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Sub-committee on compensation related to medical devices to meet industry associations next week
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Shardul Nautiyal, Mumbai
January 21 , 2019
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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.
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