Alan Lipschultz: Are You Ready? Two Big Changes on the Horizon for HTM

Two standards in development will, if approved, significantly impact the healthcare technology management (HTM) field. If they aren’t already on your organization’s radar, they should be.

The first one involves a push by medical device manufacturers to get hospital-based and non–manufacturer-based service organizations to follow some of the quality systems requirements that manufacturers currently follow. Via direct request from the Food and Drug Administration (FDA), the Medical Imaging & Technology Alliance (MITA) is taking the lead on this effort by developing a national voluntary standard: American National Standard for Servicing of Medical Imaging Devices.

The actual requirements of this draft standard are quite fluid at this point; several hospital-based HTM groups and independent service organizations are working to shape this draft standard in a manner that will be “reasonable.” Expect a focus on having a formal quality management process and on a process for qualifying substitute parts. If adopted and recognized by the American National Standards Institute (ANSI), this voluntary standard is likely to be further “recognized” by the FDA and/or the Centers for Medicare & Medicaid Services. Recognition by one of these federal agencies would make it “near mandatory.” If ANSI adopts this MITA standard, another medical device manufacturer’s organization likely will attempt to broaden the scope to include other types of medical devices. At this stage, whether ANSI will adopt this standard is unclear, in part because conflicts may exist with the scopes of the AAMI EQ56 and EQ89 documents, which also are ANSI recognized. I am a member of the committee working on this draft standard.

The second major change is one that I am personally advocating: namely, an effort to standardize the service nomenclature and coding of service information within the medical device industry. Right now, each manufacturer and independent service organization develops its own service nomenclature and coding scheme. At best, that provides consistency within one organization, but it precludes exchange of data among organizations. The long-term goal is electronic data interchange (EDI) among the various organizations servicing medical devices, for which data standardization is a prerequisite. I believe EDI offers the potential for a win-win situation for all organizations that service medical devices.

For many years, I was the director of an in-house clinical engineering program and responsible for keeping complete service records of the medical devices in the organization, regardless of who serviced the equipment. When outside vendors serviced medical devices in my organization, the best we could hope for was a electronic copy of the outside vendor’s work order, usually in PDF format. My staff then would manually summarize the vendor work order in our internal computerized maintenance management system (CMMS). The data summarized in the CMMS contained only a fraction of the information in the vendor’s actual work order.

Looking at this same situation from the viewpoint of the medical device manufacturer, I’ve now come to appreciate that the FDA holds manufacturers responsible for postmarket surveillance of their devices. From this postmarket activity, each manufacturer is supposed to spot problems and trends that pose a potential threat to patient safety and device reliability. Although manufacturers are aware of the activities of their employees, they generally are blind to service performed by in-house clinical engineering programs and other outside vendors.

At times, my team would spot a pattern with one particular model or device and report it to the manufacturer. However, within my institution, the odds of us catching a particular problem often depended on the quantity of a particular device and the ability of an individual to recognize a pattern within the data. Because we didn’t have access to similar events that might be happening in other hospitals, we never saw the big picture.

The overall system would work much more efficiently with EDI. With EDI, the outside service vendor could send the hospital a short file that could be directly imported into the CMMS. On a monthly basis (or some other interval), individual files then could be sent to the various manufacturers represented in a hospital’s inventory of all service events on that manufacturer’s devices. Then, the manufacturer could import all of those service events into its internal CMMS system. The more hospitals that voluntarily send service data to device manufacturers in a useful, uniform manner, the greater the likelihood that a manufacturer would have enough data to spot device problems sooner and therefore release timely fixes.

EDI requires all parties to use the same terminology, agree on the data elements that need to be interchanges, and agree on a common format. Given that all existing organizations have a major investment in their data structure and system, standardization and EDI will require all parties to recognize the enormous potential benefits and set a common goal that all can strive toward. I am the chair of AAMI Reliability-Centered Maintenance Task Force, and one of our goals is standardizing data within the HTM field.

My prediction is that eventually, the medical device service industry will use EDI—the only question is how long it takes us to get there. Other industries and their various players have benefited considerably by implementing EDI systems. So let’s get started!

Alan Lipschultz, CCE, PE, CSP, CPPS, is president of HealthCare Technology Consulting LLC in North Bethesda, MD. He was director of clinical engineering at Christiana Care Health System in Delaware from 1989 to 2011. He is vice president of the American College of Clinical Engineering and a member of the BI&T Editorial Board for AAMI.

4 thoughts on “Alan Lipschultz: Are You Ready? Two Big Changes on the Horizon for HTM

  1. With regards to the 2nd option, this is in effect the same requirement of all regulatory bodies around the world – the reporting of incidents and sentinel events (or never events). A system which has effectively failed the patients on the receiving end of both.

    Hospitals, users of equipment, and biomeds generally do not report either. Regulators are both slow and ineffective in their response, but just like our commitment to electrical safety testing, the wheel keeps turning.

    You simply can’t expect people who use equipment and are not competent with respect to its features and limitations to be in a position to, with confidence, identify and report an incidence. Use and user error are the metric required to measure and manage this and user troubleshooting is a skill which needs to be acquired to improve the current situation.

    Just like the GP within the healthcare system, hospital-based biomeds are the gatekeepers and should be reporting these and any other tech issues, but they don’t.

    With respect to alerts and recalls, there is a lack of transparency. Manufacturers generate the vast majority of equipment reports and the end users never get to see these even though about 10% apply to use. If users were required to read and sign off on these (i.e., equipment nurses and super users within a hospital ), they will become part of the solution.

    It seems like we adding a new system on top of a broken existing system, utilizing the same group of people who have not bought into it or see little real value in participating.

  2. Alan, thank you very much for your thoughts and leadership on this issue. I’m in full agreement with Scott’s comments. The OEMs very much want to monopolize the ability to provide service to equipment and limit the ability of third-parties and owners from doing the same. Medical device OEMs have a convenient ally in the medical device regulations. But there needs to be a balance between restraint of trade and monopolization and patient safety, quality and compliance on the other. There needs to be a win-win solution for both sides, and I commend the work you are doing in this regard. On the idea of EDI, for years, I thought that the most valuable asset we had was over 7 million CMMS entries of failure modes for various types of equipment that the OEMs could use for aftermarket compliance purposes. Some cynical friends reminded me that the last thing OEMs want is more data that may complicate their postmarket reporting, or at worst, reveal potential liability issues. I’m less cynical and do think that EDI would be an excellent way to collaborate with the OMEs for the benefit of patient safety and equipment reliability. Keep up the excellent work. Dennis Meseroll, MD, Asset Management Systems.

  3. Hi Alan,
    Thanks for the insightful update, for your work to give the HTM profession increased visibility, and your ongoing contribution to theses committees. All much appreciated.

  4. Alan, as always you are right on.

    As a working biomed, watching and participating in this topic over time, my largest concern is that our industry has an organized, methodical and formidable adversary in MITA and Peter Weems and that adversary has been able to very seriously impact HTM with legislative and regulatory initiatives at the state and federal levels on multiple fronts.

    Here in Massachusetts, they are trying to neuter our pending right to repair legislation by getting an exemption for class 3 medical devices. (Much of what biomeds work on falls in this category.) I would assume they have this request going on in other states that has similar bills in process.

    HTM seems to be struggling to mount an effective organized defense. I hope this can change in time. AAMI being “neutral” and staying out of this is handicapping HTM. My hope is with you working in these committees and groups our defense can improve.

    Ideally, HTM needs to go on offense and build a lobbying initiative that can counter our adversary effectively.

    I support your efforts and hope for the best.

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