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In addition, the agency has published a draft guidance recommending that infusion pump manufacturers start providing additional design and engineering data to FDA during premarket review of the devices.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

Copyright©2010 ScoutNews,LLC.
All rights reserved

Page: 1 2

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:11/28/2014)... 2014 Secura Consultants, based in ... marketing organizations in the country focused on delivering ... marketplace. Secura Consultants is proud to offer complimentary ... Group, a leading global financial company. , Many ... the ownership interest comes the need for business ...
(Date:11/28/2014)... Alex Kramer HealthDay ... Getting kids involved in the kitchen, through cooking classes or ... foods, according to a recent review. Cooking programs and ... and behaviors, according to the new research. And, although the ... findings suggest that such programs might help children develop long-lasting ...
(Date:11/28/2014)... CA (PRWEB) November 28, 2014 ... online, reported during the hugely popular, 2014 MTV ... antismoking organization Truth launched ground-breaking celebrity centered television ... The MTV viewership figures were estimated by ... antismoking ads placed the spotlight on celebrities photographed ...
(Date:11/28/2014)... UniWigs.com, a leader in the wig industry, has announced ... next Monday. This promotion features: , > 400 ... to 70% off (no coupon code needed), > ... on orders over $49 , Visit http://www.uniwigs.com for more ... 28th to Dec. 1st and the first 100 shoppers each day ...
(Date:11/28/2014)... An inventor from Flint, Mich., wants to minimize the trouble ... while lying in a hospital bed, unable to get up ... Buddy provides a more ergonomic and convenient way for a ... need to leave the bed, which avoids hassle and strain, ... and producible in design variations, it's ideal for elderly and/or ...
Breaking Medicine News(10 mins):Health News:Secura Consultants Offers Complimentary Buy-Sell Agreement Reviews 2Health News:Want Kids to Eat Better? Get Them Cooking 2Health News:Want Kids to Eat Better? Get Them Cooking 3Health News:Freedom Laser Therapy Applauds American Legacy’s Creative Advertising Targeting Celebrity Smokers 2Health News:Freedom Laser Therapy Applauds American Legacy’s Creative Advertising Targeting Celebrity Smokers 3Health News:Freedom Laser Therapy Applauds American Legacy’s Creative Advertising Targeting Celebrity Smokers 4Health News:Freedom Laser Therapy Applauds American Legacy’s Creative Advertising Targeting Celebrity Smokers 5Health News:Pre-X'mas Crazy Sale Starts from $0 at UniWigs.com 2
... today announced the,expansion of its proprietary pipeline, with ... orally-available small molecule compound,targeted for the treatment of ... inhibit major signalling pathways,involving Flt3 and CDK, which ... the most frequent genetic alterations,reported in acute myeloid ...
... NEWTOWN SQUARE, Pa., Nov. 27 In its ... homeopathy, Boiron,Laboratories disputes an editorial comment published in ... that its author has misinterpreted results of,clinical trials ... journal features an editorial by Ben Goldacre on,the ...
... say current labeling doesn,t reflect reports of bizarre behaviors ... (HealthDay News) -- A U.S. Food and Drug Administration ... Tamiflu (oseltamivir) should have a stronger warning label to ... who use the medication. , The FDA,s Pediatric Advisory ...
... ZMH ; SWX: ZMH) today announced that J. ... a member of the Board of Directors effective,November 30, ... John L.,McGoldrick, a current Board member, will serve as ... and Chief Executive Officer,of the Company from August 2001 ...
... Pronounced "mursa,",methicillin-resistant staphylococcus aureus (MRSA) is one of the ... it. It has,killed the elderly, babies, toddlers, teenagers and ... public schools., One of the most common places ... can start innocently, perhaps with a nick or cut. ...
... Rate..., CLEARWATER, Fla., Nov. 27 minSURG Corporation, ... it has certified over 600 surgeons in its TruFUSE ... in the basic technique at the,North American Spine Society ... believe that this milestone is a reasonable predictor that ...
Cached Medicine News:Health News:S*BIO Expands Pipeline With the Development of a Unique Flt3 -CDK Inhibitor as a Targeted Therapy for Acute Leukemias 2Health News:Boiron Laboratories Disputes British Journal's Editorial on Homeopathy 2Health News:Boiron Laboratories Disputes British Journal's Editorial on Homeopathy 3Health News:FDA Panel Backs Tougher Warning for Tamiflu 2Health News:FDA Panel Backs Tougher Warning for Tamiflu 3Health News:Ray Elliott to Retire as Chairman of Zimmer Holdings; John McGoldrick to Serve as Non-Executive Chairman 2Health News:Ray Elliott to Retire as Chairman of Zimmer Holdings; John McGoldrick to Serve as Non-Executive Chairman 3Health News:New Booklet Reveals 12 Proven Methods for Stopping MRSA from Infecting Your Feet and Your Family's Feet 2Health News:Over 600 Surgeons Certified to use TruFUSE(R) to Treat Back Pain Sufferers 2
(Date:11/26/2014)... Texas , Nov. 26, 2014 ... today announced the completion of previously announced concurrent ... million.  After fees and estimated offering expenses, Lexicon ... the transactions.  The transactions consisted of: ... common stock, pursuant to a registration statement that ...
(Date:11/26/2014)... CUMBERLAND, Md. , Nov. 26, 2014  Over ... half of those suffer from this pain daily. Chronic ... specialty of pain management is born to fulfill the ... treat all types of pain. On October ... to the Cumberland, Maryland community.  ...
(Date:11/26/2014)... ELMSFORD, N.Y. , Nov. 26, 2014  BioScrip ® , ... M. Smith , President and Chief Executive Officer, will present at ... follows: , , , Date: , , , ... , , 2:50 p.m. EST , , , , Location: ... About BioScrip, Inc. ...
Breaking Medicine Technology:Lexicon Announces Completion Of $280 Million In Financing Transactions 2Lexicon Announces Completion Of $280 Million In Financing Transactions 3New Pain Management Center Opens in Cumberland, Md. 2
... LAKES, N.J., Dec. 29 BD (Becton, Dickinson and Company) (NYSE: ... would present at the following investor healthcare conferences in January: , , ... 6, 2010, 9:15 a.m. ET, 28th ... 6:30 p.m. ET, , A live webcast of BD,s ...
... PALM CITY, Fla., Dec. 29 Connectyx Technologies Holdings Group, ... a National RV Owners Community as a marketing partner to ... over one million members and more than 3,400 individual club ... The RV Club provides its membership with essential services ranging ...
Cached Medicine Technology:BD to Present at Investor Healthcare Conferences 2Connectyx Announces MedFlash Sales Partnership with National Recreational Vehicle Club 2Connectyx Announces MedFlash Sales Partnership with National Recreational Vehicle Club 3
PremierEdge™ Stab Knives - 15°....
Interchangeable design allows you to select a single handpiece and change tips during the procedure. Universal connector. Disassembles for easy cleaning. Tips can rotate 360 degrees to re-orient port...
Interchangeable design allows you to select a single handpiece and change tips during the procedure. Universal connector. Disassembles for easy cleaning. Tips can rotate 360 degrees to re-orient port...
Infusion Cannula, 2.0mm....
Medicine Products: