Adverse Event Reporting of medical devices.

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

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INTRODUCTION
ADVERSE EVENT
REPORTING OF MEDICAL
DEVICE
OBJECTIVES
ABOUT EVENTS
TABLE
OF
CONTENTS
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WHO CAN REPORT?
WHOM TO REPORT?
TIMING TO REPORT?
TIMEFRAME FOR
REPORT?
MDAE FORM

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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.
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INTRODUCTION:
Classification of MD (CDSCO)
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INTRODUCTION:
Classification of MD (USFDA)
Medical Devices
Risk-Based
Classifications
Class I
Low Risk
Eg: Bandages
Class II Moderate Risk
Eg: Nebulizers
Class III High Risk
Eg: Pacemakers
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INTRODUCTION:
Classification of MD (EU)
Medical Devices
Risk-Based
Classifications
Class I
Low Risk
Eg: Wheelchair
Class IIa
Moderate Risk
Eg: Hearing
Aids
Class IIb
Potential Risk
Eg: Infusion
Pumps
Class III
High Risk
Eg: Stunt grafts
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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

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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.
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ABOUT EVENTS:
 An Event has Occurred
The manufacturer becomes aware of information
regarding an event which has occurred with its
device.
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ABOUT EVENTS:
Typical events are:
a) A malfunction or deterioration in the characteristics or
performance.
b) An incorrect or out of specification test result.
c) The discovery of a design flaw during design review.
d) An inaccuracy in the labelling, instructions for use
and/or promotional materials.
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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.
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ABOUT EVENTS:
 The Event Led to One of the Following Outcomes:
• Death of a Patient, User
• Serious Injury of a Patient, User
• No death or serious injury occurred but the event
might lead to death or serious injury of a patient,
User or Other Person if the event reoccurs.
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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.
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WHO CAN REPORT?
• All healthcare clinicians, pharmacists, nurses &
patients, biomedical/clinical engineers, hospital
technology managers /technicians
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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.
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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.
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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

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TIMEFRAME FOR REPORTING:
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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.

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MDAE FORM:
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MDAE FORM:
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REFERENCES:
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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.

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THANK YOU!!!
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