A Las Vegas urologist's practice of reusing single-use plastic needle guides for prostate and rectal biopsies has renewed controversy over the reprocessing of single-use devices in Nevada.
Authorities from the Nevada State Board of Medical Examiners and the Food and Drug Administration say that urologist Michael Kaplan, MD, of Las Vegas Valley, Nev., reused the single-use plastic needle guides for an ultrasound probe until they became "too bloody" over a period of about 3 months beginning in late December 2010, reports the Las Vegas Review-Journal. After an investigation, the board suspended Dr. Kaplan's medical license, and health officials urged patients who had prostate biopsies performed by him from Dec. 20, 2010, to March 11, 2011, to be tested for HIV and hepatitis.
The FDA allows some single-use medical devices to be reprocessed for reuse, but only by authorized facilities that meet certain standards. Plastic endocavity needle guides are not among the 100 or so types of medical devices approved for reprocessing under FDA guidelines, and Dr. Kaplan is not on an FDA database of authorized SUD reprocessors, according to another Review-Journal report.
But attorneys representing Dr. Kaplan say the equipment vendor told him it was OK to reuse the devices. "The ultra-sound equipment vendor represented that the plastic needle guides" he used for biopsies "could be reused "˜three to five times,'" write Dominic P. Gentile and 2 other attorneys from the Gordon Silver Law Firm in a paid advertisement that ran in the Review-Journal last week. They defend Dr. Kaplan by noting that he used high-level disinfection to process the guides before reusing them, and that "the Southern Nevada Health District has publicly stated that they have not identified any case of disease related to the investigation and risk of disease is "˜believed to be very low.'"
The ad goes on to claim that Dr. Kaplan stopped reusing the guides after less than 3 weeks of doing so, "the moment a question arose" about the practice on Jan. 6, 2011. State health officials have contradicted that claim, saying he continued the practice into March. Dr. Kaplan began using the single-use plastic guides in late December when an updated version of the ultrasound equipment required a switch from reusable stainless steel to single-use plastic needle guides.
Mr. Gentile declined to mention the name of the ultrasound equipment vendor in the ad and in an interview with the Review-Journal last week. He could not be reached immediately by phone to comment for this article.
The news that patients are again being warned of a potential infection risk from the reuse of medical devices has sparked concern and outrage among some Nevadans, who are still reeling from the hepatitis outbreak at 2 Las Vegas-area endoscopy centers 3 years ago.
Irene Tsikitas
