Yet again, I’ve come across a public consultation about nanotechnology in the US. Their Food and Drug Administration (FDA) is holding a public workshop on the use of nanotechnology-enabled medical devices on Sept. 23, 2010. From the news item on Nanowerk,
The FDA Center for Devices and Radiological Health is organizing a public workshop titled “Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations” to be held on September 23, 2010 at the Hilton Washington DC/North Gaithersburg in Gaithersburg, MD. All parties who are interested in the application of nanotechnology in medical devices are encouraged to register and actively participate in this workshop.
You can get more information (including registration details) about the workshop from this FDA website,
The purpose of this workshop is to obtain information on the safety and effectiveness of medical devices utilizing nanotechnology. Specifically, FDA would like public input on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or utilizing nanomaterials and nanostructures, including diagnostics. FDA is seeking input on these topics and requests comments on a number of related questions.
This comes on the heels of on an announcement that the first nanosensors were embedded in a patient during knee replacement surgery. From the news item on Nanowerk,
According to orthopedic surgeon Dr. Martin Roche, Chief of Orthopedic Robotics at Holy Cross Hospital and Surgical Director of The Orthopedic Institute at Holy Cross whose team performed the first sensor assisted knee surgery, the advanced sensors allow surgeons to obtain improved soft tissue balance and patient specific kinematics, which is good news for the 600,000 patients who undergo knee replacement surgery each year. “The most advanced intelligent knee surgery now incorporates computer assisted alignment, customized robotic implant positioning and optimized sensor assisted soft tissue balancing,” said Dr. Roche.
The use of embedded nanosensors during minimally invasive surgery coupled with robotic technology allows the surgeon to customize the surgery for each individual patient’s knee condition. [emphasis mine] The surgery is performed with the MAKO Surgical robot which gives surgeons precise control via the robot to sculpt the knee and replace only what is needed. Dr. Roche was consulted on the initial development of the MAKO RIO and was instrumental in bringing that technology to market. First introduced in 2006, the MAKO robot has been used in more than 300 knee surgeries at Holy Cross Hospital.
I guess this os what they call ‘downstream’ public consultation, i.e. discussion while or after implementation has started.