FDA recalls cleaning device used at UCLA Medical Center
By April Hoang
Nov. 18, 2015 11:43 a.m.
The federal government recalled a cleaning device used in the Ronald Reagan UCLA Medical Center after officials determined using the device could lead to increased risk of infection, according to a U.S. Food and Drug Administration press release Friday.
FDA officials determined the devices, made by Custom Ultrasonics, could not adequately sterilize the endoscopes, which are inserted into body cavities and organs in endoscopy examinations, according to the press release.
The new device was implemented after insufficiently cleaned duodenoscopes, which are also used in endoscopies, exposed about 175 Ronald Reagan UCLA Medical Center patients to a superbug, or strain of bacteria that became resistant to antibiotic drugs. The outbreak resulted in two patient deaths.
The FDA estimates hospitals and clinics throughout the United States currently use about 2,800 of the Custom Ultrasonics devices, according to the release.
William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the statement he thinks the recall order was necessary to protect public health. He added the company violated FDA regulation several times in the past.
The FDA has advised health care facilities that use Custom Ultrasonics devices to transition to alternate cleaning methods such as rigorous manual sterilization, after checking the endoscope’s cleaning instructions.
UCLA Health declined to comment on the impact of the device’s recall.
Compiled by Hannah Rosson and April Hoang, Bruin contributor.