http://www.yourlawyer.com/topics/overview/olympus_bronchoscope Sat, 21 Nov 2009 18:03:08 -0800 pixel-app en http://www.yourlawyer.com/articles/read/4401 Wed, 22 Jan 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4401
In a letter to the Food and Drug Administration on Monday, officials at Pittsburgh's Allegheny General Hospital say a cleaning system failed to remove bacteria from devices called bronchoscopes, which allow doctors to see into patients' lungs.

The hospital stopped using the sterilization system made by Ohio-based Steris, one of the most widely used systems after tests performed by it and the Centers for Disease Control found bacteria on the system's water filters and in rinse water.

About 500,000 bronchoscopies are performed in the USA annually. The risk of infection is estimated at 1%, although no one keeps a precise count.

''This risk happens every day in every hospital performing these procedures,'' says Dr. Richard Shannon, chairman of the hospital's department of medicine. He investigated the October outbreak of pseudomonas bacteria.

Steris Senior Vice President Gerry Reis called the allegations ''outrageous'' and ''false and misleading.'' More than 16,000 of the Steris cleaning systems have been used by more than 5,000 hospitals and clinics since 1988, he says. They are used to clean all types of medical scopes, including those used in knee surgery and for looking into the gastrointestinal tract. ''The equipment works,'' Reis says. ''It sterilizes when you follow the specific procedures outlined in the manual and training.''

Steris is cooperating fully with the FDA, he says, and will respond to each of the allegations made by the hospital.

The hospital also says it was not notified of a recall of a part on the cleaning system. The part is listed on the FDA's Web site under recalls. But Reis says the part wasn't recalled, it was ''replaced.''

The debate over the cleaning system comes shortly after a similar outbreak sickened patients at Johns Hopkins University hospital last year. In that case, the cleaning system was not blamed. Rather, a defective bronchoscope, a model that had been recalled was at fault. Hopkins says it was never properly notified of the recall.

Debate over how best to clean scopes is not new. Some hospitals and clinics use sterilization equipment. Others use disinfecting agents. Some advocates say waterborne bacteria like that which sickened patients at Allegheny can be removed by adding an alcohol rinse to the final stage of cleaning.

An FDA spokeswoman on Tuesday said the agency is investigating the outbreak at the 450-bed Allegheny hospital and does not have enough information to either agree or disagree with the hospital's conclusions. But the FDA has issued several warning letters to Steris, dating to 1998.

''The association of the Steris System 1 processor with patient infections usually caused by waterborne organisms leads us to question the ability of the process to provide a sterile water rinse,'' says an April 2001 letter from the FDA to Steris.]]> http://www.yourlawyer.com/articles/read/4426 Tue, 21 Jan 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4426
The hospital's findings amplify concerns that the federal Food and Drug Administration has raised previously about the Steris System I sterilizer, wrote Dr. Richard Shannon, chairman of medicine at Allegheny General, in a letter sent this week to the FDA.

However, the machine's manufacturer replied today that its investigation indicated the problem was with hospital personnel.

As part of its cleaning cycle, the Steris machine rinses bronchoscopes in water that is made sterile by special filters. But the hospital found that those filters can be contaminated with pseudomonas bacteria and become biologically defective. As a result, the sterile water rinses can in fact be contaminated, Shannon wrote.

Steris also failed to adequately and appropriately notify the hospital about defects in connectors that hook scopes to cleaning machines, Shannon wrote.

"The Steris System I can contribute both to incomplete decontamination of bronchoscopes, as well as potentially direct contamination of sterile bronchoscopes through break down of their sterile water filter," Shannon wrote.

The outbreak at Allegheny General affected 16 patients, one of whom died from a pneumonia caused by pseudomonas. The other possibilities considered by the hospital staff error and defects with the scopes were deemed improbable by the investigation.

In a prepared response, Mentor, Ohio-based Steris said it was outraged by the hospital's letter, calling the statements false, misleading and not refelcting an appropriate investigation of the outbreak. The real problem, according to Steris, was hospital staff.

