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Reusables vs. single-use: The next round in the World Series of Risk Assessments?

As summer starts its (hopefully) gradual fade into the record books and the marathon of the baseball season starts its kick to the finish line, it seems that we are (yet again) faced with some guidance from the federales that I think will be best served by having a risk assessment in your back pocket.

Over the past few years (truly, more than a few, but we can focus on the most recent past), there has been a lot of scrutiny regarding the management of endoscopes, including how much of a role clinical engineering might play in managing the scopes as devices, how to ensure effective processing of the scopes once they have been used, etc. And just the other day, I encountered an article discussing the FDA’s recommendation to begin transitioning to scopes with disposable parts, nominally to ensure the efficacy of the post-use processing process (don’t you just love a processing process!). You can find the meat and potatoes of the FDA’s recommendation here. I’d encourage you to read this very carefully as there is mention of process elements, such as the use of adenosine triphosphate (ATP) test strips to assess scope cleaning—a use that is not currently sanctioned by FDA—to the point that the FDA is asking facilities not to rely on the ATP test strips to assess scope cleaning. There’s some other stuff that is worth consideration, so (again), please check it out.

The recommendation does indicate (and, to a certain extent, provides for) a period of transition to the disposable scopes, but now that the proverbial horse is out of the barn, I think it is only a matter of time before our friends in the various accreditation organizations start digging into the transition process as a function of patient safety (I don’t think there’s any among us that would dispute this as a patient safety concern), particularly as to how we are keeping folks safe during the transition period. And how do we typically provide evidence of the process for mitigating risks? Why, it’s our old(er) friend the risk assessment process. I think it is crystal clear that this serves as yet another example of the collaborative process between infection control, clinical engineering, perioperative services—and I encourage you to make good use of the risk assessment process. Even more so, if you are scheduled for an accreditation survey any time in the next 12-18 months (until the use of single-use scope technology is more pervasive), I would get this on your to-do schedule as soon as possible. As with so many things, you may have lots of data to support that your existing procedures, etc., are not putting anyone at risk, but (as these things tend to devolve) we’ve already seen how a really (and I mean really, really) small incidence rate (that of risk de ligature) drive a veritable cornucopia of significantly painful survey findings. And there’s every reason to include this in the list of contenders for the next heavy duty survey focus area.

Conflagrations of unknown origin: Surgical fire prevention trends

Well, it appears that there remain opportunities for providing a fire-safe experience for surgical patients, at least based on the latest missive from the FDA. The safety communication (released at the end of May 2018) indicates that reports continue to be received by FDA of preventable surgical fires. I can’t think of too many circumstances—OK, none—in which a surgical fire could legitimately be considered unpreventable, though I have no doubt that you all have tales to tell of clinicians who feel that everything was done correctly and there was still a fire. I’d be interested in hearing some of those.

At any rate, the communication indicates several component strategies for appropriately managing the risk(s) associated with surgical fires—and if you guessed that a risk assessment figures into that equation, it may be that we have covered this ground before. So:

  • A fire risk assessment at the beginning of each surgical procedure
  • Encourage communication among surgical team members
  • Safe use and administration of oxidizers
  • Safe use of any devices that may serve as an ignition source
  • Safe use of surgical suite items that may serve as a fuel source
  • Plan and practice how to manage a surgical fire

I don’t think there’s anything that is particularly revelatory—these are by no means new expectations (for us or by us). It does appear that the FDA is going to be leaning on the various accreditation organizations (TJC, DNV, HFAP, CIHQ, AAAHC, etc., though TJC is the only organization specifically mentioned—aren’t they special!), so I think we may see yet another round of ratcheting things up in regards to surgical fire drills, providing education to clinicians, etc. I don’t know how much reaching out you might do relative to actual events in your surgical procedure areas (I can’t say that I always see a ton of information beyond fire drill and education documentation), but I think you’ll want to be able to speak to this as a proactive undertaking. Somebody must be monitoring these types of things and if it’s not you, you need to figure out who it is and keep yourself informed.

