Hospital blasted for mishandling of biopsy tool

Allan Woods and April Lindgren

The Ottawa Citizen; With files from National Post
Wednesday, November 19, 2003

TORONTO -- One of Canada's top hospitals came under fire from Ontario Premier Dalton McGuinty and a U.S. medical supplier yesterday for exposing almost 900 men suspected of having prostate cancer to an unsterilized biopsy tool.

Mr. McGuinty said it was inexcusable that 861 patients who had prostate biopsies at Toronto's Sunnybrook and Women's College Hospital between December 1999 and August 2003 only learned Monday that they might have been exposed to HIV and hepatitis.

"Sunnybrook has got some important questions to answer as to why that kind of (infection control) procedure was not in place and why they took so long to inform the public," Mr. McGuinty told reporters.

More than 200 men who received letters about the problem called or visited the hospital yesterday to learn about being tested for the blood-borne diseases. The letters informed the men that Sunnybrook had skipped an important step in the sterilization process because the manufacturer's instructions were unclear.

Dr. Bob Lester, the hospital's executive vice-president of medical and academic affairs, suggested the supplier of the tool, B-K Medical Systems Inc., should consider rewriting its instructions to prevent similar incidents.

"We are not blaming the company for anything," Dr. Lester said. "We're saying there were multiple factors, and one of them might have been related to the way cleansing instructions were presented in the manual."

Bill Gregory, president of the Massachusetts-based medical firm, said the company had an impeccable safety record over 20 years and the hospital had no one to blame but itself.

"My basic thought is that this was a human error," Mr. Gregory said. "Someone didn't follow proper procedures. If they had simply followed the manual, this never would have happened."

A copy of the instructions showed that the hospital followed instructions for "low-level disinfection" when it should have conducted "high-level disinfection" on a long, thin probe that pokes a needle through a rubber sheath and into the prostate to collect a tissue sample. The difference between the two processes is a step requiring the probe to be soaked in a special sterilizing solution.