Clark, Love & Hutson, PLLC

Scope cleaning mechanisms now under scrutiny by FDA

Many Houston area residents will need to be hospitalized this year. This can be a scary thought because recently we have all heard about the number of superbug infections that seem to be plaguing hospitals. Patients who are in the hospital to get better may now have to worry about catching a superbug infection from a defective medical device.

Recently there have been news stories covering superbug infections as the result of medical scopes that have not been properly cleaned. Now federal regulators are focusing their attention on the machines used to clean the scopes as well. These machines are called Automated Endoscope Reprocessors (AERs). The FDA is checking to see how well the AERs clean and disinfect the scopes. The FDA has done onsite inspections of the manufacturers who make the AERs, which has resulted in one manufacturer being cited.

The scopes in question are called duodenoscopes, which are put down a patient's throat to treat gallstones, cancer and digestive disorders. It has a mechanism on its tip which allows doctors to attach and control devices that extend from the scope. It is in that mechanism where superbug bacteria can grow including CRE which has a death rate of 40 percent or more.

When a Houston patient has been injured by a defective medical device it can lead to a serious injury. A medical device maker needs to make sure that their device is safe for use. When this is not the case they can be held liable for their negligence. An attorney who specializes in medical devices can help a family who is facing an injury due to a faulty medical device. The attorney can investigate the situation surrounding the injury and hold the company accountable. Compensation may be available for medical expenses, pain and suffering, and other damages.

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