New Delhi: An independent registry is in the offing to track implantable medical devices that could pose a risk to patients.

India’s highest drug advisory board will take up a proposal for setting up a national registry for all implantable high-risk devices to protect patients in its next meeting, slated for 27 November, according to two health ministry officials who asked not to be named.

The proposal is the result of a recent investigation by an expert committee on hip implants manufactured by a Johnson and Johnson (J&J) subsidiary that required some patients to undergo revision surgeries because of allegedly faulty designs.

The new registry being proposed will be on the lines of the UK’s medicines and healthcare products regulatory agency (MHRA) and the Australian registry.

“National registries are needed for all implantable devices to effectively study adverse effects associated with medical devices. This will protect patients and improve outcomes," said a senior official in the health ministry.

In the case of the J&J hip implant, the first warnings came from the National Joint Registry of England and Wales. In August 2010, the company voluntarily recalled acetabular surface replacement (ASR) implants worldwide after the England and Wales registry reported that 13% of patients with ASR implants ended up needing revision surgery. In Australia, J&J’s hip implant was withdrawn after an alert by the Australian Orthopaedic Association’s joint replacement registry.

The Drug Technical Advisory Board (DTAB) will take up the proposal at its next meeting on 27 November. The registry aims to track the usage of high-risk medical devices, which, according to experts, would help prevent adverse events. “This will help to issue warnings and alerts to the manufacturers and consumer in case of a device malfunction," said another official. The official added: “Provisions may be introduced under the law to have legal backing for issuing alerts and warnings to a manufacturer. The registry will also help in providing a trend analysis of performance and usage of various medical devices in India annually."

As many as 4,700 patients in India had received ASR hip implants manufactured by J&J subsidiary DePuy Orthopaedics Inc between June 2004 and August 2010.

In 2017, the Union health ministry formed an expert committee headed by former dean of Maulana Azad Medical College Dr Arun Agarwal that found the ASR hip implants manufactured by DePuy International Ltd to be “faulty" and to have resulted in higher instances of revision surgeries globally, including in India. According to officials at the drug regulatory authority, the new mechanism will avoid such situations.

“We will encourage healthcare professionals, patients and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues. These reports, along with data from other sources, can provide critical information that will help improve patient safety."

The committee, after deliberations on the issues and review of the documents had found the firm to be “evasive" in providing the information regarding the design of the ASR, and patient details.

“The committee is of the considered view that the patients have to live a restricted lifestyle with a compromised physical state, thus putting them at pain and agony throughout their life, will also have a bearing on their dependents apart from loss of work. Though no amount of money can fill this void, however, the committee feels that an adequate compensation needs to be provided to each and every patient who had undergone revision surgery to mitigate some of the pain and sufferings." Mint has reviewed a copy of the report.

Other than this, the government is also contemplating changes under the Medical Device Rules, 2017 to make it mandatory for companies to compensate patients in case of serious adverse events due to malfunctioning of a medical device.

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