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Post by SrCusEngr on Mar 18, 2024 20:23:42 GMT
There are two groups that own/use Fresenius equipment. Those that are owned by F and those that are not. The group that is owned by the big F must follow their rules and regulations. But those that are not aren't under any requirement to comply. They bought the machines, and it is theirs to do with as they may. Note that the gentleman from RPC indicated that components do not control 510-K approval. I think RPC, a well respected company in the dialysis community, knows what they are talking about. And for someone to come out and state "Well for F machines, you cannot..." is doing a disservice. That may be true for F owned operations, but only F owned operations. There are many independently owned facilities that can choose for themselves. Stop trying to scare them.
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joey
Full Member
Posts: 226
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Post by joey on Apr 10, 2024 17:53:38 GMT
RPC is an FDA registered medical device manufacturer. RPC specializes in products for use in dialysis. Over the past 31 years, since the inception of RPC, RPC has had zero product recalls. In the past three FDA routine audits of RPC - spanning a 12-year period – RPC has received zero citations from FDA. While adhering to FDA/ISO requirements, RPC does design and manufacture specifically for dialysis use improvement. This RPC approach – designing for improvement - includes component parts. That said, component parts do not require FDA clearance. RPC BP cuffs and the connectors are considered to be component parts and have been in widespread use in dialysis for decades. RPC has been active in the AAMI Renal Disease and Detoxification (RDD) Committee – that sets the guidelines and standards for dialysis – for decades. The AAMI RDD Committee includes FDA, CDC, CMS, Fresenius, DaVita, USRC, other manufacturers and other dialysis providers. RPC continues to have an excellent working relationship with all of these entities.” None of what you said actually addresses the issue and that is using non Fresenius approved parts voids the 510K for the machine. Is it going to hurt a patient, I would guess no. Will you be cited for it, probably not. Do I wish Fresenius would improve some parts or allow more alternative parts, absolutely, but they haven't and until they do we can't use them officially. Doesn't matter how great RPC is or how great their product is, it has everything to do with what Fresenius allows. My tip is when you use a part order the part. For machines usually I order monthly based on what I used. For everything else I order I as I use it. I replace a UV light, I order new right away that way I always have spares on hand for the just in case. What you said is not entirely accurate. If they use the RPC component parts such as these connectors, it does not negate the 510k, however, like SrCus said, if it is a Fresenius owned clinic and they have a policy or rule against you using them, then you should not use them. That is not because it negates the 510k...it is more likely they are protecting their pockets, not the patients.
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