FDA Toughening Rules For Infusion Pumps
Following a number of complaints, the Food and Drug Administration is issuing preliminary guidelines requiring that manufacturers of infusion pumps provide adequate test data before it will approve commercial sale of the devices.
The dangers of defective medical devices are extreme. Their purpose is to improve patient health, not to cause injury or death. When these machines malfunction, we have won substantial settlements for our clients.
The FDA has received “more than 56,000 reports of adverse effects associated with the use of infusion pumps,” including more than 500 deaths and other serious injuries, according to a recent press release.
The problems include:
• Failures of built-in safety alarms and other software defects.
• User interface issues, such as unclear instructions leading to dosage errors.
• Mechanical or electrical failures that could spark battery failures or pump fires.
“These pumps often provide critical fluids to high-risk patients, so failures have significant implications,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “It is time for a more comprehensive approach than we’ve taken to date.”
Infusion pumps are widely used in hospitals, clinics, and homes to improve control, accuracy, and precision in drug delivery and to reduce medication errors. There is little room for error with such devices, yet the release says 87 infusion pump recalls were conducted between 2005 and 2009 to address identified safety concerns.
The pharmaceutical injury attorneys at Schlichter, Bogard & Denton look forward to hearing from you. If you or family members have suffered injury from defective medical devices, please contact us for a free review of your case at any of our nationwide offices.