The BMJ is asking Why aren’t medical devices regulated like drugs?
“How much do you know about the safety and effectiveness of the implanted devices your patients are offered? You may assume that pacemakers, neurostimulators, joint prostheses, and breast implants have been tested rigorously before being licensed for widespread use. But this week a major international investigation, involving 59 organisations and including The BMJ, finds device regulation unfit to protect patients from harm (https://www.icij.org/investigations/implant-files; doi:10.1136/bmj.k4999, doi:10.1136/bmj.k5010, doi:10.1136/bmj.k4917, doi:10.1136/bmj.k5026).”
This is part of a wider investigation by the International Consortium of Investigative Journalists into medical implant scandals. There’s lots of informaton on the Implant Files website. Contact them if you’ve a story to tell.
We’ve been watching the evidence accumulate that shows most disasters are ISO-certified disasters. Oxebridge reports on them often. While paying the ISO 9001 tax may be declining (why else would ISO fudge the figures?), agri-food and bioscience remain big growth area for UKAS accreditation.
In the next phase people are going to find out the role of the ISO cartel in making everyone think these devices were safe.