Automated Endoscope Washing Machines to be Recalled by the FDA
Hospital-acquired infections are one of the leading causes of hospital readmittance in the United States today. The Centers for Disease Control and Prevention says that as many as 700,000 such infections are reported each year.
With so many infections being reported, many wonder what is causing this phenomenon. The defective medical device lawyers at Ferrer, Poirot & Wansbrough explain that it seems as though a lack of proper sanitation may be to blame in a number of cases.
Becker’s Infection Control & Clinical Quality reports the U.S. Food and Drug Administration (FDA) has recalled as many as 2,800 automated endoscope washing machines made by Custom Ultrasonics after it was discovered that the devices may not completely sanitize the devices they cleanse.
The problem was first discovered in 2007, but the company was allowed to continue marketing the devices after changes were made to the product’s software. However, continued violations were highlighted during a recent FDA inspection of the company’s manufacturing facility and has resulted in the agency calling for the defective medical products to be pulled from the market.
The FDA is also encouraging anyone who has acquired an infection as a result of using a device that wasn’t properly sanitized by the affected machines to report their injuries to the agency.
The legal staff at Ferrer, Poirot & Wansbrough are hopeful these actions will be enough to protect the health and safety of patients undergoing medical procedures nationwide.