ANNEXES. Medical device approval process. Annex II IMB safety notice, 27 August Annex III IMB ASR press statement.

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1 IRISH MEDICINES BOARD OIREACHTAS JOINT COMMITTEE ON HEALTH & CHILDREN DEPUY ASR (TM) ARTICULAR SURFACE REPLACEMENT AND ASR (TM) XL ACETABULAR SYSTEM 19 JULY 2012 ANNEXES Annex I Medical device approval process Annex II IMB safety notice, 27 August 2010 Annex III IMB ASR press statement. 27 August 2010 Annex IV Annex V Annex IV Manufacturer s field safety notices Commissioner Dalli s joint plan of immediate actions Revision of the Medical Devices Legislation Oireachtas Committee on Health, 19 July 2012 ANNEXES

2 Annex I Medical device approval process To place a medical device such as a hip implant (class III) on the market in Europe, the manufacturer must be authorised to do so following an assessment conducted by a notified body for medical devices. Following its assessment and once satisfied that the device meets the relevant requirements, the notified body will issue a certificate for the medical device. This entitles the manufacturer to affix a CE mark to the device. A CE mark allows the manufacturer to place that medical device on the market throughout Europe without the need for any specific national authorisation. A medical device once placed on the European market must continue to conform to the requirements of the relevant medical device Directive. The IMB, as competent authority for medical devices in Ireland, does not approve or certify medical devices for marketing purposes in Ireland or any other country but this task is fulfilled by a notified body for medical devices. The manufacturer can chose from any of approximately 80 notified bodies (with appropriate designation) based in Europe to assess their product s conformity to the relevant requirements and thereby issue certification. The manufacturer requires assessment by one notified body only to gain access to the entire European market. Notified bodies are certification organisations which have specific competence in medical device technologies. To become a notified body, the organisation must submit an application to the competent (or more specifically designating) authority in the Member State where they are based. This application provides details of their organisation, quality systems, procedures, resources and their particular qualification and expertise for medical devices. The national authority normally completes a full desk review of this documentation followed by an audit of the notified body s facilities. If successful, the authority notifies the European Commission of the specific scope of products (based on the organisation s specific competencies) for which the notified body is designated. The authority then oversees the notified body s performance on an ongoing basis through regular surveillance audits of the notified body and observed audits of the notified body s auditors when auditing a manufacturing site. A peer review system for authorities has existed at European level since 2006 which seeks to ensure that consistent standards and oversight are applied to notified bodies across Europe. The IMB is the designating authority for medical device notified bodies in Ireland. There is currently one notified body in Ireland. A manufacturer of a medical device, such as a hip implant, must submit an application to a notified body for assessment of its product prior to marketing. A notified body will receive information relating to the manufacturer, their quality system and also information relating to the specific device (typically include design specifications, detailed risk analysis, solutions to meet requirements, design verification, compatibility with other devices, details on design and construction state of the art, Oireachtas Committee on Health, 19 July 2012 ANNEXES

3 pre-clinical evaluation, clinical evaluation, labelling etc.). The notified body using appropriately qualified assessors will inspect the manufacturer and the operation of their quality system. One critical aspect of this assessment is that the manufacturer has systems in place to appropriately gather and assess data arising from the use of the device both in normal use and relating to adverse incidents (i.e. post-market surveillance and vigilance systems). In addition, for a device such as hip implant, the notified body is required to conduct a detailed examination of the specific device information, including a full analysis of all pre-clinical, mechanical and clinical testing and ensure that the requirements are appropriately addressed. A notified body can issue a certificate for a maximum of 5 years, however the certification period may be shorter based on the risk of the device. During this certification period, the notified body is required to conduct regular surveillance audits (usually annually) of the manufacturer to ensure that their quality system is operating effectively and also to assess data relating to the device e.g. post-market clinical data and safety data, arising from the use of that device. The manufacturer is required to inform the notified body if they make any significant changes to the design or manufacture of their device so that the notified body can assess and ensure that the product continues to meet the relevant requirements. During annual inspections, the notified body should check if the device has been modified in design or manufacture. If the notified body is no longer satisfied that the requirements of the Directive are met, they will seek corrective action from the manufacturer and may suspend or withdraw the certificate depending on the issue. In 2005, following a European review of Orthopaedic products, the European Commission published Directive 2005 /50/ EC which included the reclassification of the Orthopaedic Systems from Class IIb to Class III. Manufactures of these products were given a four year transition period, until 1 September 2009, to bring their products into compliance with this new requirement, including the recertification of their products. Therefore the Depuy ASR product would have been placed on the market initially as Class IIB and later as Class III medical devices. The notified body who issued the certificates for the DePuy ASR(TM) Articular Surface Replacement and ASR(TM) XL Acetabular System is the British Standards Institute (BSI) in the UK. Oireachtas Committee on Health, 19 July 2012 ANNEXES

4 Annex II IMB safety notice, 27 August 2010 Oireachtas Committee on Health, 19 July 2012 ANNEXES

5 IRISH MEDICINES BOARD SAFETY NOTICE ASR Articular Surface Replacement and ASR XL Acetabular System S A F E T Y NOTICE IMB Safety Notice: SN2010(10) Circulation Date: 27 August 2010 MANUFACTURER/SUPPLIER DePuy International Ltd. TARGET GROUPS Orthopaedic surgeons Orthopaedic theatre staff Orthopaedic registrars Risk managers Hospital CEOs General Practitioners ISSUE Recall of DePuy s ASR Hip Implant System due to higher than expected revision rate. BACKGROUND On 26th August 2010, DePuy announced a worldwide recall of the ASR Hip System. This decision is based on new, unpublished data from the National Joint Registry (NJR) of England and Wales. The data shows the five year revision rate for the ASR Articular Surface Replacement is approximately 12% and for the ASR XL Acetabular System is approximately 13%. These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patients. DePuy circulated a field safety notice (FSN) on 26th August 2010 to advise customers of this recall. DePuy has advised the IMB that there is no stock currently held at Irish hospitals. The Irish Medicines Board (IMB) is working with the HSE and orthopaedic surgeons regarding recommendations for patient review. Patients who received the ASR XL Acetabular System or DePuy ASR Hip Resurfacing System will be contacted to schedule a review. However, if patients are experiencing pain, difficulty walking or other symptoms, they should contact their GP or orthopaedic consultant for advice. ENQUIRIES All adverse incidents relating to a medical device should be reported to the: SUR-F /2

6 Irish Medicines Board Kevin O Malley House Earlsfort Centre Earlsfort Terrace Dublin 2 S A F Telephone: Fax: vigilance@imb.ie Website: Enquiries should be addressed to: Manufacturer: DePuy International Ltd St Anthony s Road Leeds LS11 8DT England Contact Person: Paul Arnott Tel: Fax: parnott@its.jnj.com E T Y NOTICE SUR-F /2

7 Annex III IMB ASR press statement, 27 August 2010 Oireachtas Committee on Health, 19 July 2012 ANNEXES

8 27 th August 2010 Recall of DePuy ASR Hip Systems ASR Hip Replacement System & ASR Hip Resurfacing System The Irish Medicines Board (IMB) is working with the HSE and Orthopaedic surgeons in relation to the worldwide recall announced yesterday by DePuy of their ASR Hip System. Most hip replacements involving the ASR hip system have been successful. However, data recently received by DePuy shows that after 5 years approximately 12 per cent of patients who received the ASR hip require replacement of their implant, a higher rate than expected, and this has led to the recall. The IMB has carefully monitored this product on the Irish marketplace and has been in ongoing discussions with the company. The manufacturer confirmed that all stock has been removed from Irish hospitals. Approximately 3500 patients have received the ASR Hip System in Ireland since it became available in Twelve incidents have been reported to the IMB to date. A hip implant is made up of ball and socket components that move against each other. The ASR components are made of metal and may wear over time. This is an expected process. There are tests that will help orthopaedic surgeons determine if the hip is working as it should. Patients who have been implanted with the affected devices will be contacted in the coming weeks for review. FOR FURTHER MEDIA INFORMATION: Ger McCarthy/Orla Molloy Tel: (01) Weber Shandwick or ABOUT THE IRISH MEDICINES BOARD The Irish Medicines Board (IMB) is the competent authority for the licensing of human and veterinary medicines and medical devices in Ireland. Its role is to protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products.

