defective medical devices

FDA Considers Regulating Wellness Technologies to Help Prevent Medical Device Defects

by Staff Blogger | January 20th, 2015

Advancements in technology have helped Americans live healthy lives, but developments in medical and health devices have raised several questions about the preventing defective medical products from reaching consumers.

Most of us concede the importance of regulations placed on items like insulin pumps or dialysis machines, but what about heart monitors people wear on their wrists while working out? Should over-the-counter gadgets be required to face the same regulations? Officials from the federal government say the answer to that question is yes.

According to Engadget, the U.S. Food and Drug Administration (FDA) is calling for public opinion on a set of rules to guide the design, manufacturing, and distribution of what’s being described as “general wellness devices.” These regulations will be placed on any device that claims to make improvements to a person’s health.

The problem is, the lines are very murky between claims to improving wellness and the treatment of medical conditions. That’s why the FDA is expected to make several changes to the drafted rules before a vote on the initiative is taken.

At Ferrer, Poirot & Wansbrough, we see the results of faulty products on a daily basis. Our defective medical device lawyers are anxious to see if these new regulations are put into place.


OpenFDA Provides Greater Insight Into Drug Injuries and Defective Medical Devices

by Staff Blogger | September 2nd, 2014

Each year, hundreds of thousands of patients become drug injury victims or are harmed by defective medical devices. Most experts agree that more transparency within the medical field is one of the best ways to reduce the number of adverse health events patients suffer due to negligence or error. This is why the U.S. Food and Drug Administration (FDA) has launched a new database known as OpenFDA.

Officials say the database, which currently holds more than 3 million documents, gives the public access to reports and records regarding incidents of patient harm. While OpenFDA is still in it’s testing phase, many believe the information provided will lead to faster action being taken when problems with specific medical products are identified.

The new system will also create a more efficient means for data to be analyzed by researchers, providing a greater insight into focused areas of medicine.

At Ferrer, Poirot & Wansbrough, our drug injury attorneys are excited about the FDA’s new system and are hopeful that it’s successful in providing a greater scope of information about the medical industry to the American people.

OpenFDA Now Includes Information About Recalled Products

by Staff Blogger | July 22nd, 2014

The U.S Food and Drug Administration (FDA) recently launched a database to create better access to the agency’s plethora of data. Now, the FDA has stated they have expanded the system to include vital information about faulty products, such as defective medical devices and dangerous medications.

According to a press release from iHealthBeat, the OpenFDA system will now feature several million reports on product recalls and their related adverse health events. The hope of adding these files is to improve transparency of the data collected by the federal government to improve manufacturer accountability and reduce the number of injuries, illnesses, and deaths caused by faulty products.

So far, the OpenFDA is being hailed as a success and has already been accessed by as many as 18,000 mobile devices with more than 2.4 million API calls.

The new system has also sparked engagement with the public, spawning a new website dedicated to answering questions regarding defective products that are recalled.

The drug injury attorneys with Ferrer, Poirot & Wansbrough are aware of the importance of the public having access to information about recalled products and are excited to see this new system give Americans the ability to retrieve such data at the touch of a button.

Defective medical device injuries associated with AEDs

by fpw | December 30th, 2010

December 30, 2010

Sometimes physical ailments can’t be cured with a medication but instead require the use of a medical device to assist the patients. However, those medical devices can malfunction.

Automatic external defibrillators have been associated with defective medical device injuries from 2005 through May of this year, the U.S. Food and Drug Administration reports. The defective medical device injuries include patient deaths and injuries, as well as device malfunctions.

However, AED manufacturers say the reports may be more related to the FDA’s manual reporting policy with this medical device than to defective medical devices.

Read more.

Have you ever suffered injury because of a defective medical device? Tell the defective medical device lawyers at Ferrer, Poirot & Wansbrough Attorneys at Law about your loss. Let them help.