News / March 10, 2021
On May 10, 2018 Porter Adventist Hospital in Denver, Colorado had to cancel all surgeries for a week due to contaminated surgical instruments being found in the O.R. after reprocessing. While this happened a few years ago, it is a great example of the incredible importance of pre-cleaning at point of use, proper decontamination and thorough cleaning of surgical instruments during reprocessing and prior to sterilization.
This was not a unique situation, but rather another case in a long line of reported cases of contaminated instruments being returned to the O.R. after they had been reprocessed by following the manufacturer’s IFUs. This problem has been expanding throughout the country and is being monitored by the FDA and the CDC.
The problem of contaminated instruments being returned to the O.R. after reprocessing was first addressed by the CDC in their September 11, 2015 Health Alert Advisory that stated:
“The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety.”1
Regretfully, even after this major Health Alert Advisory from the CDC, we have continued to see reports of contaminated instruments causing canceled surgeries, patient harm and even patient deaths. The events at Porter Adventist Hospital provide a graphic example of the problem. According to an NBC News report from Denver at the time of the incident:
John Kraswoski knew spine surgery wouldn’t be easy. He just didn’t expect to go through it twice. The 61-year-old Colorado Springs man needed Transforaminal Lumbar Interbody Fusion. The surgery was scheduled for April 4, 2018, at Porter Adventist Hospital. He said he arrived that day as planned. Hours later, he said he woke up from anesthesia and learned the surgery to fix his spine started – but was aborted before the procedure could be finished.
Krasowski said the explanations from the hospital stopped there. Krasowski’s medical records reveal a little more, explaining his doctor aborted the surgery after the “discovery of contaminant on a number of the instruments.”
Medical records also say surgical staff discovered a “brown-yellowish, what looked like a pasty material” on one of the instruments.
The same day as Krasowski’s surgery, the Colorado Department of Public Health and Environment (CDPHE) announced a disease control investigation at Porter Adventist.
CDPHE said instruments used in some surgeries were not cleaned adequately. The hospital said it identified a gap in the pre-cleaning process, prior to sterilization.
The hospital sent letters to thousands of orthopedic and spinal surgery patients, who had procedures between July 21, 2016, and February 20, 2018. Those letters said patients could be at risk for hepatitis or HIV and should get a blood test.
Krasowski was unaware of the investigation when he had surgery on April 4.
The day after his aborted procedure, the state issued new information that more patients could be at risk than previously thought.
Health officials updated the dates in which patients could be at risk of hepatitis or HIV, to include orthopedic and spinal surgeries between summer of 2016 and April 5, 2018.
The hospital resumed surgeries a week later.
Krasowski said he believes his doctor was advocating for him – the patient – when the surgery on April 4 was aborted. But Krasowski has several concerns about his experience at the hospital.
“What we want to know is, was this human error?” asked Krasowski’s attorney, David Woodruff of Denver Trial Lawyers. “Was it equipment failure? Was it… failure of policies? Or was it something the administration was simply ignoring.”
When asked for more information on his case, the hospital issued this statement: “Porter Adventist Hospital does not believe it is appropriate to discuss individual patient cases, especially when litigation is pending or threatened. Once the residue was discovered, Porter Adventist Hospital immediately and voluntarily stopped all surgeries in an abundance of caution.” 2
Protecting patients from contaminated surgical instruments is the number one goal and mission of every CS/SPD department. As the September 2015 CDC Advisory stressed, non-compliance with the manufacturer’s recommended reprocessing procedures represents a critical gap in patient safety.3
Reducing the risk of harm caused by a contaminated instrument starts by following manufacturers’ published cleaning and reprocessing IFUs. Even more important than following the manufacturers’ published IFUs is to demand IFUs that have been validated by independent laboratory testing using AAMI and FDA validation testing protocols. By only using instruments with validated IFUs you can have the documented assurance of providing clean, sterile, moisture-free instruments for every patient, every time!
1 Centers for Disease Control and Prevention Health Alert Advisory HAN00323, September 11, 2015.
2 NBC News 9, Denver, Colorado.
3 Ibid “CDC”
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