DENVER -- The Chief Medical Officer at Porter Adventist Hospital and the Senior Vice President at Centura Health went before cameras Thursday to explain a problem with the first step of a surgery equipment sterilization process that may have put 5,800 patients at risk of infection.
"Some of the reason we paused on having this dialogue is because we didn't have all the answers," said Sr. V.P. Morre Dean. "It was important for us to get those."
Dean said the Joint Commission, a body that helps the federal government look at quality in hospitals, wanted the pre-cleaning of surgical instruments to be "more robust."
7-Step Cleaning Process
Dr. Patty Howell, Porter's Chief Medical Officer, said they employ a seven-step process.
The first step is in the operating room, where staff wipe debris off the surgical equipment following surgery. The equipment is then sent to the Sterile Processing Department, where it is scrubbed by hand with special brushes and is then put into a mechanical washer that works with sprays and heat.
"It is then visually inspected," Howell said, "to see if there is any evidence of bio-burden remaining."
Then it is transferred onto trays and wrapped in blue sterile wrapping and placed into a sterilization chamber.
Howell said the viruses patients are most concerned about -- HIV, Hep B and Hep C -- are inactivated at temperatures between 56 and 101 degrees Celsius after 90 seconds. She said the hospital's machines operate at 134 degrees Celsius and cycle for 4 minutes.
"So obviously higher than needed," she said, "with the intent of having a window of safety."
When asked why staff hadn't been "more robust" in the first step of the process to begin with, Howell said she suspected it was because of the instrumentation involved in those particular (spinal and orthopedic surgery) cases.
"Some of the them are sharp," she said, "some have mechanisms that need to be taken apart, so we're really making sure they have the training to be able to go through that."
Howell said that during the time frame involved, 1.3 million pieces of equipment have been processed and they're only reached the final error process once.
Howell said there are no confirmed cases of HIV or Hepatitis being linked to the flaw in the first step, but noted "we're still in the testing phase."
State health officials originally determined that people who had orthopedic or spinal surgery between July 21, 2016 and February 20, 2018 might be at risk of contracting an infection, then later determined the risk extended to April 5 of this year.
Dean said the extended risk (between February and April) was related to a water quality issue.
"Someone opened a (surgical) tray and noticed there was some residue on it," Howell said.
The hospital's sterilization processing specialist determined that it was a mineral buildup.
"The specialist looked at the washers and saw a buildup, so we de-scaled the machines," she said. "Instead of our normal schedule of de-scaling weekly, we're going to de-scale daily."
When asked if you can get a disease from mineral deposits, Howell replied, "Mineral deposits are not bacterial, but the issue is, you want you make sure you're right and we've got a great sterilization process department expert."
Howell said there have been some regular surgical infections reported, which have not been linked to the sterilization breach, which she says is not out of the ordinary.
"The national historical data that we follow is whenever there is a surgery, between 2 and 5 percent of those incisions can become infected," she said, "when dressings are changed, even if they're done perfectly."
"What we have found," she added, "is that our total infection rate is lower than the expected average."
Howell told Denver7 that once they get the health department's statistics, they'll cross-reference it with there own and will then "drill down on the orthopedic and spine patients (data) to see if we can determine an impact on those numbers."
Morre apologized to patients.
"What I really want is for them not to be anxious and not to be worried," he said. "The worst part is not knowing."
He said concerned patients can contact their doctor and be evaluated.
"If they're still concerned, they can request a test," he said. "There's nothing better than a negative test."
The hospital has established a hotline for patient questions. The phone number to call is (303) 778-5694.