"Steris's analysis of the situation last October ... indicated the cause was improper hospital operating procedures in utilizing the equipment," the company said. "Since its introduction in 1988, more than 16,000 System 1 units have been used safely and effectively in more than 5,000 hospitals and clinics in the United States."]]> http://www.yourlawyer.com/articles/read/4321 Thu, 16 Jan 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4321
Writing this week in The New England Journal of Medicine, the physicians called for federal regulations that would require companies to send recall notices to all doctors who might conceivably use their products.

If such a rule had been in place two years ago, news that the device was capable of spreading a potentially deadly infection would have traveled widely among pulmonary specialists - perhaps in time to limit the outbreak that struck 32 patients at Hopkins.

"The regulation of devices used for medical procedures should be as rigorous as the regulation of drugs prescribed by doctors," said Dr. Arjun Srinivasan, associate hospital epidemiologist.

The outbreak of pseudomonas bacteria occurred between June 2001 and last January among patients who had been examined with a bronchoscope, a device that enables doctors to look inside the lungs and retrieve tissue samples for analysis. The bacterial infection was identified in 32 of 414 patients who had undergone the procedure - about three times the rate that normally would be expected. The bacteria can be lethal to patients with AIDS, cancer and other conditions that weaken the immune system.

At Hopkins, three of the patients died. Doctors were unable to determine whether they died of pseudomonas or their underlying disease, or whether they had been treated with the defective devices or others like them.

While infection-control specialists at Hopkins worked to find the outbreak's cause, a similar one at a Tennessee hospital was traced to a loose screw-on cap that was trapping bacteria. That discovery triggered a recall, but the recall notice sent to Hopkins was delivered to a loading dock where it apparently languished for several weeks before it was forwarded to the pulmonary division.

Last January, two months after the recall letter was mailed, Hopkins doctors learned of the recall in discussions with the U.S. Centers for Disease Control and Prevention, which had played a major role in the Tennessee investigation. By then, they strongly suspected that the device was to blame but had not identified the precise cause.

The devices were immediately taken out of service, and the outbreak stopped. Similar outbreaks at other hospitals were tied to the device, though they were not publicly identified.

"Medical technology is getting more and more advanced, and we're seeing newer and newer devices," said Dr. Trish Perl, chief of infection control at Hopkins. "There is a crying need for us to make sure that we have mechanisms in place to rapidly identify all potential sequelae [infections and other problems] resulting from these devices."

Under federal rules, drug companies are required to send notices about newly discovered side effects to doctors who might use the product.

Kathleen Hale, Hopkins' risk manager, said the hospital has tightened procedures. These include recording the serial number of any medical device used in each procedure and requiring that every piece of registered or certified mail is hand-delivered to the intended recipient. ]]> http://www.yourlawyer.com/articles/read/4352 Wed, 15 Jan 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4352
Researchers at the Johns Hopkins Medical Institutions in Baltimore conducted the study in response to a bacterial outbreak there last year. The outbreak, caused by faulty medical equipment used to inspect the lungs, infected 39 patients with potentially deadly bacteria and may have contributed to the deaths of three other patients.

The outbreak could have been prevented if tougher recall policies were in place at the FDA, says lead author Dr. Arjun Srinivasan, an assistant professor of medicine at Johns Hopkins.

"The regulation of devices used for medical procedures should be as rigorous as the regulation of drugs prescribed by doctors," Srinivasan says.

However, defective medical equipment is treated much differently than defective drugs. When a drug is recalled, manufacturers are required to send out recall letters to all physicians nationwide. For medical devices, recalls are usually voluntary by the manufacturers, and they generally send single letters to each medical institution where the device is used, Srinivasan says.

The problem with the latter system, Srinivasan says, is that physicians using the devices often don't even know when a recall has been issued.

At Johns Hopkins, doctors learned they were using faulty bronchoscopes which let physicians view the insides of the lungs to confirm or identify infections only after they saw a jump in infection cases last January.

They reviewed their methods for cleaning bronchoscopes and searched for reports about the device. Then, a month later, they found a recall letter for the bronchoscopes.

