INCREASING EFFICICIENCY OF MEDICAL DEVICE POST-MARKETING SURVEILLANCE SYSTEM IN THAILAND

Abstract

There are increasing in numbers and varieties of medical devices marketing in Thailand due to fast progress and change of medical technology. Presently, only a few types of medical devices have been technically evaluated in quality, safety and performance during pre-marketing process. The Thai Food and Drug Administration is in the preparing step to revise product approval procedure by using risk-based classification product approach following international practices and ASEAN Agreement on Medical Device Directive. To protect consumer through the whole process of pre-and post-marketing approval, this qualitative study aims (1) to find the way in increasing efficiency of medical device post-marketing surveillance system in Thailand by studying international best practices and survey opinions of involving parties including health professionals from public and private sectors and industry and (2) to survey for the list of medical devices that should be specially monitored.

From analysis of foreign practices in Japan, the U.S., Australia and Europe, in-depth interview, focus group and meeting, there are several important ways to increase efficiency of medical device post-marketing surveillance system. These include: (1) forming networking with health professional councils and hospitals including public relations and raising awareness for cooperation of all sectors (2) possibility of merging medical device vigilance system with Hospital for Patient and Personnel (2P Safety) Policy and Hospital Accreditation requirement operating by hospital safety committee. Further study for more information and opinion of stakeholders should be done. (3) developing efficient IT system including mobile application with user-friendly and convenient model for reporters (4) developing efficient database/ information management system including safety notice system. (5) consideration of international best practices to change obstacle rules or add measures for consumer protection.

For the medical devices that should be specially monitored, implantable products should be a priority and considered for recording in patient registration system. Other examples of medical devices should also be on the list such as devices used for ICU, emergency unit, surgery, monitoring devices, both high risk Class 3 and Class 4 non IVD and IVD (in vitro diagnostic) medical devices and home use devices.