There are about 70 notifying bodies scattered around Europe that are in charge of deciding whether or not a medical device can be sold in that respective country. It is their alternative to the U.S. Food and Drug Administration (FDA), which is considered more rigorous in ensuring patient safety.
Or is it?
The British Medical Journal (BMJ) wanted to find out just how loose regulations are in Europe, so Investigations Editor, Deborah Cohen, created a fake medical device, on paper at least.
Working with the Daily Telegraph reporters, the team created a device application for the Changi TMH (total metal hip), a bogus metal-on-metal hip that they intentionally described to closely resemble the recalled DePuy ASR XL acetabular system.
The “manufacturer” created a glossy brochure about the cobalt-chromium metal hip and took it to 14 notifying bodies to shop around the fake hip. The submission even contained printed material that should have shown the many flaws with the metal hip prosthesis.
Many countries were interested and the reporters, posing as manufacturers, submitted their full application complete with a payment, for processing documents to Slovakia. One Czech Republic regulator said to the investigators, “we are on your side, not the side of patients,” indicating that the device would be approved.
Of the fourteen notifying bodies they visited, only four raised concerns about the implant being a hip replacement.
The BMJ’s editor, Fiona Godlee, says the investigation shows, “a fragmented, poorly regulated, market driven system, with financial incentives to prioritize manufacturers’ interests over those of patients, and with no requirement for clinical evaluation of a device’s safety or effectiveness.”
But is the EU really that different than the US?
In the U.S. there are no clinical trials required for the approximately 3,000 medical devices approved for market in the U.S. every year. This hands-off regulatory approach in both countries has allowed a number of high profile medical devices to be sold to unsuspecting patients such as the PIP industrial silicon-filled breast implants in France, and globally, the Johnson & Johnson-made DePuy ASR metal-on-metal hip.
Both devices were recalled but not before they damaged thousands of lives.
The Government Accountability Office in June 2011 noted that without clinical data requirements, 71 percent of high risk medical devices cleared through the U.S. system of medical device approval, known as the 510(k), were later recalled over safety problems.
“The notified bodies lie at the heart of the problems with the current system….most are reluctant to demand clinical data and lack the capacity to challenge or test the data against expert advice,” conclude BMJ investigators.
“Many said they were cheap and fast, we have to ask whether this is acceptable. Our investigation suggests the few devices fail to obtain approval,” reports Cohen.
Sounds very familiar, doesn’t it?