"In our investigation, we kind of stumbled upon this recall letter," Srinivasan says. "Thousands of these bronchoscopes were in service. Who knows how many are still out there."

More than 1,000 medical devices are recalled every year, says Dr. David Feigal, an FDA official. Most of the recalls are voluntary by the manufacturer, and as many as 20 percent of them involve high-risk problems, he writes in an accompanying editorial in the journal.

Because the FDA receives so many reports of malfunctions -- more than 120,000 in 2002 it has created a new program to detect problems earlier. The Medical Device Surveillance Network, once online, will collect data about medical equipment from 250 hospitals and medical centers around the country, Feigal says.

Despite those efforts, a mandatory recall "could have shortened the duration of the outbreak we studied, decreasing the number of patients at risk," the Johns Hopkins researchers wrote in the study.

"Medical equipment is becoming increasingly complicated," Srinivasan says. "We know the FDA thinks about this, but we think it needs more attention."

Part of the difference between regulation of drugs and equipment stems from the size of those industries and the FDA branches charged with monitoring them. The pharmaceutical industry is much larger, as is the FDA's oversight of it, says Dr. Matthew Weinger, director of the San Diego Center for Patient Safety.

"Within their budget they have done an exceptional job of regulating medical devices, but they're substantially under-funded," he says.

At the same time, the two streams of regulation have developed independently.

"The regulation of drugs goes back to before 1920. We didn't really have medical devices then," Weinger says. "The device side of things is much newer. I think they've taken some things from the drug side of the FDA, but it has mostly developed separately."

Still, in 1997 the FDA was given greater authority over medical devices. As a result, it has pushed for better, simpler and more user-friendly designs that are less likely to lead to errors in the first place, says Michael Wiklund, a human factors engineer with the American Institutes for Research in Concord, Mass.

"In the long run, you want to promote the design of safe equipment from the beginning. With that, I think the FDA is doing well. There has been a tremendous push by the FDA over the last few years regarding testing of products for all possible scenarios," he says.]]> http://www.yourlawyer.com/articles/read/4322 Thu, 02 Jan 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4322
Anne Stanley, of Loyalhanna, claims she had to cope with the fear of not knowing whether she had been infected with a potentially deadly bacteria after a defective bronchoscope was used twice to evaluate a spot in one of her lungs.

The examinations were performed at Latrobe Area Hospital in January 2001 and June 2001, according to the lawsuit.

The lawsuit, filed in Common Pleas Court in Greensburg, stated that the bronchoscope used was found to have a loose valve that allowed a dangerous bacteria, pseudomonas, to form in a pocket where it could not be reached by sterilization equipment.

Some doctors said the bacteria, pseudomonas, can be deadly to people with suppressed immune systems. ]]> http://www.yourlawyer.com/articles/read/207 Sun, 10 Mar 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/207
Her husband, Marshall, floored their Buick LeSabre across the city to Johns Hopkins Hospital, then held her hand as orderlies wheeled her into the operating room. After the lung transplant was completed, she awoke and scribbled on a pad to her husband: "It's over. I love you."

The new left lung allowed the 51-year-old grandmother from Baltimore to breathe better, travel for the first time in a year, attend her political club, play and laugh with her three grandchildren.

But it wasn't over.

Last year, she started experiencing shortness of breath again and returned to Johns Hopkins on Oct. 8, Oct. 9 and Jan. 7 for tests of her new lung. Three times, doctors slid a snake-like instrument, a bronchoscope, down her throat. During the winter, she said, she became sick with coughing and fever.

Last week, her doctor warned her that the bronchoscope used in her exams might have spread a potentially dangerous bacterium into her new lung. She fears that the faulty instrument might have caused her illness and endangered that lung.

Pittman is one of more than 400 patients to whom Johns Hopkins mailed letters last week warning that they may have been examined with a defective scope made by Olympus Optical Co. of Tokyo. The company ordered a recall of 14,000 of the devices Nov. 30 because they had a loose part that harbored and may have spread bacteria.

Hopkins kept using the faulty instruments on patients for two months after the recall date because Olympus' notice to Hopkins was sent to the wrong address and got lost in the mail for a month and a half.

