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Infusion Device Safety – Update on Progress

Posted by Beth Loring on Mon, Jan 17, 2011

Infusion Device Safety Update

Back in October 2010, I reported on attending the joint AAMI-FDA Infusion Device Summit, which took place at the FDA’s Rockville, MD campus. The summit brought together 330 diverse stakeholders: doctors and nurses, clinical/biomedical engineers, hospitals and other healthcare organizations, FDA officials, device manufacturers, product development firms (like Farm), academicians, safety organizations, and others.

The initial outcome of the summit was a list of the top 13 priorities for infusion device safety, which can be found at

I had noted that these would be addressed in an upcoming action plan. I just received my copy in the mail titled, Infusing Patients Safely: Priority Issues From the AAMI/FDA Infusion Device Summit. AAMI announced in a press release the availability of the report, citing Farm as a source of bringing awareness to the upcoming publication.

Call to Action

After the summit, the AAMI Infusion Device Standards Committee organized the 13 top-priority issues into five clarion themes, and the new report is organized around these themes:

  • Standardize systems and processes for reporting, aggregating, and analyzing infusion device incidents (covers four issues)
  • Improve the integration of infusion devices with information systems and drug libraries (covers three issues)
  • Mitigate use errors with infusion devices (covers three issues but is an overarching element)
  • Improve management of multiple infusions (one issue)
  • Reconcile challenges and differences in the use environments of infusion devices (two issues)

The report also includes material from the summit presentations and a bunch of expert perspectives solicited after the summit. The lead user profiles are particularly interesting because they present solutions that various hospitals and healthcare organizations have implemented to address infusion pump safety. I think it’s great that the medical community is now sharing lessons learned.

My favorite quote was from Dr. Matthew Weinger of Vanderbilt University: “We need to design safety features that make it easy for the user to do the right thing.” I remember writing that down in my notes when he was speaking. (Dr. Weinger is co-chair of AAMI’s Human Factors Committee, which I’ve been sitting in on.)

Where We Go From Here

Another development is the establishment of a Medical Device Safety Council focusing on infusion devices (Medical Device Safety Council/Infusion). This council is being established within the AAMI Foundation, which is a charitable and educational organization. This council will have an executive committee and a number of working groups with assignments based on the five clarion themes. You can see the assignment grid, with the names of the group leaders, at

Nearly one hundred summit participants (including me) signed up to participate on specific priority issues and will be invited to join the working groups. I’m particularly interested in mitigating use errors (of course!) and in the effects of the home use environment on infusion device safety, which is not only timely but relevant to several client projects Farm is involved in.

For more information on this topic, go to:

FDA’s infusion pump website:

AAMI’s infusion pump web page:

Topics: medical device, FDA, infusion device safety