Briefing for Joint Cabinet Committee on Health & Children.

19th July 2012.

Voluntary recall of DePuy ASR Hip Resurfacing System and ASR XL Acetabular System

Background

DePuy Orthopaedics, Inc. announced on 24th August 2010 that it had commenced a voluntary worldwide recall process for two specific hip replacement implant products. Approximately 3,317 patients had received these implants in Ireland, across 16 public and 14 private hospital sites. The HSE became aware of the recall on 26th August. Worldwide approximately 93,000 components were implanted, affecting 54,000 patients. 36,000 of those devices were sold in the USA, 14,000 in the UK and 4,756 in Ireland

Governance

An Incident Management Team (IMT) was established to oversee the national recall of patients in both public and private sites in Ireland. Membership includes the Irish Institute of Trauma and Orthopaedic Surgery (IITOS), the Independent Hospitals Association of Ireland (IHAI), representing private hospitals, a Patient Representative and representative of HSE Legal Services, Finance, ICT and Procurement Directorates. Shared guidelines and procedures were issued. The IMT was responsible for interaction with DePuy and working through the logistics involved, in line with the company’s commitment to covering the costs of the recall process for patients and any medical treatment that patients may need.

Process of recall

Sites were required to identify, as a matter of urgency, all affected patients. Telephone Help-Lines were established to deal with enquiries from members of the public, and to provide information to patients. Using data supplied by the products distributors, sites commenced a process of identifying all affected patients, by matching/reconciling component product numbers, theatre logs etc. Priority was given to ensuring that all affected patients were identified and notified, whilst also ensuring that patients who had not received the affected components were advised and reassured.

Affected patients were contacted to attend for a recall assessment appointment and possible treatment. It was expected that for most patients involved, the recall would be precautionary, but for those who would require further treatment, it would be provided to them without cost to the patient.

The IMT prescribed a phased approach to the recall.

Phase 1 referred to an initial recall for all patients; clinical examination, blood and radiological tests as required.

Phase 2 referred to a smaller number of patients requiring follow up treatment or revision surgery.

The IMT compiled a detailed Incident Management Procedure Document for Phase One – giving hospital sites instructions on all the steps required to ensure an effective and patient/centered recall process. This included – identification/validation for affected patients, clinical protocols and pathways (Clinical, Radiology, Blood testing), communication with patients, and reporting requirements. This set of procedures issued to hospital sites on October 1st, 2010, with a number of subsequent iterations, incorporating updates as they became available.

Given that the recall encompassed 30 sites, some with a large proportion of the total number of patients, the timing of both the both the invitations to appointments and the scheduled appointment dates varied from site to site. However, a target date of identifying and contacting patients was set for Oct 20th 2010. The majority of sites had identified affected patients by early Nov 2010, with all patients identified and contacted by late Nov 2010. Scheduling of initial appointments commenced immediately, with recall clinics commencing in October 2010. For those sites that had smaller numbers of patients, patient’s appointments were scheduled relatively quickly. For larger sites, the numbers of patients posed some logistical problems in scheduling clinics; the approach taken was to schedule patients based on clinical need/urgency.

Clinical Matters

As part of the clinical protocols provided for the testing of blood for metal ion levels (cobalt and chromium), a streamlined process for phlebotomy, transportation and testing blood samples for metal ion levels was established. Laboratory selection was based on assessment by a HSE Chemical Pathologist and member of the clinical subgroup of the IMT. l. Samples are transported to the accredited Laboratory in London for independent testing of blood samples for cobalt and chromium levels. Samples are transported from individual sites to the laboratory by a specialized shipping company. De Puy funds this process directly, with no cost to the individual sites.

The majority of patients did not require revision surgery and have been scheduled for annual review. They are currently attending year two appointments.

A smaller number, for whom revision surgery was not an immediate requirement, but did require closer monitoring, were scheduled for six monthly review.

Three hundred and fifty seven revision surgeries have been carried out to date and with a further 166 revisions scheduled. Given the nature of hip replacement follow-up, revisions will continue to be carried out over the coming years, based on individual clinical need.

