CHAMBERSBURG — Patients of a Chambersburg urology practice recently received a potentially unsettling letter, advising them to get tested for HIV and hepatitis because reused instruments had been used for their prostate biopsies.
Medical and legal experts say reusing biopsy needles is not recommended for several reasons, and that Urology Associates of Chambersburg could now face a range of legal repercussions.
While the risk of infection is statistically very low, experts advise that every man who received a letter should be tested. the tests are being conducted at Chambersburg Hospital and paid for by the urology practice.
A 68-year-old Chambersburg area man told Public Opinion that he received his letter in the past week and went in for the blood work Friday. Due to the potentially sensitive nature of his situation, Public Opinion agreed to keep him anonymous.
He had his biopsy done about four years ago by Dr. Christopher Klinko. while the procedure was typically less than comfortable, he was pleased with the doctor’s care and said everything seemed to be done very professionally.
“Everything looked very sterile and clean, very efficient,” he said.
When he received the letter, Klinko’s patient wasn’t too concerned at first. his wife convinced him to go for the test. A phlebotomist at the hospital told him there have been a significant number of other men getting the same test done in recent weeks.
“I hadn’t given it much thought. my feeling was, with the time that elapsed, something would have shown up already,” he said. “Then I realized it could take a long time for HIV to show up.”
Dr. Jay Raman, a urological surgeon and assistant professor of surgery at Penn State Hershey Medical Center, said in some cases it takes between seven and 10 years for HIV to become apparent in an infected person. Symptoms of hepatitis typically appear within two to four years after initial infection.
“The most aggressive strains will show up early, but being asymptomatic does not mean you’re in the clear,” Raman said.
According to the letter sent to Urology Associates’ patients, the practice used biopsy needles and guides that are labeled “single use only.”
“We have recently discovered that some prostate biopsy instruments were reprocessed using a detergent scrub, sterilized and then re-used in our office,” the letter states. “Corrective action was immediately taken and instrument reprocessing has been terminated.”
Raman explained that an ultrasound probe and a tubular device called a cannula used in the procedure are not disposable. They are disinfected and sterilized after each use in a special liquid formulated to kill bacteria.
Since biopsy needles or “needle guns” actually pierce the patient’s rectal wall and the prostate to collect tissue samples, they should not be reused, he said. at his hospital, the needles are immediately placed in a “sharps” container and disposed of as biohazardous waste.
Raman said chemical sterilization is “more than adequate to kill all conventional bacteria,” but HIV and hepatitis are considered “more hardy viral agents.” He was unable to provide a statistical likelihood of patients being infected by “reprocessed” instruments, but said it is a very low.
His personal risk of contracting hepatitis if he is accidentally stuck with a bloody needle during surgery is about 1 in 500,000, Raman said. the risk of catching HIV the same way is about 1 in a million.
Add to those long odds the fact that the needles at Urology Associates went through some form of sterilization, and the likelihood of infection becomes quite rare. still, Raman recommends getting tested to anyone who received a letter.
“If it was me, I would. I think the risk is overall very low, but certainly it’s higher than zero,” he said. “In that case, I think it’s worthwhile to be better safe than sorry.”
There is another reason why reusing biopsy needles is not a very good idea, Raman said. each use would make the device a little less sharp. Performing biopsies with a blunt needle decreases the procedure’s accuracy and increases the risk of complications.
He said this is the first case of reused biopsy needles that he has heard of. Asked why any medical practice might do such a thing, he suggested that saving money was probably the motivating factor.
According to the website for a medical supply company based in New Jersey, urological biopsy needles range in price from about $100 to $240 for a box of 10. the instruments are typically 1-2 millimeters in diameter and 10-15 centimeters long, Raman said.
Public Opinion was unable to determine how many patients received letters from Urology Associates. A receptionist answering the phone at the office said the doctors are declining to comment on the matter.
According to their letter, Klinko and Dr. Louis Glass are practicing urology at the office on Fifth Avenue in Chambersburg. Some patients told Public Opinion they had been treated there in the past by Dr. William Haren, who apparently no longer works there.
A fourth urologist, Dr. Kambiz Tajkarimi, reportedly left Urology Associates earlier this year. He is now practicing exclusively with Summit Health, which operates hospitals in Chambersburg and Waynesboro, according to the organization’s spokesperson, Jessica Walter.
After Glass and Klinko sent their letter, Tajkarimi mailed a letter to about 800 of his own former Urology Associates patients on May 11.
“I had no knowledge of the conduct described in that letter and resigned from employment with the practice when I learned of this matter,” his letter states.
Walter said that while Urology Associates is an independent practice, the doctors associated with the office are also associated with Chambersburg and Waynesboro hospitals. When Summit Health was notified about the reused needles, an internal investigation was done at both locations.
“We found that we are compliant — all single-use devices are disposed after one use at both Chambersburg Hospital and Waynesboro Hospital,” Walter wrote in an e-mail.
Dr. Anna Laakman, a visiting assistant professor at Penn State’s Dickinson School of Law, is an expert in the area of medical malpractice law. she said Urology Associates could potentially face legal recourse. the affected patients would have to prove three basic elements to hold their doctors civilly liable for malpractice.
First, they would have to prove that the practitioners “breached the standard of care,” and that reprocessing biopsy needles is not considered customary medical practice.
“Certainly the needles being labeled for one use only would be powerful evidence to support the claim that they were negligent,” Laakman said.
Next, the patients would have to prove that they were actually harmed or contracted a disease.
Finally, they would have to prove the harm was caused by the actions of the doctor or doctors in question.
With the low likelihood of infection, the ultimate success of a malpractice claim in this situation would be “questionable,” Laakman said.
The doctors at Urology Associates notified the Pennsylvania State Board of Medicine, Summit Health and the primary care physicians of all their patients about the incident, according to their letter.
Kevin Murphy, a representative of the Pennsylvania Department of State, confirmed that the Board of Medicine had been notified and the matter “remains under active investigation.” He said it has also been referred to additional “federal, state and local” agencies.
He said that “if it is determined that a physician strayed from accepted practice,” the board could suspend or revoke the doctor’s license to practice medicine in Pennsylvania.
A spokesperson with the Pennsylvania Department of Health wrote in an e-mail that the department “cannot comment on any possible pending or on-going investigations.”
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Jim Tuttle can be reached at or at 262-4754.
What is a prostate biopsy?
A prostate biopsy is a medical procedure performed on men to check for the presence of prostate cancer. Dr. Jay Raman said between 25 and 30 percent of men who have the test will be positive for cancer.
Raman said the procedure is also performed at his hospital with the use of at least some anesthesia. the patient lies on his side and an ultrasound probe and guide tube are inserted into his rectum.
A series of measurements are taken using ultrasound data, and a biopsy needle is pierced through the rectal wall into the prostate. Between 12 and 14 “cores” of tissue measuring about a millimeter wide and a centimeter long are then removed for testing, Raman said.
All the samples are collected with one needle, which is supposed to be thrown out after the procedure, he said.