Safety First—and Last

The recent news about the FDA’s consent decree alleging manufacturing and quality problems with Medtronic’s Synchromed infusion pump casts a shadow on both Medtronic and the FDA Center for Devices and Radiological Health. The consent decree requires the company to suspend manufacturing and distribution of the pain pumps.

While some contend that it’s unreasonable for the FDA to hold products created two decades ago to the same standard as new devices, the fact that Medtronic failed to address three warning letters concerning corrective and preventative action might cause observers to wonder about quality control for Medtronic’s newer products. Coming on the heels of a $4.4 million settlement in a federal false claims act, this was not good for the company’s public image.

But neither was it good news for CDRH, which has come under mounting criticism lately for lax oversight of device safety in the wake of well publicized problems with power morcellators and duodenoscopes. Perhaps the most damning criticism came from Medical Device and Diagnostic Industry’s contributing editor Jim Dickinson, who wrote about the “galloping ineptitude” of the agency on the trade publication’s website. He pointed out that daily newspapers are doing a better job of uncovering device safety problems than the CDRH itself.

The insurance industry lobby group AHIP is seeking to tighten the standards for 510(k) clearance. The Journal of the American Medical Association and the Institute of Medicine have each released studies criticizing this pathway for lax surveillance of medical devices.

While it may seem hypocritical of us to attack FDA for lax oversight, given our past criticism of the agency for unnecessary delays of device approvals, in fact these trends confirm what we have suggested all along: That CDRH’s critical mission in ensuring the safety of medical devices has been seriously compromised by its over attention to device efficacy. Simply put, the FDA should be out of the business of determining medical device efficacy—an arbitrary and relative assessment in any case—and should devote its limited resources to ensuring device safety, including post-market surveillance.

The task of determining the (comparative) effectiveness of a new device or therapy should fall on the shoulders of the CMS and private insurers. This division of labor would not only put U.S. device vendors on a level playing field with their European counterparts, it would also eliminate much of the duplication of effort they must go through currently with both agencies. We suspect that many device manufacturers would welcome paying a user fee to CMS if it would expedite fair and reasonable reimbursement decisions. These fees could do much to offset a fiscal crisis CMS will face in the years ahead.

James Cavuoto

Editor and Publisher

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