Posts Tagged ‘defective medical devices’

In December 2008, the Ecri Institute released it second annual report on the top 10 technology hazards that should be on every hospital’s list of safety concerns for medical-device use.  The Ecri Institute conducts patient-safety research and investigates medical-device incidents.   Five of the hazards on the list are new. However, all of the five hazards dropped from the list are still seen as “significant concerns.”  The five new hazards just caused more problems in the past year, including retained devices and air embolism from contrast media injectors, causing them to placed on the list. 

The top 10 technology hazards are listed in order as follows:

1.  Alarm hazards
2. Injuries from needle sticks and other sharp objects
3. Air embolism from contrast media injectors
4. Retained devices and unretrieved fragments left in patients
5. Surgical fires
6. Anesthesia hazards due to inadequate pre-use inspection
7. Misleading displays
8. CT radiation dose
9. MR imaging burns
10. Fiberoptic light-source burns
     

While some problems involve a defective medical device, it tends to be inexperience and/or lack of knowledge on the user’s part that causes these devices to be hazardous.  Few people read the manual. If devices are used safely, fewer incidents would occur.  Every participant in the chain during the process has a responsibility to prevent a problem from arising. If you have been a victim of one of these technology hazards or any other technology, you may have a medical malpractice or hospital negligence lawsuit and may be entitled to a medical malpractice settlement.  You should contact a medical malpractice lawyer today for more information.

After two recent incidents involving the crash of Airbus A330 jetliners, investigators are determining whether defective airspeed sensors were the cause. These defective device sensors are similar to those being investigated in the Air France Flight 447 last month. On two different airlines that ended in safe landings, the National Transportation Safety Board has identified separate defective devices, both appearing to be the same type of defects that occurred on the Air France A330 shortly before it crashed. The defects trigger a loss of autopilot and automatic throttle. Such airspeed issues, however, although detrimental to safety, aren’t enough to bring down a jetliner. In the Air France crash, investigators believe turbulent weather, possible computer glitches, pilot actions and perhaps other factors combined to bring the jet to its fatal crash.

Advanced Medical Optics (AMO), a manufacturer of contact-lens solution, concealed complaints it received about the Complete MoisturePlus solutions causing eye infections and blindness. Government documents show AMO received complaints about the solution more than a year before it was recalled, and failed to report the complaints to the FDA as compelled by law. AMO recalled Complete MoisturePlus after the Centers for Disease Control and Prevention identified a link between the solutions and dozens of cases of serious infections called Acanthamoeba keratitis.

Acanthamoeba is a microscopic organism found in water or soil that can cause severe harm when it enters the eye. It usually enters the eye by attaching to a contact lens. Once it enters the eye, it is very difficult to kill, because it seals itself in a protective coating when faced with antibacterial drugs and protects itself from being killed for weeks or even months. If Acantheamoeba is not killed, it damages the eye and may cause blindness. In rare cases, it can even lead to a deadly infection of the brain and spinal cord. Acanthamoeba infections generally occur in, at most, two contact lens wearer per million. With 30 million contact lens user in the U.S., one would expect only 60 people to be infected. However, the figure exploded to more than 100 in 2007 alone.

Beginning in February 2006 and continuing through November of that year, AMO received a number of complaints about people diagnosed with the Acantheamoeba infections after using Complete MoisturePlus contact-lens solutions. However, these reports were not disclosed until June 2007, when the FDA went to investigate AMO’s headquarters regarding the recall. The FDA and CDC insisted that AMO recall the product after finding that contact lens wearers who had the infection were at least seven times more likely to use Complete MoisturePlus than those who did not contact the amoeba. The link between Complete MoisturePlus and Acanthamoeba keratitis is unknown, but AMO surmised it was due to improper handling and shipping of the contact-lens solutions.

Paige Reichardt was a victim of AMO’s misconduct. She became infected in 2005 and had to undergo a series of surgeries to remove her cataract lens, iris, and cornea. Ultimately, her whole eye had to be removed and replaced with a glass prosthetic. In an editorial, she described the pain as a feeling that someone had stabbed her eye with knives. Over 220 other plaintiffs had filed lawsuits against AMO, which is now part of Abbot Laboratories.

AMO’s negligence is a prime example of the devastating results that could occur when a manufacturer fails to take proper precautions in ensuring the safety of its product and properly warn people of the product’s dangers. If you are injured by a dangerous drug or defective medical device, contact a dangerous drug lawyer today.