Originally Published March/April 2001
Devices in the News: The Agony and, Sometimes, the Ecstasy
There are groans, and then there are
groans. A US pain specialist who uses
a spinal cord
stimulator to help patients suffering from severe backaches
will occasionally provoke a groan of pain. To block pain
signals from reaching the brain, the stimulator's electrode
must be precisely positioned on the spine to target specific
nerve bundles. In some cases, locating the optimal spot
requires a trial-and-error approach, resulting in a misdirected
jolt that causes the patient to voice his or her discomfort.
That is what seemed to happen during a recent session, except
that the sound coming from the patient had a more rapturous
ring than was customary. Apparently, the physician had
accidentally triggered an orgasm.
According to the Reuters news service, which carried this story, the doctor has patented the off-label use of the device manufactured by Medtronic and is attempting to persuade the firm to test and market it for this purpose. The article went on to say that he repositioned the electrode in the patient and was able to alleviate her pain. Much to the patient's dismay, however, he was unable to adjust the implanted device for multifunctional use.
This may not be precisely the type of positive coverage in the mass media that device industry associations had in mind when the issue was brought to the fore at the Global Medical Device Conference in Cancún, Mexico. It has been a little more than a year since industry leaders raised a call to arms at the confab to promote the remarkable yet often unheralded achievements in device technology. We're still waiting for the first manoeuvre. The discovery of the orgasm machine is, at best, a frivolous sidebar to the mainstream media's lead story on defective devices that are maiming patients.
We all remember the "Scandal of Killer Medical Aids" piece that was published in the 15 October 2000 issue of the Observer. The article alleged that shoddy practices at the München-based TÜV Product Service were responsible for allowing defective medical products to reach the UK market. The reporter graphically described the plight of British women who had to have soya-oil breast implants "ripped out" because they were found to be unsafe. The article listed a number of other "dangerous" medical devices, such as a mechanical heart valve and a pacemaker, that TÜV Product Service had approved. Potentially lethal devices, German complicity: How could the editor of a British publication pass up that heady cocktail? Of course, the article was as flawed as the devices it held up for public scrutiny.
TÜV's track record, it turned out, compared favourably with other notified bodies. This came as no surprise to industry observers, who generally consider the firm to be one of the more reputable notified bodies in the EU. "We cannot be 100% safe and secure, otherwise there would be no progress in medical care," aptly noted a TÜV spokesman in the article. The damage had been done, though, and readers with little knowledge of the device industry or the EU's regulatory system were outraged.
Then, in December, LifeScan pleaded guilty to criminal charges for failing to disclose that one of its blood glucose monitoring devices was defective and could endanger the lives of users. The company was ordered to pay criminal and civil fines totaling approximately $60 million. That amount will probably be dwarfed by the settlement that a legion of US lawyers now suing the firm will extract.
And then there's the case of the tipsy tables at the Royal Alexandria Hospital in Paisley, Scotland. The Scotsman reported in February that the hospital's operating theatre tables are prone to random tipping during surgery. The situation is sufficiently serious, according to the article, that patients are being advised the electronic tables could be unsafe during operations. A spokesman for the hospital was quoted as saying that surgeons were telling patients to take their chances with the tables only if delaying treatment would cause greater harm. It should be noted that the tables were purchased in 1984, and the defect may have more to do with hospital maintenance mismanagement than careless manufacturing procedures.
So all things considered, the makeshift orgasmatron is a bright spot in an otherwise dreary year of media coverage for the device industry. Of course, reporters will always chase the man-bites-dog story, digging for the dramatic and the exceptional, but that doesn't have to have a negative outcome. There are equally compelling tales to tell of the myriad miracles that devices make possible every day. The challenge for trade associations remains to raise awareness among news organizations of how industry's accomplishments affect the lives of millions of people . . . for the better.
