Standards I'd Like to See

The Centers for Medicare and Medicaid Services (CMS) Conditions of Participation (COP) standards and their derivatives (the standards from accrediting organizations such as The Joint Commission and DNV) are intended to improve the safety and quality of patient care. The one and only CMS standard for medical equipment states that such equipment must be maintained to ensure its safety and quality. Of course, we all know that accrediting organizations have added significant detail to this simple requirement. I've offered opinions—pro and con—about these details in a few columns.This time, I'd like to write about what is not included and perhaps should be. I think that, based upon common problems faced by clinical engineering departments, there should be requirements for how a hospital manages clinical alarms, how a hospital provides support for medical equipment users, and how a hospital manages educational requirements for medical equipment maintainers.There have been problems with alarms on medical equipment for as long as there have been alarms on medical equipment. Different alarms have been unreliable, unnoticeable, excessive, or difficult to use. In 2003, The Joint Commission (TJC) added a National Patient Safety Goal (NPSG): “Improve the effectiveness of clinical alarm systems.” This brought the appropriate level of attention to the issue. Interestingly, the JC dropped this NPSG after only two years. They purposely limit their running list of NPSGs so that the importance of each is not diluted. The clinical alarms NPSG did not make the short list in 2005 and the JC said that the requirement was still essentially covered by existing standards, even though clinical alarms were no longer specifically mentioned. At the time, the wisdom of this decision was questioned.12Since then, there have been numerous articles describing the problems with clinical alarms, and making recommendations for improving their safety and effectiveness.3–11 In 2007, MedSun held an online seminar, “Clinical Alarm Systems and Their Management.” Also that year, the American College of Clinical Engineering (ACCE) Healthcare Technology Foundation conducted an online survey to determine the problems with clinical alarms. The ECRI Institute has an “Alarm Safety Resource Site” available on their website. This past spring, AAMI published an entire issue of Horizons devoted to the subject of clinical alarms. This effort was supported by the ACCE, the Association of Surgical Technologists, ECRI, the Healthcare Technology Foundation, the Infusion Nurses Society, the Institute for Safe Medication Practices, and the National Patient Safety Foundation. In early October, there was a Medical Device Alarms Summit convened by AAMI, ACCE, the U.S. Food and Drug Administration, ECRI, and TJC. It remains to be seen whether one outcome will be a recommendation for a new accreditation standard.There certainly seems to be unanimous agreement that the use, design, and performance of clinical alarms are problems. There are requirements for alarm performance in individual device standards. However, there are no accreditation standards for medical device alarms. I think there should be, and I suggest this wording: The hospital manages clinical alarms, taking into consideration equipment selection, user training, maintenance, and support. These activities are documented.Since before there were biomedical equipment technicians (BMETs) and clinical engineers (CEs), clinicians have been asking for help from someone who (hopefully) knows more than they do about a piece of medical equipment when it does not seem to be working as intended. I'm old enough that I can attest to this from personal experience! Often, the alleged equipment performance problem is due to an error on the part of the user—not a malfunction of the equipment. Use errors, user errors, no problem found—what's in a name? Are you frustrated by what users do and don't do with “your” precious medical equipment? Can you see the issue from the user's point of view? There are a number of things that you can do, and probably most of you are doing already.You can visit clinical areas to look at equipment in storage spaces, corridors, and in use—really look at it! If equipment is not in use, is it stored where it should be? Should it be returned to a central distribution area? Is it in good condition or is it in need of repair? If it is battery powered, is it plugged in to maintain a full charge? Is it due for a scheduled inspection? Is it on 2E, but labeled as belonging to 3W?When visiting clinical areas, talk to users and front-line supervisors. Ask them if they have any questions or concerns about the use of any of their equipment. You will sometimes be asked about something you know nothing about. Tell them that you don't know, but that you will find out for them. You will sometimes be asked about something that clearly has nothing to do with clinical engineering. You can politely point that out, explain who is responsible for the area or offer to find out who does handle such problems, and volunteer to have the appropriate person get back to them. Take the time to be more than helpful, recognizing that you are probably better equipped to handle this than anyone else, that it will improve your reputation and your department's, and will ultimately improve patient care.BMET supervisors or managers should establish a regular schedule for these visits with the clinical area managers. If these “equipment rounds” are scheduled, clinical staff will look forward to your visits, and make them more useful and productive for both of you.Use your computerized maintenance management system to track “no problem found” calls. Provide a user-friendly report that you can share with clinical area managers, and use for constructive discussions on how to reduce or eliminate recurring NPFs. This can be a sensitive area if not handled properly. You might want to practice how to create a report, meet with a clinical manager, find out