Good read – shocking situation if the allegations are correct. Had a feeling it was something significant after the recent articles around surgery pauses and external reviews.
This is a very good article, well above the normal standard of The Ditch.
Surgeons are allowed to use anything they want within reason. Usually it is off label use, whereby a medical device intended for one type of therapy is used in a different one. The difference is that it is still generally a medical device manufactured in a controlled manner and intended for human use of some kind.
In one scenario here, they used a product which should not have been used as an implant under any circumstances. A titanium spring that wasn’t manufactured for implantation or medical use, therefore it would not have the relevant material certs, manufacturing practices and sterilisation practices in place.
The other scenario was a device which may well receive regulatory authorisation in the future and could have been performed as part of a trial. This could have been acceptable depending on the supporting evidence and patient consent.
Stories like this never go anywhere because they’re too complicated to write about. Nobody in the general Irish media is realistically going to take the risk of reporting complex medico-legal matters with the risks involved to the media and the lack of reward as well. The public generally don’t care about these stories unless there’s a simple narrative that blames one person, almost always a minister.
3 comments
Good read – shocking situation if the allegations are correct. Had a feeling it was something significant after the recent articles around surgery pauses and external reviews.
This is a very good article, well above the normal standard of The Ditch.
Surgeons are allowed to use anything they want within reason. Usually it is off label use, whereby a medical device intended for one type of therapy is used in a different one. The difference is that it is still generally a medical device manufactured in a controlled manner and intended for human use of some kind.
In one scenario here, they used a product which should not have been used as an implant under any circumstances. A titanium spring that wasn’t manufactured for implantation or medical use, therefore it would not have the relevant material certs, manufacturing practices and sterilisation practices in place.
The other scenario was a device which may well receive regulatory authorisation in the future and could have been performed as part of a trial. This could have been acceptable depending on the supporting evidence and patient consent.
Stories like this never go anywhere because they’re too complicated to write about. Nobody in the general Irish media is realistically going to take the risk of reporting complex medico-legal matters with the risks involved to the media and the lack of reward as well. The public generally don’t care about these stories unless there’s a simple narrative that blames one person, almost always a minister.