Dr. M, 59, was an experienced urologist with a busy private practice. He had been in the field for close to 30 years and was well known and respected in the community. His office was staffed by several nurses, some of whom had been working there for decades.

Drug reps or equipment vendors regularly showed up in the waiting room hoping get some time with the physician. One afternoon, Dr. M had a few minutes between patients and spent this time with a vendor for a company that made endocavity needle guards. For many years, Dr. M. had used biopsy and treatment equipment that included using stainless steel needle guides that were reused after cleaning and disinfecting. His previous equipment, however, had worn out and he was interested in purchasing something new. Dr. M had not previously purchased needle guards from this company before, but the salesman was engaging and among his claims for the superiority of these particular plastic needle guards was the assertion that, like the metal ones, they were reusable. Dr. M put in an order.

For the next few months, Dr. M used the new needle guards during procedures for prostate biopsies, implantable markers, and gold seed radiation implants. He instructed his staff that, per the salesman, the needle guards could be reused three to five times. The office staff was told to wash the needle guides in hot water, scrub them to remove blood or tissue, and then soak them in a disinfecting solution before the next use. Once the needle guards became “too bloody,” they should be discarded, the physician said.

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About three months after the office started using the plastic needle guards, Dr. M received a visit from Dr. Y, from the state Board of Medical Examiners. Dr. M was informed that the Board of Medical Examiners, in conjunction with the FDA was investigating a rumor that the physician was reusing plastic needle guards, which are single use only.

“Why yes,” Dr. M said. “I’ve been using them for the past few months. We use them on average between three to five times per needle guard. I was told by the vendor that they were reusable.”

Dr. Y was incredulous. “You’ve been in practice for over 20 years and you listened to a salesman when it came to the sterilization of medical equipment?”

Dr. Y returned to the Board of Medical Examiners and reported that Dr. M had admitted reusing the single-use guards. The board reviewed the evidence and summarily suspended Dr. M’s license to practice medicine and charged him with malpractice for reusing the disposable needle guides, and with the “continual failure to exercise the skill or diligence” normally exercised  by physicians in good standing. They reviewed his records and discovered that about 100 patients had had procedures utilizing the needle guards. The board sent letters to the patients, advising them to get tested for hepatitis and HIV.

Dr. M was devastated. His thriving practice was suddenly shut down. His reputation was potentially ruined. He hired an attorney to help with the damage control. The attorney made some inquiries and then told Dr. M that the board did not believe that a salesman had told him that the needle guards were reusable. The attorney recommended a public relations campaign to restore Dr. M’s good name.

“I suggest we put an ad in the paper, explaining the situation, but first, I think you should take a polygraph to prove that the vendor told you what you said he did,” the attorney said.

Dr. M took the polygraph, which he passed, and his attorney orchestrated the creation of a newspaper ad with testimonials from patients and other physicians, testifying about the dedication and professionalism of Dr. M.

Two weeks after Dr. M’s license was suspended, another local urologist came forward to the board to report himself. He, too, had been reusing the same single-use plastic needle guards, also on the information of the vendor.

Based on this information, the polygraph, and Dr. M’s cooperation and openness about the situation, and after negotiations with his attorney, the Board of Medicine reinstated Dr. M’s license a month after it had been suspended. The reinstatement was based on a voluntary agreement that if Dr. M were to perform an invasive procedure in his office, it would be under the supervision of a third-party monitor who was an expert in infection-control procedures. This supervision was to last for three months, and would also include random site inspections.

Legal Background

Dr. M is still facing the two pending charges by the Board of Medicine, which could carry penalties, but are not the same as being sued by a patient and facing civil (or possibly criminal) charges. At the time of the writing of this article, none of the affected patients had tested positive for hepatitis or HIV; however, if one ultimately did, that patient could certainly sue Dr. M in civil court for negligence and malpractice. The current charges against the physician are medical board actions, not court lawsuits. It is impossible to predict what the Board of Medicine will do in this case. The fact that another physician came forward with the same misinformation makes it less likely that Dr. M’s penalties will be that significant. The FDA and medical board are currently investigating the vendor of the needle guards.

Protecting Yourself

The bottom line? Don’t believe a salesman. While this should be common sense, it is clear from this case that even well-educated people can fall prey to believing what they hear. Regardless of what a salesperson or vendor states, it is essential to take the extra step to confirm it. In this case, that extra step would merely have been to read the enclosed reference guide that came with the needle guides clearly stating that “disposable components are packaged sterile and are single-use only.” The reference guide did not include any directions for cleaning or reusing the needle guides, but rather directed that once used, they be disposed of as infectious waste. Had Dr. M read the directions instead of listening to the advice of a salesman, he could have spared himself, and his patients, a great deal of misery.