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Greg Webb
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FDA Tightens Regulations On Automated Infusion Pumps

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Following repeated problems with the devices, the Food and Drug Administration (FDA) announced on Friday that it would tighten the rules on commonly used automated infusion pumps that deliver drugs and other fluids to patients; it is estimated that two million of these infusion pumps are used in hospital and clinical settings and hundreds of thousands more are used by patients in their homes. While hospitals use these pumps to deliver chemotherapy, anesthesia and antibiotics, patients are also beginning to use the device at home to deliver regular infusions of insulin.

The FDA has recently cited a dramatic increase in the number and severity of problems with external infusion pumps. It said it has received 56,000 reports of problems within the past five years, including more than 710 deaths associated with the devices. Just from 2004 to 2009, there have been eighty-seven infusion pump recalls, fourteen of which were for problems deemed life-threatening. A significant problem associated with the pump is what experts call “key bounce”, in which a number entered into the key-pad is recorded as being hit more than once; this may cause the device to release an excessive amount of medicine. For example, instead of releasing two units of a drug, the device would release twenty-two units.

To combat this growing problem, the FDA has stated it will require additional testing of pumps before they go on the market and will also ask for information on the pump’s software and other components. This marks a new initiative from the agency where instead of responding to problems from each manufacturer, it will take an industry-wide approach; a representative for the agency said this broad approach may soon be extended to other medical devices as well. One of the biggest changes affecting the pump manufacturers is the ability for the FDA to conduct investigations on plants before new pumps are approved. Though the agency does inspect company facilities, it has never required the inspections be completed before product approval, unless it is a high-risk implanted device like a heart defibrillator. Companies will also have to conduct limited clinical trials to ensure their pumps are not susceptible to misuse or have design elements that could create errors.