On April 9, the Indian Society of Hip and Knee Surgeons launched the Indian Joint Registry, a centralised database where all joint replacement surgeries performed anywhere in India will be recorded and monitored even post surgery. The registry is designed along the lines of those maintained and run by the UK government, and other registries in Australia and the United States.
India has about one lakh joint replacement surgeries every year, with a 15%-20% increase each year. Under the Drugs and Cosmetics Act, effective post-marketing surveillance is primarily the job of the government. But so far, there was no way of finding out how hip and knee implants were doing in patients. This is where the joint registry initiative steps in.
Doctors feel there is immense value in keeping a record of such replacements as the data collected from it can lead to more effective treatment. For instance, data can reveal the kinds of procedures and implants that work best on certain patients. It also enables doctors to counsel patients on risk factors based on data, again made available through the joint registry.
“The documentation will have great value for us,” said Dr Arun Mullaji, vice president, Indian Society of Hip and Knee Surgeons. “It protects the patients, surgeons and the companies that supply the implants.”
He added: “We had a manual register for about seven years. Not many surgeons recorded information on it. We are trying to completely digitise this and make it compulsory across the board.”
So far, only 160 of 600 members of the Indian Society of Hip and Knee Surgeons have sent in data. But it’s still early days now.
Joint registry data has previously helped identify faulty implants. For instance, in 2009, Australia’s National Joint Replacement Registry recorded higher failure rates in ASR hip implants, manufactured by DePuy, a subsidiary of Johnson and Johnson, after which they were recalled from the Australian market. A year later, the UK joint registry published similar data after which Johnson and Johnson, in August 2010, recalled the implant from the market all over the world, including India.
While data from such a registry could obviously lead to more effective treatment, it is not very clear whether it can be used legally in India, like in the case of the DePuy recall. Just last month, it was reported that patients fitted with the faulty ASR hip implant in Australia were expected to receive a share of $250 million as part of an agreement to settle a long-running class action suit against DePuy.
Northgate Public Services, a UK-based software outsourcing firm is helping the Indian Society of Hip and Knee Surgeons with the registry project. They will first run a pilot project in five hospitals, after which they want to reach out to orthopaedic surgeons all over the country. The data in the registry will be the property of Indian Society of Hip and Knee Surgeons, which will share it with others, including patients, at its discretion.
“They (Indian Society of Hip and Knee Surgeons) must ensure that patient information is recorded only after obtaining informed consent,” said Nivedita Saksena, from Vidhi Centre for Legal Policy, that conducts research on rights-based approaches to health. “If they plan to release this data to other people (especially if it is de-anonymised), they would have to take specific consent from the patients and the patient must be notified if any disclosure does take place.”
It is mandatory for doctors to get consent before sharing any patient information. “The patient details would never be revealed,” said Sujata Garud of Northgate Public Services. “The entire procedure would be anonymous. We leave it to the hospital to seek consent.”
But Saksena said if the registry only collected health data without any identifying information, it would be useless to patients because there would be no way to track it back to a particular patient once it’s been recorded. “And they wouldn’t be able to ask for it in any case if they want to go to court,” said Saksena. “I don’t see much benefit in that.”