Guideline on Adverse Events Reporting in Medical Device Clinical Trials
The objective of adverse event reporting during pre-market clinical investigations is to improve protection of the health and safety of patients, users and others by identifying safety issues early in the human use of medical devices so that these can be addressed. These safety issues can therefore be addressed as soon as possible by modification of the device, revision of the instructions for use, modification of the clinical investigation plan or withdrawal of the device from use.
A guidance document on adverse event reporting is available to industry.
How to Report?
Mandatory reporting by medical device dealers
Local sponsor of clinical trials using medical devices should submit reports using the following form:
Medical Device Adverse Event Report Form (for Clinical Trials) dated 1 Aug 2017
File Size: (174 Kb)
Complete the adverse event reporting form and submit by email to HSA_CT_SAE@hsa.gov.sg. Please include “Medical Device AE Reporting for Clinical Trials” in the email subject for easy reference.
What to Report?
As a general principle, there should be a pre-disposition to report rather than not to report in case of doubt on the reportability of an adverse event. Any adverse event, which meets the three basic reporting criteria listed below, is considered as a reportable adverse event.
The criteria are:
- an adverse event (or potential adverse event) has occurred;
- the device product is associated with the adverse event;
- the adverse event led to one of the following outcomes:
- a serious threat to public health;
- serious deterioration in state of health of patient, user or other person;
- 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 recurs.
- death of a patient, user or other person;
When to Report?
The reporting timeline for adverse event reporting for dealers of device products are:
- within 48 hours for events that represents a serious threat to public health;
- within 10 days for events that has led to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device or any other person;
- within 30 days for events where a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device or any other person
The report should not be unduly delayed if the information is incomplete. The initial report of an adverse event should contain as much relevant detail as is immediately available, but should not be delayed for the sake of gathering additional information.
Sponsor of medical device clinical trials are to follow up with a final report within 30 days of the initial report, detailing the investigation into the adverse event. Follow-up reports may be requested as and when necessary.