The Union health ministry’s sub-committee formed last month to decide medical compensation for serious adverse event (SAE) due to faulty medical device is scheduled to meet industry associations next week.
The committee headed by principal consultant in Directorate General of Health Services (DGHS), Dr BD Athani, which has representatives of the government, AIIMS and Safdarjung Hospitals, medical devices industry and consumers, will assess the issues related to proposal for amendment of Medical Devices (MD) Rules 2017 to include provisions for compensation in case of injury or death due to malfunctioning of medical devices.
The purpose of the meet is to address the need for medical compensation in critical cases, injury to the patient and in case of fatality. Currently, there is no rule available related to compensation therefore has to go through the judicial process.
This committee will decide the compensation formula depending upon the complex issue of singular or joint responsibility. It will examine whether it is a manufacturing defect, lack of skill of the doctor or the user of the device. Compensation will be provided if there is a SAE which implies injury which requires surgical intervention or in case of death. Not any of quality defect in the market falls under the SAE category.
Johnson & Johnson (J&J) faulty implant case has demonstrated lack of rules and robust regulatory system. As many as 4,700 patients in India had received articular surface replacement (ASR) hip implants manufactured by J&J subsidiary DePuy Orthopaedics Inc between June 2004 and August 2010, until a global recall over concerns that the metallic implants could leak toxic cobalt and chromium into patents’ bodies and pose a risk to their health.
Government has been planning to introduce a legal provision under the new MD Rules, 2017 which will mandate companies to offer compensation to patients in case of a SAE due to malfunctioning of a medical device. Due to the lack of a legal provision, the companies until now are not liable to pay compensation to the affected patients.
A health ministry expert committee headed by Arun Agarwal formed to study Johnson & Johnson faulty hip implant case which had proposed to introduce the legal provision for compensation has also recommended to create an independent registry of high risk medical devices to effectively report adverse events.