e-Monitoring Post Market Surveillance of Medical Device and PKRT

The Directorate for Production and Distribution of Medical Devices has created an e-Monitoring System for Post Market Surveillance for medical devices and HouseHold which was previously still done manually, where the company made reports and sent via post to the Ministry of Health. The making of e-Monitoring is intended for central and regional officers, business actors related to the production and distribution of medical devices and household appliances as well as the community in supervising medical equipment and household goods. There have been many found Medical devices and HouseHold that do not meet safety standards. The purpose of making this e-Monitoring is to facilitate reporting on the production and distribution of medical devices and HouseHold, improve Post Market Surveillance, and create an integrated reporting system. This e-Monitoring system is also expected to be able to detect complaints handling from users, reporting Unwanted Events (KTD)

What is e-Monitoring

e-Monitoring Post Market & Surveillance is a system in the form of an application that is built to facilitate public services in the process of reporting production results by medical device manufacturers and HouseHold as well as the process of reporting the results of distribution by electronic medical equipment distribution.

What is Post Market & Surveillance

Post Market & Surveillance is a proactive activity carried out in order to check the suitability of the quality, safety and performance of tools during circulation and conformity assessment to initial records during registration which is carried out by the government together with producers on a regular and ongoing basis through monitoring production facilities and distributors, audits quality System and Sampling of products on the market.

Vigilansi

Vigilansi adalah tindakan yang di lakukan untuk mengatasi kasus yang terjadi di fasilitas pelayanan kesehatan dan di masyarakat akibat penggunaan alat kesehatan atau PKRT yang menyebabkan cedera atau kematian terhadap pasien, Vigilansi bergerak setelah menerima laporan KTD.

Agar tidak terulangnya kejadian yang sama maka di lakukanlah Corrective Action and Preventive Action (CAPA), mengevaluasi KTD, Memodifikasi Alat Kesehatan, dan Tindakan reaktif terhadap laporan KTD yang di terima dalam tenggat waktu sesuai ketentuan pemerintah

What is KTD

Unwanted Event (KTD) is an incident related to the use of medical equipment which can be an unexpected event, an unintended event that leads to injury. Minor or serious injury. Manufacturers are required to report to the Ministry of Health any adverse events that require follow-up.

reporting

E-monitoring creates several warning systems that can recommend a step in the form of mandatory (mandatory) reporting and voluntary reporting. Mandatory reporting in accordance with the provisions is reporting on production, reporting on distribution, reporting on Unwanted Events (KTD). Voluntary reporting is a report related to the use of medical devices in health services, either directly related to the use of medical devices or not.

There are several types of reporting that exist in the e-Monitoring Post Market Surveillance system, Medical Device Production Reporting, KTD Reporting and Medical Device Distribution Reporting. Production reporting and reporting of medical equipment distribution are included in the routine reporting section. KTD reporting can be done by users/consumers who make reports on issues related to Medical devices through the recipient of the report, namely PAK, Directorate of production and distribution of Medical devices and Manufacturers. Manufacturers receive all reports, the Directorate of Production and Distribution of Medical Devices only accepts if the goods/products meet the criteria to be reported as unwanted events.

Every six months the Production Reporting and Distribution Reporting of Medical Devices must report the results of production or distribution activities to the Director General of Pharmaceutical Development and Medical Devices with a copy from the Head of the Provincial and Regency Health Offices.
KTD reporting is mandatory for Medical Device Manufacturers, Medical Device Distributors and the community, for the Ministry of Health who will disseminate learning and issue warnings in regular newsletters as well as in annual reports.

hings that must be considered in reporting KTD, there are reports that must be reported and there are also those that do not need to be reported. The KTD criteria that must be reported include, Unwelcome Events (KTD) have occurred, Suspicions caused by medical devices that have been used, adverse events that have caused serious things such as patient death, decreased health conditions or events that caused serious cedar conditions. For reporting criteria that do not need to be reported, such as shortages of medical equipment encountered by the operator before use, events caused by the patient's condition, the life of medical equipment that has exceeded its useful life, has been explained in the previous memorandum.

KTD reporting period

The KTD reporting period is divided into two, for the company and for the community. Reports from companies can be done using the online Post Market & Surveillance e-Monitoring system.

Company
KTD reporting for companies is divided into three categories, namely; 48 hours for events that pose a risk of serious injury with a mass impact, 30 days for events that may lead to death, serious health conditions of the patient, 10 days for events that can lead to death, serious health conditions of the patient.

