Endoscope Lawsuits Have Device Makers Under Fire

Endoscopes and similar medical devices have come under fire recently after being linked to serious infections in patients who underwent procedures using the devices. An endoscope is a thin tube with a camera that is inserted into the patient’s body to diagnose or help treat a health issue. Endoscopes can be used for a variety of health problems, including those affecting the airways, the joints, the urinary tract and the abdomen. The camera sends images to a nearby screen for medical professionals to review. Additional tools can be inserted into the body through the endoscope to assist with a procedure.

It has been alleged that the increasingly complex designs make proper sterilization of the devices almost impossible. Improper cleaning can result in bacteria growing on the endoscope, putting anyone who comes into contact with it at risk of developing a severe infection from a superbug. In some cases, such infections can result in death. The US Senate Health, Education, Labor, and Pensions Committee recently released a report titled “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients” that reported that incidents of antibiotic-resistant infections linked to the devices affected at least 250 people worldwide.

The 301-page report cites numerous serious infections linked to the devices and blamed device makers for failing to meet their regulatory obligations. According to the report, the manufacturers listed (Olympus Corp., Pentax and Fujifilm) “failed at every level to meet basic expectations of transparency and openness and to actively engage with FDA to address contamination issues.” Lawsuits have been filed against the device makers, alleging patients suffered serious health problems as a result of the use of their products.

The Los Angeles Times reported that Olympus knew about issues with its scope by spring 2012. However, the company failed to take action or report the issue to medical care providers or officials until after the report from the US Senate committee was released. Olympus announced a voluntary recall of its duodenoscope in January 2016. Olympus has also announced that it will redesign a portion of the device to make it easier to disinfect. Since Olympus learned of the issue, more than 140 patients in the United States have reportedly developed serious infections linked to the devices.

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