Interaction between the IMT and De Puy:

De Puy stated that they intended to cover ‘reasonable and customary costs’ of monitoring and treatment for services, associated with the recall, including revision surgeries

At the commencement of the recall the IMT had concerns regarding the process in place for contact with De Puy and the company’s ability to make rapid/significant enabling decision relating to the recall. Considerable effort was required to identify designated De Puy personnel with appropriate decision-making delegation to authorize required/necessary steps in the recall. In November 2010, the De Puy employed an n ASR Regulatory contact for Ireland and he continues to be the point of contact for interaction between the HSE/De Puy.

Non medical Patient expenses:

Whilst De Puy committed to covering the costs associated with the medical care of the affected patients, there was also the issue of non-medical, ‘out of pocket’ expenses incurred by patients e.g. travel to medical appointments, possible overnight accommodations, leave from work costs etc. De Puy appointed Thorntons Ltd (a subsidiary of UK Claims Handling Company, Crawford Broadspire), to handle the reimbursement of claims for expenses, both to Hospitals and to patients. Whilst the reimbursement of non-medical costs was not the responsibility of the HSE or private healthcare organizations, it was recognized that this aspect of the patient experience could potentially be a source of difficulty/inconvenience for patients. Patients were issued with a ‘Unique identifier number’ which would allow them to contact and claim directly from the claims handling company for any out of pocket expenses incurred.

Legal Matters

From the commencement of the voluntary recall, it was evident that a number of law firms were seeking clients for potential legal action in relation to future revisions, actions in which the hospital or the HSE would likely be defendants/co-defendants.

The IMT, at the encouragement of the Patient Representative on the team, and with the strong agreement of the HSE in-house barrister, sought to establish a mediation scheme, which would involve establishing a non-adversarial process for patients, to facilitate settlement of both the straightforward and more complex claims that would arise from the recall. The Clinical Indemnity Scheme (CIS) offered to assist with this process. De Puy did not avail of this offer. The IMT does not have ongoing involvement in legal aspects of the recall and refers these to the State Claims Agency.

The State Claims Agency, which is tasked with protecting the States interest, is currently preparing to defend those claims naming the HSE. In June 2012 approximately 100 claims were instigated/intimated.

The State Claims Agency and the HSE legal representatives continue to address any issues that arise in the context of dealing with proceedings notified and establishing any necessary processes to ensure these are addressed.


A range of other issues have been resolved between the IMT and DePuy, after an extended period of negotiation and joint working.

Patient Consent

At the commencement of the recall, and in line with their international policy, De Pay required that patients would consent to De Puy accessing various information /medical records without restriction. This was not acceptable to with the HSE or private sites on legal, data protection and patient privacy grounds. During 2010, De Pay had only agreed to reimburse costs arising for phase 1 of the recall i.e. clinical examination, blood tests, and X Rays, De Puy stated that agreement on reimbursement of Phase 2 costs, having waited the requirement to access medical notes for phase one, would certainly be conditional on access to patient medical records

Following a protracted series of negotiations between the IMT and De Puy, De Puy agreed to fund reimbursement of medical costs based on verification/ certification by the treating Consultant that the medical costs were appropriately and validly incurred as a result of the recall. (Surgeons would complete a surgeon confirmation form - DPYUS 73) This agreement was reached in Feb 2011, following escalation of the matter to senior personnel within De Puy.

Reimbursement

A Finance/Procurement subgroup of the Incident Management Team liaised with De Puy on the reimbursement process for all direct and indirect recall associated costs incurred by the HSE sites, and an agreed protocol for processing claims.

A Tariff method of reimbursement was agreed for each clinical stage was agreed with De Puy in October 2011, and enabled reimbursement of HSE hospitals by DePuy for the costs of recall appointments, tests, treatment and surgery, via submission of validated claims to the Claims handling company. A similar reimbursement process was adopted by private Healthcare providers, based on private insurer rates. Any claims for expenses not covered by the Tariff are submitted to the De Puy Exceptions Committee for adjudication on a case by case basis. Reimbursement is subject to certain exclusions as outlined by De Puy -

e.g. Size Mismatches, Traumatic injury where there is no evidence of soft tissue reaction at the time of surgery, femoral neck fractures where the fracture occurred within three months of primary surgery and subject to review on a case by case basis, or infection confirmed through positive culture.

