Is your medical provider using a recalled machine to clean its medical instruments? This is a question you may want to ask if you are going in for a procedure using an endoscopes, especially a duodenoscope. The ongoing FDA recall has changed making some wonder why the FDA is still allowing the company to market the machine as safe for cleaning one type of endoscope but not another type of endoscope.
FDA Changes Recommendation to Health Care Facilities
In an FDA Safety Communication in November 2015, the FDA ordered the recall of all Automated Endoscope Reprocessors (AERs) manufactured by Custom Ultrasonics. However, according to Custom Ultrasonics, the AERs are only recalled for “cleaning and/or high-level disinfection of duodenoscopes until further notice.”
FDA spokesperson Deborah Kotz said the AERs can still be used to clean most endoscopes and medical instruments just not duodenoscopes. According to Kotz, the FDA’s reversal on the recall notice was “based on information provided by the company.” Custom Ultrasonics has said it will send hospitals and other facilities using its machines a label to affix to the machine warning users not to use the machine to disinfect or clean duodenoscopes.
Senate Report Links AERs to Superbugs
A Senate report regarding the link between superbugs (strains of bacteria that are resistant to antibiotics) and ineffective monitoring of medical devices stated “Custom Ultrasonics’ automated endoscope reprocessors likely contributed to patient infections.” The report concluded that the duodenoscope-linked infections could not be solely attributed to Custom Ultrasonics machines but it did appear that the “defective machines” played a significant role in allowing the contamination of the medical devices between uses.
One report by the House Committee on Oversight and Government Reform estimates that over 350 patients may have been infected but the number is difficult to determine due to reporting issues. Some patients subsequently died after being infected. Custom Ultrasonics deny their machines are unsafe because some of the infections occurred in medical facilities that do not use its machines.
Are You Safe During Medical Procedures?
When you go to the doctor or the hospital for a medical procedure, you expect the medical instruments being used for the procedure to be clean and sterile. When a defective medical device or negligent care results in injury or death, you may be entitled to receive compensation from the party who is at fault. A medical malpractice attorney can help you determine if you have a valid medical malpractice claim.
Do Not Wait Too Long To File Your Medical Malpractice Lawsuit – You Do Not Want To Lose Your Right To Receive Compensation For Your Injuries!
However, you must file your medical malpractice lawsuit before the deadline for filing a claim expires. If you fail to file your lawsuit before the statute of limitations expires, you lose the right to assert a claim against the negligent party.
Have You Been Injured By A Defective Medical Device?
If you believe you have a medical malpractice claim, contact the attorneys of The Olinde Firm by calling at (504) 587-1440 or 1-800-587-1889 to schedule a free legal consultation. Our nationwide medical malpractice attorneys represent victims and their families throughout the United States. We want to help you seek justice for the damages and injuries caused by a defective medical device.