Archive for the 'Medical Device' Category

FDA corrupted safety process

Wednesday, November 19th, 2008

According to a report published on Bloomberg.com, scientists and physicians at the Food & Drug Administration (FDA) have charged that the agency has corrupted the process by which new medical devices are approved.

The names of scientists who made the charges, as well as the devices to which they refer, have been redacted in the copy of a letter released to the public.

But the allegations in the letter are troubling. The scientists charge that misconduct by managers at the FDA Center for Devices and Radiological Health (CDRH) “is interfering with our responsibility to ensure the safety and effectiveness of medical devices for the American public and with FDA’s mission to protect and promote the health of all Americans.”

The letter was sent to members of the House Energy and Commerce Committee, the Congressional arm that provides oversight of the FDA.

VIBE manufacturers told to recall machine

Thursday, November 6th, 2008

The people who manufacture a machine touted as a way to increase “inner-connectively to your DNA,” has been ordered to recall the device because it doesn’t do anything it claims to.

The Food & Drug Administration (FDA) has issued a Class I recall for the Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Electromagnetic Field Generator sold by VIBE Technologies of Colorado.

The FDA says that that the VIBE Machine is not approved, and that the company’s claims that it can be used to treat or cure medical conditions and diseases such as cancer, depression, infection, and pain are unproven.

The company had further claimed that the machine “is a technological breakthrough that enhances the human body by helping it reach its optimum vibrational energy level.”

According to the FDA, it does no such thing.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

What your doctor left behind could kill you

Friday, October 31st, 2008

The Food and Drug Administration is warning doctors — and the public — about an growing but largely unrecognized problem plaguing surgery patients: UFDs.

Unretrieved device fragments, medical devices that break and leave behind potentially deadly debris after surgery, is responsible for at least 72 deaths and 4,675 injuries since 2003, an FDA database reports.

This is on par with mistakes that have received far more attention — sponges and instruments left in abdominal cavities — with this difference: doctors usually know they’re there, but they either make no attempt to retrieve the devices or are unsuccessful when they try.

FDA records show that more than 200 medical devices contribute to the problem. The most common problem occurs when wire guides for catheters used in heart operations break or fracture, leaving the device or fragments behind. Bone screws used in orthopedic operations are often culprits as well.

Some health workers don’t tell their patients about the broken devices, sending them home with pieces that have the potential to migrate throughout the body, or to interact with future procedures such as magnetic resonance imaging.  One worry is that metal objects can overheat during MRIs, scorching patients from the inside.

While the FDA works to develop some sort of reporting system, it’s up to patients to protect themselves. Ask doctors to explain potential complications of medical procedures and devices well before surgery begins. If a device is being removed, they should ask to see it. Afterward, they should ask if anything was left behind.

If you are suffering from this sort of problem, seek out an experienced lawyer who can help you with professional insight and to determine what sort of financial compensation is available.