Notwithstanding its concerns about the safety of Alaris SE infusion pumps, the Food & Drug Administration is not requiring manufacturer Cardinal Health to recall the 140,000 pumps in use in thousands of hospitals around the country.
In late August, the agency ordered federal marshals to seize 1,300 pumps, worth about $1.8 million, from Cardinal storehouses. According to the FDA, Alaris failed to follow the agency's medical device manufacturing regulations. The seizure arose from a manufacturing flaw that resulted in "key bounce" errors and caused at least two deaths, according to the FDA. In lieu of a recall, the company has issued instructions on how to avoid the errors.
The company reports that it is taking steps to rectify the problem and to enhance the safe use of pumps in current operation.
Four models of the Alaris SE pumps, formerly known as Signature Edition Infusion Pumps, have been sold by Cardinal over the past 12 years. According to ASHP, 32% of the nation's hospitals use smart infusion pumps. Of facilities using the pumps, 84% reported using them throughout the hospital and 77% reported using pharmacist programmed drug libraries.
Key-bounce errors occur when a number entered into the keypad is recorded more than once as the result of device flaw, not an operator error. For example, if an intended dose is 3.5 ml per hour, a defective or oversensitive keyboard could enter 33.5 ml into the pump, resulting in what medication safety experts call a 10-fold error and a drug overdose.
The problem differs from what are called "double-keying" errors, which is when a key is accidentally pressed twice. "Key-bounce errors involve a flaw in the data entry pads on infusion pumps," said Allen J. Vaida, Pharm.D., Institute for Safe Medication Practices executive director.
Health-system pharmacists must be aware of this problem, said ISMP's Vaida. "They often have responsibility for providing oversight in setting up the drug information library used to program these pumps," he explained. "They need to know the potential danger of incorrect programming at administration."
Vaida went on to say that removal of pumps from existing facilities could cause as many problems as it solves, or perhaps even more. "The machines perform a very necessary function, and replacing them would be a time-consuming and expensive process," he said. "It could require that pharmacists and nurses be totally retrained, which could create its own set of [safety] problems."
Cardinal recommends taking the following steps when programming an infusion device: