New FDA Initiative will Reduce Infusion Pump Malfunction
The Food and Drug Administration announced last week that they will begin to address inherent safety issues with external infusion pumps used to deliver medications and nutrients to patients during hospitalization. Until now, medical equipment manufacturers making infusion pumps had not been subjected to strict pre-market guidelines.
Because these pumps are used to provide high-risk patients with critical life-saving fluids, any failure in the equipment could have serious implications. As a result, more comprehensive safety guidelines became a necessity. A new FDA web page will help medical equipment suppliers adhere to the new safety regulations for improved pump design.
Infusion pumps are used in various clinical settings to help doctors control drug delivery and reduce errors in medication dosage. However, in the past five years the FDA received over 50,000 reports citing adverse affects because of problems with this medical equipment. Some of the more serious incidents resulted in the death of over 500 patients. Some of the most common defects involved the failure of software and dosage safety alarms, ambiguous interface issues that led to dosage errors, and mechanical failure under routine use.
According to the FDA, 87 different infusion pumps were recalled to address these concerns in the past five years. Because most of the defects uncovered were related to medical equipment manufacturing and engineering, the FDA has ordered manufacturers to conduct additional testing and risk assessment on new or modified infusion pumps before they are brought to market. In addition, manufacturers have the option of submitting the software codes for these pumps for pre-market analysis by the FDA. Using static analysis, the agency can help detect problems related to software while the device is still in the development phase. A public workshop will be held on May 25 and 26 where participants can work to improve infusion pump design and the risk of equipment malfunction.
