FDA Announces Recall of All Custom Ultrasonics Automated Endoscope Reprocessors (AERs)

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There are a vast array of medical devices currently available for use by physicians and surgeons at hospitals, surgical facilities, long-term care centers, and other medical facilities. While many of these medical devices and implements are safe and result in drastically improved medical outcomes, there can be serious problems with certain devices or their intended uses. In some cases, the medical device may be defectively designed. A defective design means that even when the implement is manufactured and used as intended, it still contains issues that increases the risk of a severe, life-altering injury. A defectively manufactured medical device can increase the odds that the implement or device will be misused. Medical devices can also be defectively manufactured. That is, they were designed properly but an error introduced in the manufacturing process rendered them unsafe.

In a recent announcement, the Food and Drug Administration (FDA) announced that it was ordering a recall of Custom Ultrasonics Automated Endoscope Reprocessor devices due to the company’s ongoing violations of the 2007 Consent Order, Federal Food, Drug, and Cosmetic Act, and other laws.

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What is an Automated Endoscope Reprocessor?

While some medical implements and devices are intended only for single-use, others may be re-used after undergoing sufficient sterilization procedures. An Automated Endoscope Reprocessor (AER) is a free-standing independent medical device that is used to disinfect and sterilize flexible endoscopes and the accessories used with the endoscopes. Endoscopes are commonly used in tests regarding pulmonary and digestive functions.

When the endoscope is not properly disinfected, the patient is placed at a higher-risk of infection. Patients who are elderly or who may have compromised immune systems are at greater risk of being affected by this problem with the endoscopes. Furthermore, these patients are also most likely to develop a serious infection which may result in the patient’s wrongful death.

Ultrasonics Faced A Recall Order from a January 2007 Consent Order

At the beginning of 2007, Custom Ultrasonics agreed to a consent Order with the FDA due to the company’s failure to comply with the Federal Food, Drug, and Cosmetic Act. Previously, Custom Ultrasonics had made significant changes to the software on the devices without first obtaining FDA clearance. In 2012 and 2013 the company was ordered to stop production and sale of the devices. The company did obtain clearance from the FDA thereafter and the devices were permitted to remain on the market subject to adherence to certain conditions. However, the FDA has not reauthorized the company to restart new sales.

In the FDA’s most recent inspection of the company’s production facilities conducted in April 2015, the agency uncovered additional ongoing violations. Most importantly, the company still is unable to verify whether the company’s Automatic Endoscope Reprocessor are callable of sufficiently disinfecting the re-usable endoscopes to the point where the risk of infection is mitigated.

Actions Ordered by the FDA in Light of the Violations

The FDA has ordered Custom Ultrasonic to recall all of its AER devices. The company has seven business days to respond the FDA’s request and provide a written plan as to how the devices will be recalled. Furthermore, the FDA has also advised medical facilities that they should transition away from the use of Ultrasonics manufactured AERs. The agency writes that hospitals and other medical facilities should “Identify and transition to alternate methods to reprocess flexible endoscopes, such as manual high-level disinfection, liquid chemical sterilization, alternative AERs, or other cleaning and sterilization methods according to the endoscope manufacturers’ reprocessing instructions.”

Facilities that continue to use these defective endoscope reprocessor after receiving notification about their problems, may be considered negligent. While there will certainly be a transition period doctors, nurses, and medical facilities that utilize methods which are ineffective and fall below an acceptable standard of care have committed medical malpractice. Such actions increase the risk of serious injury or death in the patient. Medical professionals who fail to provide a sufficient level of care and medical device manufactures who provide defective products can and should be held accountable for the injuries and deaths that may result from medical care falling below acceptable standards.

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Were You Injured by a Medical Device?

If you have been injured by an Ultrasonics Automated Endoscope Reprocessor (AER) due to the development of an infection or if you have been injured by another medical device the personal injury and medical malpractice attorneys of The Reiff Law Firm can fight for you. To schedule a free and confidential personal injury consultation call (215) 246-9000 today.

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