9 Annex IV Manufacturer s field safety notices Oireachtas Committee on Health, 19 July 2012 ANNEXES

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14 ASR XL Acetabular System and DePuy ASR Hip Resurfacing System Recall Information for Patients DePuy makes patient safety and health a top priority and is continually evaluating data about its products. Most ASR hip replacement surgeries have been successful. However, data recently received by the company shows that more people than expected who received the ASR hip experienced pain and other symptoms that led to a second hip replacement surgery, called a revision surgery. For this reason, DePuy Orthopaedics is recalling its ASR XL Acetabular System and DePuy ASR Hip Resurfacing System. This recall means additional testing and monitoring may be necessary to ensure your hip implant is functioning well. In some cases patients may need additional surgery. New data shows that five years after implantation, approximately 12% of patients (1 in 8) who had received the ASR resurfacing device and 13% of patients (1 in 8) who had received the ASR total hip replacement needed to have a revision surgery. If you have received an ASR Hip Replacement or ASR Hip Resurfacing System, both of which will be referred to as your hip implant, the following information will help you understand what this recall means to you and the steps you should take. WHAT HAPPENS TO THE ASR IMPLANT AND WHAT SYMPTOMS SHOULD I WATCH FOR? The patients who reported problems in the first five years and had revision surgery reported a variety of symptoms. These symptoms included pain, swelling and problems walking. These symptoms are normal if you have just had a hip replacement. But if the symptoms continue or come back, it is a sign that there may be a problem such as: Loosening, when the implant does not stay attached to the bone in the right position Fracture, where the bone around the implant may have broken; and Dislocation where the two parts of the implant that move against each other are no longer aligned. Your hip implant is made up of ball and socket components that move against each other. These components are made of metal that wears over time and generates very small particles that can only be seen with a microscope. This is an expected process. Different people respond to the particles in different ways. A small number of patients may react to these particles, causing fluid to collect in the joint and in the muscles around the joint. While this condition may initially be painless, if left untreated, this reaction may cause pain and swelling around the joint and could damage some of the muscles, bones, and nerves around the hip. August 24, 2010

15 There are tests that will help your surgeon determine if your hip is working as it should and if you are having a reaction to the metal particles. Your surgeon may take x-rays of your hip. Also, a blood test can be done to indicate the level of microscopic metal particles around your hip. Your surgeon may also use an ultrasound or MRI to evaluate if you are having a reaction to the metal particles. WHAT DOES THE RECALL MEAN FOR ME? Please contact the surgeon who performed your hip implant to determine if you received the ASR System. Most people with ASR hip implants do not experience problems. However, it is important that you follow up with your surgeon on a annual basis for the first 5 years after your ASR hip surgery even if you are not experiencing symptoms to ensure that your hip continues to work well. In some cases, your surgeon may order additional blood testing or imaging to evaluate how your hip is functioning. Your surgeon will determine the best monitoring plan for you and discuss treatment solutions should they be needed. If you don t know who performed your hip replacement surgery, ask your primary care physician or the hospital where the surgery took place. DePuy Can Help: If you are unable to determine the type of hip implant you received, we can help. Please fill out the release form available on U.S. patients should mail a completed form to DePuy Orthopaedics, Customer Quality Department, PO Box 988, 700 Orthopaedic Drive, Warsaw, IN Patients outside of the U.S. should mail a completed form to DePuy International Limited, Complaints and Vigilance Department., St. Anthony s Road, Leeds, LS11 8DT. This will allow DePuy to contact your surgeon or hospital on your behalf. If you received the ASR XL Acetabular System or DePuy ASR Hip Resurfacing System, you should take the following steps: Schedule an appointment with your surgeon. Your surgeon will be able to evaluate how your ASR hip is functioning. If you are experiencing pain, difficulty walking, or other symptoms, your surgeon may want to take x-rays of your hip. X-rays will allow your surgeon to evaluate how the ASR hip is positioned, if there is any damage to the bone and if the ASR hip has remained attached to the bone. If the x-rays show problems with your ASR hip, your surgeon may recommend surgery to replace it. In some cases, your surgeon may order additional blood testing or imaging to ensure your ASR hip is functioning well. The evaluation may include a blood test that indicates the level of microscopic metal particles around your hip. If the blood test indicates a high level of these particles, your surgeon may want to do a second blood test three months later. These levels may be high even if you are not experiencing any symptoms, so this blood testing is very important. If the second blood test still indicates a high level of these particles, your surgeon may want to do an MRI or ultrasound test of your ASR hip. If such tests show a reaction to the particles, your surgeon may recommend surgery to replace your August 24, 2010

