“Guidance and Supervision (Binwas) in the field of Medical Devices and PKRT is broadly aimed at 4 (four) main factors, namely: 1. Facilities (Production and Distribution); 2. Personnel; 3. Products/Commodities; and 4. Usage.

In its use in health care facilities, partiality to domestic products has been carried out with the existence of Permenkes Number 86 of 2013 concerning the Road Map for the Development of the Domestic Medical Device Industry which is compiled based on priority needs, the ability of existing production facilities and available resources. In its utilization, it has been stipulated that the Government, Local Governments, Business Actors, Research Institutions and the Community must play an active role in the implementation of the Roadmap for the Development of the Domestic Medical Device Industry to increase the growth of the domestic medical device industry.”

This was conveyed by the Director of Medical Device Production & Distribution Drg. Arianti Anaya, MKM in the Meeting of Analysis and Evaluation of the Results of the Implementation of Supervision of Medical Devices and PKRT, which took place on September 15 to 17, 2014 at Ibis Trans Studio Hotel Bandung, West Java. The purpose of this meeting is to equalize perceptions and build synergy on the Implementation of Medical Device and PKRT Supervision, as well as to develop follow-up improvements according to the results of the analysis and evaluation of its implementation.

Health development in Indonesia is aimed at increasing awareness, willingness, and ability to live a healthy life for everyone in order to realize the highest degree of public health, as an investment for the development of socially and economically productive human resources.
Medical devices are one of the important components alongside personnel and drugs in health care facilities.

Medical Device Technology is developing very rapidly along with the development of Science & Technology (IPTEK), ranging from simple technology to high technology; and used in health care facilities, in personal health services and in households. This needs to be accompanied by a cost-benefit assessment in its utilization. In order to face free trade in the Asean Economic Community, it is necessary to increase the supervision of medical devices as one of the elements to ensure patient safety in health care facilities.

With the implementation of SJSN in the health sector, it is predicted that the need for Medical Devices will increase ± 3 times the current need for Medical Devices. The medical device test laboratory is an integral part in the implementation of the function of guidance, control and supervision of medical devices. With the availability of information on domestic producers and products, as well as information on the capacity of medical device test laboratories, domestic medical device products can develop and have competitiveness and in turn can host in their own country.

The Medical Device and PKRT Supervision System must be implemented in a comprehensive, anticipatory and integrated manner. Supervision must be carried out from the time the product is produced until it is distributed in health care facilities to the end user. The Ministry of Health implements an online system of e-info medical device surveillance, e-report and e-watch medical devices integrated with ASEAN and ASIA Medical Devices Post Market Allert. Medical Devices Post Market Allert.

e-Info Alkes contains information on the status of Medical Devices and PKRT that already have a Distribution License Number (NIE). This information can be used as a reference in the look-up process of e-Report Alkes and e-Watch Alkes reporting and as data to prove the validity of products and distributors in carrying out the procurement process in the Work Unit.

e-Report Alkes contains information on Medical Devices and PKRT produced and distributed by the manufacturer/sole agent to the last dealer/distributor before the end user. This information can be used as a reference in the procurement of Medical Devices and PKRT and can be a reference for BPJS to finance/pay claims for Medical Devices.

The Ministry of Health implements an online monitoring system e-watch medical devices, e-info medical devices and e-report medical devices that are integrated with ASEAN and ASIA medical devices post-market alert. e-Watch Medical Devices contains information on adverse events (AEs) data due to the use of medical devices. This information can be used as a reference in the NIE renewal process and can be a reference for BPJS to carry out financing / payment of Medical Device claims, especially for the use of valid Medical Devices in achieving diagnostic accuracy.

This activity was attended by 143 people, consisting of 33 participants from the Provincial Health Office, 37 from Government Hospitals, 4 KKP, 3 BPFK, 28 central participants and 23 participants from Stake holders consisting of Professional Associations of Health Equipment, Manufacturers and Distributors. Resource persons involved in this activity included from Dit. Medical Support Services and Health Facilities (Ir. Rakhmat Nugroho, MBAT), Dra. Kustantinah, Apt, M.App.Sc, Drs. Siam Subagyo, Apt, Fatmawati General Hospital, Sanglah General Hospital.

This activity was carried out in the form of presentations and discussions on technical policies, supervision implementation, the role of stake holders in services and test laboratories, and electronic implementation and group discussions on case studies that are currently developing.

 
Follow-up
Facilities that are not in compliance in the form of sending Warning Letters (SP 1 and SP 2)
The First Warning Letter (SP 1) has a grace period of 30 working days to repair the facility.
The Second Warning Letter (SP 2) has a grace period of 30 working days to repair the facility, if there is still no improvement then a Temporary Closure sanction is given.
Follow-up after being given 2 warning letters
Production Facilities: 2 Production Facilities closed, 10 Production Facilities re-monitored
Distribution Facilities: 4 Distribution Facilities closed, 28 Distribution Facilities re-monitored
Follow-up of 97 not in compliance products in circulation
It has been requested to conduct a retest to confirm the incompliant result on the same Batch number.
47 products have been re-tested
6 products have been retested -> results are qualified
2 products had their distribution licenses revoked
 

RESULTS OF SUPERVISION IN 2014 (up to August)

 
Follow-up
Production Facilities: 0 Production Facilities closed, 4 Production Facilities re-monitored
Distribution Facilities: 1 Distribution Facility closed, 27 Distribution Facilities re-monitored
Follow-up of 22 incompliant products in circulation
It has been requested to conduct a retest to confirm the incompliant result on the same Batch number.
22 products have been re-tested
4 products have been retested -> results are qualified
0 products had their distribution licenses revoked