Safety of Medical devices Medical device vigilance and Reporting
Dr. Reinhard Berger PharmMed Austria Medical Device & Haemovigilance Unit May 5th 2007
Disclaimer: The content of this presentation does not necessarily conform to the official position of AGES PharmMed and of the Bundesamt für Sicherheit im Gesundheitswesen
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1. AGES and PharmMed Austria 2. CE – mark PMS, medical device vigilance, assessment European coordination amongst Competent Authorities
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Organization chart AGES Austrian Federal Ministry of Agriculture, Forestry, Environment and Water Management (BMLFUW)
Austrian Federal Ministry of Health, Family und Youth (BMGFJ)
CEO, CFO Federal Office for Safety in Health Care
Bundesamt f. Ernährungssicherheit
Agriculture
Food
Veterinary medicin
Humanmedicin
PharmMed
Riskassessment Risk communication assessment – testing – approving – advice – research
AnalyticsCompetencecenter
risk control – the AGES cycle
R. Berger, OEGSV-0705
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AGES PharmMed Austria -
153. Federal law, changing and amending the Gesundheits- und Ernährungssicherheitsgesetz (GESG) and related legislation
Issued on December 28th 2005 Thus transferring tasks and responsibilities from the BMGFJ to the Federal office for Safety in Healthcare, and to AGES – PharmMed Austria as operating unit R. Berger, OEGSV-0705
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AGES - Agency for Health and Food Safety Dr. Heinz Frühauf Dr. Bernhard Url AGES PharmMed
Austrian Medicines and Medical Devices Agency
Austrian Federal Agency Safety in AustrianforFederal Health Care in Office for Safety
Ao. Univ.-Prof. Dr. Marcus Müllner
Health Care
Legal Expert
MMMag. Bernd Unterkofler
Quality Management DI Klaus Stüwe
Chief Medical Consultant Univ.Doz. Dr. Heribert Pittner
Pharmacovigilance
Controlling & Services
OMCL
Dr. Bettina Schade
Mag. Werner Steininger
Dr. Gerhard Beck
Marketing Authorisation of Medicinal Products & Lifecycle Management
Inspections
Science & Information
Mag. DDr. Alexander Hönel
Ao.Univ.-Prof.Dr.Andrea Laslop
DI Dr. Christa Wirthumer-Hoche
Controlling
Pharmaceutical Chemical Analysis
Mag. Werner Steininger
Dr. Andreas Mayrhofer
Archive
Pharmaceutical Technical Analysis
Dr. Michael Behounek
Mag. Roman Macas
PharmMed Services
Biological Chemical Analysis
Franz Knapp
Dr. Friedrich Lackner Biological Analysis DI Heidemarie Schindl
Regulatory Affairs National Procedures
Pharmaceutical Inspections
Mag. Helga Lacina
Mag. Andreas Kraßnigg
Regulatory Affairs MR and DC Procedures Dr. Kristof Liszka
GCP Inspections
National Affairs Dr. Ilona Reischl
IT / Medical Devices Inspections
Dr. Peter Platzer
DI Dr. Ronald Bauer
Dr. Christoph Baumgärtel Veterinary Medicinal Products Mag. Eugen Obermayr Herbal Medicinal Products and Homeopathics Univ.Doz. Dr. Heribert Pittner
Mag. Thomas Lang
Mag. DDr. Alexander Hönel
Qualitiy Assesment of Medicinal Products
Safety and Efficacy Assessment of Human Medicinal Products
International Affairs
Medical Devices & Haemovigilance Dr. Reinhard Berger
Medical Devices & Haemovigilance Unit Federal Office
Head of Unit (Berger)
QM
assistant
(Schleicher)
(Münster)
administration
medical assessors
technical and regulatory assesors
Konrad
Fournier
Berger
Muenster
Pilacek
Konrad
Schleicher
Kou-Keferböck
Stummer
NN
Glechner
NN
NN ver 02.11.2006
processes - tasks
market surveillance
clinical assessment
vigilance Vigilanz
conformity assessments SER
FSC
Medical device & haemovigilance unit
delineation classification
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1. AGES and PharmMed Austria 2. CE – mark PMS, medical device vigilance, assessment European coordination amongst Competent Authorities
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medical devices - 1
approx. 8 000 different types, approx. 500 000 products .