Doctors at Hopkins, who blame the company for a botched recall effort, don't know how many people might have been sickened by the flawed devices. In Pittman's case, the source of the bacterium and her breathing problems is not clear, her doctors say. Her surgeon suggested that her body may be rejecting the new lung.

Investigators know that two of the 400 people died of pneumonia, and they suspect that the lungs of 100 more people may have been infected or exposed to the bacterium.

A step forward, then back

"I am very upset and distressed by this because I don't know how this infection will affect the longevity of the new lung that I waited so long to get," said Pittman, speaking slowly between hissing inhalations from the tubes curling out of her oxygen tank.

"It's almost as if you get a good thing going, your life gets better," she says, pausing to inhale. "And then they take it away from you."

Her husband, Marshall Pittman, said he's bothered by the idea that doctors may have used a flawed medical device on his wife after its recall date.

A doctor's doubts

But the surgeon who performed her transplant, Dr. Stephen Yang, said the bronchoscope is unrelated to the breathing problems Pittman is reporting. "This whole thing is ridiculous," Yang said of attempts to link the instrument to her illness. "She's got rejection [of her lung], and that's it."

Friends say Pittman has been stoic about her health problems. She's a scholarly book lover and amateur genealogist from Northwest Baltimore who was one of 11 children of a longshoreman and school dietitian.

She married Marshall Pittman, a Vietnam veteran who works as a coordinator of veterans services for the state.

They raised two children and have three grandchildren.

Search for family roots

Friends describe Frances Pittman as the kind of person who would prefer to spend a free afternoon prowling through the stacks of the National Archives in Washington, hunting up bits of information about her family's history, stretching back to their years in slavery in Southern Maryland.

"I spend so much time on it because I want the rest of my family to know their roots - where they came from and what they did to survive," said Pittman. "We have a lot of successful young people in the family, and I feel they need to know how people had to work to get them where they are today."

For more than 15 years, she worked in customer service at a Federal Express office in Columbia, answering phones, helping customers with billing questions.

Inspiration to others

She was an inspiration to her co-workers because she had enough energy to take night courses at the Johns Hopkins University, said longtime co-worker Airuel Singletery, 40. Pittman earned an undergraduate degree in 1990 and followed that up two years later with a master's degree in behavioral science.

Pittman began to experience breathing problems in 1986. Pittman said her doctors diagnosed sarcoidosis, a chronic but little-understood autoimmune disease that causes inflammation of the lungs and other organs. The disease made it progressively harder for her to breathe and walk distances, and she took a medical leave in 1997.

Her doctors at Johns Hopkins told her she needed a lung transplant. She waited on a list for a year, feeling both hope and fear when doctors in March 1999 told her they had a donor for her.

During a six-hour surgery, her surgeon cut under her left arm, removed a rib and replaced her left lung.

"At first, after the surgery, it was great, she could do everything," said Shirley Robinson, a retired teacher who volunteers with Pittman in a small political organization, Woman Power.

"She could attend our meetings, go to church, get around and visit with friends," Robinson said.

Problems resurface

But then her friends noticed her becoming ill and having breathing problems again last summer and fall. Terrified of germs that might overwhelm her weakened immune system, she avoided public places, kept her grandchildren out when they had sniffles. She wouldn't even kiss her mother when she had a cold.

Pittman went to Hopkins on Oct. 8 for a bronchoscopy to see whether she was rejecting her lung, according to her medical records. After giving her an anaesthetic, a physician slid the pencil-thin device into her right nostril. But the doctor was unable to take an adequate sample of her lung tissue.

Pittman returned the next day for a more successful test, and this time doctors detected no evidence of organ rejection. They also found no signs of rejection during a third bronchoscopy Jan. 7. However, cultures taken from her turned up Pseudomonas bacteria, according to her medical records.

Her pulmonologist, Dr. Jonathan Orens, said her case is complex. Although samples of liquid taken from her lungs through the scopes did grow Pseudomonas bacteria, it's unclear whether the bacteria came from her lungs or the scopes, Orens said. Doctors don't know whether the bacteria were growing in her lungs or whether she had a "pseudoinfection" - a false positive because of a contaminated device, Orens said.

