Skip to Content

Tag: Food & Drug Administration (FDA)


News

Senators urge GAO to review FDA oversight of recalls 

December 14, 2023HME News Staff

WASHINGTON – U.S. Senate Majority Whip Dick Durbin, D-Ill., and U.S. Sen. Richard Blumenthal, D-Conn., have sent a letter to the Government Accountability Office (GAO) calling on the agency to update its 2011 report entitled “Medical Devices: FDA Should Enhance Its Oversight of Recalls” in the wake of the Philips Respironics recall.    The Senators sent the letter following the Pittsburgh Post-Gazette’s and ProPublica’s reporting on the recall of certain...

FDA oversight, Food & Drug Administration (FDA), Philips Recall, Sen. Dick Durbin, Sen. Richard Blumenthal


Read Full Articlered right arrow icon

Also Noted

FDA updates Philips report count 

June 6, 2023HME News Staff

AMSTERDAM – The U.S. Food and Drug Administration received more than 6,000 medical device reports (MDRs) associated with the PE-PUR foam degradation in certain recalled Philips CPAP and BiPAP machines and ventilators from Jan. 1, 2023, through March 31, 2023, including 40 reports of death. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. A wide range of injuries have been reported in these MDRs, including...

CPAP, Food & Drug Administration (FDA), Philips Recall


Read Full Articlered right arrow icon

News

In brief: MSC and Trace Medical make buys, FDA extends EUA 

March 31, 2023HME News Staff

CLEVELAND – Medical Service Company has acquired OhioHealth Home Medical Equipment in Central Ohio.  “Through its three community locations and several in-hospital offices and liaisons, OhioHealth HME supports lightning-fast discharges for the OhioHealth hospital network,” MSC stated in a press release.  MSC has also entered a long-term partnership with the OhioHealth health system, which comprises a family of 35,000 associates, physicians and volunteers, and a network...

CPAP, Emergency Use Authorization (EUA), Food & Drug Administration (FDA), Medical Service Company, Trace Medical, Ventilator


Read Full Articlered right arrow icon

Also Noted

Vivos receives clearance for appliance to treat OSA 

January 9, 2023HME News Staff

LITTLETON, Colo. - Vivos Therapeutics, a medtech company focused on developing innovative treatments for patients suffering from obstructive sleep apnea, has received clearance from the U.S. Food and Drug Administration for its proprietary daytime-nighttime (DNA) appliance. With FDA clearance, the DNA appliance offers a new treatment regimen that opens the airway by expanding the palate and training the tongue to rest in the proper position, converting patients to nasal as opposed to oral breathing. ...

CPAP Alternative, Food & Drug Administration (FDA), Obstructive Sleep Apnea, Vivos


Read Full Articlered right arrow icon

Vendors

FDA releases alert on Philips BiPAP machines

August 30, 2022HME News Staff

WASHINGTON – The U.S. Food and Drug Administration is alerting patients, caregivers and health care providers that Philips Respironics has recalled 386 affected bi-level positive airway pressure (BiPAP) machines that may contain a plastic contaminated with a non-compatible material.  “If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs),” the FDA stated. “The plastic may also cause the machine...

Food & Drug Administration (FDA), Philips, Recall


Read Full Articlered right arrow icon

Also Noted

Philips recall: FDA reviewing, assessing medical device reports 

May 24, 2022HME News Staff

WASHINGTON – The U.S. Food and Drug Administration says it received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the foam breakdown or suspected foam breakdown of recalled Philips BiPAP and CPAP devices. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers and patients. A wide range of injuries were reported in the MDRs, including cancer, pneumonia, asthma, other respiratory...

CPAP, Food & Drug Administration (FDA), Philips Recall


Read Full Articlered right arrow icon

Vendors

FDA to Philips: Improve communication on recall 

March 11, 2022HME News Staff

WASHINGTON – The U.S. Food and Drug Administration says efforts by Philips Respironics to notify patients and others of its recall of certain ventilators and CPAP and BiPAP devices and the risk of harm from the polyester-based polyurethan (PU-PUR) sound abatement foam used in those products have been “inadequate.”  The FDA on March 10 issued a notification order to Philips Respironics requiring the company to notify all device users, DME suppliers, distributors, retailers,...

CPAP, Food & Drug Administration (FDA), Philips Recall, Ventilator


Read Full Articlered right arrow icon

Vendors

FDA warns Invacare about its complaint process

December 3, 2021HME News Staff

WASHINGTON – The U.S. Food and Drug Administration on Nov. 18 sent Invacare a warning letter outlining a number of violations found during an inspection earlier this year.  The violations include, but are not limited to, the following:  Failure to investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation...

Complaint, Food & Drug Administration (FDA), Invacare


Read Full Articlered right arrow icon

Frans van Houten

Vendors

Philips says updates are ‘imminent’

July 27, 2021Liz Beaulieu, Editor

AMSTERDAM – Philips could hear back from the U.S. Food and Drug Administration in August about its plans to replace the foam in certain CPAP devices and ventilators, based on a timeline provided during the company’s July 26 conference call to discuss financial results for the second quarter.  Philips filed "multiple packages" of CFR 806 applications for corrections and removals with the FDA in June and CEO Frans van Houten said, based on prior experience, there’s typically...

CPAP, Foam, Food & Drug Administration (FDA), Philips Recall, Ventilator


Read Full Articlered right arrow icon

Vendors

FDA classifies Philips recall as ‘serious’

July 26, 2021HME News Staff

AMSTERDAM – The U.S. Food and Drug Administration has classified the voluntary recall of certain Philips CPAP devices and ventilators as Class I.   The FDA defines Class I as “a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”  The agency posted recalls for the various affected devices, along with their classification, to its database on July 13 and July...

CPAP, Food & Drug Administration (FDA), Philips, Recall, Ventilator


Read Full Articlered right arrow icon