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mrplunkey
New member
1) Picture two FDA-approved medical devices, both used to control blood, saline and contrast media.
2) Both devices feature compatible, industry-standard connectors. These two devices are to be connected in one of several configurations for which these products were designed.
3) Customers request the two items shipped pre-connected, to reduce the chance for error (hooking them up to the wrong place) and improve throughput in the cath lab (faster setup).
4) To insure safety, the two devices are bonded together using the same compound used to bond the industry-standard connectors to the original devices. This prevents the connector from loosening and potentially introducing air into the system (which could hurt or kill a patient).
Seem reasonable?
FDA in its infinite wisdom has declared this a new medical device since they are bonded. No one will go through that, so the connectors are instead shipped unbonded with a warning note in the package to inform users they need to hand-check the connection to insure air doesn't get into the system. The irony is that inserting the note costs more than just bonding the connectors in the first place.
USA! USA! USA!
2) Both devices feature compatible, industry-standard connectors. These two devices are to be connected in one of several configurations for which these products were designed.
3) Customers request the two items shipped pre-connected, to reduce the chance for error (hooking them up to the wrong place) and improve throughput in the cath lab (faster setup).
4) To insure safety, the two devices are bonded together using the same compound used to bond the industry-standard connectors to the original devices. This prevents the connector from loosening and potentially introducing air into the system (which could hurt or kill a patient).
Seem reasonable?
FDA in its infinite wisdom has declared this a new medical device since they are bonded. No one will go through that, so the connectors are instead shipped unbonded with a warning note in the package to inform users they need to hand-check the connection to insure air doesn't get into the system. The irony is that inserting the note costs more than just bonding the connectors in the first place.
USA! USA! USA!
