Medical device suspected of spreading potentially life-threatening bacteria. The Japanese manufacturer of a medical device suspected of spreading potentially life-threatening bacteria at a U.S. hospital said Wednesday that faulty cleansing of the equipment was likely to blame for any infections.
Tokyo-based Olympus Optical Co. said that in December it had voluntarily recalled thousands of bronchoscopes, which are used to probe the lungs, because proving they didn’t cause the infections would be difficult.
On Monday, Baltimore-based Johns Hopkins Hospital told 415 patients that they may have received a dangerous lung infection from the equipment. Of those patients, 100 have tested positive for the Pseudomonas bacteria and two have died.
At a news conference Wednesday, Olympus acknowledged it knew in September that a screw-on part of the bronchoscope could come loose and bacteria could get trapped inside the opening.
However, the company’s tests showed the bronchoscope did not pass on infections as long as it was sterilized properly, Olympus senior executive officer Hiroyuki Furihata said.
The company still decided to recall 14,000 bronchoscopes made in Japan since 1997 and sold worldwide. Olympus denied any wrongdoing in failing to start a recall until December even though the company knew about the defective part in September.
“We decided on a voluntary recall,” Furihata said. “The safety of the patients comes first.”
Olympus said that it sent out recall letters Dec. 4, including three letters to Johns Hopkins
Olympus said that it sent out recall letters Dec. 4, including three letters to Johns Hopkins, and notified the Food and Drug Administration (news – web sites) in the United States on Dec. 3. It sent a similar report to the Japanese health authorities Dec. 11.
Johns Hopkins physicians said they didn’t learn of the recall until early February. In December, they noted a two- to threefold increase in the number of patients infected with the Pseudomonas bacteria. By early February, they determined that the devices were the likely culprit.
Pseudomonas bacteria can cause pneumonia in patients already suffering from critical illnesses. Most of those treated at Johns Hopkins were suffering from cystic fibrosis, AIDS (news – web sites) or lung cancer, or had recently received lung transplants.
The problem was was brought to Olympus’ attention last September after a hospital in Tennessee noticed an unusually high number of tests on lung fluids drawn with the faulty bronchoscopes were positive for the bacteria.
At that time, the company began investigating the cause and had not determined what was responsible, officials said. “We believe we did everything we could,” said Olympus president Tsuyoshi Kikukawa. “We will do our utmost to investigate the cause.”
No other cases of infections possibly linked to the bronchoscopes have been reported, Olympus said. About 48 percent of the 4,418 machines exported to the United States and around 82 percent of the 3,176 devices in Japan have been returned so far, the company said.
Recalls have begun in other regions, including about 4,700 such devices in Europe.