Friday, September 29, 2006

Post-market Surveillance of Heart Devices

Most people are aware of the marvels of technology that help prolong life in people with heart disease. This is particularly keen in my field, where heart rhythm disturbances can cause sudden unexpected death, but implantable cardiac defibrillators are an effective weapon against this risk. Nonetheless, these complicated mechanical devices have a certain failure rate and can be subject to "advisories" from the manufacturer warning about certain problems that develop after the introduction of a new make or model to the public.

Unfortunately, occassionally these problems can lead to peoples' death, as we have seen. Doctors in their judgement have rushed to replace these devices, only to find later (hind site is always 20-20), that the risk of infection replacing the device can exceed the risk of failure of the device. It's a complicated and worrisome problem for all involved.

The Heart Rhythm Society has come forth with its recommendations to attempt to correct the existing shortcomings regarding the long-term management of device failures. They include:


  • Should inform patients not only about the benefits and risks of devices, but also about the overall expected performance of devices, including potential malfunction rates.

  • Should return all malfunctioning devices after explant to the manufacturer for analysis whether the replacement is routine or because of a malfunction. This will lead to more timely identification of potential malfunctions and a better understanding of the true 'denominator' for a particular device.

  • Should consider the risks of explantation and re-implantation of a new device when considering with their patients how to respond to an advisory notice that a device malfunction has been identified.

  • Manufacturers:

  • Should use expanding wireless and remote monitoring technologies to identify abnormal devices earlier and automatically.

  • Should establish independent, standing committees of outside experts to analyze device performance reports and to recommend appropriate action.

  • Should communicate with physicians and patients directly using standard physician and patient communication forms to notify patients regarding potential malfunctions.

  • FDA:

  • Should use simple language to communicate important information about device malfunctions and eliminate the term "recall" in public communications.

  • Should enhance the existing databases to more readily identify devices that may pose a danger to patients.

  • Should establish a post-marketing surveillance advisory panel of independent expert advisors to assist FDA with this function.

  • Congress:

  • Should recognize the FDA needs the appropriate resources, funding and focus to perform post-market surveillance, analysis and reporting.

Doctors will now have to think about adding a line to their documentation of "informed consent" that discusses performance failure rates of devices, but care should be taken to keep this "failure rate" broad, since these rates are not published for all devices and all manufacturers yet.

No doubt the manufacturers and FDA will do their part, too. But Congress giving more money to the FDA? There's the sticking point. From my perspective, Congess will try to get the manufacturers to foot most of the additional cost for oversight.

Hopefully these recommendations will serve as a wake-up call to Congress.


1 comment:

Anonymous said...

We refer to a tertiary facility for ICD implants. Since all of the recalls/advisories I now discuss the indication/rational and a global discussion of risks, including risk of device malfunction prior to even making the referral for implant. But this is not part of the informed consent.