Regulations For Everything Except : "I've Fallen & Can't Get Up "
In a world that regulates toxic waste disposal ,fuel emissions, food additives , communications signals and hundreds of other areas touching our daily lives , we don't regulate the quality of the medical devices we place in our bodies . Yes -- it's true , "I've Fallen & Can't Get Up " could very well apply to the fact that the entire medical implant community has no compelling reason to check or inspect the various bone screws and associated , hip ,knee ,elbow, shoulder ,or spinal devices that are placed inside thousands of patients yearly. It's hard to believe that the only FDA guidance on implant quality control comes under the guise of 510 (K) processes which only mandates device manufacturers adhere to "best practices". It's no wonder that there is a lengthy list of implant recalls and multiple lawsuits clogging our courts today.
We the people simply don't realize that when we go in for an implant procedure the devices being used have a high risk of never been inspected for flaws, material strength or overall compliance to design specifications. We see the results of our misguided assumptions daily as the recalls and lawsuits pile up. The device & implant companies' solution is shockingly arrogant. They set up massive funds in advance to settle expected lawsuit settlements that range from $200,000 -$500,000 and employ larger legal teams then quality control specialists. We see story after story in newspapers, on TV and the internet covering the pain and suffering caused by implant malfunctions. Yet with all these exposures we fail to grasp that the crux of the issue is demanding the parts going into our bodies undergo the same quality control we expect in every other device that touches are daily lives.
Is There A Better Way?
Yes technology exists that is far superior and quantitative to what medical device manufacturers are using today- if anything to insure the parts that they are placing into the community are within tolerance to design specifications. If manufacturers are doing anything about quality control they are relaying on technology from 1906 optical comparators, slightly more modern coordinate measuring machines or microscopes to inspect thousands of parts. All these methods are very suspect in terms of actually providing modern quality metrics. Through the utilization of various types of robotic automated inspection technology the medical manufacturing industries could measure and ensure part tolerances to a very high degree. These 3-D approaches would be a winning play for all concerned. Manufacturers could pay out the money now earmarked for lawsuits to their shareholders and the public would be insured that the implant parts going into their bodies were within the design tolerances they were specified at. We all win under this scenario and pave the way for cost reductions to the concept of Affordable Care going forward.