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In addition, the agency has published a draft guidance recommending that infusion pump manufacturers start providing additional design and engineering data to FDA during premarket review of the devices.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:5/1/2016)... ... May 01, 2016 , ... Women’s Excellence has ... mothers a better understanding of what to expect after they deliver. The guide ... postpartum, · The blues and depression, · Breastfeeding beyond postpartum · Baby basics ...
(Date:5/1/2016)... (PRWEB) , ... May 01, 2016 , ... Good Circle ... in need of chiropractic help. The agency offers a verity of health, life and ... need. According to Chris Nelson at the firm, “Many insurance plans don’t cover chiropractic ...
(Date:4/30/2016)... ... April 30, 2016 , ... Powerful ... with Hypnotherapist, Mary O'Maley. What is hypnosis and hypnotherapy and why after ... weight control), pain relief (chronic and acute), birthing processes and medical procedures, depression, ...
(Date:4/30/2016)... ... April 30, 2016 , ... Dr. Trevor Gardner, ... EMED, today signed a multifaceted agreement which will allow for the research and ... Department of Natural and Applied Sciences, Allied Health and Nursing will work together ...
(Date:4/30/2016)... ... 30, 2016 , ... Orlando-based Maximized Living has selected Dr. Nick Wilson of ... Under the care of Maximized Living doctors at the London Olympics in 2012, ... Living is sending the largest contingent of elite chiropractors to Rio to support and ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)... April 28, 2016   Click here for ... Inc. (NYSE: DPLO), the nation,s largest independent specialty ... definitive agreement to acquire Valley Campus Pharmacy, Inc., ... a leading specialty pharmacy that provides individualized patient ... . In 2015, TNH generated approximately $400 ...
(Date:4/28/2016)... Research and Markets has announced the addition ... report to their offering.      (Logo: ... plastic surgery products market is expected to grow at ... ,The growing adoption of laser in aesthetics is another ... Lasers are used to treat a broad range of ...
(Date:4/28/2016)... , April 28, 2016 ... George Phillips und Stephen ...    ArisGlobal®, ein führender Anbieter ... gab heute bekannt, dass neue Führungskräfte zum ... gestoßen sind, die vielfältige Erfahrungen mitbringen.  Dies ...
Breaking Medicine Technology: