Ralstonia found in more Vapotherm devices, recall launched.(Pulmonary Medicine)

From: Family Practice News | Date: March 1, 2006| Author: | Copyright information

Vapotherm respiratory gas administration devices are being voluntarily recalled, following federal government reports that twenty-nine hospitals in 16 states found Ralstonia organisms colonizing the devices, and cultures from approximately 40 pediatric patients also yielded the bacteria.

The Centers for Disease Control and Prevention and the Food and Drug Administration late last year had advised clinicians to use alternative devices to provide humidified oxygen therapy until the source of contamination has been identified and removed. They also recommended that any patients ...

Related newspaper, magazine, and trade journal articles from HighBeam Research

(Including press releases, facts, information, and biographies)

Abolishing the FDA
; The Food and Drug Administration (FDA) started out as a bulwark against snake...and subservience to the drug industry. The FDA seems indifferent to the many deaths its...come to seriously consider abolishing the FDA. Before 1992 the FDA was no friend of the...
A TIP FROM FDA LED TO SEC'S SUIT AGAINST BIOPURE
; The FDA dropped the dime. According to a government...and several executives hid from investors the FDA's safety concerns about its products while...effects of the closer cooperation between the FDA and the SEC to police biotechnology companies...
Not good enough: Some feel FDA's easing of off-label rules still falls short
; Some feel FDA's easing of off-label rules still falls short...recently released draft policy guidelines, the FDA would let pharmaceutical manufacturers distribute...failed to attract enthusiastic support. "The FDA's action indicates that it continues to believe...
Not enough warning: GAO report finds FDA's medical device monitoring lacking.(General Accounting Office, Food and Drug Administration's monitoring deaths and injuries involving medical devices)
; GAO report finds FDA's medical device monitoring lacking The...underreporting of device-related problems to the FDA by user facilities, such as hospitals. In...medical-device law in 1990 to boost field data at the FDA's disposal by making user reporting mandatory...
One Man's Ode to the FDA; Agency Is Often Criticized, but Employees Sing Its Praises
; "FDA Centennial Anthem" won't be mistaken for "The...singing along. The anthem might be true to the FDA's roots in the Progressive Era of Theodore Roosevelt...stanzas of lofty sentiment does it acknowledge FDA setbacks, such as the handling of Vioxx, a drug...
FDA rejects expert panel recommendation, blocks OTC switch for Plan B emergency contraception.(For the Record)(Food and Drug Administration)(over-the-counter)(Panel Discussion)
; The Food and Drug Administration (FDA) on May 6 overruled the recommendation of...Pharmaceuticals, Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research...to support conclusions about safety. The FDA told Barr that, before the drug could be...
FDA deserves thanks, not scorn
; Under scrutiny Director of FDA holds one of the most difficult, thankless jobs in the world The stakes are high with the FDA job. People and governments around the world look to the FDA to lead when it comes to deciding which drugs and...
LEANER, MEANER FDA LEAVES MARKETERS WONDERING.
; The FDA's fiscal 2000 budget finally came down in November...there were signs on several fronts that the FDA is going to take off the gloves when it meets...mandatory cost-of-living salary increases for FDA employees ($34 million, up 4.8 percent) and...
Beware the FDA & its "aggressive enforcement strategy".(FDA Update)
; On June 30, 2003, The FDA released its latest data on its enforcement...correctly) institutionally scared of the FDA. Some of that attitude has been warranted...being imminent inspections and microscopic FDA oversight of your operations. The FDA's...
FDA on labeling claims: the war rages on. (Food and Drug Administration regulation of labeling claims of skin care products) (Cosmetic, Toiletry and Fragrance Association supplement)
; FDA on Labeling Claims: The War Rages On WASHINGTON (FNS) - The...federal regulatory actions. Industry officials complain that the FDA should resolve the matter once and for all. Yet, it appears...subjective. Therefore the industry constantly maneuvers and the FDA must decide if this moves [a cosmetic ...