Q: Is the proposed legislation that would require the registration with the FDA any person who owns or operates any establishment in any state engaged in the servicing of a device or devices, or is otherwise engaged in the servicing of a device or devices a good idea?
A: In my opinion, your guess is as good as mine. Call me a cynic, but the proposed legislation is very broad and could migrate into areas purportedly not subject to this rule making. It is reported that hospital-based programs and their employees are not subject to this proposed legislation. Unfortunately, I see this as the “camel’s nose getting under the tent.” Once the “camel’s nose is in the tent, eventually the whole camel will be in the tent.” It is my opinion that this legislation must be eliminated from consideration. There is nothing that this legislation will fix as it pertains to patient safety. This notion of quality associated with the delivered service product always comes down to the individual who is preforming the service, whether or not that person works for the OEM, ISO or in-house department. If the end result of this legislation is to make the patient experience safer when health care is being delivered, then would not it be the appropriate solution to have the “servicer” of the equipment “armed” with all of the information to ensure that any corrective and preventive maintenance is done properly? Why is it that “servicers,” regardless of who employs the “servicer” has to “fight” to acquire all of the documentation and special test equipment to perfom the service? If “servicers” had access to all of this documentation, special test gear, and access to parts, I bet that might make patients safer.
A: Well said.
A: I agree and add that more interference from another clueless government entity would only make things worse.
A: I think the hospital based biomed/HTM would be under the exemption (to register).
A: I feel this legislation is nothing more than an attempt by the major manufacturers to eliminate any competition, especially a true cost-savings avenue for medical providers. I think better enforcement of currently written regulations and laws would provide a much safer patient environment. If the FDA would enforce the requirement that “all service documentation” be provided we could lessen the chance of an event. We have had to actually add a penalty as a line item on POs to get the required documents. By claiming to exempt certain groups to make this look good is nothing more than getting a foot in the door, once its opened it cannot be closed and then you are not exempt anymore. If you look at the history of the major manufacturers’ quest for ultimate dominance you will see that they consistently claim only manufacturer repairs are authorized. Then, they form there own “multi-vendor service group” and sell this service to repair other manufacturers’ equipment. Not just a little hypocritical at all.
Q: We are currently not happy with the ambulatory multi-therapy pumps we are using. We are looking for a new platform. Does anyone have any thoughts on a particular brand/model? We need one capable of TPN, PCA, and epidural.
A: We use Alaris units and they have a wide array of uses. The pickings are also kind of slim.
A: We are using the Alaris system for infusion as well. We have had them for almost 10 years now and have experienced no major problems with the system.
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