BRIEFING PAPER ON ACTIONS BEING UNDERTAKEN ASSOCIATED WITH AN MRHA ALERT NOTICE ON METAL ON METAL HIP PROSTHESES

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1 AGENDA ITEM December BRIEFING PAPER ON ACTIONS BEING UNDERTAKEN ASSOCIATED WITH AN MRHA ALERT NOTICE ON METAL ON METAL HIP PROSTHESES Report of Paper prepared by Medical Director Divisional Manager, Surgical Division Executive Summary Action/Decision required Link to other Board Committee (s) and subcommittees Link to Standards for Health Services in Wales This paper describes the background for a recall of patients who have undergone metal-on-metal hip replacements at or on behalf of Cardiff and Vale UHB. These prostheses, particularly those associated with a single manufacturer, have a higher than anticipated failure rate and the paper describes the UHB response in terms of supporting structures and detailed actions. The Quality and Safety Committee is asked to support the proposed recommendations Orthopaedic Board Metal-on-Metal Sub Group of the Orthopaedic Board Divisional Quality and Safety Group Standard 7. Safe and clinically effective care Link to Public Health Agenda on Metal on Metal Hip Prostheses Page 1 of December

2 Link to UHB Strategic Direction and Corporate Objectives / Legislative and Regulatory Framework Link to relevant evidence base The paper describes the approach to managing the recall and compliance with MRHA guidance. MRHA guidance on MOM hip prostheses. on Metal on Metal Hip Prostheses Page 2 of December

3 BRIEFING PAPER ON ACTIONS BEING UNDERTAKEN ASSOCIATED WITH AN MRHA ALERT NOTICE ON METAL ON METAL HIP PROSTHESES INTRODUCTION In April, the MRHA issued an alert notice on metal-on-metal (MOM) hip prostheses. This was issued in response to emerging evidence of unacceptably high revision rates, with higher rates reported with specific prostheses (notably the ASR system manufactured by Depuy). The MHRA identified the need to recall patients and review their clinical status and the level of blood metal ions. In the light of emerging evidence, orthopaedic surgeons had changed clinical practice and ceased implanting such devices in early 2009 and local arrangements to review patients commenced in January. The paper describes the actions being undertaken to manage the recall from a quality and safety perspective. UHB RESPONSE In the light of clinical governance issues, a meeting was held in early October with the Medical Director, one of the Orthopaedic Surgeons and managerial representatives of the Directorate and the Division. This scoped the UHB response and led to the creation of a subgroup of the Orthopaedic Board that is operating under the following terms of reference: The Terms of Reference are summarised below: Identify relevant patients and develop a database to support the UHB s response; Ensure that actions identified in the MHRA alert are undertaken, including timely review of patients; Effectively manage communication with patients, suppliers and external stakeholders; Undertake revision surgery with the UHB when required; Recover costs from suppliers where appropriate; Provide reports for the Orthopaedic Board and the UHB Quality and Safety Committee. on Metal on Metal Hip Prostheses Page 3 of December

4 The Group meets fortnightly and comprises: Mr Steve Jones Mr Alun John Ian Morris Simon Rogers Caroline Ash Hip Surgeon Hip Surgeon Divisional Manager Directorate Manager Project Support ACTION PLAN An update action plan for the recall is included at Appendix 1. COHORT OF PATIENTS A patient tranche has been created with a single master database. To date a total of 1429 patients have been identified with MOM implants, with a number of validation checks being undertaken to ensure a comprehensive list is maintained. This represents the number of patients who have had an implant at Cardiff and Vale UHB. In addition there is a further cohort of patients who had their MOM procedure under the auspices of the Second Offer Scheme at Spire, Cardiff. Collaboration work is being undertaken to ensure the review of these patients, with a similar database. The table below summarises progress to date. Number of patients 1429 Patients seen in 355 Patients declining review 2 Patients deceased 9 Did not attend 26 It is apparent that revisions have already been undertaken on a cohort of patients (29 to date), and a separate database is being maintained for such patients. on Metal on Metal Hip Prostheses Page 4 of December

5 PROGRESS UPDATE Since the last meeting of the Quality and Safety Committee meeting the following has been undertaken. Slimlining the Nurse led clinic appointments at CAVOC to enable more patients to attend each clinic o Questionnaires now sent direct to patients with their appointment letter rather than handing to patient in clinic. o Band 5 nurses being trained to participate in the Nurse led clinics. Previously only band 6 nurses led these clinics. o Nurses no longer need to carry out physical assessments at the Nurse led clinics. General Practitioner letters o Letters sent to GPs informing them of patient s impending attendance to Metal on Metal follow up nurse led clinics. o Letters being sent to GPs updating them of patient s attendance at follow up Metal on Metal nurse led clinics DePuy correspondence Clinics o Various DePuy correspondence and a questionnaire, has been referred to the UHB Legal Department for advice. o Two Consultant led clinics will be forthcoming on the 1 st and 15 th December. These will address the patients who have been seen in the nurse led CAVOC clinics. The clinics are initially aimed at either Comet patients or ASR patients in the first instance. CAVOC and general outpatients have been approached for any available clinic sessions which can be allocated to Metal on Metal patients. on Metal on Metal Hip Prostheses Page 5 of December