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Medical devices, such as bandage, infusion sets, ECG electrodes, contact lenses and their accessories such as cleaning solution Medical devices for handicapped, such as wheel chairs, crutches
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medical devices - 2 Medical equipment, such as X-ray equipment, ECG, defibrillators, audiometers, rf-surgery tools, endoscopes, catheters, infusion pumps Implants - active implants, such as pacemakers, neurostimulators, radioactive implants - non active implants, such as joint replacement implants, bone screws, breast implants In vitro diagnostics, such as HIV, HCV, HBV - tests, pregnancy tests, glucose tests In vitro diagnostic laboratory equipment, such as fully automated IVD analyzers for blood testing, blood gas analyzers, analyzers for glucose, PCR Medical software, such as software to control medical devices, medical expert systems
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market access for medical devices manufacturer
product
notified body competent authority before
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Declaration of conformity
design validation, clinical validation, conformity assessment
post market surveillance, medical device vigilance
CE - mark
competent authority
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manufacturer The manufacturer (or the authorized European representative) is fully responsible
• the manufacturer must perform the conformity assessment
• if passed, the manufacturer can issue the declaration of conformity, thus declaring that the product fullfills the essential requirements of all applicable directives
• then the manufacturer can affix the CE-mark on the medical device
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requirements
– the manufacturer shall implement and maintain a Post Marketing Surveillance System (PMS System)! – the users / medical practitioners / health professionals, and manufacturers as well, shall comply with the requirements about reporting (§§ 70ff MPG) – the federal office for safety in health care registers the reported cases, investigates and assesses them
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requirements
an essential part of the PMS-system is the
vigilance system
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definition
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The purpose of the Vigilance system is to improve the protection of health and safety of patients, users and others by reducing the likelihood of the same type of adverse incident being repeated in different places at different times. This is to be achieved by the evaluation of reported incidents and, where appropriate, dissemination of information which could be used to prevent such repetitions, or to alleviate the consequences of such incidents. 16
scope
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Therefore a functioning medical device vigilance system protects - the patient - the health care professionals - the medical doctor - the manufacturer - the distributor 17
vigilance – reporting
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What shall be reported?
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all serious incidents / events , which happened in Austria all potential serious incidents / events, which potentially happened in Austria but have been avoided, or incidents, which could have happened in Austria, as those devices are placed on the market in Austria all field corrective actions (e.g. recalls), without any exception
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vigilance – reporting
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How to report whom?
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Reports shall be sent to the Federal office for safety in health care (refer to § 70) The form should be used (www.ages.at) The reports shall be filed immediately/without delay (according to Austrian law, the outlined schedules in the guideline MEDDEV 2.12 are legally not correct in Austria)
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download the forms
www.ages.at
R. Berger, OEGSV-0705
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processing …….
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the staff of the unit ...
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collects the reports assesses of the report by means of a risk assessment about any likelihood of further occurrences, risk control and reduction measures, for safeguarding the patients and public health Contacts the manufacturer (authorized representative) or the Austrian distributor investigates ...... (if applicable within the EEC)
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vigilance - structure • • • •
The medical device market is an open market within the EEC … All European Competent Authorities communicate with each other There are several procedures for communication and information exchange implemented („Helsinikiprocedure“, MSOG,…) Although this is a decentralized organization, in several cases one CA takes the lead and coordinates the European activities 22
vigilance
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Therefore – it‘s all about safety and efficacy and the benefit of the patient
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So let‘s cooperate and work together to resolve issues in the interest of public health
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To achieve out goal
safe and efficient medical devices risk – benfit
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clinical safety and efficiacy
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www.ages.at
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Pfad: | home | Das Unternehmen | Bundesamt für Sicherheit im Gesundheitswesen | Formulare | Medizinprodukte und MedizinprodukteVigilanz | Formulare Medizinprodukte und Haemovigilanz |
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http://www13.ages.at/servlet/sls/Tornado/web/ages/content/FF1494909796F444C12570D5002C02C1
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Meldeformular für klinische Prüfungen:
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F_D02_meldung_studie_mp.doc F_D04_beiblatt_pruefzentrum_mp.doc F_D06_beendigung_studie_mp.doc F_P08_SAE_mp.doc Meldeformular für Vorfälle und Nebenwirkungen außerhalb von klin. Prüfungen:
F_D10_VigiMeldeForm_mp.doc 25
and that‘s the final slide ....
discussion ……….
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