give updates of progress and completion to GAU via the feedback form EBME Manager will close the alert on their MHRA Monitor spreadsheet when actions completed What do these terms mean? MDA - Medical Devices Alerts are the prime means of communicating safety information to healthcare environments on medical devices. MDA s are prepared by the MHRA and are distributed nationally with the same reference, content and format FSN - Field Safety Notice is an important communication about the safety of a medical device that is sent to customers by a device manufacturer, or their representative Dissemination of Alerts Within BCPFT for Reusable Medical Devices Page 2 of 7 Version 1.0 December 2015
FSNs tell you what you need to do to reduce the specified risks of using the medical device. The actions are referred to as Field Safety Corrective Actions (FSCAs) CQC - Care Quality Commission is the independent regulator of health and adult social care in England. They make sure health and social care services provide people with safe, effective, compassionate, high-quality care and encourage them to improve GAU - Governance Assurance Unit support the Groups at BCPFT to implement and monitor their risk/safety and governance framework. They also provide assurance to the Board that the Trust is compliant with statutory regulations and is managing and monitoring risk and governance across all services EBME Department - Electro-biomedical Engineering Department is responsible for the maintenance, repair and management of medical equipment within the Trust, safeguarding both patients and users from any risk that may occur while using medical equipment F2 Database - F2 is a Medical Asset Management database system MHRA - Medicines and Healthcare products Regulatory Agency is a government body which was set up in 2003 to bring together the functions of Medicines Control Agency and Medical Devices Agency. These include the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents Dissemination of Alerts Within BCPFT for Reusable Medical Devices Page 3 of 7 Version 1.0 December 2015
Flowchart of Process of Dissemination of Alerts within the Trust for Reusable Medical Devices Alerts received by Governance Assurance Unit (GAU). All alerts relevant to the service identified Reusable medical equipment related device alerts sent to Lead Managers of EBME to identify if the affected devices are located within the BCPFT. Alert not relevant Alert relevant EBME Manager will identify departments/sites where the affected devices are located by completing the feedback form to GAU within two working days EBME Manager completes feedback form and returns it to GAU within two working days GAU will send the alert to all relevant Groups for actioning /awareness Responses are collated by Group Governance leads and 1 response sent to GAU identifying actions taken within agreed timescales Withdrawal of affected devices alert GAU to alert the relevant Groups to withdraw affected devices, place in secure location and arrange collection in accordance with the alert recommendations. Modification of device part alert EBME Managers will upload alert into F2 database and log work requests for all relevant individual devices for the relevant work to be carried out by EBME staff Local action plans and any withdrawal of devices should be highlighted on the response form to GAU with a copy of all action plans. EBME Managers will give updates of progress and completion to GAU via the feedback form. On completion GAU to inform EBME Managers. Dissemination of Alerts Within BCPFT for Reusable Medical Devices Page 4 of 7 Version 1.0 December 2015
Where do I go for further advice or information? Medical Devices Group Ensure that the Trust has access to appropriate expert advice as required to support this procedure Review incidents including governance issues relating to medical device management Receive quarterly incident analysis reports related to medical device related incidents reported to MHRA Receive quarterly performance reports related to the dissemination of MHRA medical device alerts across the Trust Governance Assurance Unit Provide central point of contact for the Medicines and Healthcare products Regulatory Agency (MHRA) Disseminate safety alerts and other notices issued by agencies such as NHS England, Medicines and Healthcare Products Regulatory Agency (MHRA) and NHS Estates to a nominated representative in each Service when relevant Maintain a record of actions taken as a result of the safety notices/alerts Produce a monthly Central Alerting System (CAS) status for the Quality and Safety Steering Group Ensure failure to meet deadlines for action is recorded on the Trust risk register and escalated in line with the Trusts escalation procedures Ensure incidents involving medical devices are appropriately investigated and reported to the MHRA Nominated Medical Device Leads (Clinical Groups) and Team Leaders in Community Services Key point of contact for ensuring Medical Device Alerts, Patient Safety Notices and other Safety Alerts are acknowledged by their managers and to act on the managers behalf when they are unavailable Team Leaders/Ward & Department Managers/Senior Nurses/Operational Managers Take ownership and be responsible for the medical devices used in their areas Infection Prevention & Control Team Advise accordingly in line with this procedure The Medical Physics and Clinical Engineering department Assist the Trust with the investigation of incidents involving medical devices Technical and clinical support of the equipment and staff during its life time Training Staff may receive training in relation to this procedure, where it is identified in their appraisal as part of the specific development needs for their role and responsibilities. Please refer to the Trust s Mandatory & Risk Management Training Needs Analysis for Dissemination of Alerts Within BCPFT for Reusable Medical Devices Page 5 of 7 Version 1.0 December 2015
further details on training requirements, target audiences and update frequencies. Monitoring / Review of this Procedure In the event of planned change in the process(es) described within this document or an incident involving the described process(es) within the review cycle, this SOP will be reviewed and revised as necessary to maintain its accuracy and effectiveness Equality Impact Assessment Please refer to overarching policy Data Protection Act and Freedom of Information Act Please refer to overarching policy Dissemination of Alerts Within BCPFT for Reusable Medical Devices Page 6 of 7 Version 1.0 December 2015
Standard Operating Procedure Details Unique Identifier for this SOP is State if SOP is New or Revised BCPFT-CLIN-POL-12-1 New Policy Category Executive Director whose portfolio this SOP comes under Policy Lead/Author Job titles only Committee/Group Responsible for Approval of this SOP Month/year consultation process completed Clinical Deputy Chief Executive & Director of Resources Medical Devices Group Medical Devices Group April 2015 Month/year SOP was approved November 2015 Next review due December 2018 Disclosure Status Key words relating to this SOP B can be disclosed to patients and the public MDA, FSN, GAU alert, MHRA, medical devices warning, safety information Review and Amendment History Version Date Description of Change 1.0 Dec 2015 New Procedure established to supplement Medical Devices Policy Dissemination of Alerts Within BCPFT for Reusable Medical Devices Page 7 of 7 Version 1.0 December 2015