Specific recommendations for each of the key audiences include:

Physicians:

• 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 resour
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