Medical device’s regulation in South-East Asian countries: Current status and gap areas

As Medical device application in disease prevention, diagnosis or treatment is evolving to a greater extent; there is a need for regulation to monitor its quality, safety and efficacy. The present article attempts to study the medical device regulation available in eleven South-East Asian World Health Organization (WHO) member countries. The information searched from the available sources reveals that medical device regulation exists in seven countries. Most of the countries follow the International Organization for Standardization (ISO) 13485 for their quality standards in medical devices. Most countries also specified the time frame and authority to which adverse event is to be reported. Countries like India and Thailand have separate Adverse Event reporting forms for the medical device. The present study reveals that there is no separate web-based database for adverse event reporting of medical devices. Therefore, WHO South-East Asian Regulators Network (SEARN) under South East Regulatory Office (SERO) office may provide handholding support to these regions in developing a common software or tool for the management and analysis of signals arising from the adverse events.

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An Analysis of FDA Adverse Event Reporting Data for Trends in Medical Device Use Error

Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care ◽

10.1177/2327857920091024 ◽

2020 ◽

Vol 9 (1) ◽

pp. 130-134

Author(s):

Benjamin M. Knisely ◽

Camille Levine ◽

Kush C. Kharod ◽

Monifa Vaughn-Cooke

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Medical Device ◽

Medical Devices ◽

Product Life Cycle ◽

Risk Mitigation ◽

Adverse Event Reporting ◽

Mitigation Strategies ◽

Event Reporting ◽

Device Use

Humans can contribute to error at all stages of the medical device product life-cycle. Use error associated with medical devices can result in catastrophic consequences for end users and inefficient use of healthcare system resources. Industry-wide statistics about medical device use error has the potential to aid in identifying opportunities for human factors intervention, however publicly available statistics are sparse. The Food and Drug Administration (FDA) requires medical device manufactures, importers, and device user facilities to track and report adverse events for post-market surveillance through medical device reports (MDRs). This data is available in an online database: Manufacturer and User Facility Experience (MAUDE). This study provides a comprehensive evaluation of use error adverse events in MAUDE (2010-2018) based on device class, device operator, and event outcome, to address the lack of industry-wide statistics on medical device use error. Results indicate that use error is significantly represented in adverse event reporting, constituting 28.1% of reports labeled with device problem codes. Events associated with patient device operators were predominately associated with diabetes-related medical devices, while provider operators were associated with a wider array of devices. Additionally, it was found that most use error reports were attributed to issues with device output; using the device in accordance with manufacturer expectations; and physically activating, positioning, or separating device components. This work demonstrates the viability of using MAUDE to attain industry wide statistics on medical device use error for later integration in industry-wide or device-specific risk mitigation strategies.

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Materiovigilance: Current status in India analogous to its global status

Journal of Pharmacovigilance and Drug Research ◽

10.53411/jpadr.2020.1.2.4 ◽

2020 ◽

Vol 1 (2) ◽

pp. 24-31

Author(s):

Nalini Pandey ◽

Mohammed Imran

Keyword(s):

Adverse Event ◽

Medical Device ◽

Medical Devices ◽

Adverse Event Reporting System ◽

Health And Safety ◽

Adverse Event Reporting ◽

Current Status ◽

Regulatory Body ◽

Global Status ◽

And Performance

Introduction: Medical devices are boon to the healthcare system and are available in the market since long ago. More than 500,000 different types of the medical devices are available in the international market. Thus, from the patient safety view point, assessment of the quality and safety of these medical devices is essential. Objectives: This review article discusses the classification and regulation of medical devices in India and the world with framework of adverse event reporting system for medical devices in India. Methods: To address the aforesaid issue International Medical Device Regulators Forum (IMDF) was established in 2011 was established at international Level. In India, 4 years later in 2015, Materiovoigilance Program of india (MvPI) was introduced with the prime aim of improving the protection of the health and safety of patients, healthcare professionals and others by reducing the likelihood of reoccurrence of an adverse event associated with the use of medical devices. Results: At present, there are 50 Medical Device Adverse Event Monitoring Centres (MDMCs) in India. Every country has its own regulatory body and guidelines for monitoring and reporting of adverse events due to medical devices eg: USFDA in USA, TGA in Australia, MHRA in UK, ENVISA in Brazil, CDSCO in India etc. Conclusions: In India, the provisions of regulation of safety, quality and performance of medical devices are laid down in the Drugs and Cosmetics Act, 1940 and rules 1945.

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Basics and Essentials of Medical Devices Safety Surveillance

10.5772/intechopen.97248 ◽

2021 ◽

Author(s):

Vivekanandan Kalaiselven ◽

Shatrunajay Shukla ◽

Nikita Mishra ◽

Pawan Kumar

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Medical Device ◽

Medical Devices ◽

Adverse Event Reporting ◽

Scientific Data ◽

Event Reporting ◽

Healthcare Facilities ◽

The Public ◽

Regulatory Policies

Medical devices are being used in healthcare facilities for diagnosis, monitoring, prevention and treatment of an array of diseases. To ensure user/patient safety associated with the medical devices being used in healthcare industry, it is of utmost importance to closely monitor the adverse events associated with the medical devices through a robust, sustainable and scaled surveillance. Materiovigilance Programme of India (MvPI) provides a reliable system to report adverse events associated with medical devices. Under MvPI, various modalities to report adverse events associated with medical devices have been developed. These modalities include an editable medical device adverse event reporting form, a toll-free helpline number and a field safety corrective action form (FSCA). FSCA form is used to notify the regulatory authority and healthcare professionals on corrective actions or recall by the manufacturer. Due to the emergence of the Coronavirus disease 2019 (COVID-19) pandemic, one-page editable form has been developed to boost the adverse event reporting of Personal Protective Equipments (PPEs). MvPI also coordinates with healthcare facilities and medical device industries across the country for reporting the medical device-related adverse events. The collected scientific data is utilized to develop regulatory policies and enhance measures to ensure the quality of medical devices. All the healthcare workers are, therefore, encouraged to report adverse events to MvPI. This chapter aims to describe the systems, procedures and modalities available for the reporting of Medical Device Adverse Events (MDAEs) in India, in order to intensify the nature of reporting and creating an environment that encourages the public to perform MDAE reporting.

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Real-world data-based adverse drug reactions detection from the Korea Adverse Event Reporting System databases with electronic health records-based detection algorithm

Health Informatics Journal ◽

10.1177/14604582211033014 ◽

2021 ◽

Vol 27 (3) ◽

pp. 146045822110330

Author(s):

Hyunah Shin ◽

Jaehun Cha ◽

Youngho Lee ◽

Jong-Yeup Kim ◽

Suehyun Lee

Keyword(s):

Adverse Event ◽

Adverse Drug Reactions ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

World Health ◽

Drug Reactions ◽

Event Reporting ◽

Medical Databases ◽

Electronic Health

Pharmacovigilance involves monitoring of drugs and their adverse drug reactions (ADRs) and is essential for their safety post-marketing. Because of the different types and structures of medical databases, several previous surveillance studies have analyzed only one database. In the present study, we extracted potential drug–ADR pairs from electronic health record (EHR) data using the MetaNurse algorithm and analyzed them using the Korean Adverse Event Reporting System (KAERS) database for systematic validation. The Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Adverse Reactions Terminology (WHO-ART) were mapped for signal detection. We used the Side Effect Resource (SIDER) database to select 2663 drug-ADR pairs to investigate unknown drug-induced ADRs. The reporting odds ratio (ROR) value was calculated for the drug-exposed and non-exposed groups of drug–ADR pairs, and 19 potential pairs showed significant signals. Appropriate terminology systems and criteria are needed to handle diverse medical databases.

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