Case is complex

Doctors don't know which of the 400 patients were examined with the defective instruments because the brand or model numbers were not recorded in their medical records, said Dr. Paul J. Scheel Jr., vice chairman of medicine at Hopkins.

Scheel said the hospital's investigations are complicated because many of the patients involved are seriously ill - suffering from AIDS or cystic fibrosis or recovering from lung transplants - and might have harbored the bacteria before doctors slid scopes down their throats.

"Pseudomonas infections can cause pnuemonia ... that means fever, cough, shortness of breath," said Scheel. "But these are also the kind of kind of sick patients who were probably feeling these symptoms before they came in."

Sorting out responsibility

All of this makes for a great deal of anxiety for Pittman and the other hundreds of patients who were sent letters by Hopkins.

Pittman has hired a lawyer, Marvin Ellin, who is sorting through the records and trying to figure out who is responsible.

"She would never have consented to the exams with the bronchoscopes had she known the risk of infection," said Ellin. "She doesn't know if she will have to lose the lung she waited so long to receive." ]]> http://www.yourlawyer.com/articles/read/188 Thu, 07 Mar 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/188
Experts say bronchoscopes, which doctors use to examine lungs and take tissue samples from airways, pose a small but real risk of transferring germs from one patient to another, despite the sterilizing steps used to clean them.

The scopes are the focus of an investigation at Johns Hopkins University in Baltimore, which is trying to determine whether the devices were responsible for infecting at least 100 patients with the Pseudomonas aeruginosa bacteria. Two patients have died so far, said Gary Stephenson, a Hopkins spokesman, and "there may be other deaths that we don't know about presently."

Health officials have issued at least two reports since the early 1990s notifying doctors of the problem. The alerts, from the Centers for Disease Control and Prevention (news - web sites), each stated that automated sterilizing gear failed to completely destroy bacteria clinging to the instruments. The cleaning machines themselves also housed colonies of dangerous germs.

Dr. Norman Edelman, a scientific consultant for the American Lung Association, said inadequate cleaning of bronchoscopes "has been an issue" in the past. "Good programs check whether the sterilization is effective," he added.

"Getting pneumonia or infection from bronchoscopy is always a complication," said Dr. Marc Judson, a pulmonologist at the Medical University of South Carolina in Charleston. "It's more likely to occur with a bronchoscope that was recalled."

The risk reflects the fact that bronchoscopy isn't a sterile procedure, Judson added. When doctors thread the snakelike tube through a patient's mouth or nose, it may transfer harmful germs loitering there deeper into the body. "The scope itself is not sterile, and even if it was sterile, you're going to bring bacteria down into the lung," Judson said.

And when the devices have flaws that shield these bacteria from cleaning machines, or when the cleaning machines don't work properly, infections can spread from patient to patient.

In the latest incident, Olympus America issued a recall notice last November to hospitals that use its bronchoscopes alerting them to a loose biopsy port that might have hidden bacteria.

Doctors at Hopkins detected a surge in Pseudomonas aeruginosa infections in late December, officials there said. They found traces of the bacteria in three of their seven Olympus bronchoscopes.

Hopkins officials said they didn't learn of the recall until February. On March 4, the university sent letters to 415 patients who had undergone bronchoscopy at Hopkins, warning them of the potential infection risk.

Of those patients, 100 have tested positive for Pseudomonas bacteria, two to three times as many as would normally be expected, according to a university statement.

Many of the patients have serious illnesses such as AIDS (news - web sites), cancer, and cystic fibrosis, the statement said. Because of that, "it is likely that some of these patients carried the Pseudomonas bacteria before they came to Hopkins for their bronchoscopies," the statement said. Whether the defective bronchoscopes were to blame is "what we're trying to ascertain now," said Stephenson, the Hopkins spokesman.

An official at the Centers for Disease Control and Prevention said this week that Olympus learned about the problem with their bronchoscopes in September but waited until November to notify hospitals. The official, Dr. William Jarvis, said Olympus, a unit of the Japanese optics maker, didn't inform the Food and Drug Administration (news - web sites) of the defect until December, according to the Associated Press.