16 implant. This is a decision that you and your surgeon need to discuss based on your own personal health needs. If you do not have any symptoms or test results that suggest you may need to have your implant replaced, then you should follow your surgeon s recommendations for continued follow-up. If you do need to have an additional surgery, several options are available and your surgeon will select the appropriate implant system for you. WHO WILL PAY FOR MY TESTING AND TREATMENT? Your safety and health is important to DePuy and we do not want cost to be a barrier to treatment. DePuy intends to cover reasonable and customary costs of testing and treatment if you need services, including revision surgery, associated with the recall of ASR. Bills for services should first be submitted to your insurance company or Medicare in the usual manner and DePuy will then reimburse you for your out of pocket expenses. Detailed information about the reimbursement process will be available shortly. Please visit our web site at or call the ASR Help Line at the number below. WHO CAN I SPEAK WITH? We recommend contacting your orthopaedic surgeon directly. DePuy Can Help: Additional questions? We are here to help. Do not hesitate to call the DePuy ASR Help Line beginning August 27, Patients in the U.S. and Canada: Callers from the U.S. and Canada should dial the toll-free number The U.S. and Canada call center will be active from 8 a.m. to 9 p.m. EST. Patients outside of the U.S.: Please secure an operator and instruct them that you need to place a collect call to the United States at The operator will make the connection and transfer you to a representative who will greet you in English. Please respond in your preferred language to the representative. You will be transferred to a translator who speaks your language. The transfer to the translator may take up to two minutes. DePuy appreciates your patience while the call is being transferred. The OUS call center will be active 24 hours a day, 7 days a week. Additional information is also available at Please check depuy.com on a regular basis for additional updates and information. August 24, 2010

17 Health Care Professional Letter August 24, 2010 ATTN: DePuy Customers I am writing to share urgent and important information about DePuy s decision to voluntarily recall the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System. (Note: The DePuy ASR Hip Resurfacing System was only approved for use outside the U.S. and the ASR XL Acetabular System was available worldwide.) The official recall notice is attached. Most ASR hip replacement surgeries have been successful. However, data recently received by DePuy shows that more people than expected who received the ASR hip require revision surgery. For this reason, DePuy Orthopaedics is voluntarily recalling its ASR XL Acetabular System and DePuy ASR Hip Resurfacing System. This recall means additional testing and monitoring may be necessary to ensure your patients hips are functioning well. In some cases, patients may need revision surgery. Our goal is to help you answer your patients questions and support their prompt follow up care and treatment. Please contact your patients and request that they schedule a follow up appointment for evaluation. Included with this letter are several documents that you may use to communicate with patients, including: --Sample patient cover letter --Information for Patients --Medical Release Form The recommended patient follow up protocol is that patients with radiographic changes indicative of product failure should be treated according to normal procedures. All other patients should be followed according to the April 22, 2010 and the May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.1, 2 Per the April 22, 2010 Device Alert, a small number of patients may develop progressive soft tissue reactions to metal wear debris without exhibiting any symptoms. The debris can cause soft tissue damage which may compromise the results of the revision surgery. Early revision of poorly performing hip replacements that generate metal debris should give a better revision outcome, so metal ion testing is extremely important. Therefore, metal ion testing should be considered in cases where the surgeon is concerned about the hip replacement even if the patient is asymptomatic. It is important to note that DePuy intends to cover reasonable and customary costs of monitoring and treatment for services, including revisions, associated with the recall of ASR. Diagnostic testing, as recommended by the MHRA, may be used when you have concerns about a patient with the ASR System, even when they re asymptomatic. The procedure for the reimbursement process will be provided to you at a later date, but fees for services should first be submitted to payors in the usual manner and DePuy will then reimburse patients and payors for out of pocket reasonable and customary expenses. Document ID: DPY 8

