Hillary Groff: HTM’s Crucial Role with Incoming Medical Equipment

According to The Joint Commission (TJC) requirements, “The hospital evaluates new types of equipment before initial use to determine whether they should be included in the inventory. Before initial use of medical equipment on the medical equipment inventory, the hospital performs safety, operational, and functional checks. In addition, the hospital maintains a written inventory of all medical equipment.” Because of these mandates, our department’s standard operating procedure calls for inspections on all medical equipment brought into the medical center for clinical use. These incoming inspections must be performed by clinical engineering or healthcare technology management (HTM) personnel prior to the equipment being put into use.

During an incoming inspection, the equipment is examined visually, and an electrical safety check is conducted. In addition, there is a performance check to ensure that the equipment meets manufacturer and purchase specifications. The criticality of the equipment also is assessed to determine its inclusion in the preventive maintenance (PM) program. If the criticality assessment is missed, it would be difficult to meet TJC standard that ”the hospital identifies the activities and associated frequencies, in writing, for maintaining, inspecting, and testing all medical equipment on the inventory.”

Sometimes, a new piece of medical equipment is brought into the medical center for evaluation, loan, or demonstration without notifying all stakeholders, including HTM. This equipment, not owned by the medical center, still must be fully documented. The equipment may be entered in the PM program, especially if it stays on station longer than six months.

How can we ensure that all new medical equipment is inspected by HTM before being put into use? To begin with, HTM should be involved with all aspects of equipment procurement—from the initial discussions of new or replacement equipment to the actual implementation of the equipment. If such involvement can be achieved, HTM can reduce the number of surprises that arise when unexpected medical equipment is delivered. This involvement also creates a higher reliability system to mitigate future failures. The discovery of undocumented equipment during rounds will also decrease as HTM gets more involved in the cradle-to-grave management of equipment acquisitions.

Many medical centers have a standard, designated equipment procurement process.  The process should include a review by HTM, which should be asked to literally sign off on any procurement decision.  A cost analysis also is crucial so that the organization can understand the short- and long-term resource implications of supporting that equipment. In addition, clinical staff should be educated on the equipment procurement process, along with the process to obtain a loaner device or have a device brought into the hospital for demonstration. This education should stress the importance of equipment inspection and documentation to safe and effective maintenance.

In short, when HTM knows early on about new medical equipment coming into the medical center, the potential risks to patients and clinical staff are reduced, along with possible violations of regulatory compliance.

Hillary Groff, MSBME, is a biomedical engineer with the Central Arkansas Veterans Healthcare System.

9 thoughts on “Hillary Groff: HTM’s Crucial Role with Incoming Medical Equipment

  1. I would like to add that in many facilities, service of highly specialized equipment (MRI units, C-Arms, surgical robots, ultrasound diagnostic units, patient ventilators, etc.) is outsourced and biomed is not qualified to perform on that equipment anything other than visual inspection and electrical safety tests. Probably the only way to handle the upcoming inspections is for biomed to do visual and electrical safety inspections and to file vendor installation reports that indicate operational and functional tests performed by the vendors.

  2. Hi Mr Hyman. Here is another way to look at this: Each biomed has to be his own “gatekeeper.” It’s called “professional integrity.” What’s the value of the initials of a biomed who will put a sticker on a device without having and reviewing a service manual? To himself? His department? His employer? The caregivers and patients? We are in the situation we are in now with service manuals and OEMs withholding them because too many biomeds and CEs did not meet this basic professional standard. I think this may even link into the recent call for the FDA to review repair, refurbishment and maintenance practices, right along with the CMMS requirement about OEM maintenance practices that had us all jumping thru hoops the last couple years. If a salesman can walk into a hospital and be given a demo sticker just by getting a wave of the electrical safety tester, what kind of message does that send back up the chain to his people who make corporate policy? Any thoughts? anyone? Am I off base on this?

  3. If in-house service and repair were to become restricted, by future FDA action for example, would hospitals still be able to maintain an HTM department to provide the kind of essential services described here?

  4. I worked at a facility from 1983 to 1997, and we evaluated every piece of equipment prior to purchase; that was a our procedure. That was a county-run facility that had 233 beds. In 1996, a new building was built on the same site, and we did the same thing. We did a full examination on all the new equipment upon arrival. It was in the inventory months before the facility was populated.

    Today, I’m in a corporately owned facility, and things are a bit different here. The doctors and the corporate office make the decisions for new equipment without HTM input.

    We get reps that try to bring in new equipment, trying to convince doctors its the best thing going. Fortunately I have proposed to the doctors and staff that we need to standardize our equipment, and it seems that it is starting to work.

    With those standard equipment Reps, they bring in stuff without being requested. If I don’t have cause to kick the equipment out, I hold them to the Sunshine Act six weeks and the stuff is OUT. If the equipment is brought up during the quarterly meeting of the partners they make a decision.

    Today, I am working with the corporate office to make sure we only get the equipment that’s needed. We don’t need a fully loaded monitor when we only need to monitor basic vital signs. I have 29 high-level patient monitors for a low-risk facility. WE don’t do IBP, but we do 3500 surgeries a year.

  5. Hi HiIlary and HTM community. The KEY thing everyone needs to know about this topic is that for every biomed who does not have a service manual they need, there is a CE or biomed who failed in a big way when a salesman presented a device and asked for a “sticker” to DEMO the equipment. This is the point in time when a biomed has power and responsibility. If you don’t have the service manual and have read it and understand what the device is and how to test it, what “value” do your initials on that demo sticker have? If you don’t get the factory service manual at this point, you are putting your hospital, coworkers, caregivers, and their patients at risk by failing to get and review the documentation to back you up, guide your inspection, and meet the prevailing professional standard.

    The inspection of the device has a number of key check points. 1. Are there safety certs on the device like UL ETL, or TUV? (Note: the CE mark does not qualify as a safety mark.)
    2. Does the OEM have and provide to you, before the inspection, an NFPA-99 compliant factory service manual ? IF either of these 1st two checkpoints are not met, the device fails before the salesman gets it set up for you to physically test. Failure of the salesman to present the service manual needs to be an instant stop and fail if you, as a biomed, value professional integrity. For the HTM profession, we need to move toward a zero tolerance policy for OEMs and salesmen who don’t provide NFPA-99 compliant factory service manuals. That’s my story and I am sticking to it.
    Scot Mackeil CBET Quincy Ma.

    • Thanks Scot,
      All this is very true. Until the FDA tells the OEMs to supply the complete manuals and send them with the salesman/rep, this is a moot point. Several OEMs say their manuals are proprietary and can’t be supplied. The FDA does nothing to this point.
      The OEMs say they will release them when a training course is taken. The training courses are limited, too small, too few, too costly.
      We used to have the training put into the purchase price. To my understanding that is no longer available, and I have yet to hear a good explanation.
      In a facility like mine, a single biomed has little power. All I can do is trudge the road of happy destiny.

      • If you don’t have a service manual you need, it is because another biomed failed when the device was brought into the hospital. Our service manual problem is of our own making. Every biomed needs to put his or her foot down. And if questioned, invoke the magic word “liability.” I can’t accept that device into my shop without the service manual because of “liability.”

      • While biomed should be an important influence, it cannot be the gatekeeper without the support of higher administration. “No manuals, no sale” should be hospital policy, not just biomed policy, and biomed should work toward convincing administration of this. The OEMs will get the message when they can’t sell the product.

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