Olympus defended its handling of the recall, saying in a statement that it notified its customers in a "timely" manner about the troubled devices.

Sandra McDonald, a spokeswoman for Olympus, said the company issued two recall notices, one on Nov. 30 and a follow-up letter on Feb. 27, regarding the flaw. Both were marked "Urgent: Recall" in large, bold lettering.

In all, Olympus sent 2,361 notices to hospitals and institutions that own the instruments, McDonald said. "All of those institutions have been notified through the certified mail recall process following FDA guidelines," she added.

Sharon Snider, an FDA spokeswoman, said Olympus has been "cooperative and responsive" to the agency's requests for information about the defective bronchoscopes.

"We want to make sure that the hospitals were properly notified and make sure that these devices are out of circulation," said Snider, who added that the root cause of the infections at Hopkins has not been confirmed.

In a 1991 report, the CDC detailed infections linked to bronchoscopes and endoscopes -- similar devices which enter the body from the rectum or urethra --in Wisconsin and Missouri. Those infections, which included Pseudomonas aeruginosa and another dangerous germ, Mycobacterium chelonae, were traced to the automated cleaning devices used to sterilize deployed scopes.

In July 1999, the CDC released a report on three clusters of bronchoscope-related infections in New York. The cases, which occurred in 1996 and 1998 and included tuberculosis, were again related to problems with automated machines used to clean the devices. ]]> http://www.yourlawyer.com/articles/read/176 Wed, 06 Mar 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/176
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, 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.]]> http://www.yourlawyer.com/topics/overview/olympus_bronchoscope Wed, 06 Mar 2002 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/olympus_bronchoscope Olympus Bronchoscope Johns Hopkins Hospital is alerting 415 patients and their families that a defective medical instrument may have given them a potentially life-threatening lung infection. The instrument, made by Olympus American, was used to perform bronchoscopies, which inspects a patients lungs and take tissue samples.

A thin, tube-like instrument, about the width of a pencil, is placed through the nose or mouth and into the lungs. The tube has a tiny camera at the tip and uses fiber-optic technology to produce pictures of airways. Some patients who were examined by one of three contaminated bronchoscopes have died.

Hospital officials discovered the problem after realizing that 128 patients had been infected with a bacterium known as pseudomonas. The number was two to three times higher than the hospital would expect, said Dr. Paul J. Scheel Jr., vice chairman of medicine. Hospital officials told The Sun of Baltimore in Sunday editions that they have not determined how many patients have been infected or died but have sent certified letters warning 415 patients.

Those at risk include anyone who had a bronchoscopy procedure between June 1, 2001, and Feb. 4, 2002, the letter says. The letter asks patients to call their doctors if they experience symptoms that include fever, coughing, phlegm or shortness of breath. The national Centers for Disease Control and Prevention and the Food and Drug Administration are investigating the problem, in part to determine if the device has triggered outbreaks elsewhere, The Sun reported.

Most of those treated at Johns Hopkins were suffering from cystic fibrosis, AIDS or lung cancer, or had recently had lung transplants. "We don't know the cause and effect between patients who died and this infection," Scheel said. "People are going through medical charts to try to ascertain this."

The University of Maryland Medical Center in Baltimore has also stopped using the tool and is searching its records for patients with the infection. The state Department of Health and Mental Hygiene and the Baltimore health department were trying to determine if the problem exists in other hospitals.

Dr. Ross J. Brechner, the state's epidemiologist, said he sent e-mails to colleagues throughout Maryland and the country detailing the Hopkins discovery and asking whether they have noticed the same elevated infection levels after using the popular device.

The recall letter to Hopkins, dated Nov. 30, wasn't immediately acted on because it was mistakenly addressed to the loading dock of the Hopkins physiology department, the paper said. In recall letters, Olympus described the defective instruments as having a loose valve that trapped bacteria.

If you or a loved one suffered injuries from an Olympus Bronchoscope, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.]]>