Posts Tagged ‘ Medical devices ’

Consumers Union: Manufacturers Should Warranty Knees and Hips

Sep 12th, 2013 | By
Consumers Union Safe Patient project logo 218

Your big screen television and new car comes with a warranty- why not the most important medical purchase you will make in your life? Consumers Union, an arm of Consumer Reports, has come up with a novel and common sense approach. Manufacturers of medical devices should warranty their products. They claim they are safe and
[continue reading…]



FDA Asks Consumers to Report Product Failures

Jun 10th, 2013 | By
FDA medwatch form 200

June 10, 2013 ~ New and Improved? The U.S. Food and Drug Administration (FDA) is celebrating 20 years of the MedWatch program by providing consumers with a new form that should encourage consumers and medical professionals to report adverse events, complications and bad outcomes with drugs and medical devices, cosmetics, medical equipment, food or supplements.
[continue reading…]



FDA Helps Industry Push Medical Device Innovation

Dec 4th, 2012 | By
Medical Device Innovation Consortium logo

December 4, 2012 ~ The FDA will collaborate with the medical device industry it regulates in a public-private collaboration, all to speed up the approval of new devices. The newly formed nonprofit group,  Medical Device Innovation Consortium (MDIC), has a goal of speeding up and simplifying the design and testing of medical devices, reports CBS
[continue reading…]



The FDA’s Internal Employee Struggles

Nov 26th, 2012 | By
FDA logo 100

November 26, 2012 ~ The U.S. Food and Drug Administration (FDA) is a large public agency that regulates consumer products that make up about $1 trillion in annual spending or 25 cents of every dollar spent on food, cosmetics, drugs, medical devices and tobacco products. The Partnership for Public Service supported by the Pew Charitable
[continue reading…]



FDA Whistleblower Case Moving Ahead

Nov 13th, 2012 | By
whistleblower 200

November 13, 2012 ~Round one in the FDA whistleblower scandal goes to the U.S. Food and Drug Administration. Regulatory Focus (here) reports the FDA had a minor victory November 9, in its case against the National Whistleblower Center (NWC) which is representing five both current and former employees of the FDA who claim they were
[continue reading…]



The Scandal of Defective Medical Device Approval in UK

Oct 29th, 2012 | By
Deborah Cohen, BMJ investigator

October 28, 2012 ~ Working with undercover reporters from The Daily Telegraph in the UK, the British Medical Journal’s (BMJ) Deborah Cohen has exposed, “a fragmented, poorly regulated, market driven system, with financial incentives to prioritize manufacturers’ interests over those of patients, and with no requirement for clinical evaluation of a device’s safety or effectiveness,”
[continue reading…]



ProPublia: Four Medical Devices that Bypassed FDA Scrutiny

May 10th, 2012 | By
Mesh after removal

May 10, 2012 ~ ProPublica, an independent journalism organization, reports on four medical devices that are among the thousands pushed into the marketplace every year that do not undergo Food and Drug Administration (FDA) scrutiny. The bottom line – medical devices are big business bringing over $100 billion-a-year to the industry, giving industry the muscle
[continue reading…]



Politics Gives a Pass to Negligent Doctors, Drug and Device Makers

Mar 20th, 2012 | By
Public Citizen logo  200

March 20, 2012 ~ The advocacy group, Public Citizen in a letter (here) to Congress issued Monday, March 19 calls on the U.S. House to Reject the medical liability bill called H.R. 5. The House may vote this week on the legislation called the Help Efficient, Accessible, Low-Cost, Timely Healthcare Act. It essentially shields the
[continue reading…]



Sen. Grassley Comes to Defense of One Whistleblower in Letter to Hamburg

Feb 8th, 2012 | By
Sen.Chuck Grassley

February 9, 2012 ~ “Whistleblowers point out fraud, waste and abuse when no one else will, and while they do so while risking their professional careers, they are often treated like skunks at a picnic,” Grassley wrote. “Whistleblowers have played a critical role in exposing harmful government actions and retaliation against whistleblowers should never be
[continue reading…]



Showdown in House Hearings Over Mesh, Medical Devices

Jan 24th, 2012 | By
Allergan Lap-Band video

January 23, 2012 ~ House Democrats are asking Republicans for a hearing on Johnson & Johnson synthetic surgical transvaginal mesh used to treat pelvic organ prolapse, and the Allergan Lap-Band for weight reduction because of a growing number of patient injuries and a fear that device makers and the U. S. Food and Drug Administration
[continue reading…]