Report Medical Device Adverse Event

A Beginner’s Guide

Shatrunajay Shukla ,  Assistant Scientist, Indian Pharmacopoeia Commission, Ministry of Health Family Welfare, Govt. of India

Vivekanandan Kalaiselvan ,  Principal Scientific Officer, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India

Gyanendra Nath Singh ,  Secretary cum Scientific Director, Indian Pharmacopoeia Commission, Ministry of Health Family Welfare, Govt. of India

Medical devices are being extensively used in all branches of medical science not only in India but around the globe, notably for diagnostics, monitoring, support and also for the prevention and management of an array of diseases. Therefore, like pharmaceuticals, post market surveillance of medical devices is greatly required for ensuring efficacy and patient/user safety. In order to protect the health of patients and users, Indian Pharmacopoeia Commission (IPC) under the aegis of Ministry of Health & Family Welfare, Government of India has developed a medical device adverse event reporting form for stakeholders. Any person including medical practitioners, clinicians, biomedical/clinical engineers, hospital technology managers, pharmacists, nurses and technicians and third party can report medical device adverse events encountered in the course of their work to IPC.

Introduction

After several horrific cases associated with malfunctioning of medical devices like infants burnt to death due to short circuits in incubators, or hip implants causing pain and blood poisoning, the Ministry of Health and Family Welfare (MoHFW), Government of India (GoI) has commenced Materiovigilance Programme of India (MvPI) in an effort to address potential adverse events related to medical devices. Indian Pharmacopeia commission (IPC), an autonomous institution of MoHFW, GoI, has been entrusted with the National Coordination Centre (NCC) responsibilities related to MvPI since July 6, 2015 with an objective to improving Indian patient safety by monitoring, recording, analysing root cause of adverse events or risks associated with the use of medical devices and suggesting regulatory bodies for appropriate action with a sole intention of improving patient/user safety. As the new Medical Device Rules 2017 being effective pan India since January 2018, the MVPI programme under the aegis of IPC is imperative for the successful medical device adverse event reporting in the country.

MvPI came into existence to create a nation-wide system for patient safety monitoring, analyse the benefit-risk ratio of medical devices, generate evidence-based information on safety of medical devices, support regulatory body in the decision-making process on use of medical devices, communicate the safety information on use of medical devices to various stakeholders to minimise the risk, emerge as a national centre of excellence for materiovigilance activities and collaborate with other healthcare organisations for exchange of information and data management.

Medical device adverse event (MDAEs) reporting

All types of suspected adverse events associated with medical device, whether they are serious or non-serious, known or unknown, frequent or rare, disregarding of an established causal relationship between event and medical device, can be reported to NCC-MvPI, IPC either directly or through our pan India network of medical device adverse event monitoring centres (MDMCs).

Who can report?

All medical practitioners, clinicians, biomedical/clinical engineers, hospital technology managers, pharmacists, nurses and technicians, whether public or private sector or self-employed, can report medical device adverse events encountered in the course of their work to NCC-MvPI. Medical device manufacturers/medical device importers-traders can also report adverse events specific to their products to NCC-MvPI, IPC, Ghaziabad.

What to report?

In order to foster the habit of reporting among all, MvPI encourages reporting of all types of adverse events (abnormal behaviour) related to medical devices, irrespective of the fact whether they are known or unknown, serious or non-serious, frequent or rare though MvPI is primarily concerned with adverse events associated with medical devices used in India only. It must include the name of the medical device, device details, a description of the incident and consequences and the reporter’s contact details.

Why to report?    

Medical devices have been associated with several adverse effects and at times become fatal to the patients. An isolated medical device adverse event may not of interest to the community but, if it is repeated, the regulatory authorities can be alerted to undertake the necessary measures; reporting medical device adverse event is one’s ethical and moral duty toward colleagues and patients.

How and whom to report?

The ‘medical device adverse event reporting form’ for healthcare professionals and consumers are available at www.ipc.gov.in and may be used to report adverse event due to the use of medical devices (figure 1). A reporter can send filled MDAE reporting form directly to NCC-MvPI via e-mail to mvpi.ipcindia@gmail.com or their nearest MDMC (List of approved MDMC pan India is available at www.ipc.gov.in). In case of MDMC, these reports are confirmed by healthcare professionals/biomedical engineers and then submitted to NCC-MvPI for further assessment. The information must be traceable. A toll free number (1800 180 3024) is also available to report adverse event associated with use of medical devices to NCC-MvPI (on weekdays from 9:00 am to 5:30 pm)1. These reports are then finally reviewed at NCC and the obtained information is entered in the safety database, analysed, and assessed by the experts to identify new signals. The submitted MDAE report does not have any legal implication on the reporters. The patients’ identity are held in strict confidence and protected to the fullest extent. Therefore, healthcare providers are encouraged to report adverse events for better understanding of the risk associated with the use of medical devices and to safeguard the health of Indian population.

Reporting medical device adverse event

The customised medical devices adverse event reporting form (figure 1) primarily aims to capture the adverse events associated with the use of medical devices, IVDs, medical equipments, medical instruments.  The healthcare professionals are solicited to report the adverse event for known, unknown, serious, non-serious, frequent or rare adverse events.

