Navigation Links
FDA Targets Safety Problems With Infusion Drug Pumps
Date:4/23/2010

More than 56,000 reports of problems, 500 deaths have prompted agency to act,,

FRIDAY, April 23 (HealthDay News) -- Infusion pumps used in hospitals and homes to deliver medication and nutrients to patients have been a source of persistent safety problems that have now prompted the U.S. Food and Drug Administration to address these issues, health officials said Friday.

Over the past five years, the FDA has received more than 56,000 reports of problems with these pumps, including more than 500 deaths.

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

According to the FDA, from 2005 to 2009, there were 87 infusion pump recalls to deal with safety problems.

Common infusion pump problems include:

  • Software glitches such as failures of safety alarms.
  • Confusing instructions leading to dosing errors.
  • Mechanical or electrical failures, such as battery failures, sparks or pump fires.

These problems have been found in pumps from many manufacturers and are most likely caused by defects in the design and engineering of these products, according to the agency.

To start correcting these problems, the FDA has sent a letter to pump manufacturers advising them that additional risk assessments may need to be conducted to support clearance of new or modified pumps.

In addition, the agency has published a draft guidance recommending that infusion pump manufacturers start providing additional design and engineering data to FDA during premarket review of the devices.

The letter also invites manufacturers to submit their infusion pump software codes to the agency for analysis of potential software problems.

The FDA is also asking doctors to consider the following steps to make infusion pumps safer to use:

  • Be prepared to deal with pump failures.
  • Label pumps and tubing to avoid errors.
  • Check pump settings to prevent under-dosing or overdosing.
  • Report problems to the FDA.

More information

For more information on infusion pumps, visit the U.S. National Library of Medicine.



-- Steven Reinberg



SOURCE: U.S. Food and Drug Administration, news release, April 23, 2010


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Global Leader Readied For Healthy Aging Boom, Targets Wall Street With New Center In Trump Building
2. Scott & White Healthcare researchers studying investigational agent that targets breast cancer
3. Hot Pepper Itch Remedy Targets Kidney Disease Patients Suffering From Chronic Pruritus
4. New Study: Improved Immune System with Gene-Eden, a Natural Antiviral Supplement that Targets Chronic Viruses
5. Compound found that targets wide range of viruses
6. AIDS Campaign Targets Neglected Segment of Black America
7. Samaritans of New York Targets Service Industry
8. VHGI: VHGI Gold Targets Candidates to Fill Key Advisory Board Position to Evaluate International Mining Acquisitions; Internet Town Hall Meeting Details Emerge, Kitco Gold Coverage Initiated
9. Plerts Lets You Tap Your Social Safety Net for Medical and Personal Safety
10. Construction Accident Lawyer Says Recent News Of Mine Disaster Holds Lessons For Construction Safety
11. Partnering to Enhance Consumer Safety with Residential Fire Sprinklers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... ... , ... According to an article published February 1st on Consumer ... is being recalled due to the discovery that it contains dangerous adulterants. According to ... supplement on the market proven to help people safety lose excess weight, such cases ...
(Date:2/11/2016)... ... February 11, 2016 , ... Florida Hospital presents Heart Health Awareness night ... Louis Blues at the Amalie Arena. The puck drops at 6:00pm, but fans will ... MEGA Heart, prior to the game. The MEGA Heart will be located on Ford ...
(Date:2/11/2016)... , ... February 11, 2016 , ... ... reverse diabetes has been gearing up for their simultaneous grand openings in March. ... about right now that you’re probably wondering, is reversing diabetes possible? According to ...
(Date:2/11/2016)... ... February 11, 2016 , ... veEDIS Clinical ... technology, with highly adaptable algorithms, has been updated to help Emergency Department physicians ... symptoms consistent with Zikas and a travel history to affected regions, or potential ...
(Date:2/11/2016)... Orange City, FL (PRWEB) , ... February 11, ... ... has announced the commencement of a master charity program created to assist the ... every 60 days, working closely with nonprofit organizations and community leaders. Their hope ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... , Feb. 11, 2016  Governor Andrew M. ... will create 1,400 jobs throughout Western New ... partnership with the SUNY Polytechnic Institute, includes a major ... Building in Buffalo , as well ... manufacturing facility in Dunkirk . The ...
(Date:2/11/2016)... WILMINGTON, N.C. , Feb. 11, 2016 /PRNewswire/ ... a leading provider of custom manufacturing and development ... announces expanded sterile fill-finish capabilities and capacity in ... Substantial growth in demand has driven several recent ... in 2001 it had one filling line with ...
(Date:2/11/2016)... Iowa , Feb. 11, 2016  Proliant Biologicals ... Zealand Bovine Serum Albumin (BSA) manufacturing facility.  The facility ... New Zealand , in Feilding. ... was done to functionally duplicate the systems in the ... same vendors used for U.S. installations.  --> ...
Breaking Medicine Technology: