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FDA Orders Recall of Ultrasonic Medical Scope Cleaning Machines Due to Risk of Infection

December 17, 2015  ·  By HM&M

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Doctors and surgeons rely heavily on medical devices to ensure patient safety. Unfortunately, there is an alarming number of defective medical devices out there. When physicians learn the truth, they are often disturbed and upset, but it is the patients who pay the ultimate price—with their health, their wellbeing, and sometimes even their lives. Such may be the case with the FDA’s recent recalls on nearly 2,800 Custom Ultrasonics machines.

Custom Ultrasonics’ Previous Bar from the FDA

Trusted by hospitals and medical clinics throughout the United States, Custom Ultrasonics’ endoscope reprocessing devices are intended to kill the bacteria and microorganisms found on flexible endoscopes after a procedure, enabling safe re-use of the expensive and important medical equipment.

Unfortunately, the manufacturer has a history of violating federal manufacturing and quality control rules. It is that very history that led them to a legal settlement with the FDA where they were barred from making or distributing any more machines. But the bar did not keep them from servicing existing machines, and it did not require them to recall them—and therein lies the current problem.

FDA Inspectors Uncover Ongoing Problems

According to the FDA investigators, Custom Ultrasonics failed to provide any proof that their devices adequately wash and disinfect endoscopes during their April inspection. This, paired with their history of federal law violations, led to the FDA’s issuance of a consent decree in which the company must now recall each and every one of their devices. It will remain in effect until the FDA is able to determine that Custom Ultrasonics has fixed their alleged problems.

Doctors and Hospitals Advised to Switch Machines

In light of the recent recall, and a series of life-threatening bacterial outbreaks tied to medical scopes, the FDA is recommending that all physicians and hospitals switch to alternate machines to protect patient safety. This now places the responsibility back in the hands of physicians and hospital administrators. One can only hope that they all comply.

Seeking Compensation for Death, Illness, or Injury from Defective Medical Devices

When hospitals, doctors, and surgeons do all they can to ensure patient safety and something still goes wrong because of a medical device, victims must probe deeper to reach the root of the problem. However, they are still entitled to compensation. They are no less a victim than one who has been killed or injured by a medical professional. It can make matters more complicated, however.

The experienced Chicago defective medical device attorneys at Hurley, McKenna & Mertz, P.C. have the skills and resources needed to fully investigate the source of medical injuries, illnesses, and deaths caused by negligent medical device manufacturers. We provide aggressive representation and protect victims’ rights against the multimillion giants of society. Ask how we can help with your case. Call 312-553-4900 today and schedule your free initial consultation.


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