Malcolm Ridgway: It’s Time for HTM to Take Care of Business

About five years ago, it came to the attention of the Centers for Medicare & Medicaid Services (CMS), that The Joint Commission (TJC), which is the largest provider of hospital accreditation surveys dealing with CMS requirements, was not enforcing a longstanding requirement. Specifically, the requirement—found in in the interpretive guidelines of Medicare’s Conditions of Participation—calls for medical equipment to be maintained “according to the manufacturer’s guidelines.”

When this was revealed, representatives of TJC were initially successful in persuading CMS that this very strict requirement was unnecessarily burdensome. They showed that documented patient injury statistics seemed to confirm that the more cost-effective alternative maintenance programs that have been in widespread use throughout the nation for many, many years were clearly adequate and acceptably safe.

As a result of this discovery and its subsequent discussions with TJC and other stakeholders, CMS issued a series of “clarification” memos, the first of which (in December 2011) relaxed the original requirement and permitted the use of alternate maintenance methods for all medical equipment, except for:

  • New devices for which there is still insufficient data on its safety, and
  • Other devices that are deemed “critical to the health and safety of patients and staff by a risk-based assessment performed by qualified personnel.”

However, at the urging of some of the equipment manufacturers’ lobbyists, a subsequent revision of the CMS requirement (in December 2014) has reintroduced significant restrictions for a few major device types. And clearly, without a more robust justification for TJC’s original contention that no patients are being put at risk by the traditional maintenance practices, the door remains open for the manufacturers to prevail upon CMS to extend these same restrictions to an even broader list of devices—again, presumably, only by virtue of their political clout and with no substantial technical justification.

The rebuttal from the healthcare technology management (HTM) community to this unnerving series of fundamental missteps backwards has, so far, been weak and ineffective, with no apparent prospect of convincing the CMS staff that preventive maintenance-related patient safety during these many, many years of conventional maintenance practices has been completely acceptable. This is particularly disappointing, but the challenge created by CMS’ discovery of this long-time non-conformance still provides an enormous opportunity for the collective HTM community to showcase its professional credentials and capabilities.

We need to come together to ensure that everyone at CMS and TJC understands the right way to perform a true, evidence-driven, risk-based assessment—and proceed from that point by initiating and overseeing the completion of just such an assessment. We concur completely that, as the nation’s watchdog on the effectiveness of services provided to Medicare patients, CMS has every right to ask for reassurance that those responsible for maintaining the nation’s medical equipment know what they are doing—and are able to prove beyond a reasonable doubt that the maintenance programs provided by independent (other than manufacturer) service providers are safe and effective.

Ladies and gentlemen, if we are really the managers of healthcare technology, we need to manage one healthcare technology issue that’s the size of an elephant in the room. Let’s get on with it and take care of our business!

Malcolm Ridgway is a retired clinical engineer who has been a leader in several initiatives aimed at elevating the HTM field and advancing the works of its professionals.

 

, , , ,

Connect

Subscribe to our RSS feed and social profiles to receive updates.

6 Comments on “Malcolm Ridgway: It’s Time for HTM to Take Care of Business”

  1. Malcolm Ridgway Says:

    Thank you to all who responded to my earlier post. The exchange has been very helpful. All of the comments have been positive and thoughtful. While we have not been overwhelmed by volunteers willing to help organize the reformation of our PM practices, the responses have made me realize that we do need to be more clear on why the old ways need to change. Out in the real world, nothing much has changed for the frontline practitioners “in the trenches,” and they may be confused on what this discussion is all about. (Thank you J Scot Mackeil for bringing this to my attention). Indeed, The Joint Commission is still going to be looking for the same attention to be paid to getting PMs for a substantial fraction of the facility’s medical equipment done on time–as usual. And, as I understand it, the biomed schools are still teaching the need for PMs the way they always have.

    A couple of years ago, I did try to organize a volunteer task force to address the implications of the changes initiated by the CMS and even set up a wiki–type website with a database all ready to receive the all-important data (the evidence) that we need to aggregate–see http://www.HTMCommunityDB.org *–but this effort has not resulted in any real progress or even created a helpful consensus among the “leaders”–at least, not yet.

    * Instructions for logging on to http://www.HTMCommunityDB.org: After clicking the “here” link on the opening page, you will be able to see the main page. This is a password protected wiki-type website, so follow the instructions at the top of the main page to gain read-only access. When asked to log in, use “view” as your username and “view” as your password. (Do not attempt to create an account.)