18 Reimbursement is subject to the completion and submission of required documentation to DePuy to confirm eligibility. Eligibility will be determined, in part, by validation that the patient has an ASR component implanted and has consented to provide DePuy with x-rays, explants and any other requested medical information after the revision surgery. The completion of the patient release form will allow you to share information about this patient s case with DePuy and will allow DePuy to provide information directly to patients regarding the ASR Hip System. DePuy will also use this information to process claims efficiently and to help DePuy to better understand the causes of the problems with the ASR Hip System. Patients should complete the form and bring it with them to the appointment. We will provide you with a brief form to be completed for each patient, including date of surgery, components implanted, follow up status and the results of any metal ion testing. We appreciate your assistance with this process, and we will provide compensation at a rate of $50 per patient for each completed form that is submitted to DePuy. You can access the latest information about the recall by visiting our website at If you have additional questions, please contact the physicians listed below: U.S./Canada/Latin America Rodrigo Diaz, Scientific Information Officer, Mikhail Chkolnik, Project Leader, Clinical Research, EMEA Jens Krugmann, Director Product Safety and Risk Management, Dirk Parwis Ghadamgahi, Manager, Customer Education, Greg Medalla, Manager Clinical Research, ASPAC Aran Maree, Vice President Strategic Medical Affairs, Thank you for your assistance during this recall process. Sincerely, Pamela L. Plouhar, Ph.D. VP, Worldwide Clinical Affairs Document ID: DPY 8

19 Patient Letter August xx, 2010 Dear, I am writing to share important information about your hip replacement implant, the DePuy ASR Hip System. A small number of patients with the hip implant you received have experienced problems that require additional care and potentially further treatment. For this reason, DePuy Orthopaedics, Inc., the maker of your hip, has advised me that they are recalling the ASR Hip System and recommending that patients be evaluated. Please call my office to schedule an appointment for the evaluation of your hip. During that appointment, I would like to discuss with you any symptoms/problems you are having, additionai testing that has been recommended and the best plan for ongoing testing and treatment for you. DePuy will pay for the examination and any medical follow up as described in the attached Information for Patients sheet. The Information for Patients sheet, provided by DePuy, will help to address any questions you may have about your hip implant, the reason it is being recalled and what you need to do. If you have any questions regarding the performance of your hip implant, please contact my office. If you have questions about payment for treatment, please contact DePuy using the phone number included in the Information for Patients sheet. Also included with this letter is a Medical Release Form. Your completion of this form allows me to share information regarding your hip with DePuy. It is important to share this information with DePuy so that DePuy may contact you directly regarding any additional information regarding the ASR Hip System and process your claims efficiently. Please complete the form and bring it with you to your next appointment. Once again, please contact my office as soon as possible to set up a follow up appointment so that I may address your concerns and discuss the best treatment options for you. Sincerely,

20 Annex V Commissioner Dalli s joint plan of immediate actions In early February 2012, Commissioner John Dalli (Health & Consumers) wrote on two occasions to each of the national Ministers for Health across Europe indicating the need to increase control on medical devices to provide an appropriate level of protection to European citizen and restore trust and confidence in the regulatory system for devices. Commissioner Dalli, recognising that legislative revision would take several years to come into effect, identified the need to act immediately to achieve these objectives. In the second letter dated 9 February 2012, Commissioner Dalli included a joint plan with immediate, short and medium-term actions for the Member States, Competent Authorities, Notified Bodies for medical devices and the European Commission to undertake. These actions had largely already been identified by the European Commission as key areas for inclusion within the revision of the medical devices legislation. The Commission now intend to use implementing measures provided for in the existing legislation to bring about some of the necessary changes, in whole or in part in the more immediate future. This plan is welcome and allows for many necessary improvements to be made in the regulatory system for medical devices in advance of the future and broader legislative revision. Effective and coordinated implementation is however critical to ensure that it achieves the most valuable outcome. The Commission in June presented draft legislative texts in relation to these implementing measures on notified bodies for medical devices, which require some further development and discussion to ensure the desired outcome of improving the oversight of and the functioning of notified bodies. The areas included with the plan are to improve the functioning of notified bodies, to enhance market surveillance, to improve coordination on vigilance and market surveillance activities and to enhance communication and transparency throughout the regulatory system. Some of the most significant actions for include: i. Review the designation scopes of notified bodies for class III medical devices to be conducted by September Critically linked to this is the action to enhance the requirements and criteria for designation of notified bodies on which the Commission will launch a formal legal measure on in October ii. Surveillance inspections of notified bodies from 2013 will involve joint assessments by colleagues from other European authorities and the European Commission. iii. National competent authorities are asked to reinforce market surveillance measures. iv. As part of enhanced market surveillance, authorities are requested to conduct physical and laboratory checks on medical devices in addition to existing documentary checks. Oireachtas Committee on Health, 19 July 2012 ANNEXES

