Govt puts medical devices under lens, to set up surveillance body

NEW DELHI: Abhijeet Bagga, 56, underwent angioplasty last year. By the time he was discharged, the implanted stent — a tiny, mesh-like tube that was used to open up his narrowed diseased arteries — failed.

“I was told before the surgery that chances of a stent failure are 5% to 10%... I had to undergo another surgery,” Bagga said. Failure of medical devices such as cardiac stents, incubators, orthopedic implants and heart valves are relatively common.

Aiming to curb such failure, the government is developing a system of surveillance and adverse event reporting for medical devices. The ministry of health and family welfare is working on a draft to kickstart a programme, dubbed as Materiovigilance Programme of India (MvPI), by August. “We are drafting the programme to control the spike in number of cases of malfunctioning of medical devices,” said a senior bureaucrat from the health ministry.

According to industry estimates, failure of medical devices has spurted over 20% in last three years. “The programme will ensure that unsafe products are weeded out of the market,” said Sanjay Banerjee, chairman of India working group, AdvaMed India, a medical device trade association. “However, regulatory personnel must be trained to international levels for appropriate classification of medical device adverse events.”

The programme, developed by a health ministry-appointed panel, will establish MvPI cells at 10 medical schools that will track and report adverse events.

The government is planning to increase staff and resources to regulate medical devices. “For the first time in India, bio- medical engineers would be recruited to regulate medical devices, not pharmacists as before,” a senior official from department of pharmaceuticals said. “The department is also planning to set up dedicated medical device testing laboratories in three states.”

“Failure of devices used for cardiac procedures is not uncommon but in India, there no data that could help specialists with real time evaluation of any device,” said Sanjeev Aggarwal, senior consultant, cardiology at Sri Balaji Action Medical Institute, who performs about 700 cardiac procedures in a year.