Q: CMS and The Joint Commission require an “incoming inspection” before a medical device can be used on a patient. What is actually required for that inspection? Are there written regulatory requirements detailing what my inspection and documentation has to include? Is an electrical safety inspection and a basic mechanical “yes it works” enough? I’m assuming (love that word) the manufacturer sent me the new device fully functional and it survived transport to me intact? On a brand new device, do I need to do a full performance and output verification or can I just tag the unit, add it to my inventory, schedule the PMs, document an electrical safety inspection and call it done?
A: I do not know of any detailed requirement from TJC or CMS other than you need to do an incoming inspection. Always perform an electrical safety inspection if applicable and operational check. Over my career, I have seen many out of box failures with both electrical safety inspections and/or operational checks. There will always be equipment that your staff is not trained on, so electrical safety and making sure the unit turns on would be the minimum you would do. You can check with the representative that sold you the device or call the company directly on any operational check that might need to be done.
A: Basically, all you have to do is an electrical safety check and physical inspection. We require the manufacturer to provide the factory specification sheets, GE has been really good at providing this information without having to hunt it down. I don’t think this is required by TJC and CMS, but we require it. We feel that categorizing the item and getting it into our database with the proper documentation (such a PM schedule, risk analysis and vendor contact information) is equally important.
A: We have a checklist sheet that we use. Listing Lab, Hospital grade plug, EST, Performance Test and included Ops and Service manual.
A: Incoming Inspection should be done aaccording to The Joint Commission EC.02.04.03 EP1. “Before initial use and after major repairs or upgrades of medical equipment on the medical equipment inventory, the hospital performs safety, operational, and functional checks.”
A: We review the manufacturer’s manual to see what it says needs to be done prior to first use. If the manufacturer details incoming inspection requirements or has checks required prior to first use then they must be done to meet The Joint Commission requirement that you follow manufacturer’s guidelines. From my experience, there can be anything from a detailed procedure to just turning it on and verifying the self test passes. If there are no requirements we at least verify the electrical safety and that any scheduled PMs have been completed. We often have vendors bring equipment in for short-term use and act like they have never heard from anyone else that a manual is required or that anything other than electrical safety needs to be done.
One vendor brought a piece in that the manual clearly stated an annual PM was required, but had not been serviced in the five years the rep had the equipment. It had been checked by several biomed shops and passed through for use on patients. He contacted service and sure enough they wanted it back for PM and sent him another unit overnight. We are the frontline for this equipment and have to make sure that not only are we following requirements, but that the manufacturer is following their own requirements as well. If we don’t then no one will.
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