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IFU? No, you IFU!

As this little screed represents the closing of the 2015 blogging season (I figure there’s gotta be a lumberjack tie-in—blogging and logging are just too close for words), I’m going to try and keep it relatively brief. If brevity is indeed the soul of wit, then I tend to be rather more witless than not…

Another recent trend in survey findings relates to the management of some of your more “peripheral” patient care equipment, particularly the stuff that gets used by the good folks in the rehabilitation/physical therapy world: hydrocollators, paraffin baths, etc. While I do believe that we have things well in hand from a medical equipment standpoint (most of the equipment being cited falls very clearly into the low-risk/no-risk category), where this is skidding a bit sideways is when the devices in question are not being maintained by the end users in accordance with the manufacturer Instructions For Use (IFU). Now, I will freely indicate that some of the equipment we’re talking about is almost Biblically ancient and the IFUs might not be easily obtainable, but in the absence of a risk assessment to indicate that maintaining this stuff in a manner that is not in strict accordance with the IFUs results in an acceptable level of operational performance/reliability/cleanliness, etc. then you’re at risk for yet another of the (seems like) gazillion little imperfections that are gracing survey reports across the continuum. Interestingly enough, these findings do seem to be “clumping” under the Infection Control standards (pretty much IC.02.02.01, EP 4, which deals with the storage of supplies and equipment), so this may not be on everyone’s radar at the moment. That said, it might be a good idea to poke around a little bit—including any offsite rehab/PT locations—to see if you have any survey risk exposure. Once again, I’m not convinced that this represents a significant risk to patients, but my being convinced (or not) doesn’t necessarily keep you out of trouble during survey. We need to be very sure about where we “stand” in relation to what manufacturers are recommending and what practices and conditions provide appropriate levels of safety, cleanliness, etc. The Joint Commission doesn’t tell us how to do these things, but we need to be able to respond definitively when the questions are (and there is a certain inevitability here) raised during survey.

And on that note, I wish each and every one of you a most prosperous, safe, and successful 2016. See you next year!

May you live in interesting times…no duh!

Well, now that we are well and truly ensconced in the post-July 2014 world, perhaps things will quiet down a bit on the updated standards front. It’s been a very busy first half of 2014 relative to The Joint Commission’s ongoing alignment with the CMS Conditions of Participation and perhaps they’ll allow the smoke to clear a bit so we can get down to figuring out how much impact the changes to the standards will have in the medical equipment and utility systems management pursuits. Kind of makes you wonder what’s left to update/align, but let’s hold that card for another day.

So, the last salvo in June saw some fairly interesting edits of (to? you be the judge) the medical equipment and utility systems management standards and performance elements (visit here for details). As near as I can tell, the most eventful changes relate to the change of the life support and non-life support equipment categories to a somewhat more expansive (or at least it seems that way to me) categorization of high-risk (which includes life support medical and utility systems equipment) and non-high-risk (which includes pretty much everything else). To be honest, most (probably all, but I don’t want to use too big a blanket for this) of the programs I’ve had the privilege to review/evaluate have moved to the high-medium-low-no risk strategy for assigning preventive maintenance activities and frequencies, so I’m not sure that this will require any fundamental changes to how folks are administering their programs. But (and there’s always, always, always one of those when there is an official change in the standards), I am curious to see how these changes will be applied during accreditation surveys. I expect the life safety surveyors to have a good grasp on the practical impact of the changes, but what about the rest of the survey team as they wander around the corridors of healthcare organizations across the country. It’s not unheard of for standards changes to “drive” an increase in findings in those particular areas as surveyor knowledge expands/contracts/evolves/mutates so it will be interesting to see what types of findings may fall out of the changes.

I guess my best advice at the moment is to do a careful assessment of where your program is relative to the “new” standards, particularly if you have adopted an “alternative equipment maintenance” (AEM) program (this must be that alternative lifestyle I keep hearing about…). I suspect we are all going to need to be prepared to make full use of the post-survey process (especially the clarification process) to demonstrate the “compliance-ness” of our programs. As I tell folks at virtually every stop on my never-ending tour of hospitals, there will always be surveyors that will disagree with programmatic decisions that you’ve made. Your task/responsibility is to have a very clear understanding of how your program meets the intent and the spirit of the standards, regardless of how something might “look” to a surveyor. At the end of the day, it’s about supplying to our customers safe and reliable medical and utility systems equipment—and as long as we can demonstrate that within the confines of the standards –then we have fully honored that obligation. And that, my friends, is what compliance-ness is all about.