    There is quite a lot of material up there, but the most recent document, titled HTM ComDoc 15 “The Heart of the PM Debate,” is a fairly quick read. It attempts to provide concise answers to the four very important questions listed below. You can view this document by clicking on the link on the main page. The link is the first part of the title (HTM ComDoc 15).

    The four questions addressed are:
    1. To what extent does performing PM on medical equipment improve patient safety?
    2. Which devices can be made safer by periodic PM and which devices cannot be made any safer by periodic PM?
    3. Why do we need to standardize the format of our maintenance reports?
    4. Is there a simple metric that can be used to provide an indication of a device’s documented level of reliability and PM-related safety?

    If you can take the time to read through this one document, I would really appreciate your feedback before the AAMI Annual Conference in June. Do you agree with all of the answers, only some of the answers, or only some parts of some of the answers? You can respond by replying to this blog, or–if you prefer–by e-mail to htmc.mptf@gmail.com .

    There is another very compelling story up on the website which is pivotal to this whole new awakening. It is titled HTM ComDoc 14 “An Introduction to RCM; the modern approach to PM” and it is recommended reading for anyone interested in understanding that equipment maintenance in healthcare is the only industrial sector not utilizing the modern concepts embodied in the RCM approach.

    All of the material posted on the site is up for comment and suggestions. If you have the time and interest in reading any of it, I would appreciate your comments and/or suggestions by e-mail to the same address (htmc.mptf@gmail.com).

    Thank you (in anticipation) for your help with this important initiative!

    Reply

  2. Rick Schrenker Says:

    Thus spake the usual suspects…

    I have to give my usual cynical self some space in the following, but before I do I want to applaud Malcolm for speaking up as he has. Ditto everyone else for their as usual thoughtful comments, even where I don’t agree with them (for the most past, I do). I particularly resonate with Steve’s comments regarding what amount to the accrued opportunity costs of the current approach.

    OK, that’s enough of being nice…

    Among the insidious while simultaneously ridiculous practices of clueless bureaucrats that Joseph Heller skewered In “Catch-22” was that of coming up with an easy-to-obtain indicator of mission success, regardless of whether it provided any real indication whatsoever of obtaining the mission’s actual objective. In the book’s case, the indicator was how tight bomb patterns were during WWII bombing raids. Pilots of planes under heavy flak for some reason tended to try to evade being blown out of the sky, and as a result the photographs of the bombs they dropped tended to show them falling all over the place, often resulting in missed targets. Officers removed from the action decided to attempt to change that behavior by rewarding crews for making tight bomb patterns. On encountering heavy flak, one crew turned away from the coastline towards where they were heading and went back across the ocean towards their home base, dropping their bombs over a calm sea and thereby obtaining a tight bomb pattern that got them all medals.

    This battle has been going on within clinical engineering since before I stumbled in the door. We know – WE KNOW – that people are being hurt and even killed by mistakes and errors in aspects of health care delivery, some of which can be addressed via technological means. We know – WE KNOW – that there is little if any relationship between much if not most of the scheduled maintenance work that is being done and those mistakes and errors. We know – WE KNOW – what scheduled maintenance we do that actually does make a difference, and we know that it is decreasing with the nature of the changes that are continually occurring in technology. And yet we increase even more of our precious resources to the clinical engineering equivalent of producing tight bomb patterns.

    We know it. We’ve known it for decades. And we don’t push back. We don’t. Not really. We play nice in public, saying nice things about manufacturers who for decades have refused to provide us with the information we tell them we need to do our jobs, while behind the scenes we bitch and moan about the very real problems that and other of their practices create. And they’ve done it again, as Malcolm points out:

    “However, at the urging of some of the equipment manufacturers’ lobbyists, a subsequent revision of the CMS requirement (in December 2014) has reintroduced significant restrictions for a few major device types.”

    I’m reminded of Simon and Garfunkel’s words:

    “All lies and jests, til the man hears what he wants to hear and disregards the rest.”

    Bill, you were close. You’re right, we don’t live in a rational world. So why tango foxtrot do we continue to play the game as if we do? Where are the young ‘uns, and why aren’t they fighting back?