As something of a preemptory thought, I ran across a podcast entitled “Nurses for Health Environments” (you can find some background and links to the podcast here). I haven’t had a chance to check it out (I listen to podcasts as I work towards my 10K steps before breakfast, but I always seem to have a backlog of stuff to listen to), but I do believe that (particularly as a very large percentage of the healthcare culture) partnering with nurses and other clinicians in managing the environment makes a great deal of sense. Stewardship of the environment has to happen at every level of every organization, so I would urge you to check it out and maybe recommend it as a listening opportunity for the clinicians in your organization. I’ve always believed that marketing is an important piece of what we do as safety professionals and any (and every) insight into what folks are thinking about, etc., is worth consideration.

One less thing to pull out of your arsenal…

As we play yet another round of mishegas, it occurs to me that it’s been a while since I’ve really been able to tee off on something. Oh well, I guess it’s the little stuff that makes things interesting…maybe the February issue of Perspectives will provide fodder for my rant-mill… stay tuned.

First up, we have the (probably timely) demise of that titan of healthcare apparel, the powdered medical glove. It seems that the Food & Drug Administration (FDA) has determined that the risks to the health of users and those upon whom those gloves are used (including bystanders) are so egregious that it instituted an immediate ban on their use, effective January 18, 2017. The potential dangers include severe airway inflammation from inhalation of the powder; wound inflammation and post-op adhesions from contact with the powder, and allergic reactions from breathing powder that carries proteins from natural rubber latex gloves. You can get the whole picture here. While I do believe that powdered wigs are still de rigeur in certain circles (constitutional re-enactors, for one) despite the opening line in the VIN News article, I hope that these actions are not a prelude to restrictions on powdered doughnuts (or donuts, depending on your preference—for the record, my favorite is raspberry jelly!)

Breaking it down with TJC

Our friends at the American Society for Healthcare Engineering (ASHE) announced this week that they will be offering a series of webinars aimed at uncovering the mysteries of deep space, no wait, to introduce us to the inner workings of the 75 new performance elements in the Joint Commission standards, effective, well, pretty much right now. The featured presenter for the kickoff presentation is none other than Joint Commission’s Director of Engineering George Mills and it promises to be a rollicking good affair. That said, I do hope you are an ASHE member: if you are, the webinar is free; otherwise it’s $125, which seems a little steep for a single program (the advertising says this is a series of webinars, but this appears to be the only program scheduled at the moment, so your guess is as good as mine at this point). If I may indulge in a short rant, I’m still not convinced that having to pay to obtain access to TJC information that is not otherwise available as part of one doing business with the accrediting agency is a good thing. Not everyone has money in their budgets to do this (either membership in professional organizations or accessing educational programs) or the personal means to do this stuff on their own. While I am absolutely in favor of participation in professional organizations, I’m not sure that access to the insight of regulators is, while nice, the way things should be. Shutting up now…

Cue heavy breathing…

And let us end on a note of “Holy smokes, that was a near miss” (and I definitely did not see this one at the time—nor did I hear a ton of squawking). Last May, CMS decided to disallow hospitals from having security units that provide care for justice-involved individuals such as inmates and those in the custody of law enforcement or the state Department of Corrections. I’ve not worked with a ton of hospitals that have forensic units, but they are an important means of enabling hospitals to provide a safe environment for all while ensuring your forensic patient populations have appropriate access to needed inpatient healthcare services. Again, I didn’t hear a lot about this one, so it may be that the hue and cry was aimed in other directions; the American Hospital Association took up the cause and were able to convince CMS to rescind the “ban” (you can see the revised Survey & Certification memorandum here). This would have been a big time pain in the posterior for at least some number of folks, and may still be – I would encourage you to take a peek at the memorandum, including the scenarios presented at the end of the document—probably worth sharing with your organization’s leaders. I’m not exactly sure why CMS would have elected to go the route of disallowing security units for “justice-involved individuals” (that makes ’em JIIs—probably not an acronym that will catch on), though I would guess that ensuring patient rights are not violated in the process is a likely contributing factor. That said, any time a memorandum goes out on a specific topic, it seems to result in that topic becoming a wee bit hotter in the aftermath. No guarantees, but this might be a focus area in the coming months…

My heart is black and my lips are cold

Crash carts on flame with rock and roll!

