Post Market Surveillance and Vigilance in Japan. Medical Device Safety Division, Office of Safety I
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1 Post Market Surveillance and Vigilance in Japan Medical Device Safety Division, Office of Safety I 1
2 Overview of Adverse Event Reporting 医療機関 Healthcare professionals /facilities 2. Investigation 3. Investigation Manufacturer 1. Reporting an event In 15 or 30 days (depending on seriousness and predictivity) MAH (Marketing Authorization Holders) 4. Adverse event report 2
3 Definition of Adverse Event Adverse event means unfavorable or harmful. Regardless of occurrence of health hazards 1. Breakage, Malfunction, Poor Operating Performance, etc. 2. Defective Products 3. Problem with device specifications Regardless of occurrence of product problems 4. Health Hazard related to use of the device 5. Inadequate Information on Package Inserts(IFU) Decided to be a cause of operational errors 3
4 Information included in Adverse Event Reporting Event description What happened to the device What happened to the patient How the patient was treated after the event occurred Technical information How the device was used Maintenance records Experience of the user Opinion of the user Device quality Specification/Durability Manufacturing records Cause analysis Device analysis results Simulation experiments Occurrence of similar events (trends) MAH s conclusions Patient information Age, gender, weight Background Complications Medication/Treatments Clinical examination value Condition Patient outcome Safety measures (as necessary) - Taken measures& Future plans Recall, Repair Written in package inserts/ifu Field safety notice Device modification Improvement of Training program 4
5 Adverse Event Report (1) - Domestic Case Malfunction, failure, breakage, leak, fault, etc. of a medical device Possibility of Health Damage Serious Description in the package insert/ifu (unanticipated) (anticipated) Report s due date 30 days (Uncomprehended elevation of the incidence rate of AE) 30 days (Except reports shown above) Non-Serious Annual reports - 5
6 Adverse Event Report (2) - Foreign Case Malfunction, failure, breakage, leak, fault, etc. of a medical device Possibility of Health Damage Serious Description in the package insert/ifu (unanticipated) (anticipated) Report s due date 30 days (Uncomprehended elevation of the incidence rate of AE) 30 days (Except reports shown above) Non-Serious - - 6
7 Adverse Event Report (3) - Domestic Case Health damage (in case relation with the medical device cannot be denied) Health Damage Description in the package insert/ifu Report s due date Death / Serious Except death (Uncomprehended elevation of the incidence rate of AE) 30 days (Except reports shown above) Non-Serious Annual report - 7
8 Adverse Event Report (4) - Foreign Case Health damage (in case relation with the medical device cannot be denied) Health Damage Description in the package insert/ifu Report s due date Serious Death (Uncomprehended elevation of the incidence rate of AE) 30 days Non-Serious Except death (Uncomprehended elevation of the incidence rate of AE) 30 days - - 8
9 Other Reports Adverse Infection Report Health Damage Description in the package insert/ifu Report s due date Domestic Serious Non serious - Foreign Serious Non serious - - Study report :Submitted within 30 days Foreign Field Safety Corrective Action (FSCA) Report: Submitted within 9
10 Overview of Adverse Event Reporting 医療機関 Healthcare professionals /facilities 2. Investigation 3. Investigation Manufacturer 1. Reporting an event Within 15 or 30 days (depending on seriousness and predictivity) MAH (Marketing Authorization Holders) 4. Adverse event report 6. Consideration of safety measures 5. Share information, Cooperation Ministry of Health, Labour and Welfare (MHLW) 10
11 Foreign Field Safety Corrective Action (FSCA) Report Manufacturer Collecting information MAH ANSM BfArM EMA FDA MHRA TGA Regulatory Agencies Collecting information FSCA Report (within ) Detailed information about the action taken in foreign countries Actions taken in Japan (recall, repair, provision of information, etc.) 11
12 Current Status and Issues of Adverse Event Reporting Current Status Adverse Event Reporting is voluntary. Cases without adverse event is not reported. Issues Certain information gathering is needed to take appropriate safety measures. Denominator of patient exposure in medical devices of interest is unknown. 12
13 Registry broadens limitation of Post-Market Surveillance Registry is : A system constructed to manage patient data centrally and feedback its analysis to healthcare providers. (based on IMDRF Registry Working) Information of all products of interest Add registration in database to conditions for approval. Information of all patients exposure Database Add registration in database to conditions for use. Central management 13
14 Registry broadens limitation of Post-Market Surveillance Registry makes it possible to : Survey Long Period Use-Result. Calculate accurate incidence of Adverse Events. Conduct thorough monitoring and safety measures to medical devices which were approved under few clinical data. 14
15 Information gathering system of J-MACS Hospital Register adverse events (1) Death (in ) (2) Device malfunction (in 30 days) (3) Infection (in 30 days) (4) Nerve disorder (in 30 days) (5) Massive bleeding (in 30 days) (6) Other adverse event (periodic report) Database Definitions of adverse events are harmonized not to cause differences in criteria in each hospital. Information of adverse events MAH Adverse Event Report 15
16 Case Disconnection of Transdermal Cable of Ventricular Assist Device (VAD) Disconnection of Transdermal Cable occurred frequently in Post-Market. The disconnection is a serious adverse event, because it causes an error on pump function. Ascending Aorta Left Ventricle Transdermal Cable jp/medical/index.html 16
17 Case Disconnection of Transdermal Cable of VAD Bend Stress caused disconnection. Old model Improvement of the cable made 23 times stronger than the old model. Improved model 17
18 Application of Registry Data Registry Hospital B Hospital A Clinical Record Hospital C Application of Registry Data Database Marketing authorization Re-examination Historical control Publication Guidelines Patient Data 18
19 Summary Post-Market safety measures are to restore unbalanced riskbenefit balance to a former condition. Safety measures are taken based on domestic and foreign safety information such as adverse event report, FSCA report, etc. reported by MAH. Registry makes it possible to take more appropriate and rational safety measures through more complete information gathering. Registry data is expected to apply not only to safety measures but also to reviews, studies, development of guidelines, etc. 19
20 Thank you for your attention! 20
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