Why aren’t medical devices regulated like drugs? BMJ

What are medical devices?

Examples of medical devices include surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. Examples of diagnostics include in vitro diagnostic reagents and test kits such as pregnancy test kits, and imaging systems such as magnetic resonance imaging (MRI). [Ref]. One of the new types that may be categorised as a ‘medical device’ is the Apple watch 4 

According to the FDA, “A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

“How much do you know about the safety and effectiveness of the implanted devices your patients are offered?”

You may assume that pacemakers, neurostimulators, joint prostheses, and breast implants have been tested rigorously before being licensed for widespread use. But this week a major international investigation, involving 59 organisations and including The BMJ, finds device regulation unfit to protect patients from harm (https://www.icij.org/investigations/implant-files; doi:10.1136/bmj.k4999, doi:10.1136/bmj.k5010, doi:10.1136/bmj.k4917, doi:10.1136/bmj.k5026).

‘The government must act urgently to reform the lax regulation system governing medical devices, including a compulsory registry of all new implants’, says the Royal College of Surgeons.

Manufacturers have claimed that Europe’s rapid licensing procedures protect innovation and investment while incurring no added risk to patients. But research published in The BMJ found a threefold greater rate of safety alerts and recalls for devices registered in Europe than for those registered in the US (doi:10.1136/bmj.i3323).

Sources of harm to patients include a lung sealant that leaked, breast implants that went rancid, implanted pacemakers that stopped working, and deep brain stimulators that had to be removed. Reports of these malfunctions and injuries are currently confidential, but the investigation found that their number has tripled in the past nine years in many European countries.

The medical device industry is booming, but transparency is lacking. Millions of people’s lives have been saved or made better by implanted medical devices, but information about the safety of devices can be hard to find … even for 250 journalists. linkhttps://www.icij.org/investigations/implant-files/what-you-need-to-know-about-the-implant-files/

What happens when the world’s biggest medical device maker becomes a “health services provider”?

A new cardiac suite with state-of-the-art equipment is developed for a cash strapped hospital in Mexico by the world’s leading medical device maker. What’s not to like? Jeanne Lenzer reports from Tijuana, Mexico, on a new public-private model that is being rolled out across the world amid criticism such deals introduce commercial concerns into clinical decision making LINK https://www-bmj-com.ezproxy.uws.edu.au/content/363/bmj.k4917

How lobbying blocked European safety checks for dangerous medical implants

Industry lobbyists have wrecked plans to overhaul safety regulations for medical devices in Europe, report Simon Bowers, Deborah Cohen, and colleagues from the International Consortium of Investigative Journalists. Meanwhile, confidential injury and malfunction reports have tripled in less than 10 years in many European countries LINK https://www-bmj-com.ezproxy.uws.edu.au/content/363/bmj.k4999

FDA recommends “modernizing” review of devices in wake of global investigation

LINK https://www-bmj-com.ezproxy.uws.edu.au/content/363/bmj.k5026

The US Food and Drug Administration is making changes to how medical devices are cleared for sale after a scathing investigation into the industry.

The global investigation into the medical device industry by journalists from 36 countries, including The BMJ, BBC Panorama, and the Guardian and led by the International Consortium of Investigative Journalists, unearthed thousands of documents to reveal rising numbers of malfunctions and injuries.1

Scott Gottlieb, FDA commissioner, and Jeff Shuren, director of the Center of Devices and Radiological Health, said in a statement that there would be changes to the 510(k) pathway that is used to clear four in every five devices for sale.2 The pathway approves devices not on the basis of testing in humans but on how similar devices are to previous devices, called “predicates,” some of which were approved decades ago.3

Gottlieb and Shuren said that about a fifth of devices were cleared on the basis of predicates that were more than 10 years old. They said they were “encouraging” manufacturers to “use more modern predicates,” adding that the use of older predicates didn’t mean a device was unsafe. This change, they said, was the “most impactful” change they could make to “modernize” 510(k).

FDA has issued a statement that its working with “tech industry to spur innovation in digital health”

A detail discussion of the Apple watch Ver 4 and the FDA approval is available at this CNBC web link.

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