When a person in Houston has a health issue involving their throat, larynx, trachea or lower airways their physician may use a bronchoscope to evaluate their condition. However, according to one report, these devices are difficult to clean and could cause patients to suffer worsened medical conditions.
What is the scope of the problem?
According to the U.S. Food and Drug Administration, unsanitary reusable flexible bronchoscopes can cause infections. From January 2010 to June 25 the agency received 109 reports regarding infection or contamination involving reusable flexible bronchoscopes. From July 2015 to January 2021, the agency received 867 further reports of infection or contamination involving reusable flexible bronchoscopes. Seven of these incidents resulted in fatalities.
What are some causes of these problems?
The failure to follow the manufacturer’s direction on using the device, including maintenance and mechanical issues led to some of these problems. Specific microorganisms led to infections and fatalities, particularly if patient comorbities were an issue. However, the FDA notes that it is not entirely possible to reach a definitive determination of the cause of these fatalities.
What has been the FDA’s response?
The FDA has ordered manufacturers of these instruments to conduct postmarket surveillance studies with regards to whether these devices, which are difficult to clean, can be reused in clinical settings. The FDA has also approved two endoscopes that have the potential to reduce contamination issues.
Learn more about medical products liability
Unfortunately, this information may come too little too late for those who have already been harmed by faulty medical products. When this happens, patients will want to make sure they understand all their rights and options. Our firm’s webpage on defective medical devices may be a good starting point for those who want to learn more about this topic.
