On Low Standards and Lawsuits: An Argument For Infection Control in the Clinic Setting

Few people realize the true scope of potential harm in an every day visit to a local clinic, until you see a headline like this hit the news. Is it anecdotal? Well, yes, in the sense that it's a potential outbreak and not a research project. But it's also important to note that no patient signed up at the clinic to see if they could get infected by a poorly processed medical device. That potential risk was just thrown in for free.


Which brings me to the topic at hand...

A few months ago in ENT Today, Dr. David Chang wrote an intriguing little mini-refutation of the growing weight of infection control guidelines in the clinic setting entitled "Overinterpretation of Sterilization Guidelines Could Interfere with Patient Safety." Among other things, he argued the following:

"[A]ttributing infectious disease transmission to an outpatient clinical instrument such as a nasal speculum is going to be very difficult to prove, unless you implement a system that closely tracks each instrument from the stages of reprocessing through to specific patient contact. Big data may provide associations, but they may not be granular enough to provide a pinpoint-specific cause unless you have a widespread outbreak or an outbreak of a rare infection.  Therefore, many agencies and institutions have adopted safety measures based on conjecture, legal repercussions, and manufacturer recommendations—not data."

The broad implication of his article runs like this: patient risks have to be balanced against various costs, and organizations such as the CDC, AORN, Joint Commission, and others may have overstepped the actual data-driven arguments for what should constitute an "evidence-based" recommendation. Fair enough...almost.


As a jet-setting infection control consultant myself, each week I get to do case-studies in clinics all over the country. And in these clinic settings in particular, I far too often see a level of non-compliance with fundamental concepts of cleaning and disinfection that would stun the average patient sitting in the waiting room. Now, because I'm a thoughtful bloke, I realize much of this non-compliance and misunderstanding related to how cleaning and disinfection works is due primarily to a lack of education, training, and equipment that has been made available to medical assistants and technicians on the frontlines. (One of the many reasons we started and continue to produce the Beyond Clean podcast each week)


But now I'm going to touch on a few nerves (if I haven't already). One of the primary reasons for this lack of investment into the personnel and cleaning equipment of our nations clinics is because the clinics themselves lack appropriate incentive to do so. And this gets us back to the crux of my disagreement with Dr. Chang's article (thoughtful though it was). Where he sees a regulatory arm overreaching and over-interpreting infection control guidelines, I see a myriad of clinics far too removed from the guardrails of recommended best practice -- often doing "what they've always done," regardless of anything happening in the wide world around them. This is our reality. This is the tremendous challenge that is currently operating in towns and cities near you. Ill-equipped, under-trained, and all of this invisible to the patients walking in the front door.


All of this drives toward a an overarching -- and philosophically important -- disagreement that I have with Dr. Chang's apologetic. I believe that "adopting safety measures...based on legal repercussions" actually is what we owe to the patients who put their lives and their health in our hands. While I admit the lawsuit- fanaticism that occasionally raises its head in the US, plaintiff attorneys often fill the gap where regulatory oversight fears to tread (or in the case of regular auditing, is unable to tread). Now, no one wants their physicians to act out of legal fear rather than our best interest as a patient -- but a similar vein of this logic is true as well: No one wants their physician to compromise with established industry recommendations regarding how clean, disinfected, and sterile their instruments are made.


At the end of the day, patients don't give a damn about data, they want to know whether their devices have been properly cleaned. And as providers, technicians, and consultants, that should be our guiding light as well, even if it takes an attorney to keep the lamps trimmed and burning...

What say you?


W. Hank Balch Ⓒ February 2019


Hank Balch is the co-founder and Principal of Beyond Clean, a next generation Sterile Processing consulting firm with focus on operational improvement, accreditation survey preparedness, interim-leadership placement, and brand consulting for CS/SPD vendors. He is also the Co-Founder & Host of the Beyond Clean Podcast, a weekly international podcast discussing industry topics with the biggest names in Sterile Processing. You can find over 100 other Sterile Processing articles and commentary here, along with published articles in Becker's Hospital ReviewInfection Control TodayAAMI NewsAAMI BI&T JournalOutpatient Surgery Magazine, and contributions to Healthcare Purchasing News. Hank's CS/SPD team in Louisville, KY was named the "2016 CS/SPD Department of the Year" by HPN, he's served as the President of the South Texas Association of Sterile Processing Services and President of the Kentuckiana IAHCSMM Chapter, and was nominated for the 2017 President-Elect & 2018 President-Elect of the International Association of Healthcare Central Service Materiel Management.

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