New Delhi: In order to keep a record of all orthopaedic implant surgeries and track surgical outcomes at the All India Institute of Medical Sciences (AIIMS) New Delhi, is all set to start a registry.
According to a recent HT report, the decision comes in view of the ongoing Johnson & Johnson’s faulty hip implants controversy. Since the Orthopaedic Department of the AIIMS performs about 1500 hip- and knee implants in a year, it has decided to record each and every surgery in the registry.
For the purpose of documentation, the Orthopaedic Department is in the process of drafting a proposal to ICMR so that it can be executed as an ICMR supported project, which can further be initiated in other regions of the country where implants were being used. According to hospital authorities, there is a need for an audit as only about 1%-2% of around 3 lakh implant surgeries are being done in government-run centres; the rest are done at private centres.
Documentation of the results of all surgeries including revision procedures, infection rate etc, are also necessary. The Head of the Orthopaedic Department, AIIMS, Dr Rajesh Malhotra told the HT, “We are starting our own hospital-based registry, and have the in-principle approval of the director. The work has already begun on the project that we plan to execute with the support of the Indian Council of Medical Research (ICMR).”
“It is important to know how many total surgeries are being performed, what types of artificial joints are being used, how many patients need revision surgeries and reasons for it. At the moment, people are supposed to share data voluntarily but the need is to make it mandatory so that people don’t conceal surgical outcomes,” he further added.
Dr Malhotra further informed that the documentation needs to be done uniformly to get to know the trend about which implant is working the best in our country, and what is causing implant failure etc.
Those doing implant procedures are expected to furnish safety details as part of the national pharmacovigilance system.
A Senior Health Ministry official informed the daily, “It’s there in the law to share safety data with the regulatory authorities. It needs to be enforced harder as not all are sharing relevant data with the government.”