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 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.
Single-Use vs Multi-Use Endoscope Connectors
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.
FDA Recommends Against Using 24-Hour Multi-Patient Connectors
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:
- Do not use 24-hour multi-patient endoscope connectors because they carry a risk of cross-contamination.
- Use single-use endoscope connectors with backflow prevention features; or
- Use reusable/multi-use (not 24-hour multi-patient) connectors with backflow prevention features, and ensure the connectors are adequately reprocessed before each use.
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.
Evaluating Your Endoscope Infection Case
When clients contact us about their potential medical device claims, one of the first questions they usually ask is, “Do I have a case?”
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:
- Listening to your story – A lot of the information we learn about your claim is through you. You know your medical history and symptoms best, and we will listen to your experiences with compassion and an ear for understanding whether someone might have been negligent.
- Ordering your medical records – Particularly with a procedure like an endoscopy, you are likely not going to know what devices and component parts your physician used. We will order your medical records to understand what products were involved and to capture a complete picture of your care and injuries.
- Consulting with experts – We have access to a vast network of medical and product experts who will be able to review your records and provide opinions about the conduct of the potential defendants. In most types of litigation, you need expert testimony to build a winning case.
- Strategizing a path forward – When we have all of the information in hand, we will be able to present you with your legal options and decide together what plan is best for you and your family. If we are all in agreement that we should file a lawsuit, we will begin drafting a petition and decide the best filing venue.
When you retain our law firm, you can feel confident you are represented by experienced professionals who care about achieving the outcome you deserve. We place our clients’ interests first, and we know timely answers and effective communication are key. Our attorneys would love to be able to tell everyone within a few minutes whether they have viable claims, but the ideal way for us to serve you is to perform a diligent review of your case before making decisions about how to move forward.
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.
Contact Parker Waichman LLP for Your Free Case Review
Parker Waichman LLP provides no-obligation case consultations at no cost to potential clients. When you contact our endoscope infection injury law firm, you will have the opportunity to meet with one of our attorneys to review your case without paying a dime. We are available by phone at 1-800-YOURLAWYER (1-800-968-7529) or through our website when you fill out our Contact form.
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