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1. As a technologist that does a lot of work related to adverse event reporting I applaud the Reporting Device Adverse Event Challenge that is being proposed by the ONC, however I believe the real technical challenge that would benefit patients before they experience adverse events would be a reporting system that tracks devices approved through the 510K approval process.

   Simply described the 510K approval process allows a manufacturer to stipulate that their product operates essentially like another product that has already passed FDA scrutiny, therefore it does not need further safety testing prior to release. A prime example is the highly reported case that has led to mass tort litigation and hundreds of law firms nationwide filing on behalf of claimants in a class action litigation against the manufacturers of Surgical Mesh used in the treatment of Pelvic Organ Prolapse and Stress Urinary Incontinence. Attached is a link to one of the many attorney sites filing on behalf of injured parties. http://www.womenshealthattorney.com.

   This case became front page news in part because so many manufacturers were involved. I believe the reason this occurred is because most received clearance for their mesh devices based on the fact that it was very similar to another company’s product that had already received approval.

   This well intended method of fast tracking new medical products has several disturbing flaws. First, not unlike the children’s game of whispering a secret from person to person, the story becomes less cohesive the more times the story is passed on, resulting in products that are no longer like the original entering the marketplace with little or no testing prior to release.

   Secondly, when a 510 K is submitted for approval we are relying on the manufacturer to fairly evaluate the device as essentially the same as a predecessor device and presumes their assessment is being presented without other motivating factors influencing their decisions. This is a reckless assumption since millions of dollars are at stake if the product is not released timely in terms of lost opportunity cost, as well as the significant cost associated with conducting viable safety studies. Finally, poor safety results could prevent the product from coming to market at all and all of their R&D costs as well as the cost of testing are a total loss.

   Finally, there is no mechanism by which all products that are essentially the same are pulled from the market when the original product or sister products safety comes into question or is proven to be defective. In the case of Transvaginal Mesh the original product which cleared the way for many of the other mesh products to gain entrance into the market was pulled from the market in a recall after it was shown to have been unsafe for patient use, yet the similar products that claimed acceptance based on their similarity to the withdrawn product and all other sister products remained on the market and their next generation products now receive 510K clearance based on being essentially similar to the faulty progenitor.

   As recently as July 2011, even with all of the media attention and FDA warnings surrounding the efficacy and safety of these products new 510K’s were approved on vaginal mesh using the progenitor’s devices to gain approval.

   This process is circumventing the purpose of the FDA to protect consumers from defective medical products and brings into question the wisdom of allowing manufacturers to self govern. Having used the 510K process to gain access to the market by stipulating their product was essentially the same as a product that was later found to be defective one would assume that manufacturers would not wait for further patient injuries before pulling their own products from the market. Yet this type of industry self governance does not occur, because regulators are not able to enforce it.

   An application that could track all products that were essentially the same would give regulators enormous clout to pull dangerous products from the market when needed or standardize labeling practices when black box warnings are issued for a product that is proven to be dangerous in the aftermarket period. Standard software that would immediately correlated these kinds of records coupled with native language analysis that could be applied to archived 510K filing records make the goal of normalizing this kind of record keeping possible and could prevent tens of thousands of debilitating patient complications and deaths over time.