BMJ feature recommends tighter controls on devices, but is this really the way to go?
Published date : 05 November 2010
Article date : 05 November 2010
In this week’s British Medical Journal (6th November 2010), an editorial and a feature article raise concerns about regulatory approvals for medical devices, particularly in relation to the FDA’s treatment of an implantable vagus nerve stimulator.
There are concerns that the regulatory traditions of the device world lag behind those of the pharmaceutical, and in particular that the present system allowing approval of devices on the basis that they are “substantially similar” to existing devices is not rigorous enough. Observers of the FDA will have noticed that approval to market a device for meniscal replacement in the knee (the Menaflex Collagen Scaffold) has recently been withdrawn after the realization that the device was in fact not as similar to preexisting (predicate) devices as had been thought – in particular it was intended to stimulate the growth of new tissue rather than replacing it
The leader by Jerry Avorn (Professor of Medicine at Harvard) in the BMJ complains that devices are not routinely held on a register, making post marketing surveillance difficult and points out interestingly that stents used for treating peripheral arterial disease were in fact only approved for the treatment of biliary duct stenosis.
The feature article by Jeanne Lenzer and Sharon Brownlee discusses the problems associated with the use of an implantable vagus nerve stimulator (VNS) manufactured by Cyberonics and used for the treatment of epilepsy not responding to drug treatment. Deaths have been reported amongst patients with the device, some of whom have had asystolic episodes which improved after the device was deactivated. The proposed solution includes a requirement for manufacturers to register adverse events and independent monitoring of outcomes.
Whilst the need to protect patients is important, it is to be hoped that the regulators avoid a response that makes it more difficult for new devices to get to market. The system for regulating drugs is not without its problems – clinical trials are expensive because of the underlying assumption that drugs should be absolutely safe and the trials process is prohibitively expensive. Many new pharmaceutical agents that could help patients never make it to market because of these economic and regulatory considerations. Getting the balance of risks right is tricky. Calling for tighter regulation is easy – doing what is really best for patients is not.
