New York, NYThe US Food and Drug Administration (FDA) announced that it is requiring makers of infusion pumps to provide more test data before those pumps can be approved to go on the market. The announcement was made because of concerns about the safety of infusion pumps.
According to The New York Times (04/24/10), the FDA has received reports of 710 deaths linked to the infusion pumps, although because of low reporting rates, the actual number of deaths could be much higher. Furthermore, the FDA Center for Device and Radiological Health reportedly received more than 10,000 complaints each year about the infusion pumps from 2005 to 2009.
Infusion pumps are used in medical settings—such as hospitals and clinics—and also by patients at home, to intravenously provide patients with food, fluid, pain medications and cancer treatments.
The New York Times notes that some patient deaths occurred after patients suffered drug overdoses when software included on the infusion pumps malfunctioned. One official with the FDA said the agency now requires more information on the pumps before approving them because the agency believes the pumps can be made safer. Under the new requirements, makers of infusion pumps would have to conduct trials to show their pumps are not susceptible to misuse or errors.
Pump manufacturers have defended their products, saying most issues arise when health care workers enter the wrong information into the pump. FDA officials, however, say they believe many issues are related to how the pumps are designed and manufactured.