This report originally appeared in the July 2011 issue of DOTmed Business News

Over the past six or seven years, in addition to delivering nutrients and medications to patients, infusion pumps have delivered some major headaches for health care providers and some manufacturers with a number of recalls taking place during that time.

One of the industry’s most traumatic recalls is actually still ongoing. On Jan. 23, 2009, the Food and Drug Administration sent a letter to Baxter International Inc. ordering the recall and destruction of all its Colleague volumetric infusion pumps in use in the U.S. Baxter issued a Class I –meaning there was risk of serious injury or death – in response. The recall took place after the company identified software and battery failures that result in a delay or interruption of infusion that may cause serious injury or death, according to the information provided on the FDA website.



But many of these pumps are still in use. The recall made allowances for hospitals and facilities that filled out paperwork saying they needed to continue using the pumps for patients. However, the FDA required that even this extended use would have to end by July 14, 2012.

The recall, which the FDA estimates at 200,000 units, left many hospitals scrambling for a stop-gap, with some taking the SIGMA Spectrum infusion system distributed by Baxter as a replacement. Others turned to different manufacturers, either terminating their lease or receiving cash back for their recalled units.

Problems squared
Some hospitals chose to turn the clock back and return to older tried-and-true units. The idea was reasonable, but it delivered undesirable results. Baxter Flo-Gard was called into service, but because many nurses weren’t familiar with the older pumps, a series of errors were again reported, in that case though, it was a question of training rather than product malfunction.

If the problems ended (or would be ending) with the recall of the Colleague pump, everyone involved would just be counting down the days waiting for next July to come and go. Unfortunately, it’s not that simple. While the Colleague recall was one of the more significant actions in the sector, it was far from the only one.

The numbers
According to the FDA’s most recent numbers, more than 56,000 infusion pump problems have been reported, including 710 patient deaths. Those problems resulted in 87 recalls. However, that data was gathered between 2005 and 2009.

Since then, there have been at least a half-dozen recalls involving infusion pumps. Ironically, the SIGMA Spectrum was in that group with a recall initiated Sept. 15, 2010. The units were recalled because there was a risk of inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow, according to the FDA.

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.

That type of feedback could prove useful to manufacturers as they plan their next generation of pumps.

Pumps of the future
For manufacturers, most of their energy is being directed toward tying infusion pumps to other information systems. The pumps already speak wirelessly to a pump server, with event logs going to the server for example. Now, according to Sparnon, it needs to go to other systems. “If you tie your pump server to the pharmacy information system, you can pull patient specific dosing information and send it to an infusion pump,” she says.

“Another side is documentation. Once you’ve started infusion of the machine it can talk back to the electronic medication records system, it can save nursing time,” Sparnon says. “Currently, nurses are asked to enter data into the electronic medication record, manually. But with automatic documentation, they can wait to confirm the automatic data until the end of their shift or a quiet moment. That’s actually a function being pursued by all the different pump suppliers.”



DOTmed Registered Infusion Pump Sales & Service Companies
Names in boldface are Premium Listings.
Domestic
Anwar Abdelqader, CBE Medical, Inc. , CA
DOTmed Certified
Arnold Wiesel, MFI Medical, CA
DOTmed Certified
Peter Leonidas, Soma Technology, CT
DOTmed 100
William Clarke, Bio Med Tech, FL
James Fowler, BioMed Techs Inc, FL
Carlos Vargas, INCAV, FL
DOTmed Certified
John Mc Mahon, Quality Medical South, FL
Monte Montain, Alternative Source Medical, IL
DOTmed Certified
DOTmed 100
Bob Gaw, PRN, MA
DOTmed Certified
DOTmed 100
Alda Clemmey, Saffire Medical, MA
DOTmed Certified
DOTmed 100
Peter Stuart, Universal Hospital Services, Inc., MN
Bob Caples, Med-E-Quip Locators, MO
DOTmed Certified
DOTmed 100
Alison Fortin, Global Inventory Management LLC, NH
DOTmed Certified
DOTmed 100
John Carrubba, A-1 Ultrasound Services, NJ
Victor Landeros, OMED, NV
Kevin Mullane, HR Medical, Inc., TX
DOTmed Certified
KEITH CASTELAMARE, B&K BIOMEDICAL SERVICES, VA
Janet Lessnau, Hyperbaric Clearinghouse, Inc, VA
Joseph Cramer, IV Technologies, Inc., VA
DOTmed Certified
DOTmed 100
Philip Mothena, Simple Solutions, Inc., VA