Betsy Q. Cliff / The Bulletin

What a St. Charles Bend technician believed to be a simple leak last fall turned out to be a much more serious error that put patients at risk of severe infection.

Now, at least two of those patients have sued or are planning to sue the hospital for negligence.

The incident was first noticed on Oct. 1, when a technician at St. Charles Bend saw fluid around the machine that cleans and sanitizes colonoscopes and endoscopes, probes used to see inside parts of the digestive system. The technician stopped using it that day.

When a representative from the manufacturer came to look at the machine a few days later, that person discovered the machine had left the disinfection step out of its cleaning process.

It had potentially exposed 18 patients who had colonoscopies or endoscopies on Sept. 29 or Sept. 30 at the hospital to an increased risk of serious infection, including HIV, Hepatitis A, B and C and helicobacter pylori, a bacteria that causes stomach infection and ulcers.

Fixed on Oct. 6

The machine was fixed on Oct. 6 and no additional patients are at risk, said Jay Henry, CEO of St. Charles Bend.

The hospital said it was unaware of any patients who had developed infections as a result of the mistake.

One lawsuit was filed last week. Jennifer Coughlin, a Bend attorney who is representing at least two affected patients, said she planned to file the second lawsuit as early as next week.

The first lawsuit was filed by a woman in her early 20s who has Crohn’s disease, a digestive disorder, said Coughlin. She is identified in the suit as Jane Doe to protect her privacy.

“She is stressed out and really scared,” said Coughlin. “It doesn’t really matter to her that other steps were taken if the disinfection step was not.”

That lawsuit asks for $250,000 in non-economic damages plus $20,000 for medical bills.

Though a manual cleaning is done in every case, and was done in these cases, it is usually followed up by a machine that disinfects the scopes.

In that automated procedure, disinfection was not done.

“It’s important that all the steps be done and they be done according to protocol,” said Dr. David Greenwald, a spokesman for the American Society for Gastrointestinal Endoscopy and an expert on the cleaning of this type of equipment.

Having said that, Greenwald said the steps prior to the automatic disinfection remove the vast majority of any bacteria or potentially harmful germs. The manual cleaning, he said, reduces the amount of microorganisms on the endoscope by 99.99 percent.”

St. Charles blamed the manufacturer, Medivators, for the mistake.

On Sept. 28, a representative from the company had been in the hospital doing a routine check of the machine.

That day, the representative reprogrammed it, said Pam Steinke, chief nursing executive at St. Charles Health System, the parent company of the Bend hospital.

At the New Jersey headquarters of Cantel Medical Corporation, the parent company of Medivators, president Andy Krakauer, said the company “is investigating the situation,” and that he was not able to comment further.

Once the hospital learned of the error, it investigated who was affected and what were the potential risks, said Laura Mason, risk manager for St. Charles Bend. On Oct. 20, the hospital sent letters to all of the affected parties informing them of the mistake, encouraging patients to get a series of lab tests for possible infection and offering to provide the tests at no cost.

“We were reassured by the infectious disease expert (the hospital consulted) and medical director that the risk of transmission was extremely low,” said Mason.

But, hospital executives said, despite the low risk, they felt it was important to be up front with patients. “We believe in transparency and we wanted to reach out,” said Henry.

That kind of honesty is rare, said Leslie Ray, a patient safety consultant at the Oregon Patient Safety Commission. “Being transparent about it is a very good sign.”

Fallout from error

The mistake could have affected a lot more people. The leak that prompted the technician to call Medivators was unrelated to the programming error, Mason said. That means, had it not occurred, it may have been much longer before the hospital realized anything was wrong.

“I think that this process is pretty easy not to realize that (a mistake) happened,” said Ray. She said that similar incidents had been reported to the Patient Safety Commission in recent years.

St. Charles Bend did not report this incident to the commission or any other organization, the hospital said, because it was not required to report incidents that do not result in death or serious injury.

Since the incident, the hospital has changed some of its practices. After each cleaning, the machine prints a ticket showing the steps completed.

Prior to October, technicians were not looking at it very closely, said Mason. They are now required to check the tickets and sign off that all of the steps in the cleaning process have been done.

As for the affected patients, the hospital has been working with them to allay their concerns and take care of the required laboratory tests. It called each patient individually.

But the hospital did bill patients for their procedure that day.

“They still had the service,” said Lisa Goodman, a spokeswoman for the hospital.

Coughlin said one of her clients does not have health insurance and some of her bills from that procedure have now gone to collections.

For the colonoscopy in which the error occurred, Coughlin said, St. Charles Bend billed her client $6,772.66.