A: I give the spare parts requirement with technical specifications to a section in the purchase department of my organization which is responsible for procuring medical and surgical items to be used in the organization. Most of the times they turn back to me to ask for the list of suppliers that may be in the capacity to supply those spares. Also, they ask me the approximate price of the spare parts. I don’t think this is a better approach considering the fact that most of the members in the purchase department have less knowledge on medical equipment and may not be in a position to lock onto the right source for the right spare and turn back to me a number of times causing unwanted delays.
A: Both vocations I have been at, we, CE, enter the order into a system and then purchasing cuts the purchase order number and orders it for us.
A: Biomed orders our own parts. We have our own purchase orders and, when needed, our own credit cards. If left up to purchasing there would be delays, incorrect parts and general confusion.
A: In our system, CE opens purchase orders for parts ordered. Some items are done centrally, but for the most part, CE does the parts ordering.
A: As a general rule, biomed specifies the part number and manufacturer, but materials generates the purchase order and places the actual order. If there is an urgent need, or extenuating circumstances, then we will place the order directly.
A: The first question, is whether a medical device is still under a manufacturer’s warranty or under a manufacturer’s maintenance agreement – there may be contractual requirements for use of only the OEM’s parts. When considering an alternative battery, the third party must meet the same regulatory requirements as the original equipment manufacturer. The third party should be registered with the FDA, Health Canada or the regulatory bodies of other countries. They should also have a quality system in place demonstrated by ISO certification and a complaint management system. You can request data from a third party, such as numbers of product complaints, failure rates, details of the inspections by regulatory agencies, ISO certificates, etc. A well-designed and manufactured third-party battery for a medical device should have no different performance from the OEM’s battery.
A: I want to be clear here. Has the manufacturer done something to prevent you from using a third-party battery or are you trying to get something from them saying it is OK to use a third-party battery? If it is the latter then I doubt they can. In a recent review meeting with FDA on 510K filing on a piece of lab equipment they wanted to know what we were doing to prevent the operator from making changes to our compiled code. We had to explain that compiled code isn’t the same as a text or Word document. The point is, there may be something in their filing that prevents them from authorizing use of batteries that they didn’t test.
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