Cardiac Stents Account For 47.95% Of Total Medical Device Associated SAEs

Mumbai, 3 Feb 2020:

Cardiac stent was the most reported medical device for serious adverse events (SAEs) with 926 events out of 1,931 adverse events reported so far, as per Ghaziabad-based Indian Pharmacopoeia Commission (IPC) which is the National Coordinating Centre (NCC) for the Materiovigilance Programme of India (MvPI) started in 2015.

Cardiac stents SAEs alone accounted for 47.95% of the total adverse events.

Six cases of SAEs alone reported were related to Absorbs Bio-resorbable Vascular Scaffolds stent with risks like stent thrombosis, myocardial infarction, stent stenosis and device malfunction.

From July 2015 to October 2019, the IPC received 1931 adverse event reports, mostly from marketing authorization holders, 1,277 were serious events. Reporting increased markedly after 2017.

Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India. Supported by a nationwide network of monitoring centres, the IPC coordinates adverse event reports from manufacturers, legal representatives and patients or users. The commission follows-up and reviews reports with subject expert groups and sends recommendations on necessary action to the national regulatory authority.

Before 2015, no systematic structure was in place to collate adverse events associated with medical devices. Several reports of deaths and hospitalization due to faulty hip implants, cardiac stents and poor-quality devices prompted the health ministry to launch MvPI.

To encourage a culture of reporting, the commission has raised awareness about the programme among stakeholders, developed user-friendly reporting tools and guidelines, and conducted training for hospital personnel on medical device adverse event reporting.

Uptil now Medical Devices Adverse Events (MDAEs) used to be reported through the Pharmacovigilance Programme of India (PvPI). Central Drugs Standard Control Organisation (CDSCO) had launched PvPI in July 2010 and MvPI in 2015 to track adverse drug reactions (ADRs) and Medical Devices Adverse Event (MDAE) respectively.

MvPI is meant to enable safety data collection in a systematic manner so that regulatory decisions and recommendations on safe use of medical devices for India could be based on data generated in India. This is also envisaged to develop the culture of reporting of adverse events in healthcare institutions in the country.

MDAEs need to be intensively analysed in view of patient safety as devices are different from drugs which have a different shelf life.

IPC has also set a mandate to set up a total of 300 ADR monitoring centres (AMCs) by 2020 as part of PvPI with focus on North Eastern (NE) states. It is in the process of identifying district hospitals in NE states which wish to participate as AMCs under the PvPI at district level.

The Union health ministry in the past had mandated AMCs across the country to report MDAEs as part of the MvPI.

The MvPI is being coordinated by the IPC at Ghaziabad which functions as the NCC and Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram acts as the collaborating centre. Technical support is being provided by the National Health Systems Resource Centre (NHSRC) in New Delhi.

The purpose of the programme is to study and follow MDAE and enables dangerous ones to be withdrawn from the market. Pharmabiz