Certain Endoscope Components Linked by FDA to Cross-Contamination, Infection The U.S. Food and Drug Administration (FDA) recently released correspondence indicating that certain multi-use endoscope connectors have been linked to cross-contamination when used in gastrointestinal endoscopy. Cross-contamination presents a risk of severe infection to patients, and the FDA is recommending against the use of these […]
The U.S. Food and Drug Administration (FDA) recently released correspondence indicating that certain multi-use endoscope connectors have been linked to cross-contamination when used in gastrointestinal endoscopy. Cross-contamination presents a risk of severe infection to patients, and the FDA is recommending against the use of these connectors.
The attorneys at Parker Waichman LLP litigate medical device and medical malpractice cases on behalf of injured patients across the nation. These endoscope components can lead to serious infections and secondary injuries, and our lawyers are investigating new cases to seek compensation for victims and families. If you contracted an infection following a gastrointestinal endoscopy procedure, contact our firm today for a free, confidential consultation with an experienced medical device lawyer.
A gastrointestinal (GI) endoscopy allows a physician to view your GI tract. Depending on the symptoms or problems you are reporting to your doctor, you might receive an “upper” GI endoscopy (through the mouth and esophagus) or a “lower” GI endoscopy (through the rectum and sigmoid colon). The endoscope is a long, bendable tube with a light and camera on the end that will produce images of your GI tract for your doctor to review.
An endoscopy will often involve a process called “irrigation,” in which the physician introduces sterile water to wash away gastrointestinal mucosa and to keep the camera clean. The physician does this by using a water jet channel (also called auxiliary water channel) in the endoscope tube and a water bottle at the end of the tube. The endoscope contains one or multiple connectors, resembling caps, which join all of the parts together.
Some of these connectors are marketed as single-use, meaning they are only used one time on one patient, and others are marketed as multi-use, meaning they can be used multiple times on multiple patients. Usually, multi-use connectors are “reprocessed,” or cleaned and sterilized between each use, and eventually discarded. They also commonly contain “backflow prevention” features that prevent patient fluids from flowing backward into the endoscope.
A subset of multi-use connectors, known as 24-hour multi-patient use endoscope connectors, are marketed for use on multiple patients without the need for reprocessing. These also connectors do not contain backflow prevention features.
On April 18, 2018, the FDA released correspondence to health care providers advising against the use of 24-hour multi-patient use endoscope connectors over concerns that these connectors expose patients to a risk of cross-contamination. Because these connectors do not have backflow prevention features and do not have indications for reprocessing, endoscopy patients are at serious risk of exposure to other patients’ fluids, including blood and stool, and development of severe infections.
The FDA went as far in the letter as saying it had not received acceptable testing to date that demonstrated safe use of these connectors. It then outright advised physicians and healthcare facilities in receipt of the communication to not use 24-hour multi-patient connectors.
Specifically, the FDA called out a connector called the ERBEFLO port connector, manufactured by Erbe USA Inc. The FDA said this connector did not have backflow prevention features, and its instructions and design did not adequately mitigate the risks of cross-contamination. Erbe markets this product as the “clever cap” and as “breakthrough innovation” in the field of endoscopy procedures. The FDA clearly disagrees.
In the close of its letter, the FDA made the following recommendations to physicians and facilities performing GI endoscopies:
It is rare for the FDA to take this measure and outright advise against the use of a medical device or piece of medical equipment. It reserves this action for serious cases of risk wherein the potential harm to patients significantly outweighs the benefits.
If you developed an infection following a GI endoscopy, you have legal rights. Contact our endoscope infection lawsuit law firm today to discuss your potential case and learn about your options for recourse against the manufacturer and other parties.
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We understand clients want to know right away whether they can file lawsuits, but we need to take a few steps to best answer your case questions. The best way to answer your questions is through a full investigation of your potential claims. Our lawyers will investigate your claims by doing the following:
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If you have a potential medical device case or medical malpractice case related to an endoscopy procedure, contact our law firm today. Remember, statutes of limitations apply to all cases, and time could be running on your claim. Do not delay in hiring representation to protect your legal rights.
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