Urologist defends practice of reusing devices on patients


A Las Vegas Valley urologist whose medical license has been suspended for reusing single-use needle guides blames an unnamed equipment vendor for suggesting he could do so, according to a paid advertisement in today's Review-Journal.

The ad, produced by Dr. Michael Kaplan's attorney, Dominic Gentile, appears on Page 3B of the Nevada section. (Download a pdf of the ad here.)

Kaplan's medical license was suspended nine days ago by the Nevada State Board of Medical Examiners after a joint investigation with the Food and Drug Administration, the federal agency that regulates the use of medical devices.

Authorities said that for three months, Kaplan reused single-use-only plastic needle guides for prostate/rectal biopsies, discarding them only when they became "too bloody."

The ad said an unnamed ultrasound equipment vendor "represented that the plastic needle guides could be reused 'three to five times.' "

"Dr. Kaplan reused these guides after being informed that it was perfectly safe to do so," the ad states, noting that Kaplan had switched to the new plastic needle guides after using another stainless steel system "for roughly 20 years."

In an interview late Tuesday, Gentile did not reveal the name of the vendor who sold Kaplan the equipment. The attorney did give the reason he took out an ad rather than having Kaplan or himself answer questions from the media.

"I can control the message this way," he said.

The ad says Kaplan used a process known as high level disinfection to clean the needle guides, and it quotes the Association of periOperative Registered Nurses as saying that "there is no conclusive evidence that sterilization reduces patient infection risk more than high level disinfection."

The ad disturbs Dr. Dale Carrison, chief of staff and head of emergency medicine at University Medical Center as well as chairman of the Nevada Homeland Security Commission.

"I can't believe the guy is using an ad to try to justify what he's done," he said.

"If it says it's for single use, that's what it means -- single use," he said. "You have to be on the side of the patient when it comes to safety. What advantage is there to the patient for the doctor to reuse something that's single use? I can't think of any. Can you?"

Carrison said the question is what advantage is there to the doctor in reusing single-use equipment.

"Money, that's all it is," he said. "Generally, you bill each patient for a new device when you do a procedure. Or did this doctor say to each patient before he reused a device: 'Hey, I can save you some money by reusing a device. I'll clean it the best I can and I'll pass the cost savings on to you.' "

Each plastic needle guide costs about $10. The guides, plastic sheaths through which needles are directed to obtain biopsy material, go through the anus to the rectum. They regularly come into contact with blood and bodily fluids, which could be passed to another patient if the guides are reused, according to federal, state and local authorities.

Local doctors have said the correct standard for safely using single-use items is one use and one use only. Those doctors include Dr. Ronald Kline, president of the Nevada State Medical Association, and Dr. Mitchell Forman, president of the Clark County Medical Society.

The ad also quotes a study done by the federal General Accounting Office: "Single Use Medical Devices, Little Available Evidence of Harm From Reuse, but Oversight Warranted." The study, according to Gentile, was done in response to concerns about reuse of single-use devices that was done "unknowingly."

The report states: "Approval of a device as a single-use means that a device can be used safely and reliable once, not necessarily that it cannot be used safely and reliably more than once if it is properly reprocessed."

"I'm asking you again, how does reuse help the patient?" Carrison said. "If cost savings are passed on to the patient, maybe I could have some sympathy for what this doctor has done. But it still wouldn't make it right."

According to the ad, the "moment a question arose" about Kaplan's behavior, "he stopped the practice immediately." While the ad says Kaplan began the practice when the medical board says he did -- Dec. 20, 2010 -- it differs with authorities on the ending date. The medical board and Southern Nevada Health District list the end date as the beginning of March 2011. The ad says: "Use of the new plastic needle guides was halted by Dr. Kaplan less than three weeks later on January 6, 2011."

The health district has sent letters to 101 of Kaplan's patients, advising them that they should get tested for HIV and hepatitis. The notification came three years after Las Vegas was rocked by an unrelated breach of accepted medical practices traced to reuse of syringes and single-dose vials of anesthetic at Dr. Dipak Desai's endoscopy centers. More than 40,000 of Desai's patients were warned of possible exposure to hepatitis and HIV, the largest such notification in U.S. history. At least 100 men and women are thought to have contracted hepatitis.

"Dr. Kaplan isn't like Dr. Desai," Gentile said.

The ad says Kaplan treated only 33 patients with the plastic needle guides.

In bold letters, the ad reminds readers what has been reported in the media every day: The Southern Nevada Health District has not identified any case of disease related to the investigation.

Kaplan has been a defendant in at least nine medical malpractice cases since 1995, the most recent coming in 2007, according to District Court records. In that case, which was dismissed two years later after an apparent settlement, a woman sued the doctor after her husband bled to death following a 2006 operation to remove his prostate. In a 2002 case, a woman settled her lawsuit against Kaplan for $1.25 million after he operated on the wrong side to fix an obstructed ureter.

In the ad, Kaplan is referred to as "one of the most respected physicians in Nevada."

"Dr. Kaplan is 'a doctor's doctor,' ... the personal urologist for many of our leading physicians and their family members," the ad states.

Contact reporter Paul Harasim at pharasim@ reviewjournal.com or 702-387-2908.

 

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