what the problems are, and provide recommendations. Perhaps the best person with whom to practice is a clinical area manager with whom you have a good rapport. (If there isn't at least one such person at your hospital, then you need more help than I can provide in a simple article.)When you do determine that there is a recurring issue with equipment use, find out what nurse educators do to train staff on equipment use. Using advice from these folks, do a couple of 15 to 30 minute presentations for staff at change of shift so you can catch everyone. Make sure that you use good presentation skills, including the proper tone, and the appropriate technical level.Binseng Wang and Brian Poplin recently wrote an interesting opinion piece about managing risk as well as severity.12 They point out that risk-based scheduled maintenance programs typically weigh the severity of an equipment malfunction, but don't really factor in the likelihood of a malfunction. They go on to encourage working with clinical and administrative staff to include problems with “use errors, environmental issues, and better selection of equipment.” I have always taken this one step further. I think that the three primary functions of a BMET are scheduled inspections and maintenance, repairing medical equipment, and user support. However, the priority order for getting these tasks done is: (1) user support, (2) repairs, and (3) scheduled inspections. Users come first because they are taking care of patients right now. Repairs are second because the downed equipment is depriving or delaying patient care. Scheduled inspections are third because you shouldn't be looking for new problems until the current ones are out of the way. Besides, the yield from scheduled inspections is going to be very low, versus a 100% yield from user support and from repairs, right?You can probably infer that user support is an expectation of accreditation standards. However, for a medical equipment management issue that is so important and so prevalent, a requirement for user support should be explicit. I suggest: The hospital addresses the needs of medical equipment users, taking into consideration equipment selection, user training, maintenance, and support. These activities are documented.It's safe to assume that every employer has education requirements for every job. This is also required by accreditation standards. TJC and DNV standards do a commendable job of taking education and training beyond job descriptions and orientation. They also require continuing education, demonstrated competency, and performance evaluations. This should be enough reason for any department, including a clinical engineering (CE) department, to plan, ju.tify, and fund an adequate program for staff training and education.All too often, however, CE departments do not have a plan for continuing education, and have no budget earmarked for that purpose. Dennis Cox recently wrote an excellent article on education and training programs for CE departments.13 He explains how to determine needs, the types of training that should be provided, and some alternatives for providing training and education at little or no expense beyond a little extra effort on your part.With the general requirements from accreditation standards and plenty of specific guidance available, why is it that we are constantly hearing complaints from CE departments that they have no budget for training? Hospitals, like every other segment of society, go through economic cycles. When this happens to schools, they cut “optional” programs, such as physical education, art, and music. When this happens to hospitals, the “optional” programs they cut are travel, continuing education, and lunch meetings. Eliminating continuing education and the travel budget to get to manufacturers' service schools for a year or two can be tolerated, but go beyond that, and it really starts to inhibit one's ability to do one's job. In fact, it could be shown that this actually costs more than it saves if repair costs rise as a result. (I won't go into the long-term harm done by eliminating lunch meetings.)Perhaps it just isn't obvious enough that continuing education and training are critical to the continuing success of CE departments. To make it more obvious, there should be an explicit requirement for the types of continuing education that CE departments need. There is a precedent for having a specific requirement for the physical environment (which includes medical equipment management) when there is a similar, general requirement for the entire hospital. TJC accreditation manuals have a chapter devoted to performance improvement standards, and the DNV accreditation requirements manual has a chapter devoted to quality management standards.Both manuals also have specific requirements for performance improvement and quality management, respectively, in their chapters on standards for the physical environment. Therefore, specifically for medical equipment management, I suggest: The hospital addresses the need for continuing education and training for medical equipment maintainers, taking into consideration the knowledge and skills required to maintain the organization's medical equipment, and to support the organization's medical equipment users. These activities are documented.I have often said that standards get you to do the right thing for the wrong reason. Speed limits are posted so that drivers limit their driving speed to a safe standard. How many of you are like me and limit your speed because of the standard—not because of the underlying safety? In the healthcare technology management arena, clinical alarms, medical equipment user support, and medical equipment maintainer education continue to be issues. All of us know that they should be addressed. If there were explicit standards for clinical alarms, medical equipment user support, and medical equipment maintainer education, odds are we would be doing a much better job of improving or eliminating these longstanding problems.