University Health System and Founder & CEO of iSterile

Weston Hank Balch

There are few more frightening phone calls that a surgical patient could receive than one notifying them that “Our sterilization processes failed. You may be infected with HIV, hepatitis B, or hepatitis C.”

WHAT!?

A million thoughts go racing through the mind—”I had a knee replacement. What does that have to do with HIV?”, ”What’s the life expectancy of someone with hepatitis C?”, ”What about my friend who had surgery a month after I did? Are they at risk for hepatitis B as well?”, and “How could this happen?”

This was the experience of 18 months worth of surgical patients from Porter Adventist Hospital in Denver, Colorado this month, as they were notified of “an infection-control breach involving surgical instruments.” Specifics to this story are still sparse, but particular attention has been given to the potential issues related to “pre-cleaning” and “water quality” as referenced in various news reports. Knowing what we do know about this quality breakdown, and related issues such as at Detroit Medical Center, there are at least five critical lessons we need to take away from this event:

1) Pre-Cleaning Non-compliance is Still a Major Issue

If you go back and read the CMS reports coming out of the Detroit Medical challenges, the same theme took center stage as we are seeing at Porter Adventist—non-compliance related to point-of-use cleaning in the Operating Room. When gross soil is not wiped off surgical instruments during the procedure and lumens/cannulated items are not being consistently irrigated with sterile water throughout the case, AORN Guidelines and AAMI recommendations are being blatantly ignored. As this bioburden dries inside surgical instruments, the potential for the development of biofilm increases with each passing moment. Even with appropriate equipment and processes in Sterile Processing, non-compliance at the point-of-use is nearly impossible to overcome.

"All members of the continuum of patient care must feel empowered to raise a concern and stop the line"

2) Sterilization Breaches can Easily Become the Status Quo

There is a myth out there that many in the perioperative setting can be lulled into believing that a breach in sterilization is always obvious, an event that reaches out and grabs your attention. A rip in a disposable blue wrapper, a pin hole in the filter of a rigid container and a tear in a peel pack: While these breaches are easy to see, many other sterilization issues can go on for long periods of time before being discovered—even while some in the process are aware of the possible breach. Regular testing of washer/disinfectors can drop off. Cycle parameter compliance can be assumed for new instruments, without reviewing current instructions for use (IFUs). Processing steps for Da Vinci robotic arms can be skipped to comply with pressures for quick turnarounds. One of the most difficult things in our industry is to constantly question this status quo—even when others around us seem not to notice. All members of the continuum of patient care must feel empowered to raise a concern and stop the line—regardless of how long the issue has been at play.

3) The Court of Public Opinion is a Frightening and Expensive Way to Fix a Problem

If you were to ask Morre L. Dean, Chief Executive Officer of Porter Adventist in Denver, if he had this all to do over again, would he invest more time, energy, and resources into ensuring his Sterile Processing protocol was compliant through the entire cleaning process. I have a feeling I know what his answer would be. But for Dean and a growing number of other hospital administrators across the US, these infection control problems are not fixed until catastrophe strikes or the story breaks on the Evening News, whichever comes first. There’s obviously a better way—and it starts with hiring high-quality experts in the Sterile Processing field to run these departments, and then, just as importantly, listening to them when they raise a concern and voice a need. Will this mean an upfront investment to drive efficiency and hardwire safety?—Yes it will. Still, it’s infinitely better than making these decisions with CNN sitting in your driveway and patients crying in your waiting rooms.

4) The Reality of Surgical Instrument Cleaning Dangers is Worse Than You Think

Porter, Detroit, Brooke Army—these are the facilities whose surgical instrument quality issues made headlines, but they are by no means the only hospitals in the US where there are potential short falls related to infection control in Sterile Processing. Many departments across the country are operating with woefully inadequate space (especially for decontamination), processing equipment that is near the end of useful life, a lack of properly maintained surgical inventory, and a host of other quality-indicators signaling potential danger across the department workflow. While there are a number of processing teams who are operating ahead of the quality curve, the state of many of our departments are still troublesome, and if you talk (and listen) to the SPD processing leaders themselves, they will tell you this: It’s still a scary, dangerous, and too often poorly supported world out there.

5) There Will be Another Porter (Just Like There Was Another Detroit), Unless...

The final lesson here is a warning, as much as a takeaway from the latest sterilization scare—there will be another Porter. If we have learned anything in recent years, it’s that even as these stories may scare the hell out of our patients and trouble our industry—many hospital administrators are still refusing to give Sterile Processing departments the investment, support, and direction they deserve. We have learned the dangers are real and the damages to our patient trust and public relations are massive, but the determination to solve these issues is too often still met with half-hearted nods from a C-suite who assume if surgeries are still happening, everything must be okay in Sterile Processing. As each of these sterilization scares show us, that is most definitely not the case. The only real way to protect your hospital and your patients from being the next Porter is to take these quality threats seriously before it’s too late.

The right response to these headlines is not ultimately to just look at them! Instead, it should be a serious and thoughtful look at ourselves to see how we might save our patients and loved ones from the kind of phone call that no one should ever get.