Let’s Use Our Head with Brain Safety

This has been a challenging month for the medical device industry, and St. Jude Medical, in particular. The company temporarily pulled its Brio DBS system off the market in Europe, reportedly citing header problems in a letter to clinicians. And St. Jude was thrashed in a New York Times article about medical device safety. Although the article didn’t mention neuromodulation devices, it took the company to task for its less-than-forthcoming disclosure about lead problems in cardiac defibrillators.

The journal HeartRhythm published a report that found that 20 deaths were attributable to lead failures in the company’s ICD devices. St. Jude sought a retraction of the journal article and sharply criticized the report’s author. The company did not dispute the 20 deaths but rather pointed out that their competitor Medtronic was responsible for even more deaths from failed leads in its ICD devices. The journal refused to retract the article and St. Jude’s efforts at damage control only brought scorn and suspicion their way.

This episode reminds us of a safety issue in the cochlear implant business 10 years ago. When implant maker Advanced Bionics pulled its device from the market following a meningitis scare [NBR Aug02 p1], its competitor Cochlear sought to capitalize on the situation by pointing out differences in product features of its device that made it less of a risk for meningitis. While that may have gained them some market share in the short term, in the long term the entire industry—including market leader Cochlear—took a big hit. One lesson here is that it is seldom a good idea for one vendor to highlight safety problems in a competitor. The public—and regulators—often lack the sophistication to differentiate one product from another and public perception is everything in a situation like this.

Another lesson in particular for vendors of implanted brain stimulation devices is to take heed of the dangers—perceived and real—of unnecessary or accidental delivery of current to the brain. Efforts by researchers and vendors involved with epilepsy neuromodulation interventions to reduce the occurrence of false alarms—and thus needless stimulation—seem particularly worthwhile in this light [see article on page 1 of this issue].

Finally, neurotechnology vendors should tread carefully before attacking a critic who has raised safety or ethics concerns—regardless of how baseless the vendor thinks the criticisms are. Such a response will almost always be seen in a negative light and could possibly lead to increased scrutiny for the vendor and more sympathy for the critic.
When it comes to brain safety, we should all use our heads before putting our mouths in gear.

James Cavuoto
Editor and Publisher