FDA Launches Initiative to Reduce Infusion Pump Risks

Agency calls for improvements in device design

| Apr 27, 2010

Last week the U.S. Food and Drug Administration announced an initiative to evaluate safety problems that may occur with external infusion pumps.  These devices are used to deliver fluids or medications to patients in a controlled manner. Insulin pumps, for example, release insulin into the body at a controlled rate to compensate for a lack of insulin production in people with type 1 diabetes.

Federal health regulators on Friday announced steps to improve the design and safety of drug pumps that have been linked to more than 500 deaths in the past five years. The FDA is issuing a draft guidance and letter to infusion pump manufacturers. 

"These pumps often provide critical fluids to high-risk patients, so failures have significant implications," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health in a press release from the FDA. "It is time for a more comprehensive approach than we've taken to date."

Pumps typically allow a greater level of control, reducing medication errors and increasing accuracy, and precision in drug delivery. But infusion pumps also have been implicated in safety problems. The FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps in the past five years. Those events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns, according to FDA data.

The FDA will also sponsor a public workshop May 25-26, 2010.  Participants will discuss observed safety problems, and explore opportunities to work with others, including foreign regulators, to improve the design of infusion pumps on the market or in development, in order to reduce pump malfunctions and errors.

According to the FDA press release, the most common types of reported problems have been related to:

  • Software defects, including failures of built-in safety alarms;
  • User interface issues, such as ambiguous on-screen instructions that lead to dosing errors; and
  • Mechanical or electrical failures, including components that break under routine use, premature battery failures, and sparks or pump fires.

The FDA has the following advice for users. To help reduce infusion pump risks, consider the following general strategies:

  • Plan ahead and be ready to respond in the event of a pump failure.
  • Label infusion pump channels and tubing to prevent errors.
  • Check infusion pump settings and monitor for signs of over- or under-infusion.
  • Use available resources to prevent and respond to pump problems.
  • Report adverse events promptly to the FDA.

* * *

For more information:

Center for Devices and Radiological Health information on infusion pumps.

White Paper: Infusion Pump Improvement Initiative.



FDA press release

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Posted by Anonymous on 28 April 2010

I am assuming my endocrinologist has access to above information regarding the unreliability of insulin pumps. ( If he does not -- he is unreliable and I need to go elsewhere.)
If he does know -- how can he recommend such faulty equipment? If I had no choice --- I could understand. I give myself insulin shots 5 times a day --- and do not complain. Shots don't hurt -- finger pricks for testing blood for glucose are a nuisance, but even there I do not complain.


Posted by shosty on 28 April 2010

it would help a lot of pump companies had a better way to tide patients over when a pump failed. We have had to wait 4-5 days for a replacement! There are pump sales reps within driving distance anywhere, why not provide them with replacement pumps, even if temporary ones, while we wait for new pumps to arrive in the mail?

Posted by Anonymous on 28 April 2010

I have had my insulin pump for 7 years and have had excellent use of it. I'm so thankful not to be taking shots anymore. I am a little surprised to hear of so many problems and even deaths. If makes me wonder if I am overlooking something. My A1C is usually between 6.9 and 7.5. Any response would be appreciated.

Posted by InsulinPumpPRO on 28 April 2010

As an RN, CDE, CPT I take have to commit on the above and the FDA advice. #1 Some pump companies will send a back-up pump if going out of the country (Animas) and Roche (AccuChek Spirit) pump comes with a backup pump. It is the responsibility of the user to ALWAYS have a BACK-UP PLAN. #2 "Label tubing" sounds as if the FDA ic confused about a IV pump with more than one line. (Any good nurse knows to label IV lines when dealing with more than one). # 3 "Check settings and Monitor" That is what regular Blood Glucose monitoring is all about. The settings should only be changed by someone who takes the time to review your BG logbook and is trained in insulin pumps. # 4 "Report Adverse events" This is an area that we should all be concerned with but with the general population the FDA may be geting alot of needless phone calls. As someone who uses an insulin pump I must take responsibility for bolusing with meals, changing my sites, replacing the battery and having a back-up plan. Where do we draw the line? If my pump is not working properly I need to call the 1-800# on back of the insulin pump (24/7/365-Some one is always their) and allow their rep. to guide me or send out a replacement pump. Mr./Mrs. FDA please contact the pump manufactures to report major problems and the rest of us users will call the FDA if we have a serious problem. Maybe pump companies need to put the FDA # on the back of all insulin pumps? Something to thing about.

Posted by Anonymous on 28 April 2010

How many injuries and deaths occur on shot therapy (vs. pump)?

Posted by Anonymous on 28 April 2010

It has been 7 years since I started on the pump and love using it. However, twice my pumps failed and had to be returned to the manufacturer. Each time a new pump was sent out in a timely manner. One year when I did a trade in, I paid a nominal fee to keep one as a spare. It has come in handy when traveling or when 1 pump was sent back. I would recommend to everyone to try to get a spare pump or if you are traveling, get a loaner from your manufacturer. Why worry when you are away from home!

Posted by AnnetteUK on 28 April 2010

I think the safety of an insulin pump is all in the hands of the owner/user..like a car.
44 years on shots and 8 on a pump... I have been in control of how much insulin enters my body... no-one else...just me.

Posted by Anonymous on 29 April 2010

THE FDA IS PLAYING CYA. They have been resisting approval and testing of a practical artificial pancreas using insulin pumps and wireless continuous blood glucose sensors. They are pre-occupied with finding fault with existing pump software, batteries or tubing. Software is always being updated, batteries die, tubes get kinked, BIG DEAL!

The FDA is pushing this info as a smokescreen for their part in slowing down development of a closed loop glucose level detection and insulin delivery system that will actually REDUCE the danger of insulin over-delivery from pumps during hypoglycemic episodes. Europe is far ahead of the USA in this Research & Development.

Read the May 2010 edition of WIRED (article available online as PDF: http://www.wired.com/images/press/pdf/pancreas.pdf). A quote from that article,

"...speeding the FDA’s decision making process might eventually require the kind of marches and protests that other advocacy groups have used. For its part, the FDA insists it is moving as fast as possible and that its caution is justified. “The approval process in Europe is not anywhere near as rigorous as it is in the US,” says Arleen Pinkos, who leads the agency’s Artificial Pancreas Critical Path Initiative...People suffering from type 1 might not wait for the agency to act. Some have begun whispering about hacking their pumps to control them wirelessly. The likelihood of someone actually doing that increases with each passing day of bureaucratic paralysis."

James Hill, RN, BSN (former AADE member)

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