Recently, the Ministry of Health has issued guidance on Post Market Surveillance in Indonesia, one of which is Adverse Event Reporting. Ministry of Health has launched an online reporting system called e-watch (http://e-watch.alkes.kemkes.go.id/). By using this system, health facilities or distributors can do adverse event reporting immediately, once it happened. In the issued guidance, MoH also elaborates the adverse event considered mandatory to be reported and also the timeline of reporting. Following are the details:
A. Criteria for adverse events (KTD) need to be reported
1. An adverse event has occurred.
2. The medical device is associated with an adverse event.
Examples of causes of adverse events (KTD) for medical devices:
- - Malfunction or decrease in characteristics or performance.
- - False or out-of-specification test results (eg false-positive test results or false-negative test results resulting in an incorrect status assigned to the individual)
- - Inaccuracies in marking, instructions for use and/or promotional materials
- - Discovery of a serious public health threat
- - Use error.
Examples of causes of adverse events (KTD) for DIV medical devices:
- - Errors when designing or manufacturing DIV medical devices;
- - inadequate instructions for use;
- - inadequate care and maintenance;
- - modifications or adjustments made locally;
- - inappropriate use of DIV medical devices by users;
- - inappropriate In Vitro Diagnostic medical device management procedures;
- - Mistakes in choosing DIV medical devices that are not suitable for the purpose.
3. Adverse Events (KTD) led to one of the following outcomes
a. A serious threat to public health
- - The event or other occurrence is a hazard arising for systematic failure of the medical device that becomes known to business actors.
- - The event or other occurrence may lead to the death of, or serious injury to, a patient, a user of medical devices, or other people.
- - The probable rate of occurrence or degree of severity of harm caused by the hazard was not previously known or anticipated by the product owner of the medical device.
- - Business actors must take immediate action (including recall of medical devices) to eliminate or reduce the risk of these hazards in accordance with applicable regulations.
b. Death of a patient, user or other person (Sentinel Events)
c. Serious deterioration in state of health, user or, another person (Sentinel Event) includes
- - life-threatening illness or injury
- - permanent impairment of a body function or permanent damage to a body structure
- - conditions that necessitating medical or surgical intervention to prevent permanent impairment of a body functions or permanent damage to body structures
d. no death or serious injury occurred but the event might lead to death or serious injury of a patient, user, or other people if the event recurs.
B. Reporting Adverse Events
All Adverse Events (KTD) must be reported by the business actor/owner of the Marketing Authorization License to the Director General of Pharmaceuticals and Medical Devices with the following timeframes:
- i. Adverse Events (KTD) that cause serious threats to public health or have the potential to have a broad impact must be reported within 48 (forty-eight) hours at the latest.
- ii. Adverse Events (KTD) that has led to the death, or serious deterioration in state of health, of the patient, user or other people must be reported within 10 (ten) days at the latest.
- iii. Adverse Events (KTD) where 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 must be reported within 30 (thirty) days at the latest.
Therefore, in handling Adverse Events Reporting Measures, a reporting collaboration between foreign manufacturers and distributors is required.
Guidance for Reporting Adverse Events (KTD) of Medical Devices Procedure