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FDA May Raise Standards For Medical Devices

A recent report from the Chicago Tribune reveals a chilling issue that is seldom discussed. Medical devices have the potential to become breeding grounds for “superbugs,” or infectious bacteria that becomes resistant to regular antibiotics.

The article opens with the claim that endoscopes, devices used by doctors to view the internal workings of a person’s body, are particularly prone to developing these bugs. In some cases there have been warnings and even recalls on medical devices that have caused outbreaks. The supposed cause for this is that much of the regulatory legislation surrounding medical devices is not as strict as the legislation used for drugs. Most drugs have to go through rigorous trials and testing to make certain of their effectiveness and their safety whenever a change in formula is made. Currently, medical device manufacturers do not have to do the same when they change their designs.

Endoscope Problems

The news report cites that in recent years, multiple manufacturers of endoscopes have changed the designs of a more specialized version of a standard endoscope known as a duodenoscope, which is used for smaller areas in the intestines. The design change essentially made the instrument much harder to clean, as a small channel could trap bacteria within. This bacteria, over time, would eventually become cultured and strengthened by isolation, effectively creating a so-called “superbug.”

A hospital in the Netherlands that spotted the problem, and informed the manufacturer, Olympus, of the issue two years after the change took place. The FDA quietly requested that Olympus make changes to the device and get new clearance. However, the FDA did not issue any recall or alert the public about the errors in the devices currently in use. This is just one of many problems the FDA has with regulating medical devices.

Petitioning The FDA

Congressman Ted Lieu from California is seeking to change the way the FDA regulates medical devices. Lieu states that as it stands right now, medical device manufacturers have the option of informing the FDA of any changes in the designs of their product. Lieu’s plan is to close the “loopholes in the law” that allow changes in medical devices to slip through the cracks of FDA regulation. However, prior bills attempting the same thing have not had great success in Congress, allegedly due to making too burdensome demands of medical device manufacturers. Lieu’s proposal takes a less heavy-handed approach, and instead seeks to get a foot in the door and slowly expand regulation.

It is alarming that some companies can change medical devices without being held to appropriate standards. Medical devices are relied upon by doctors and patients alike. Both doctors and patients expect that devices they place into their body will be functional and safe to use. A change in the design of a medical device that goes unannounced, unregulated, and unnoticed can have catastrophic consequences for the patient.

About the Author

Briggs Bedigian
Briggs Bedigian

H. Briggs Bedigian (“Briggs”) is a founding partner of Gilman & Bedigian, LLC.  Prior to forming Gilman & Bedigian, LLC, Briggs was a partner at Wais, Vogelstein and Bedigian, LLC, where he was the head of the firm’s litigation practice.  Briggs’ legal practice is focused on representing clients involved in medical malpractice and catastrophic personal injury cases. 


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