Do you remember? Or even yesterday…

Way back in September of last year, we were chatting about the importance of appropriately managing conditions in the patient environment, primarily the surgical environment. For those wishing for a refresher, you can find that post here. (I talked about how I’ve noticed recent citation in surveys regarding the surgical environment, including the maintenance of temperature and humidity, ensuring appropriate air exchange rates, and making sure that your HVAC systems are appropriately maintaining pressure relationships, etc.)

One of the things I didn’t really cover back then was when you have documented out-of-range values. Could be temperature, could be humidity, could be those pesky air exchanges and/or pressure relationships. The fact of the matter is that we live in an imperfect world and, more often than not, our success comes down to how effectively we manage those imperfections. And that can, and does, come down to how well we’ve prepared staff at the point of care/service to be able to respond to conditions in the environment. But, in order to get there, you have to undertake a collaborative approach, involving your infection preventionist and the folks in the surgical environment.

The management of risk in the environment doesn’t happen because we have (or don’t have) nifty technology at our disposal; it’s because we can work collaboratively in ways that no building automation system or self-regulating HVAC equipment can. This idea has become an increasingly important part of the survey process. We know that more folks are harmed by hospital-acquired infections and other related conditions and I’ve seen it become a fairly significant survey vulnerability. So, let’s start talking about this stuff with the end users and make sure that we’re ahead of the curve on the matters of the care environment.

Manufacturer recommendations?!? We don’t need no stinkin’ manufacturer recommendations…

As you’re no doubt aware, there is some movement afoot relative to the inclusion (or exclusion, depending on your preference and organizational experience) of the risk assessment concept when it comes to the establishment of preventative maintenance frequencies for medical equipment. The Joint Commission has historically encouraged the use of data and past performance to provide a backdrop for the most efficient utilization of clinical engineering resources. However, CMS has been pretty adamant and absolute in their preference for manufacturer recommendations for PM frequencies to be the “be all, end all” source for determining such things.

As we take on the next in our informal series—CMS – what up with them?—we bounce once again to the web–

Click here.

–and find that, lo and behold, there has been some relaxation in terms of scheduled PM frequency. The caveat, at least for the moment, is that although we can judiciously schedule preventative maintenance activities to our heart’s content, we’d best not stray from the manufacturer recommendations for what those activities will include.

Now, off the top of my head, I can’t think of too many instances in which you would modify manufacturer recommendations for such activities, but maybe you can. I’m not sure how effective this will be; my gut says it helps in the long run; the fundamental change is toward a more flexible planning (they’d have been looking for us to follow manufacturer recommendations for the PM activities anyways, so this is really nothing new as near as I can tell – please feel free to disabuse me of that notion).

What say all you clinical engineers out there?

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]

Look beyond The Joint Commission for rules on who inspects imaging items

The Joint Commission does not specify in the environment of care standards who inspects imaging equipment, but where this all kind of spins out from is in the CMS Conditions of Participation (COPs).

The Joint Commission has been working very diligently– though often, seemingly, at the business end of a sharp stick — to come into closer compliance with the COPs.

The COPs section on nuclear medicine (and yes I recognize that imaging and nuclear medicine are not necessarily synonymous, but sometimes compliance becomes a function of how far you can stretch a concept) requires the following [more]

Medical equipment cleaning: Bags, tags, and ribbons

The trick when it comes to cleaning medical equipment is how will frontline staff differentiate between clean and dirty items.

Some of the options I’ve seen include [more]

Stick to required policies in your physical environment program

Sometimes you hear about Joint Commission surveyors requesting to see certain policies in your physical environment program.

Joint Commission standards are not very prescriptive when it comes to the identification of specific policies. The only required policies are [more]

A 24-hour reporting period for medical device injuries is a good approach

I was asked by a hospital about its policy for reporting patient injury or death related to medical equipment use. The policy states that the reporting time frame for an incident is within 24 hours of the occurrence.

I looked at information posted [more]

Generators act as protagonists in a Katrina-themed court case

I wrote an article for HCPro’s sister company, HealthLeaders Media, about a trial going on in New Orleans that, believe it or not, may connect a patient death following Hurricane Katrina to poor emergency generator system design.

How many times have you either personally experienced or read about post-drill critiques that recommend infrastructure changes due to emergency power concerns? I hear about it [more]