Sean Fenske, Editor-in-Chief10.16.18
In the latest issue of MPO’s sister publication, Orthopedic Design & Technology (ODT), my Editor’s Letter posed a question regarding regulatory approval of implants. Specifically, I wondered if all implanted devices should be required to submit a removal protocol to gain regulatory approval/clearance (read it here: http://bit.ly/odt181099). The question had been addressed during a Mike on Medtech podcast discussion (http://bit.ly/mpopodcast), and ultimately, a significant factor was brought up. That is, the FDA does not regulate the practice of medicine. Since an implant removal procedure would be considered the practice of medicine, the FDA has no jurisdiction. But that then counters the need for instructions for use and labeling requirements (to a degree).
That was essentially the comment from one ODT reader who sent me a brief note about the ODT Letter. He said, “The ‘practice of medicine’ bogeyman is a sham excuse and doesn’t answer the question of why instructions for (initial) use are required, but instructions for subsequent events are somehow different.”
The reader makes a very good point. If FDA requires instructions for use, why would instructions for removal be any different?
That moves the industry into a new and potentially unsettling realm. Should the FDA’s reach extend to specifically identified “practice of medicine” procedures? Does it make sense to alter the FDA’s charter such that it oversees certain aspects of healthcare delivery within the hospital or doctor’s office? I can guess immediately how the American Medical Association might respond to that suggestion.
To be fair, the idea may swing the FDA’s oversight of such matters too far in the other direction. A balance would need to be found for it to work efficiently. Further, resources are stretched thin as it is at the FDA, so how would giving the agency even more responsibilities help anyone? Well, the answer to that would require a significant, but perhaps logical, reorganization of some government agencies.
I’ve heard the idea floated of combining the U.S. Department of Agriculture with the FDA’s food segment. The FDA would then be left to primarily oversee drugs and medical devices. (Cosmetics and tobacco could potentially stay, or be placed into other agencies as well; for example, the Drug Enforcement Agency could potentially be tasked with tobacco.)
The idea would need further thought and revisions, but what remains would likely resemble a healthcare-centric task force. Or perhaps, more appropriately, the formation of the United States Health Force (USHF). I can’t take credit for the idea of the USHF; that goes to Chris Oleksy, who fleshes out the idea further in his column, The Supplier Advisor.
Another layer to this idea originates with the push for personalized healthcare and the advancements we are seeing in device fabrication capabilities. Additive manufacturing technologies are enabling innovative solutions at the point of care. There have been a number of stories where a 3D-printed tracheal splint was created at a hospital by doctors to treat pediatric patients. While still the exception, in my opinion, it won’t be long before we see many more stories like these for other therapeutic applications. Ultimately, they will undoubtedly become commonplace.
That concept brings us back to square one—the FDA’s lack of oversight into the practice of medicine. Certainly, with additively manufactured devices being fabricated in the hospital, the lines between the practice of medicine and manufacturing processes that need to be validated are blurred. When a surgeon can custom fabricate a spinal implant for placement during a procedure to accommodate an unusual anatomy, will that need to be under the oversight of FDA? When replacement organs are able to be grown in a laboratory setting within a healthcare facility, will that be deemed the practice of medicine or will that only be considered as the actual implantation procedure?
The difference between the two may be clear right now, but it will not be very long before these questions will need to be addressed. As manufacturing capabilities become more advanced, the medical solutions that can be addressed will grow. Ultimately, that’s a fantastic thing, but we want to ensure it is done safely. Companies will figure out the logistics of getting implant designs to the hospitals where they can then be modified for a specific patient and fabricated in an additive manufacturing machine. (I don’t expect the physicians to design an implant from scratch). But these machines will need to be inspected to ensure they remain at the required level to output medical devices and implants. Whether that’s tasked to the FDA, the USHF, or some other entity remains to be seen.
Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com
That was essentially the comment from one ODT reader who sent me a brief note about the ODT Letter. He said, “The ‘practice of medicine’ bogeyman is a sham excuse and doesn’t answer the question of why instructions for (initial) use are required, but instructions for subsequent events are somehow different.”
The reader makes a very good point. If FDA requires instructions for use, why would instructions for removal be any different?
That moves the industry into a new and potentially unsettling realm. Should the FDA’s reach extend to specifically identified “practice of medicine” procedures? Does it make sense to alter the FDA’s charter such that it oversees certain aspects of healthcare delivery within the hospital or doctor’s office? I can guess immediately how the American Medical Association might respond to that suggestion.
To be fair, the idea may swing the FDA’s oversight of such matters too far in the other direction. A balance would need to be found for it to work efficiently. Further, resources are stretched thin as it is at the FDA, so how would giving the agency even more responsibilities help anyone? Well, the answer to that would require a significant, but perhaps logical, reorganization of some government agencies.
I’ve heard the idea floated of combining the U.S. Department of Agriculture with the FDA’s food segment. The FDA would then be left to primarily oversee drugs and medical devices. (Cosmetics and tobacco could potentially stay, or be placed into other agencies as well; for example, the Drug Enforcement Agency could potentially be tasked with tobacco.)
The idea would need further thought and revisions, but what remains would likely resemble a healthcare-centric task force. Or perhaps, more appropriately, the formation of the United States Health Force (USHF). I can’t take credit for the idea of the USHF; that goes to Chris Oleksy, who fleshes out the idea further in his column, The Supplier Advisor.
Another layer to this idea originates with the push for personalized healthcare and the advancements we are seeing in device fabrication capabilities. Additive manufacturing technologies are enabling innovative solutions at the point of care. There have been a number of stories where a 3D-printed tracheal splint was created at a hospital by doctors to treat pediatric patients. While still the exception, in my opinion, it won’t be long before we see many more stories like these for other therapeutic applications. Ultimately, they will undoubtedly become commonplace.
That concept brings us back to square one—the FDA’s lack of oversight into the practice of medicine. Certainly, with additively manufactured devices being fabricated in the hospital, the lines between the practice of medicine and manufacturing processes that need to be validated are blurred. When a surgeon can custom fabricate a spinal implant for placement during a procedure to accommodate an unusual anatomy, will that need to be under the oversight of FDA? When replacement organs are able to be grown in a laboratory setting within a healthcare facility, will that be deemed the practice of medicine or will that only be considered as the actual implantation procedure?
The difference between the two may be clear right now, but it will not be very long before these questions will need to be addressed. As manufacturing capabilities become more advanced, the medical solutions that can be addressed will grow. Ultimately, that’s a fantastic thing, but we want to ensure it is done safely. Companies will figure out the logistics of getting implant designs to the hospitals where they can then be modified for a specific patient and fabricated in an additive manufacturing machine. (I don’t expect the physicians to design an implant from scratch). But these machines will need to be inspected to ensure they remain at the required level to output medical devices and implants. Whether that’s tasked to the FDA, the USHF, or some other entity remains to be seen.
Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com
