Friday, April 27, 2012

Medical Device Advisories: Moving the Needle

In 2005, a flurry of medical device recalls shook the implantable cardiac defibrillator market.  The first of these recalls occurred after the former Guidant Corporation (just purchased by Boston Scientific) was forced to admit that a header malfunction of one of their Prism II ICD's had short-circuited and failed to deliver appropriate resusciating shocks to several patients. The company had decided not disclosed the known defect immediately to physicians since the frequency of the events were rare.  It was only after two physicians reported their findings to the mainstream media, that a recall of the device was announced the following day.   Guidant stock tanked.  A flurry of negative press and lawsuits resulted and the ICD market was forever changed.

Shortly thereafter Guidant's other competitors had recalls of their defibrillator pulse generators.  First, Medtronic had a defibrillator battery with a shorting issue.  To avoid the fallout that Guidant had experienced, they initiated a "recall" and offered to pay for device replacement.  Hundreds of devices were replaced nationwide as a result.  Unfortunately, another problem came to light as a result of that action: infection.  Only after some time was it recognized that the infection rate of device replacement was higher than the device failure the replacements were supposed to fix. 

Time offers unique insights to device problems, we learned.

Even St. Jude Medical, who escaped the early firestorm of recalls,  had their own issue with cosmic radiation's effects on some of the components of their devices. Another physician advisory letter was issued.  Fortunately, the lessons from the other generator recalls helped doctors to be slower to react reflexively.  A more cautious wait and watch approach ensued.

The development of a robust registry of implanted device utilization took on new urgency.  Devices capable of self-checks that automatically transmit alerts to a central database without patient intervention were developed (see here, here, and here).  We felt we were on top of our game.

But then the problems with pulse generators evolved to defibrillator leads.  In October, 2007, Medtronic's down-sized but highly popular 7-French Sprint Fidelis defibrillator lead was beginning to show a higher-than-expected failure rate.  Several deaths occurred as a result.  At first when Medtronic attempted to determine a "root cause" for the problem, they identified several clusters of failure and suggested to physicians that the problems might be due to physician implant technique.  Later when it became obvious that even there most trusted implanters were having problems with the lead, Medtronic had a "mea culpa" moment and issued a sweeping lead "advisory." (There was concern that the word "recall" might spur doctors to extracting these leads in all cases).  And while many of those leads are still in place today, it is clear the Sprint Fidelis still shows problems with its reliability over time.  To facilitate , careful survellance of the leads using software enhancements to existing devices, the problem appears to be managable, though remains challenging.

More recently in 2010, St. Jude Medical recalled earlier versions of their downsized 7Fr Riata and Riata ST defibrilaltor leads because of a different failure mechanism: so-called "inside-out" insulation problems.  Deaths were reported with this lead also, but St. Jude took the unusual tactic of seeking a withdrawl of the information from a peer reviewed journal, arguing that the analysis of their lead's performance was improper when it's characteristics were compared to their competitor's defibrillator lead that remains on the market.  Given the history of the market recalls before, implanting doctors (including this one) were surprised to see such an action.   Where things will fall out on this issue continues to evolve.

What is clear from all of this, is that these devices, no matter how wonderful they may seem, all can have problems.  In fact, electrophysiologists are increasingly aware of system components that might fail and lead to problems with these devices, irrespective of manufacturer.  As much as we'd like to think these amazing devices are fool-proof, we are constantly reminded they are not.

But an interesting thing happened earlier this week;  something that was a welcome development in this continuing saga of device recalls and advisories.  

Yesterday, the press got hold of Boston Scientific's latest "product performance update" notification that involved a transformer component of one of their newer defibrillator product lines that, by Boston Scientific's own admission, had resulted in one patient death.  Predicably, the stock market price of Boston Scientific plummeted with the news.  The major news organizations spread the news far and wide. But then the stock price rebounded to within 8 cents of the stock's price before the news. 


Unlike the original Guidant mess in 2005, Boston Scientific took the step of quietly notifying their physician base over a week before the news hit the wire by way of a personalized request to review their latest "product performance report.".  The magnitude of the problem was fairly well quanitated, occurring in an estimated "1 in 8900 devices."  Doctors had time to digest the information, and while still concerning, it's implications to patients understandable when compared to the problems with other advisories.  While still early in this latest advisory, doctors are increasingly realizing that these problems with the many human-made components of these devices are not infallible. 

So we're seeing a glimpse of a new era of device recall management.  Rather than waiting for several deaths, the first case of death is divuldged.   Importantly, doctors who deal with these devices are informed early.  When this occurs, trust in the integrity of the device companies is improved as both doctors and their patients learn the magnitude of the inevitable challenges with these devices. 

Call me an idealist, but I think we're making progress in management of these sophisticated devices and I think that there's lots of good that can be learned by Boston Scientific's latest decision to come clean early with their latest device problem.  While there are still many issues that need improvement, like post-market surveillance of devices, things seem to be heading the right way.

Our next big challenge will be helping patients understand the realities concerning the reliability of these complex devices when deciding to implant them and communicating the efforts underway to assure their continued safety.



Anonymous said...

Doc, I understand that these issues put you in a very hard place, but from my viewpoint, a "welcome development" is NOT a bounce back in the stock price. I can see who would be reassured by that outcome, but it is Not a patient or a physician.

Anonymous said...

Okay, I admit, I'm sad that my comment got moderated. Illusions of online dialogue. Sort of like the illusion that people can have a conversation with their doctor.