Explant Management

Decontamination of explanted (removed) components posed some operational and regulatory difficulties which required clinical and legal expertise; in particular the issues of custody of the explant and decontamination of explants.

Initially DePuy requested access to explants and agreed to fund decontamination and storage on that basis. They later changed that position and determined that they did not want access to explants under any circumstances. Subsequently the Irish Medicines Board outlined that since the products had been recalled, they required DePuy to undertake investigations into the reason for the device failure as part of the IMB statutory role in regulating medical devices.

In Aug 2010, Patients were initially given three options prior to undergoing revision surgery, via written consent:

1.  Send the implant to DePuy for product failure investigation ( process funded by DePuy in order to discharge its requirement to provide inspection reports to the IMB)

2.  Hospital Disposal: The HSE or private hospitals can dispose of the device once it is removed.

3.  Patient Custody: Where patients wish to retain the implant themselves, they will be required to arrange the decontamination, transport and storage of the implant, at their own expense.

Legal advice was received from HSE legal advisors to confirm these options were reasonable.

Subsequently, patients’ legal representatives sought clarification on a number of issues, including those of - informed consent, access to explants upon request, provision of inspection reports etc. An updated suite of consent documentation was drafted by the HSE Legal advisors, in conjunction with De Puy legal representatives and patient legal representatives to reflect the following – (and issued by the IMT in Oct 2011) -

·  Ownership and control of explants at all times rest with the patient,

·  Where the patient consented to forwarding their explant to London Implant Retrieval Centre, De Puy would not take possession of the explant.

·  Inspection reports would be furnished by the LIRC upon request to the patient/legal representative, De Puy, Irish Medicines Board.

·  The explant could be returned to the patient at a future date.

As the explants were not reusable implantable medical devices, the normal decontamination protocols did not apply. Usually such devices would be disposed of upon removal. However, the issue of retention of such explants for possible evidentiary purposes in any future litigation arose. Advice from the Irish Medicines Board was that in such cases, decontamination of devices would be in accordance with the manufacturer’s protocol. Difficulties arose in that the majority of sites in the HSE/Private Healthcare providers did not have the required facilities to enable decontamination according to the De Puy protocol. Where patients chose to send the explant to De Puy under the De Puy funded retrieval process, the accredited implant retrieval facility undertakes this decontamination process in accordance with the relevant manufacturer’s protocols, which have been applied by court order in the United States.

With regard to those patients who choose to retain their implant, the HSE has engaged with the implant retrieval facility (who are providing the service on behalf of De Puy) , to facilitate a separate process to arrange for the decontamination/inspection/storage of the explants separately for those patients who do not consent to De Puy accessing their explants.

In early 2012 it became evident that a number of patient/legal representatives were instructing sites to forward their explants to storage facilities, who did not offer decontamination/inspection services. Sites were being instructed by patients/legal representatives to release such explants The HSE sought the IMB advice on this matter, particularly with regard requirements regarding transportation of bio hazardous material. The IMB referred the HSE to the Dept of the Environment. The Dept of the Environment advised that it was satisfied with the HSE proposed position of releasing such explants upon receipt of assurance that the carrier /packaging complied with relevant sections of ADR Regulations regarding transport of bio hazardous material.

Private Health Insurers –

A number of private Health insurance companies contacted the HSE seeking details of privately insured patients who had been identified as having received the ASR implants. Private Hospitals were obliged as part of their contract to provide such information. The HSE position initially was that data protection legislation placed certain obligations on the organisation regarding the transmission of patient information to third parties. Subsequently legal advice was that the patient authorisation, which the patients signs on private insurance claim forms, is sufficient to cover, on a retrospective basis, the required information. Sites are now providing the following information to Private Insurers;