#ImplantFiles – First official red flags: over 500 adverse events

The Indian Express, in its investigation into the medical devices industry and its nexus with doctors and hospitals, accessed these MDAE reports to find that what began as a mere trickle, 40 cases in 2014, has increased to as many as 556 this year alone. These include about a dozen deaths after stents were implanted.

These reports are maintained by the Indian Pharmacopoeia Commission (IPC) and are drawn from 13 MDMCs (adverse event monitoring centres) across the country.

The IPC is an autonomous institution under the Health Ministry and is responsible for setting standards for drugs. It is also the coordinating centre for the Ministry’s three-year-old vigilance programme to analyse the risks, and generate and communicate information on the safety of medical devices available.

An analysis of its reports reveals a telling pattern:

* Since 2014 when it first began, 903 adverse events have been reported: 325 are linked to cardiac stents; 145 to orthopaedic implants; 83 to IUCDs (intrauterine contraceptive devices); 58 to intravenous cannulas; 21 to catheters, and 271 adverse events of various other medical devices.

* The IPC has matched device reports with manufacturers: Abbott, the world’s leading manufacturer for drug-eluting stents, is linked to as many as 290 of the 556 adverse events for 2018; followed by other stent manufacturers, Cook Medical (18 adverse reports) and Terumo Europe (14 adverse reports).

* In categories of other medical devices, Johnson & Johnson features in 19 reports related to orthopaedic implants, and Bayer AG in 36 reports, mostly for its IUD named Merina.

* Hospitals in smaller cities like Nagpur, Jaipur, Rohtak, Kota, Thrissur, Dehradun, Panchkula, Kochi and Gohana have begun filing adverse event reports in batches while there is negligible reporting from metropolitan cities, including New Delhi and Mumbai. For example, not a single adverse event has been filed in 2018 by the AIIMS in New Delhi, one of the designated MDMCs.

* There are about a dozen 2018 adverse event reports — marked yellow in the IPC database — in which patients did not survive. Each casualty took place in a hospital following implant of a cardiac stent.

Each casualty report has a summary. For example, in a death reported from Jammu in March 2018, the report says “the stent caused or contributed to the patient’s death.” But in another report, from Coimbatore, the summary concludes that “the death of the patient was not related to the device”.

Significantly, in each fatality, the adverse event report ends with the sentence: “There was no patient sequela and no clinically significant delay in procedure” — sequela is a term used to describe a condition resulting from a previous disease or injury.

* In the case of cardiac stents, there are several instances where between 1 and 4 such “incidents” have been recorded for the same batch/lot. On the number of identical devices still with them, hospitals have filled in that they have, say, hundreds of identical stents from the same manufacturer in stock, and in the case of a device like a catheter, the holding stock may be lakhs of pieces.

* Almost one third of the MDAEs are listed under “others” — hospital after hospital is reporting a defect in a healthcare product which may not be a device at all. These include gloves, dressings, adhesive plaster, diapers, swabs, episiotomy scissors, even urine and sputum containers.

* Serious aberrations have been reported in heart valves, pacemakers, respiratory ventilators (there are two complaints of Chinese-made products), defibrillators, infusion pumps and dental implants.

Dr S Eswara Reddy, who heads the Central Drugs Standard Control Organisation (CDSCO), which is the national regulatory body for pharmaceuticals and medical devices, told The Indian Express that they were yet to be informed by the IPC about any patterns from the adverse events received. “But we have a system in place whereby the IPC passes important adverse event sequences to a technical Committee. We do not want to create a panic among the people,” he said.

Speaking on the quality of MDAE reporting, Vivekanandan Kalaiselvan, IPC’s Principal Scientific Officer, said the “non-serious” nature of several reports is an indication that the reporting culture is just about catching up, though very slowly, in India.

“The MDAE reports on items such as bandages and gloves show even large hospitals do not know which medical device to report. What we want to do is bring in a culture of reporting as well as improve the quality of reports. We are treating this as confidential material and a decision on whether to make the MDAE reports public or not will be taken by the CDSCO to whom we forward a monthly analysis,” Kalaiselvan told The Indian Express.

The monitoring centre at AIIMS, New Delhi is headed by Dr Pooja Gupta, a clinical pharmacologist, and she says one reason for the poor reporting in several monitoring centres is that the IPC has not posted scientific associates at a majority of the centres as required.

“The reporting from New Delhi is very poor and there is resistance from doctors and surgeons in reporting defective devices,” she said. “The reason for this is that doctors and surgeons feel the report may implicate them, and it is this inherent insecurity among the medical community which has to go before a culture of adverse event reporting sets in. A lot more awareness and publicity is needed for things to change.”