ADVERSE EVENT REPORTINGOF MEDICAL DEVICE

Adverse Event Reporting of medical devices.

1. ADVERSE EVENT REPORTING OF MEDICAL DEVICES Presented By: Tanisha Jain 2308212170005 > < Guided By: Mrs. Khyati Patel Assistant Professor

2. > < TABLE OF CONTENTS 2

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4. > < INTRODUCTION: Medical Device: A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose. 4

5. > < INTRODUCTION: Classification of MD (CDSCO) 5

6. > < INTRODUCTION: Classification of MD (USFDA) 6

7. > < INTRODUCTION: Classification of MD (EU) 7

8. > < Adverse Event Reporting of Medical Device: Adverse Event includes undesirable medical condition that can be symptoms (nausea , chest pain), signs (tachycardia , enlarged liver) or the abnormal results of an investigation (laboratory findings, electrocardiogram). Adverse Events are not necessarily caused by the medication – the event just needs to have occurred after taking a medicine. 8

9. > < OBJECTIVES: Importance of monitoring patients for an adverse event. Identify the common causes of an adverse event. Review the management of an adverse event. Review the outcomes for patients affected by an adverse event. 9

10. > < ABOUT EVENTS: An Event has Occurred The manufacturer becomes aware of information regarding an event which has occurred with its device. 10

11. > < ABOUT EVENTS: Typical events are: A malfunction or deterioration in the characteristics or performance. An incorrect or out of specification test result. The discovery of a design flaw during design review. An inaccuracy in the labelling, instructions for use and/or promotional materials. 11

12. > < ABOUT EVENTS: The Manufacturer’s Device is Associated with the Event. Complaint trends History of previous similar events. Information collected from healthcare professional about the event. 12

13. > < ABOUT EVENTS: The Event Led to One of the Following Outcomes: Death of a Patient, User Serious Injury of a Patient, User No d eath or serious i njury o ccurred but the event m ight lead to death or s erious injury of a patient , User or Other Person if the e vent reoccurs . 13

14. > < ABOUT EVENTS: Examples of Reportable Events : Loss of sensing after a pacemaker has reached end of life. Adverse reaction of an orthopaedic implant due to loosening. A batch of out-of-specification blood glucose test strips is released. Patient uses strips according to instructions, but readings provide incorrect values leading to incorrect insulin dosage, resulting in hypoglycaemic shock and AE. Unprotected ECG cable plugged into the main electricity supply – patient died. 14

15. > < WHO CAN REPORT? All healthcare clinicians, pharmacists, nurses & patients, biomedical/clinical engineers, hospital technology managers /technicians 15

16. > < WHOM TO REPORT? Adverse Events must be reported to a regulatory Authority according to applicable requirements in each jurisdiction. Regulatory Authorities should provide a contact point to manufacturers for reporting. 16

17. > < TIMING FOR REPORTING: All other reportable events must be reported as soon as possible by the manufacturer, but not later than 30-elapsed calendar days following the date of awareness of the event. If after becoming aware of a potentially reportable adverse event, there is still uncertainty about whether the event is reportable, the manufacturer must submit a report within the timeframe required for that type of event . 17

18. > < TIMING FOR REPORTING: All report times refer to when the authority must first be notified. This notification may be in the form of an initial report, final report or trend report as required. If additional information is required, the manufacturer should provide a follow-up or final report as soon as the information is available or as requested by the authority. 18

19. > < TIMEFRAME FOR REPORTING: 19 Reporter What to Report To Whom When Manufacturers Medical device adverse event (MDAE) or incident on MDAE reporting form with causality assessment report. MvPI Within 30 calendar days of becoming aware of an event. Manufacturers Reports for an event on MDAE reporting form with remedial action to prevent an unreasonable risk of substantial harm to public health. MvPI Within 5 work days of becoming aware of an event. Healthcare service provider Medical device adverse event or incident on MDAE reporting form with causality assessment report. MvPI MDAE reporting form within 5 work days of becoming aware and root cause analysis in next 30 calendar days.

20. > < MDAE FORM: 20

21. > < MDAE FORM: 21

22. > < REFERENCES: 22 GHTF/SG2/N54R8:2006 FINAL DOCUMENT Global Harmonization Task Force Title: Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices.

23. > < THANK YOU!!! 23