Errors continue to plague smart pumps
June 12, 2014 in Medical Technology
The use of smart pump technology has been proven to reduce the frequency of errors in the administration of intravenous drugs. But software glitches and other potentially dangerous problems persist.
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The latest incident involved CareFusion’s Alaris Pump model 8100, which was recalled because of a software failure. The recall was reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program in May.
In a letter sent to its customers, CareFusion reported that the pump module will not properly delay an infusion when the “Delay Until” option or “Multidose” feature is used. As a result, the infusion starts earlier or later than intended and is not immediately detected and stopped by the clinician.
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This could result in serious injury or death. CareFusion said that despite the risk, no adverse events or deaths have been reported.
A spokesperson for the FDA told Healthcare IT News that the agency continues to work with manufacturers on problems with infusion pumps.
This is the third time in five years that the Alaris has had to recall the same product. In 2012 a malfunction on the same model could have led to serious injury or death.
CareFusion isn’t only top-tier pump manufacturer that has experienced a product recall in the past several years. In 2011, it was reported to the FDA that Stryker Corp. had to recall smart pump extension tubing and a smart pump tourniquet pump. In 2013, the Abbott Acclaim Infusion Pumps and Hospira Acclaim Encore Infusion pumps were recalled. Earlier this year, Sigma Spectrum Infusion Pumps from Baxter were recalled due to system malfunctions that resulted in nine adverse events.
The good news, according to industry experts, is that smart pump manufacturers generally respond quickly to problems and in most cases notify customers promptly.
“It’s been my observation that manufacturers take these very seriously and of course hospital managers will respond to the most critical recalls,” said Michael Cohen, president of the Institute for Safe Medication Practices, an industry watchdog group and certified patient safety organization.
Allie Woods, director, section of pharmacy informatics and technology, for the American Society of Health System Pharmacists said infusion pump manufacturers are normally very prompt to respond to issues.
“When there is a problem, they work with the health systems to make sure that normal operations can continue without disruption to patient care,” she said.
Healthcare industry aware of problems
In 2010, the FDA’s Center for Devices and Radiological Health issued an Infusion Pump Improvement Initiative. The agency found that many problems related to infusion pumps were related to deficiencies in device design and engineering.
The FDA has received numerous reports of adverse events associated with the use of infusion pumps, including serious injuries and deaths. Between 2005 and 2009, 87 infusion pump firms conducted recalls in order to address identified safety problems.
The FDA has recommended a series of actions directed toward manufacturers designed to foster the development of safer, more effective infusion pumps and to support the safe use of these medical devices. They include:
- Establish additional requirements for infusion pump manufacturers.
- Proactively facilitate device improvements.
- Increase user awareness.
The FDA concluded that although infusion pumps have contributed to significant improvements in patient care, they are not without problems. Through its IPII, the FDA has vowed to establish additional requirements for infusion pump manufacturers, proactively facilitate device improvements and increase user awareness in order to address infusion pump problems.
Preventing future problems
Health system pharmacists seem to play a positive role in helping to address and prevent problems associated with smart pumps.
In many health systems, an informatics pharmacist is responsible for creating and maintaining the smart pump drug libraries. The informatics pharmacist will typically work with nurses and clinical pharmacists to determine the parameters for each drug that is programmed.
“When a new drug is added to the pump library or there is an issue with a current entry, it is usually the informatics pharmacist’s responsibility to contact the appropriate people to ensure the pump is correctly updated,” said ASHP’s Woods.
Once the pump has been distributed to the floor, the pharmacist plays a minor role in its use. But Woods points out that many pharmacists know how to set the pump for patient infusions when needed, but the nursing staff typically performs this role.
Cohen said that smart pumps have become a critical part of infusion safety in most U.S. hospitals. However, he also said hospitals must have a program for their drug libraries to be properly set up and maintained.
“Ultimately of course the libraries must be utilized by clinical staff so there needs to be education and oversight and of course constant monitoring of available quality data from the pumps,” said Cohen. He added that wireless capabilities are critical for updating the software, especially in light of occasional drug shortages that might force a change in solution concentration.