6 o CAVOC has been approached for any spare clinic capacity during the forthcoming Christmas and New Year season o Possibility of Saturday morning Nurse led clinics o Biochemistry support has been sought and agreed, depending on demand. o CAVOC staff participation is being sought, but concerns have been raised due to current high sickness rate and salary rates. o On receipt of a decision regarding staff salaries, an approach will be made to the radiology department. o Dedicated nurse led clinic sessions are on-going every Thursday pm and every other Friday in CAVOC. Patients are allocated slots in other clinic sessions as and when appropriate. Introduction of Proformas o ASR Validation Record Proforma will raise any anomalies prior to clinic appointment. If anomalies appear the patient is discussed at the fortnightly senior management and medical meeting. o Review outcome form to be completed at clinic. To establish way forward for patient. The undertaking of additional consultant led clinics and operating will be subject to a paper being taken to the Operational Board of Directors in December. RECOMMENDATION The Committee is asked to: SUPPORT the actions being undertaken in support of the MOM recall. on Metal on Metal Hip Prostheses Page 6 of December

7 RECALL OF METAL ON METAL DEVICES ACTION PLAN Date: 8 th October Appendix 1 Action Date Lead Individual Status Informal discussions with British Hip Society colleagues Mid 2009 SJ/AJ Mid 2009 onwards Local decision to start recall January SJ/AJ Hip surgeons meeting decided Special clinic set up at Llandough Hospital March AJ Approx 300 pts seen to date. Estimated total Identified Clinical Fellow to coordinate data collection and monitoring Additional exercise to track patients who may have received MOM implants via 2 nd offer Commencement of surgical revision recalls cohort March AJ Data currently being analysed to evaluate revision rate October TBC Identifying process September SJ/AJ MHRA alert notice 11 April MHRA De Puy ASR recall 24 August De Puy Discussions with Hip SR/SJ Surgeons on process for surgical recall Meeting with Medical Director of UHB with Directorate and Hip Surgeon Agreement to establish a sub committee to the T&O Board for MOM recalls 4th October 1 st meeting to be before end of October Directorate to draft action plan 8 October Clinical Governance arrangements to be established and agreed, including clarity over future liability Agreement required at next T&O or MOM meeting which ever is sooner GS/AJ/SR/IJM GS/AJ/SR//IJM SR Needs sign off by Medical Director A number (TBC) have been revised surgically to date Confirmed no ASRs now held Draft list has now been assembled. Awaiting approval to proceed. MD fully briefed and arrangements agreed. Terms of Reference to be drafted Drafted TBC on Metal on Metal Hip Prostheses Page 7 of December

8 Division to liaise with De Puy re recall process Division to draft overall paper for T&O Board, including Terms of Reference for Sub committee Agree financial terms with De Puy, including reimbursement for operations already carried out. Agree financial arrangements for UHB staffing Develop project plan including timetable for full recall of cohort and remedial surgery if required Agree process for arranging capacity to treat as part of overall delivery plan for rest of /11 and 2011/12 Target to secure agreement by end of October In time for initial MOM sub committee meeting and T&O Bd Target to secure agreement by end of October December IJM IJM IJM/Directorate IJM/Directorate Meeting held. Paper taken to Orthopaedic Board on 29 th October In principle agreement made Paper to be taken to December OBD. Ongoing Directorate Detailed work plan developed By end of December Directorate/Division Subject to OBD approval. on Metal on Metal Hip Prostheses Page 8 of December

9 IMPACT ASSESSMENT Health Improvement Workforce Education and Training Financial Legal Equality The actions being taken will address the surgery needs of those patients who require revision surgery Additional support has been prioritised to underpin the UHB s response, with excellent clinical engagement. It has been agreed that costs associated with the Depuy ASR system will be recovered from the manufacturer (Depuy). Discussions will be held with other manufacturers, informed by local revision rates. Legal input is being sought from Morgan Cole. Class actions are being undertaken against Depuy in the United States. There are no identified equality issues. Environmental A project office has been established at UHL RISK ASSESSMENT Clinical/Service Financial Reputational Low. The risk to the clinical service will be mitigated by surgeons undertaking additional lists/clinics Medium. Although the primary manufacturer will reimburse costs, this has yet to be agreed with other manufacturers. Medium. A significant cohort of patients have had MOM implants and as such the UHB s response must be proportional. on Metal on Metal Hip Prostheses Page 9 of December

10 Acronyms and abbreviations MHRA Medicines and Healthcare Products Regulatory Agency MOM Metal on Metal UHB University Health Board CAVOC Cardiff and Vale Orthopaedic Centre GP General Practitioner CONSULTATION AND ENGAGEMENT Orthopaedic Board Metal on Metal Sub Group of the Orthopaedic Board Divisional Quality and Safety Group SOURCES OF INFORMATION MHRA Metal on Metal Guidance on Metal on Metal Hip Prostheses Page 10 of December

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