Reporting begins with an investigation of the producer after the type of schedule information is reported to the Ministry of Health of the Republic of Indonesia, the Director of Medical Device Development who will later determine actions such as Withdrawal from Circulation by producers supervised by the government, Repair of Medical Devices or Monitoring of Medical Devices facilities. If the report is not further reported, the producer will be asked for a Complaint File, Trends, after that it can be reported

Public
The KTD report for the Community/Public is received directly by the Ministry of Health. The public must immediately report the KTD As soon as possible using the reporting form available in the form of a customs post, the reporting form downloaded from the e-Monitoring Post Market & Surveillance system, Reporting on Medical Devices and HouseHold the community can go through the online Post Market Surveillance e-Monitoring system. .

The public can report directly to the Ministry of Health of the Republic of Indonesia Directorate. The Alkes Study Program Bina will determine actions such as withdrawal from circulation, repair of medical equipment, or monitoring of medical equipment facilities.

Modul

This electronic reporting system has six main modules, Frontpage, Information module, Production Registration Module, Production Module, Input Module, Expenditure Module, distribution recap module, and KTD Module.

Frontpage Module
Yang di maksud dari frontapage ialah tempat dimana informasi pendahuluan diletakan, dan kolom login untuk memasuki web atau pun membuat laporan. Terdapat beberapa informasi dan berita yang dapat anda baca diantaranya tentang peraturan menteri kesehatan, buku manual, daftar istilah, berita kegiatan, press release kementerian kesehatan yang berhubungan dengan penyaluran dan pengawasan alat kesehatan.

Modul Registrasi Produsen
This is a mandatory module for producers or distributors, because this producer registration module is already connected to the http://regalkes.depkes.go.id/cms.php/ system to see who I am previously registered in the system. In addition, data updating can be done through http://regalkes.depkes.go.id/cms.php/ Manufacturers or PAK (Alkes Suppliers) are required to register or update their company profile data first if the look-up data does not appear.

Information Module
This module is a place where key information such as user profiles, news, top ten charts, and other information are placed. This module can be accessed after you enter the web and login on the first page or what is commonly called Home.

Production Module
This module is a facility for collecting data on stock of goods and distribution of production which is also part of the e-Monitoring Post Market & Surveillance system. This module is connected to the regalkes database which is useful for checking distribution permit data. There are two methods in this module, namely via a web form and uploading excel.

Expenditure Module
This module is a facility for recording stock of goods before being distributed. This module is connected to the old regalkes database and the new regalkes database to check distribution permit data. There are two methods in this module, namely via a web form and uploading excel.

Production/Distribution Module
This module is a facility used by producers/PAKs and the Ministry of Health as executives to make various kinds of reports. In addition to the report recap, this module also provides export files to excel and graphs to serve as the basis for decision making

KTD Module
This module is a facility for the public and community services to report any allegations of adverse events including product abuse and product quality. This module does not require a special login, but this module requires verification from the reporter to use it, because this module is made for the public which is placed in front of the web (login page). This module is divided into two categories, namely for the public and producers. For access the manufacturer requires a login on the web.

Report Handling

The Ministry of Health conducted an investigation after receiving the results of the report. Likewise for follow-up to the reporting institution regarding the trend of the incident and its resolution. This report is not publicly accessible.
The government will issue recommendations for improvement and improvement of patient safety. reports can be accessed publicly, but patient data is kept confidential

Process
The Directorate of Production and Distribution of Medical Devices will receive reports from Manufacturers in the form of reports on the production of Medical devices and PKRT, Distributors in the form of reports on receipt and distribution of medical devices, Stakeholders in the form of KTD reports. The production report will be compiled, received and distributed as well as sorting out the KTD reports in accordance with the causes of KTD. Analysis and evaluation of KTD reports will be carried out by the Directorate of Production and Distribution of Medical Devices based on a priority scale. Products that have a high risk will be prioritized.
If a case report of a suspected adverse event can cause death, serious injury and a serious threat to public health, the report will be coordinated on the use of medical devices. The expert team will review and evaluate the report which will be followed up by the Directorate of Production and Distribution of Medical Devices that have been recommended from the expert team.

Field Safety CorrectiveAction

An action against safety in the field by the company through recall, destruction, or risk reduction from identified hazards even though the medical device is no longer in production and spare parts are no longer available. Reporting must contain complete and relevant information to cases that occur.

Actions The actions taken by FSCA can be in the form of evaluating the reported adverse events, modifying medical device products if possible, making recalls, disseminating information through the public that reads (Public Warning) to prevent the same thing from happening again or to reduce the consequences. of the incident.

Follow Up

There are several stages that must be carried out in the handling of this follow-up such as evaluating the results of the supervision report, determining the nature/type of follow-up to be carried out, determining whether or not follow-up is necessary, the nature of the time the follow-up is being carried out Mild/Medium/ The severity and type of follow-up carried out, whether a written warning, notification of administrative sanctions, permits, etc., local security/withdrawal of products from the market, public warnings, or criminal sanctions.