I figured I’d start out the newly minted 2017 with a few brief items of interest: a device warning from FDA, some thoughts regarding post-Joint Commission survey activities, and a free webinar that some of you might find of interest.

On December 27, the Food & Drug Administration (FDA) communicated a warning letter to healthcare providers regarding potential safety issues with the use of battery-powered mobile medical carts. The warning is based on FDA’s awareness of reports of “explosion, fires, smoking, or overheating of equipment that required hospital evacuations associated with the batteries in these carts.” Apparently, the culprits are those carts powered by high-capacity lithium and/or lead acid batteries and it also appears that there is a distinct possibility that you might just a few of these rolling around in your facility. Fortunately, the warning (you can see the details here) also contains some recommendations for how to manage these risks as a function of the preventive maintenance (PM) process for the battery-powered mobile medical carts; as well as recommendations for what to do in the event a fire occurs (might be a good time to think about testing your organization’s fire response plan as a function of response to a Class C electrical fire). The warning letter also contains some general recommendations for managing the mobile medical carts. So, if you were wondering whether you were going to have anything interesting to put on the next EOC Committee agenda, this one might just fit the bill. As a final thought on this, I think it very likely that our comrades in the regulatory surveying world might be interested in how we are managing the risks associated with these carts—and if you’re thinking risk assessment, I couldn’t agree more!

Moving on to the post-survey activity front, TJC division, for those about to be surveyed (I salute you!), I have some thoughts/advice for preparing yourselves for a slight, but nevertheless potentially dramatic, shift in what you will need to provide in your Evidence of Standards Compliance—a plan for ongoing compliance. Now I will admit that in some instances, being able to plot a course for future compliance makes a lot of sense; for example, managing pressure relationships in procedural areas. If you get tagged for that during a survey, I think it’s more than appropriate for them to want to know how you’re going to keep an eye on things in the future. But what about the million and one little things that could come up during a survey (and with the elimination of the C elements of performance, I think we all know that it’s going to seem like a million and one findings): doors that don’t latch, barrier penetrations, dusty sprinkler heads, etc. There already exist processes to facilitate compliance; are we going to be allowed to continue to use surveillance rounds as the primary compliance tool or is the survey process going to “push” something even more invasive? It is my sincere hope that this is not going to devolve into a situation in which past sins are held in escrow against future survey results—with compounding (and likely confounding) interest. Sometimes things happen, despite the existence/design/etc. of a reasonably effective process. As I’ve said before (probably too many times), there are no perfect buildings, just as there are no perfect plans. Hopefully perfection will not become the expectation of the process…

As a final note for this week, one of the bubbling under topics that I think might gain some traction the new year is the management of water systems and the potential influence of ASHRAE 188: Legionellosis: Risk Management for Building Water Systems. I know we’ve touched on this occasionally in the past and I think I’ve shared with you the information made available by our good friend at the Centers For Disease Control and Prevention (check it out, if you haven’t yet done so), but in the interest of providing you with some access to a little more expertise than I’m likely to muster on the topic, there is a free webinar on January 19 that might be worth your time. In the live online event, “Following ASHRAE 188 with Limited Time, Money, and Personnel: Pressure for Building Operators and Health Officials,” respected expert Matt Freije will briefly discuss the pressure facing building operators as well as health officials regarding compliance with ASHRAE 188 to minimize Legionella risk, suggest possible ways to reduce the pressure, and then open the conversation to the audience. The 60-minute webcast begins at 1 p.m. EST. It’s free but space is limited; you can register here.

So that’s the scoop for this week. I hope the new year is treating you well. See you next week!

Steris SS1 fans have new alternative to consider that is FDA-cleared

Those of you who have been fans of the maligned Steris System 1 (SS1) processor may be interested in knowing that the FDA has approved an alternative to that product from Steris.

The new item is called [more]