    Reply

  3. Stephen Grimes, FACCE FAIMBE FHIMSS Says:

    I am concerned about the issue of scheduled maintenance (of which true preventive maintenance is only a smaller and smaller component) because most HTM programs spend close to 50% of their manpower on these activities. I’m concerned because while I’ve seen that the type of medical technology being produced in recent years benefits less and less from scheduled maintenance (i.e., maintenance that generally is not improving reliability and that cannot be relied upon to assure users equipment is safe and effective), HTM continues to spend its limited resources on scheduled maintenance to the exclusion of addressing new challenges brought about by the introduction of increasingly complex and integrated systems. To a significant degree, I believe HTM continues to use scheduled maintenance to solve a problem that doesn’t exist to the degree it once did–that has in fact been designed out of much of the new technology–while they are largely ignoring new problems inherent in the those new technologies.

    So I believe continuing to spend HTM resources at the same rate on scheduled maintenance of new technologies not only significantly wastes those resources, but it diverts many of those resources from where they could have the greatest benefit.

    Here is where I believe we must consider seriously applying risk management and an evidence-based approach to maintenance.

    I believe arrayed against this kind of thinking is inertia, vested interests and proponents of the status quo. To gain some momentum and challenge the status quo, we all would need to pull together–to replace cacophony with drums beating in unison from our industry leaders. Perhaps we should consider asking AAMI to sponsor a task force that would provide a credible base from which we might orchestrate reform in this area. Such a task force would give a forum to HTM reps, regulators, manufacturers, CMMS developers, and other relevant stakeholders. It would be tasked with developing evidence-based guidelines for application of scheduled maintenance that could inform future “best practices,” mfg recommendations, future standards (or informative annexes to those standards), and regulations (from CMS, TJC, DNV, etc.).

    The risk of continuing to waste HTM resources on services for which there is no demonstrable benefit is too great to ignore this issue. We need look to where the evidence shows those resources can be most effective and reform our practices accordingly.

    Reply

    • Ted Cohen Says:

      I agree with Steve and Malcolm and second any effort to recommend

      ” … AAMI to sponsor a task force that would provide a credible base from which we might orchestrate reform in this area. Such a task force would give a forum to HTM reps, regulators, manufacturers, CMMS developers, and other relevant stakeholders. It would be tasked with developing evidence-based guidelines for application of scheduled maintenance that could inform future “best practices,” mfg recommendations, future standards (or informative annexes to those standards), and regulations (from CMS, TJC, DNV, etc.).”

      AAMI has the unique capability to bring together the HTM professionals with the manufacturers. Manufacturer representation would be key to this initiative. Beyond battery management, there are very few devices requiring true PM anymore.

      Meanwhile, we continue to waste huge amounts of valuable HTM resources in order to keep our institutions from being potentially cited for “violating” outdated regulatory requirements, and most of us cannot unilaterally do much about it because our employers are justifiably “gun-shy” about being cited by regulatory agencies.

      Perhaps AAMI can jump-start an initiative is this regard at the annual meeting in Denver.

      It’s about time we acted to correct this important problem so we can spend our time on clinically important issues (e.g. interoperability, alarm management).

      Ted Cohen, MS, CCE, FACCE

      Reply

  4. J Scot Mackeil CBET Says:

    Many posts on this forum are from the very top level leaders in the industry. I hope the views of those of us who work day in and day out with tools in direct support of caregivers are of value as well. My view from the BMET workbench is this: While there may be many OEMs who may call for “too much” or unrealistic PM, there are others who, in my humble opinion, for lack of understanding our industry’s professional standards, don’t call for enough or the “correct” PM.

    PM is a thing that we do because, among many reasons, we as an industry are professional, moral, and ethical. A key reason to perform valuable, meaningful, and effective PM is to ensure the doctors who treat our hospital’s patients are using equipment that is in good condition and functioning correctly, reliably, consistently, and accurately. A well-run and effective PM program is evidence that the hospital is exercising “due diligence” morally, ethically, and legally. The PM sticker you put on a device with your initials on it is in many ways a promise to the caregivers who use the device, that the device is as it should be and helps those caregivers meet one of many obligations they have: “First, do no harm.”

