Chennai: A report led by the International Consortium of Investigative Journalists (ICIJ) and its partner news organizations. The British Medical Journal and BBC Panorama revealed that 83,000 deaths and 1.7 million injuries were associated with faulty medical devices. The safety regulations do not keep up with the advancements in med tech, raising the need of a better regulatory system on the medical devices.
One of the earlier reports by the BMJ revealed that hip replacement surgeries use implants with no readily available evidence related to their safety and effectiveness. The researchers said that eight percent of all implants had no
evaluated evidence due to the lack of a proper regulation process.
The high failure rate of implants highlighted the need for an adequate evidence base for medical implants. Many implants are available to surgeons without an evidence of clinical effectiveness to support their use.
The report highlighted that governmental authorities do not review medical devices before they reach the market. Instead, medical device companies seek approval from notified bodies for approval. Though the scenario was based on the European market and med tech industry mainly, various countries such as India are main consumers of the same.
The report said that safety and efficacy of medical devices are not subject to the same transparency rules as medicines; so much so that surgeons performing these procedures don’t always see the evidence related to the devices.
Responding to the report, UK’s Royal College Of Surgeons demanded drastic
regulatory changes in the way medical devices are evaluated. Medicos say that all implant devices should be registered and tracked to monitor efficacy and patient safety in the long term.