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Off Label Use

In a previous post, Medical Device System Network Install Issues, I suggested that when health care providers don’t follow medical device manufacturer’s specifications when installing medical device systems they were using the system “off label.” This site’s latest contributing author, William Hyman, provides an alternative perspective:

My interpretation of off-label use has been that it pertains to the actual use of the medical device, not the way it is set-up. Thus it isn’t off-label use until it is actually used, and use here is with respect to the Indications for Use, which do not generally address set-up and configurations as opposed to what the device is for.

Therefore a set-up or installation that is different from the manufacturer’s recommendations/specifications may be a modification rather than an off-label use. Other types of reconfigurations and changes would also be a modification.

Practice of Medicine Doctrine

Off label use is unregulated per the “practice of medicine doctrine,” but comes with some risk management issues. Also please note that this doctrine applies to physicians, not health care provider organizations. According to Hyman:

This is more than a semantic distinction. Off-label use of a medical device, at least by physicians, is legal and unregulated. This of course does not necessarily mean it is safe, smart, or well justified. The defense of an unsafe off-label use (if necessary) would be an after the fact liability matter, not a regulatory matter. However hospitals might be wise to have their own controls on off-label uses and require appropriate justifications.

After some research, I found that there’s very litte published — by the FDA or others — about the issue of post-market regulated device modification, especially by health care providers.  Hyman delivers more: (more…)

Read More: http://feedproxy.google.com/~r/MedicalConnectivityConsulting/~3/xmpfM25Banc/