Mandatory Problem Reporting
Mandatory problem reporting element is mandatory for every establishment licensed by the Medical Device Authority. Section 40 of Act 737 provides for the mandatory responsibilities of each establishment to provide the investigation report the problem, and carry out corrective and preventive action to reduce problems involving medical devices from recurring.
The objective of the report is to raise the issue of mandatory health protection and safety of patients, users and others to disseminate information that helps prevent the recurrence of mishaps.
Submission of the mandatory problem reporting does not, in itself, represent a conclusion by the manufacturer that the content is complete or confirmed that the device is failed in any manner. It is also not a conclusion that the device caused or contributed to the incident. It is recommended that reports carry a disclaimer to this effect. Possibly, the establishment does not have sufficient information to make an informed decision. In this case, the establishment must make a thorough investigation as soon as possible for additional information to make decisions. Establishment must consult and cooperate with medical practitioners or professionals involved with health care, and do the best to recover the affected device involved with an incident, for further technical investigation.
If the establishment is aware that their medical device are involved in an incident, they with the user must be able to determine whether it is an event that may be reported as an incident or not, and determined whether it should be reported to the Authorities or not. Users are encouraged to report any incidents involving medical devices because they are directly involved in the use of the medical device.
For an event that involves the issue of mandatory reporting, establisment must notify the Medical Device Authority by category as follows:
- The failure of the medical device.
If the incident is related to a medical device failure or deterioration in its effectiveness, or any inadequacy in its labeling or in the instructions for use, the report shall be made within thirty days of the discovery.
- Death or serious deterioration
If incidents occur, leading to death or serious deterioration in the health of patients, users or other persons, or lead to recurrence, the report shall be made within ten days of discovery.
- A serious threat to public health
If the incident is a serious threat to public health, where there is a risk of death, serious injury, or a serious illness and may require immediate corrective action, the report shall be made within forty-eight hours of discovery.
The severity of a threat to public health is determined by the Medical Device Authority and a decision will be made by the Ministry of Health.
To Report for Mandatory Problem/Incident /Adverse Event Reporting
Mandatory Problem Reporting form templates can be downloaded HERE
The completed form can be submitted to the Office of the Medical Device Authority at the address :
Level 6 , Prima 9 ,
Prima Avenue II , Persiaran APEC ,
email to mpr @ mda.gov.my