by
Sean Ruck, Contributing Editor | July 19, 2011
From the July 2011 issue of HealthCare Business News magazine
The industry has taken notice of all the recalls and even groups that haven’t traditionally seen eye to eye have begun working together for the common goal of improving pump safety.
The FDA teams up
Last year, from Oct. 5-6, the Association for the Advancement of Medical Instrumentation held an infusion pump safety summit at its headquarters in Silver Spring, Md. The summit hosted more than 300 industry professionals from diverse backgrounds including manufacturers, clinicians, clinical engineers and biomeds, IT experts, hospital administrators, regulators and of course, AAMI representatives along with representatives from other professional associations, including the ECRI Institute.
At the conference, the FDA shared its concern about the many problems they saw with infusion pumps. The information was based on data gleaned from their database which is populated with user-supplied information.
“Everyone had a handful of opinions,” recalls Erin Sparnon, senior project engineer for the ECRI Institute. “They pared these down to dozens of main ideas and 13 clarion themes,” she says.
AAMI took those ideas and created a council to develop guidelines which were also released last year in draft form. The priorities included a call to improve training, alarm management and compatibility issues, among other things.
A second summit was held on June 28 to review the initial guidelines.
Other resources
For those who can’t wait for the outcome of the more recent summit, there are some resources that can prove useful.
For instance, ECRI runs boot camps to help hospitals reach decisions regarding pump purchases. “In 2007, we ran a series of boot camps with Massachusetts General Hospital,” Sparnon says. Each boot camp was attended by about 35 people, representing about seven organizations, so about five people from each making up a team.”
Each team was given a task to perform and they were to perform the same task on every pump that was on the market at that time. “One of the interesting things we observed was that not only did different teams come to different conclusions, but even members of the same teams came to different conclusions,” says Sparnon.
The teams provided a varied skill set among members with biomeds and nurses working side-by-side. The exercise provided a learning experience not just for those attending the boot camp, but for Sparnon as well. “For instance, one of the devices had a text-based pharmaceutical library and some people liked it if they were familiar with texting, while those without that comfort level, didn’t like it at all,” she says.