The information to be provided in the reporting form under different categories as follows:

a.    General information

This part of the form includes date of report on which the event was reported to IPC-MvPI, type of report whether the event is initial/follow up/final/trend. Initial report is the first report that a reporter is submitting about an event once becoming aware. Follow up report is the additional information about the previous report whereas final report captures all the information related to the event from the date of report to the root cause analysis of the event. Trend is the significant change (increase or decrease) in the frequency of the occurrence of the adverse events. Reporting of trend is important so as to monitor the trends of significant adverse events. In order to track the report, the reporting centre is responsible to provide a reference number of the reporter to be filled in the format •Centre •Location •Month-Year •Case No

b.    Reporter details

This part of the form captures the details of the reporter, whether the type of reporter is manufacturer/ importer/distributor/healthcare professional/patient and others. Secondly if the reporter is not the manufacturer such event and devices shall require to be informed to the concerned manufacturer besides reporting to NCC- MvPI. Thirdly the information of the reporter such as name of the reporter, address and contact details is covered which remains confidential.

c.    Device category

Under this category, the reporter is guided to select from the device categories whether it is a medical device, medical equipment or in-vitro diagnostic. An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose is defined as medical device. Medical equipments are devices requiring calibration, maintenance, repair, user training, and decommissioning-activities usually managed by clinical engineers. IVD means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. Secondly details of the subcategories according to usage are covered so as to determine whether it is a  therapeutic/diagnostic/preventive/invasive/homecare use and others.

The general information, reporter details and device category remains common for all the reports to be reported. Further the form is divided into sections from A to F with respect to the device category;

Section A: Device description

This part seeks the device details which includes device risk classification as per Indian regulation, license no. (Manufacture/import), catalogue no., model no., lot/batch no., serial no., software version, associated devices/accessories, nomenclature code if applicable; GMDN/UMDN, unique device identifier (UDI) no. (If applicable), installation date, expiration date, last preventive maintenance date, last calibration date, year of manufacturing, manufacturer/importer/distributor details, regulatory details for tracing the potentially affected device related to the event. This helps officials to make themselves alert in ensuring the proper functioning of similar devices in the healthcare facility.

Section B: Event description

This part of the form aims to collect the event description such as date on which the event occurred or any near miss incident took place, implantation/explantation date, device operator, device location, seriousness of the event i.e. death/life threatening/disability or permanent damage/hospitalisation/ congenital anomaly/required intervention to prevent/permanent impairment/damage device, detailed description of the event and frequency of occurrence of similar adverse event of last three years to trace if any trend is being followed.

Section C: Patient information, history and outcome

This part of the form captures the patient details which include patient hospital ID, age, gender, history and outcome of the patient after the occurrence of the event.  

Section D: Healthcare facility information

This part of the form gives the information regarding the details of the hospital in which the event took place and contact details of the person at the site of event for the follow-up communication related to the adverse event

Section E: Causality assessment

This part of the form aims to collect the information regarding the investigation process carried out by the clinical specialists/concerned personnel from the manufacturing organisation, further drawing out the root cause of the problem and immediate action taken to rectify the adverse effect, if possible. The root cause would ascertain the most likely reason why the problem occurred.

Section F: Manufacturer/authorised representative investigation & action taken

This part seeks the information related to the investigation methods performed by the manufacturer/authorised representative device history which includes a review of similar occurrence of the events of same batch/lot, the analysis report of the event related to the medical device, corrective/preventive action/recall taken so as to prevent the patient from being affected by the device if any.

Conclusion

The prime objective of the MDAE reporting is reduction of the magnitude of risks resulting from the malfunctioning or errors related to medical devices. The reporting form developed will empower consumers and others to report malfunctioning of device marketed and used in India, improve the communication between the reporter and the coordination centre and communicate the data which are important for the assessment of medical device related errors. Though reporting trend in India has increased significantly from last couple of years but still need an escalation that can be achieved through sensitisation of healthcare professionals, suppliers, importers and third parties by conducting awareness programmes regularly at zonal/state level and upgradation of online/offline tools and techniques.

Acknowledgement

The authors are grateful to MoHFW, GoI to provide financial support to run the MvPI, efficiently.

Conflict of Interest

The authors declare no potential conflict of interest.

Reference
1.    Kalaiselvan V, Mishra P, Singh GN. Helpline facility to assist reporting of adverse drug reactions in India. WHO South-East Asia journal of public health. 2014; 3(2):194.

Shatrunajay Shukla

Shatrunajay Shukla is an assistant scientist at the Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India. He graduated from the National Institute of Pharmaceutical Education & Research, Kolkata, India and received his PhD in Toxicology from the CSIR-Indian Institute of Toxicology Research, Lucknow, India. He is currently associated with Medical Devices vigilance programme and engaged in monitoring, reporting, collating and analysing or accessing the adverse events associated with the use of medical devices in Indian population.

Vivekanandan Kalaiselvan

Vivekanandan Kalaiselvan is an Principal Scientific Officer at the Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India. He is heading the Materiovigilance Programme of India (MvPI), a Govt. of India’s initiative to ensure the protection of the health of patient and users from medical devices in the country. Earlier, he was associated with the Pharmacovigilance Programme of India (PvPI), a programme to promote the safe use of medicines in the country.

Gyanendra Nath Singh

Gyanendra Nath Singh is currently Secretary-cum-Scientific Director at the Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India. He has previously served as Drugs Controller General of India (DCGI), Head of India’s main regulatory body for pharmaceuticals and medical devices known as the Central Drugs Standard Control Organization (CDSCO). Dr. Singh has championed the cause of public health by raising the quality of medical products with an element of affordability.