New Delhi: Soon a registry is going to take care of the use of medical devices which posses a high risk to the patients.
TOI reports that the health ministry is planning to set up an independent registry that is going to track use of medical devices which are considered to have a higher risk of problems or complaints. Many consider it an aftermath of the recent Johnson and Johnson faulty hip implants case which left many patients in India in physical and financial distress.
The development follows recommendations of a government committee, led by Dr Arun Kumar Agarwal, former dean of Maulana Azad Medical College, which examined complaints regarding replacement surgeries using the J&J hip implants and had suggested a base amount of Rs 20 lakh each for all the patients who were received defective implants and had to be replaced with corrective surgery.
The committee report states, “Provisions may be introduced under the law for a legal backing for issuing alerts and warnings to the manufacturer.”
It has been reported that once the registry gets functioning, doctors and hospitals will have to mandatorily report data related to the high-end medical devices like orthopedic implants and stents which were used while conducting surgeries to the registry.
They also will have to report the data related to the manufacturer of the implant along with side-effects and any adverse events reported by patients post-surgery.
The government will immediately recall the product after evaluating the data if a significant number of concerns are reported with regard to the particular product. However, in case the effects are not very severe, an alert or a warning can issue by the regulator on the usage of the product which will be printed on product packages or even in the form of advisories to hospitals and doctors.
A senior official told TOI, “This will not only help save many patients from suffering adverse fallouts but also help in providing a trend analysis of performance of various medical devices in India annually.”
Developed nations including US, European nations, Australia and Japan already have such registries that often helped regulators raise an alarm in case of faulty products without waiting for the manufacturer to withdraw the device or take action. However, in India, there is no such mechanism in place for medical devices.
“There is no authentic data on number of implants used or replacement surgeries conducted,” the official told TOI.