Deborah Cohen, BMJ investigator
There are about 70 notifying bodies scattered around Europe, some a small office over a garage such as one in Istanbul, Turkey. It is up to these offices to decide whether or not a medical device can be sold in that country.
MDND readers however understand that thousands of medical devices are cleared for marketing in the U.S. with no clinical trials required, so the U.S. and EU systems are both decidedly hands-off.
The investigators created a fictitious hip implant, called the Changi TMH (total metal hip), which was modeled on a recalled hip, one that was taken off the market in 2010.
Cohen, the investigations editor of the BMJ, began the investigation after a number of high-profile device failures in Europe, such as metal-on-metal hips and industrial silicone-filled breast implants (PIP) that began leaking in women.
BMJ investigation undercover Czech Republic regulators
The Changi hip was shopped to several notifying bodies at a time even though that is not allowed by law.
The “manufacturer” created glossy brochure about the cobalt-chromium metal hip and took it to 14 notifying bodies shopping around the hip in this undercover investigation complete with a submission that showed many flaws with the hip prosthesis.
Many countries were interested, and the investigators submitted their full application complete with a payment for processing documents to Slovakia. One Czech Republic regulator said to the “manufacturer,” ‘we are on your side, not the side of patients.’
Of the fourteen notifying bodies they visited, only four raised concerns about the implant being a hip replacement.
This is a fascinating story of how backroom offices operate in the sketchy yet lucrative world of medical device regulation and the regulator-gatekeepers who get them on the market.
“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 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.
Cohen and the BMJ asked the EU’s version of the FDA, called the MHRA, how many high risk devices – those implanted inside the body- were currently in use and “refused to say what data had been submitted by manufacturers because this was deemed commercially confidential.” (here)
BMJ, October 23, 2012, Faulty Hip Implant Shows up Failings of EU Regulation