21 Annex VI Revision of the Medical Devices Legislation The three primary European Directives relating to medical devices are being substantially revised by the European Commission and it is expected that they will adopt two Regulations relating to medical devices in September or October 2012 and will be subject to debate at the European Council and Parliament. It is expected that these Regulations will be subject to significant discussion and debate. When these Regulations come into force they will replace all of the current medical devices directives. The key principles that are expected to be included in the medical devices revision that are commonly agreed amongst all stakeholders include: improving the performance and the oversight of notified bodies for medical devices; enhancing the coordination, assessment and communication on vigilance issues and enhancing and better coordinating market surveillance; improving coordination, cooperation, management and decision making in the regulatory system in Europe; and improving the transparency and availability of data relating to medical devices. The Commission s internal impact assessment of the medical devices revision was presented to the Commission s Impact Assessment Board in September The document has not been made available but it is anticipated it will assess the possible impact on public health, economics, environment etc. of the various proposals on patients, healthcare professionals, industry etc. The IMB understands that full pre-market assessment of a medical device by a central authority with a central authorisation/approval for that device has been considered by the Commission as part of its impact assessment. Previous discussions on the topic with the Commission and other stakeholders have included comparison with the US FDA pre-market approval system which it has been argued is burdensome, time-consuming and unpredictable but yet it is argued that there is little evidence to suggest that there is a safety benefit e.g. reportedly no major difference in the numbers of medical device recalls between the EU and US. In June 2012, the European Parliament agreed a Resolution on medical devices arising from debate on defective silicone filled breast implants. This resolution included a call for the European Commission to move to a system for pre-market authorisation of certain categories of medical devices, including, at least Class IIb and III medical devices (which would include long term implanted devices). The Commission is currently finalising the text of the two Regulations to revise the medical devices legislation. At this time it is anticipated that the Commission will propose an enhanced scrutiny mechanism of high risk and implantable medical devices by Competent Authorities prior to completion of the assessment and certification by a notified body. Oireachtas Committee on Health, 19 July 2012 ANNEXES

22 Draft texts containing extracts from the revised legislation were made available by the Commission in February 2012 for discussion and development by the European Medical Device Expert Group. Current provisions include: Enhanced provisions for oversight of notified bodies including joint assessments (involving European colleagues and Commission colleagues) and much more specific criteria in relation to resource, qualifications, quality, organisation and process requirements. Mechanism for scrutiny of certain conformity assessments in which authorities will have a means of examining the notified body assessment conclusions for a high risk or innovative product prior to that product being certified. Systems for vigilance and market surveillances will be enhanced with more coordination on assessments and more communication with European and international regulatory partners. In addition, the notified bodies assessing medical devices will be required to receive certain vigilance reports from the manufacturer in order that they can directly decide whether certification is affected. In relation to market surveillance it is also anticipated that the Commission will introduce provisions for implant registers, at national/european level. Reference laboratories are expected to be used at European and through national networks to test medical devices on request of competent authorities or the Commission. Enhanced provisions on traceability: it is expected that each economic operator will be responsible for tracing each device through the supply chain to the end user. In addition, a system for unique device identification is expected as is a requirement to ensure that patients are provided with a specific record of which device they were implanted. Oireachtas Committee on Health, 19 July 2012 ANNEXES