    I am a particular proponent of the “general equipment PM” in both the ASHE book, maintenance management for medical equipment, and the health devices general PM procedure by ECRI and book called Medical Equipment QA 2009. I think such procedures also may be considered a professional standards of practice. It also could be considered a template that a prudent OEM uses to gauge the PM procedures it writes and publishes. Sadly in my practice, I am finding many OEMs publish so called PM procedures that fall far short of the mark. What can our industry and the CE leadership do to correct this sad trend?

    A case in point: I recently had a medical equipment manufacturers rep here doing annual PM on the company’s surgical aspirators. I am vigilant about what goes on in my environment part of my job. Whenever I find vendors doing things with our equipment that I am not aware of, I stop and ask what they are up to. Most of the time all is well. I ran into two reps and a PM tech from this one company doing what they called “PM” on the aspirators. (These people looked like complete “fish out of water” in the care environment). I met the PM tech and asked about the PM. When I asked him how he was doing his EST, a blank look came on his face. He stated he had never heard of electrical safety testing, had never done it, and none of the hospitals he had worked in had asked about it. He said the factory PM procedure didn’t call for it, and he only did what the factory trained him to do. I said, “When you went to biomed school, I am sure you learned how to do an EST?” He said, “No, I didn’t go to biomed school. I have an IT background.” I asked if he was sure, and he reconfirmed his answer.

    I bit my tongue, voiced my concern gently, told this tech that he really should be doing an EST as part of the PM and left it at that. I checked the company’s factory manual and saw that there really is no mention of EST in it. Why had no other hospital asked about this?

    To me, someone with no more qualification than an “IT background,” doing PMs in any hospital on equipment that handles mass quantities of conductive fluids, in a wet surgical locations, who does not know what electrical safety is or how to check it, raises many red flags. That the OEM manuals make no mention of doing EST as part of the PM, is even worse and raises a few NFPA-99, CMS and TJC red flags.

    There is much being said by TJC and CMS about hospitals following OEM maintenance procedures, but little or nothing is being said about ensuring that OEMs create procedures that meet minimal professional standards. As a guy that works on the very front end of the CE profession, I am not the least bit thrilled about the way things are going. Too many OEMs are behaving badly with respect to service manuals, procedures repair parts, software, diagnostic access codes, etc. Many do this in direct opposition to the new CMS/TJC maintenance requirements.

    This particular occurrence really strikes me as a type of sentinel event and makes me ask what kind of course our industry and its leaders will take with the topic of “manufacturers recommended PM procedures.” Is it a one-way street? Or do we have a responsibility to push back in support of our professional standards?

    Is there a light at the end of the tunnel for us guys out here in the trenches? What are your thoughts?
    What are the thoughts of our leaders in the CE profession?

    Reply

  5. William Hyman Says:

    Malcolm continues the good fight on calling for rational determination of what are necessary maintenance intervals and necessary maintenance procedures. Unfortunately, we do not appear to live in a rational world.

    It can be noted that there was semi-organized resistance to full adherence to manufacturer’s recommendations (or guidelines, but rarely requirements), which ended up with the current state of partial adherence. But what we have is still not rational with respect to which devices are acceptable for alternative maintenance and which are not. It can also be noted that it is not CMS or TJC that have to actually do and pay for the work; they only have to declare that someone else do and pay for the work. Perhaps we can forgive TJC since it is just mimicking CMS’s requirements in order to sustain their deemed status, i.e., that being accredited by TJC (or some others) is taken as CMS compliance. Some states also have strict follow requirements, e.g., New York.

    It can also be noted that since there was no evidence that current practices were putting patients at risk, there will likely be no evidence that patient safety has been improved, even if someone looked for that evidence. Thus, we have a “solution” to a problem that doesn’t exist, which isn’t much of a solution. It would be possible to collect data on what is found while doing the required maintenance, to see if any value is accruing, but there is no systematic effort to do that that I am aware of.

    Who benefits is a tricky issue. Many believe manufacturers benefit, but some non-manufacturer sectors of the service industry also may benefit. Even in-house departments might benefit after a fashion if they get the resources needed to up their maintenance efforts and thus increase their perceived position in the hospital. On the hand, if people are doing more with the same (or even less), then either they weren’t that busy before, they are now overworked, or the burden is being carried by some other means and expense.

    Besides HTM (and its professional organizations) stepping up again. and stepping more boldly, the hospital executive industry needs to be heard from based on stronger input from their HTM providers, assuming the providers are not happy with the status quo.

    Reply

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: