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O’ Standards, Where Art Thou? Vendors, Users, and Hard Questions about the State of Sterile Processing

I would say that I hesitated to write this article, but that would only be a half-truth. Part of me has no hesitation whatsoever asking questions that I honestly do not know the answers to. The other part, however, is the one that knows I’m about to poke the proverbial bear and touch a sacred cow that a great many of my industry friends, peers, and mentors have given the better part of their careers to improve. With that transparent admission out in front, I ask that you read this article with grace and a measure of understanding that this is my experience, and my opinion, with which you can disagree without getting angry or upset at me for raising the questions.

Now, who wants to know what all this is about?

What we know: Vendors wait, hope, cajole, and strategize around updating standards to serve their product lines
Caveats all up front; not all vendors wait, hope, cajole, and strategize around industry standards. The majority of the ones that do are still good companies with great products that really do serve the industry, improve our sterile processing departments, and positively impact patient care. This is not a knock against being good at playing the game; it’s simply an honest statement that much of what we call industry recommendations or standards is just as much a marketing game as it is real, hard science or real, neutral development of best practices. Anyone who really knows what’s going on and is honest with themselves and the rest of us will admit this fact. Many companies and product lines wait with bated breath or work tirelessly within the structure of these organizations to influence the newest update to a particular industry standard, not primarily because they believe settled science is on their side, as much as they see the massive marketing advantage they would have if the framework of their solution just so happened to become enshrined in the holy writ of an industry guideline.

Vendors know this. Increasingly, accreditation organizations are starting to see it. I believe the organizations themselves that publish these standards even see this, although they are at a loss for how to counteract it or have just come to terms with the dynamic as the permanent state of affairs. Admittedly, there are a few free-market forces at play here, where competing interests (clearly seen and represented by competitive companies) do keep themselves in check at times, keeping some aspect of these standards in the middle of the road. One of the problems that occurs is when these competitive interests align and agree on a particular industry recommendation because it serves both of their market interests, either at the expense of smaller competitors, established science, user financial realities, or all of the above.

There are many vendor representatives involved in guideline development and industry recommendations who do not play this game. They earnestly advocate for best practices and industry progress from a neutral perspective, building consensus for their views, and seeking input from users. This, however, does not negate the obvious and not-so-obvious pressures placed on these documents that come more from financial incentive of vendors than evidence-based best practice. Vendors do use industry guidelines as marketing tools, and do strategize around how existing recommendations can be modified or updated to give their product or solution an edge in the competitive landscape of the sterile processing industry. Don’t shoot the messenger, but do listen to the message.

What we know: Sterile processing users are hardly involved in crafting our standards
So where do the users end up in all this? What kind of input and leverage do the actual technicians and department leaders have who do the hard work of sterile processing in the hospital setting? What impact do these users have on developing the very guidelines that are later implemented in their facilities? It is well documented and discussed among the industry that true end users and active sterile processing professionals make up a slim percentage of the groups who develop, vote, and publish these powerful industry documents. Are there users involved? Yes. Are they far outnumbered by manufacturers and vendors who, by human nature and the nature of business, have a vested interest in seeing these recommendations go one way and not another? Absolutely. To the credit of these users and the organizations that develop industry recommendations, there is a regular, transparent call for additional users to take part in the process to better even out these dynamics. One such recent example of this is David Jagrosse’s article “AAMI Wants You,” where he explains, “A large majority of this group are vendors with a small group known as users that are CSSD professionals representing the profession and their respective hospitals. This committee needs the help of more users, or people like yourself.”

What we don’t know: Where do we go from here?
While it may be easy to understand how manufacturers see the value in being involved in crafting industry standards and recommendations, what we don’t quite know is why so few sterile processing users see the same value. Why are the engagement numbers so startlingly low from the very professionals who often struggle to implement these recommendations in their own departments? Is it simply that department leaders and frontline technicians are not aware of the opportunities to get involved? I do not think that is the case. Is it that involvement requires an unpaid time commitment, membership dues, and potential travel costs to attend in-person development events? Perhaps that gets us a little closer to some answers. After all, it would be safe to assume that most manufacturer representatives in these groups are being paid to attend by their employers, as well as having much of their travel covered. It would be much more unlikely to see the same compensation and expenses covered by a healthcare facility for their sterile processing technician to attend a similar meeting.

If the answers to all this were simple, someone would have already come up with a solution. However, as the old cliché goes, the first step to recovery is always admitting that we have a problem. The fact that manufacturers have a controlling interest in the conversations that drive the development of sterile processing industry standards is a problem. There’s no denying this. Now we need to ask every user, organization, and vendor in our industry what exactly are we going to do about it, because ultimately, he or she who controls the standards controls the future.


Feature articles exclusively for Ultra Clean Systems by Weston “Hank” Balch, BS, MDiv, CRCST, CER, CIS, CHL

Weapon of Mass Microbial Destruction * Professional Clean Freak * Podcast Host * Safety Addict * CS/SPD Consultant

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