How a fake surgical device was registered
Professor Andreas ObermairMDVIE, FRANZCOG, CGO
How a fake surgical device was registered
Posted by on 20 November 2013 | 0 Comments
I was wondering for a long time how stringent the requirements are to register a surgical device.
It is common knowledge that surgical devices only need to be tested for “Safety”. For example you need to prove that a surgical device does not explode or go up in flames all by itself in theatre. Safety in this context does not necessarily mean “safe for patients beyond the day of surgery”.
Safety is different from efficacy. Efficacy addresses if the surgical devices actually does what it promises. An adhesion barrier to prevent the formation of adhesions; a haemostatic agent to stop bleeding, etc.
As surgeons we normally assume that devices such as adhesion barriers, haemostatic agents, mesh or sutures will need to prove that they are safe for patients and actually work; we assume that they are tested prior to being used on real patients. The actual fact is that many of these devices are not tested at all. They are not tested because there are no legal requirements for them to be tested.
There is no need for an adhesion barrier to prove that it prevents adhesion formation. It would even be possible that an adhesion barrier actually increases the formation of adhesions and cause actual harm to patients.
There is no need for haemostatic agents to prove that they stop bleeding. It would even be possible that a “haemostatic” agent has no effect whatsoever. It is even possible that the “haemostatic” agent causes adverse events to the patient and no one would pick it up.
There is no need for a mesh to prove that it strengthens human tissues. It is even possible that meshes cause harm, erode into human tissues and cause adverse effects on those patients who had it implanted.
There is no need for a new suture to prove that it holds tissues together. It would be even possible that the new suture does harm to patients but no one would pick it up.
The new suture – like any “novel” device – only needs to prove that it is strikingly similar to what is registered at present already. The new suture does not need to prove that it is better than the suture we use at present. Companies will claim it is (far) better – but that is only a claim made by Reps to surgeons. In order to avoid clinical testing the official claim to TGA is that it is “equivalent” and “strikingly similar”. So far, this is the Australian situation.
The editor of the BMJ together with a journalist from the Daily Telegraph set out to test Europe’s system to register new surgical devices.
For the sake of this experiment they invented a fake hip prosthesis that only existed on paper. It was modelled on a prosthesis that was one of the biggest surgical disasters in orthopaedic surgery history. A prostheses that had to be recalled from market and legal action apparently is pending.
For the sake of this experiment the two authors claimed to have set up a company (in reality that company was never registered anywhere) and created a (pretend) fake hip prosthesis (that was never created) solely on paper.
The team of authors obtained quotes from European “notified bodies”, which are in charge of registering surgical devices in Europe. At the time there were approximately 70 such notified bodies, many of them have set up a practice in former Eastern Europe.
Those companies seem to compete for business with each other. Registering as quickly as possible with the least inconvenient enquiries, detailed paperwork, at the lowest cost differentiates those notified bodies. These companies proud themselves that no surgical device has ever been refused registration and all surgical devices applying for certification get through the approval process.
It is obvious that the standards of registrations vary. The fake hip prosthesis got registered without hassles. No one ever needed to show the actual prosthesis, confirm that it actually existed or show any data confirming its safety to patients or even that it has been tested in any way.
No original studies had to be completed about its potential for adverse effects, infection rates, levels of metal ions in the body, etc. prior to use in humans.
Apparently the European Certificate is critical to companies for an application to the Australian TGA. In Europe, the US or in Australia surgical devices do not need to prove their efficacy. Until efficacy data become available, patients have no chance knowing how safe surgical prosthesis and devices are that we as surgeons introduce into our patients pelvis.
Class action against surgical corporates will be the logical consequence of not testing surgical devices properly or suppressing inconvenient test results obtained in properly conducted test series.