Government Should Better Regulate Quality Control For Device Implants

quality assurance, quality control

Today's orthopedic practitioner and their technology-driven assets are a far cry from the bone saw wielding image of 100 years ago.

Today's implant surgeons are aided by all types of imagery, robotic assistants, and multiple types of implant devices for any type of knee, hip, spinal, hand or foot procedure that can be conceived. Yet with the operating room containing more supportive electronics than would have been found in even the most advanced medical research centers of the last century, implant manufacturers use 20th century techniques for quality control and manufacturing on the implants these same surgeons place inside us.

It appears that the medical community is just as unaware of the quality disconnect as they are of the actual cost of that implant. In a recent survey sample of 500 orthopedic surgeons, only 20% guessed the cost of the implants used in a variety of situations. Given that track record you can assume that the orthopedic surgeon of today is equally unaware that manufacturers claim they are complying to the “best practices “aspect of the vague FDA 510-K legislation by using the optical comparator which was developed in 1908 and the CMM (Coordinate Measuring Machine) of the 1960’s.

We need to focus on understanding this incredible lack of quality control being applied to medical implants instead of constantly covering stories about joint implant lawsuits or the size of warchests manufacturers build to combat those suits. Instead we need to focus on the fact that Medicare spends more than $20 billion+ each year on implantable medical devices and half of that for orthopedic procedures. The aging and active population will drive these numbers exponentially higher.

We need to ask ourselves “Are we going to continue on one hand using modern implant techniques and designs in the orthopedic surgical area and address manufacturer quality as if we were using Ether or having patients to bite on belts?”

The above dilemma is equally muddied by the Affordable Care Act reducing the amount of money paid for implant procedures and in parallel assessing the device community with a medical device tax.

So what’s the way out of this seeming huge disconnect?

It appears to me we first need to examine all the players and their motives.

Patient: The patient desires an implant to extend their mobility and quality of life. They trust the medical provider and believe that since their whole world is regulated via government standards, legislation and monitoring agencies, so is the implant they are about to have placed inside them.

Orthopedic Surgeon: As described above while potentially gifted in surgical implant skills only 20% have a grasp on overall implant costs. Can we assume they are equally oblivious to implant quality issues? How will they recoup lost revenue from declining Medicare Reimbursements while at the same time cover escalating malpractice premiums driven in part by thousands of pending implant recalls & lawsuits?

Hospital: Currently locked into paying negotiated prices on implants sold to them by manufactures who are paying little to no heed regarding quality.

Device Manufacturer: Knowing they have been given a very lenient mandate from the FDA via FDA's standard 510-K process that just mentions “best practices,” they are free to do as they please in the area of quality control and where and how the devices are manufactured.

Insurance companies: Faced with understanding the dynamics of the Affordable Care Act and trying to predict revenue in uncharted statistical waters, they are sputtering along. Some say they will pull out of the Affordable Care Act league and others setting up consortiums ala Costco to buy medical supplies of all kinds including implants and then push them into the healthcare provider community that they have established.

Government: While monolithic in all other areas of regulation and monitoring they are the absent catalyst. Placing even modest regulatory control on medical devices would seem to be a far better approach than taxing them. Maybe there is a grander agenda with this approach I’m not seeing yet.

Legal Community: Taking advantage of thirty plus years of lawsuits, class actions and implant recalls, the implant legal community is akin to Levi Strauss selling jeans to the gold miners. It's a great boutique business with legal firms specializing on one device manufacturer’s suit or another.

Implant Finance groups: Need some quick cash and cant wait the three to four years for settlement; no problem –simply take the suit after it’s filed to a finance group specializing on implants and they will advance the money.

Evolving Third Parties (Healthcare Consortiums, offshore care options): Fancy a trip to Europe or other exotic destinations that will combine travel with implant surgery at a fraction of the cost in the U.S. No problems just go online and comparison shop. As discussed earlier all types of consortiums are being established to buy in bulk and resell every possible medical product. Consider the litigation around that model with poor to no device quality control in play.

If you think all of the above is making for a huge paradigm shift then I’d say you are right.

The question is can we educate the public as to the absence of any true mandated and monitored legislation dealing with medical device quality or will we just be witness to mounting piles of litigation driven by an increasing number of defective implants .

[Photo Credit - iStockphoto.com user aluxum] 

- James Falasco is technology manager at Falcon Medical Systems.