Sunday, June 6, 2010

Medical Device Safety

FDA’s Center for Devices and Radiological Health (CDRH) is currently taking steps to help assure that medical devices are safe to use not only in medical facilities but also when they are used in the home. CDRH held a workshop in May to discuss the safe use of all medical devices in the home as this is becoming an increasingly important public health issue.

The aging of the population and shifts towards shorter hospital stays continues to make home healthcare more common. With these trends, a significant number of medical devices including infusion pumps, ventilators, and wound care therapies are now used in the home.

FDA and the panel participants at the workshop discussed establishing guidelines for manufacturers of home devices. FDA has not yet developed a clear regulatory pathway for these devices or helped manufactures with the information that they need when they are designing, testing, and labeling such devices.

To address the problem, FDA is going to develop with input from device manufacturers, a guidance document recommending actions that the manufacturers will need to take to receive FDA approval or clearance for devices to include usability testing with users in a non-clinical setting. The new guidance document will recommend post market surveillance that manufacturers should undertake to identify and address adverse events that occur in the home.

To specifically address external infusion pumps, CDRH held another workshop in May to discuss their safety. FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps in the last five years. These events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns, according to FDA data.

The most common types of reported problems are software defects, user interface issues, and mechanical or electrical failures. Failures of infusion pumps have been observed across multiple manufacturers and pump types and according to the FDA, and many of the reported problems appear to be related to deficiencies in device design and engineering.

FDA recently announced a new initiative to address the safety issues involved in using external infusion pumps to deliver fluids to patients. As part of the initiative, FDA published draft guidance recommending that infusion pump manufacturers begin to provide additional design and engineering information to the FDA during premarket review of the devices. Also FDA has issued a letter to infusion pump manufacturers, informing them that they may need to conduct additional risk assessment to support clearance of new or modified pumps.

FDA is also launching a new web page devoted to infusion pump safety. The web page will feature steps that patients and healthcare professionals can take to prevent and report safety problems, even before new or redesigned pumps are brought to the market.

For more information on medical devices, go to