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COMPLIANCE


sional or another responsible party who has received the appropriate training from an HTM professional. The pre-use evaluation must include an electrical safety test and a test of all installed functions, as well as a physi- cal inspection for visible damage. The results of these activities should be documented in the inventory. This can be easy with a good CMMS or diffi- cult without one.


User training: At this stage, our device has been added to inventory and evaluated for function and safety for use within the EOC. It is nearly ready


for patient care. The same


EP that addressed who can perform the inspections on equipment also addresses who can use it. User training must be done and documented for end users. This is a clinical step and is often associated with the user’s manual or instructions for use (IFU) documents. The sales vendor will often provide this training. The CMMS is a great place to track this training and have it associated with the device, according to EC .03.01.01 EP1. Here is where the transient and fixed assets differentiate a bit. If a transient asset is only to be used for a short period, like a demo unit, the assignment to the inventory can be temporary. Manufacturer service documents should be requested and added to the inventory if possible. The device can be de-activated when it leaves the building and nothing more needs to be done. Short-term transient assets can be deployed into the EOC at this stage if they will not remain in the building long enough to allow the manufacturer recommended preventive maintenance (PM) cycle to lapse.


Manage risks: If a device is a fixed asset, meaning that it will remain in the EOC over more than one PM cycle, it must have specific PM tasks and frequencies assigned and be man-


aged on a schedule, by personnel that meet the criteria put forth by the manufacturer. These HTM person- nel should have the appropriate train- ing and certified testing equipment. They should be willing to provide documentation regarding both. This is where the CMMS is a lifesaver. CMMS were designed to document, schedule and report this kind of data.


Failures, incidents, recalls and notices: To complete its journey to the EOC, a device must have a writ- ten plan for how equipment fail- ures will be handled and escalated. There must also be a plan for inci- dent reporting and product recalls and notices that come from the man- ufacturers or other agencies, accord- ing to EC.02.04.01 EP 3, EP 5 and EP6). These can be simple policies or complex contingencies depend- ing on the device. It is a different sit- uation when a patient monitor in a


recovery bay has a dead display ver- sus a monitor on a C-arm. The plan for one might be to remove it from service until it is repaired, the other might require a backup or a rental strategy. These choices are site spe- cific but a written plan is required. A CHTM is a great resource to assist in developing a strategy that works best. The device is now ready for


deployment into the EOC. With an effective MEMP in place, it will be managed appropriately throughout its lifecycle and receive documented manufacturer recommended service at recommended service intervals by qualified personnel until it is ready to be retired from service and removed from the written inventory.


Ray Marden is the chief executive officer of Insight HTM, LLC in Bend, Oregon. Write him at ray@insighthtm.com.


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