A Medical Device Daily
Following are selected highlights from the recommendations just released by Heart Rhythm Society (Washington) concerning pacemakers and implantable cardioverter defibrillators. Importantly, the recommendations address four groups: physicians, makers of the devices and two groups of national regulators, the FDA and Congress.
- 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.
- 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 patients directly using standard patient communication forms to notify patients regarding potential malfunctions.
- 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
- Should recognize the FDA needs additional resources and funding to perform postmarket surveillance, analysis and reporting.