Advances in health care happen in a variety of ways.
Sometimes they occur as a matter of necessity – the desperate attempt to save a life.
Sometimes they occur as a matter of luck – the “eureka” moment of discovery.
Most of the time they occur as a result of thoughtful innovation, development and assessment, and then tested for reliability and safety.
When you take a prescription or an over-the-counter drug, you probably don’t give very much thought as to how that particular medication came to be; you know what it does, potential side-effects and why you’re taking it.
But there’s a strong process in place for developing new drugs and making them available to the masses, to ensure quality, safety and effectiveness:
- The drug manufacturer tests it and submits evidence through a “new drug application” to the FDA’s Center for Drug Evaluation and Research (CDER).
- A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists then review the data provided in the application and propose labeling, should it be approved for use.
- After that a clinical research process continues to test the validity of the studies and role of the medication in the treatment process.
Clear. Effective. Tested.
Ever wonder how the tracheostomy came to be a surgical method of treating an obstruction in the trachea?
The technique was clearly an innovation at the time. But it was not required to go through a randomized controlled trial or other strictures required of new prescription drugs and medical procedures.
You can take a drug “off label” for other uses – there’s a clear method for researching alternative uses and effectiveness as such.
Shouldn’t we have something similar in place for new surgical techniques? For surgical and procedural cases, the “off label” uses are not as clearly understood or often as rigorously scrutinized.
Once the “off label” procedure is proven to work, how do we ensure that it is safely performed by other surgeons and proceduralists?
Patient safety during the learning curve posed by all surgical innovation has been a matter of concern for about a decade.
Enter an international collaboration of surgeons and related professionals from University of Oxford in England.
The group responded with the creation of IDEAL – its recommended guidelines that provide a new set of patient safety standards coordinated for Innovation, Development, Exploration, Assessment and Long-term Study.
The standards are offered as a framework for developing, performing and reporting surgical innovations that, unlike new medical treatments, are not under strict regulations and control.
Those guidelines made it possible for a group of Henry Ford Hospital surgeons to do something extraordinary in India – a first-of-its-kind in the world.
Three years ago, Henry Ford surgeons and researchers set out to test a minimally-invasive kidney transplant cooling technique conceived by Mani Menon, M.D., chairman of Henry Ford’s urology department and a pioneer in robot-assisted surgery.
They decided to develop, test and learn the technique using the IDEAL guidelines.
After the study period, the innovative surgery was recently described in several peer-reviewed research papers published in European Urology, the journal of the European Association of Urology.
The Henry Ford researchers designed the study in collaboration with their counterparts at Medanta Hospital in Gurgaon, India, where pioneering work in robot-assisted kidney transplant surgery is also being conducted.
They reasoned that since minimally invasive robotic surgery has proven to be a great benefit to healthy kidney donors, it might also be a boon to the ill and fragile transplant recipients who are at greater risk of complications.
They also noted British research in 1971 that showed kidney function was partially impaired in recipients if blood flow was interrupted for longer than 30 minutes during transplant.
Dr. Menon’s concept was to address that hazard by cooling both the donor kidney and the transplant site with sterile ice slush in hopes of increasing the amount of time in which they could safely learn and perfect the robot-assisted surgery.
When their study period was over, healthy kidneys had been successfully transplanted in 100 recipients using the new technique at Medanta Hospital.
The hope is that this success – achieved by using the IDEAL guidelines – will encourage other transplant teams to try the new technique.
“As far as we are aware, (this team is) the first to take a surgical innovation through consecutive stages of the IDEAL Framework using the guidance provided in the Recommendations,” wrote Peter McCulloch, chairman of the IDEAL Collaboration, who commended the Henry Ford research team in a recent editorial on the Oxford group’s website.
“The information supplied in their published articles demonstrates the benefits of this approach and we congratulate them on their pioneering work.”
Within the next few months, this now-proven procedure will be available Henry Ford Hospital.
Congratulations to the Henry Ford team for its pioneering research and extraordinary work, demonstrating proven practices that place patient safety at the forefront, while opening the door to future surgical innovation!