June 27, 2013
I am Dr. Jennifer Yttri and I am speaking today on behalf of the National Research Center for Women & Families. Our organization does not accept funding from device manufacturers and therefore I have no conflict of interest.
Our nonprofit research center includes scientists and medical and public health experts who analyze and review research on a range of health issues. In addition to conducting research and publishing our findings in medical journals, we provide objective and understandable information to patients, health care providers, and policy makers through briefings, CMEs, testimony, and other materials and formats.
We strongly support the FDA’s mission to protect public health, and our president is on the Board of Directors of two nonprofit organizations dedicated to helping the FDA obtain the resources it needs: the Reagan-Udall Foundation and the Alliance for a Stronger FDA.
Implanted blood access devices should remain Class III devices and be subjected to pre-market approval because they are part of a life-supporting and life-sustaining system. When they aren’t held to higher standards we lose 4 important safeguards:
1. Proof of safety and efficacy based on short-term clinical trials
2. FDA’s authority to require post-market, long-term clinical trial safety data as a condition of approval
3. FDA’s authority to inspect the manufacturing facility prior to approval
4. FDA authority to rescind approval if the device is later found to be unsafe
Some panel members may not realize that under the law, the FDA can’t require post-market studies as a condition of approval for any devices cleared through the 510(k) process. And, if anything goes wrong, FDA can’t rescind approval for a device cleared through the 510(k) process. Approval through the PMA process could occur based on short-term clinical trials that indicate new devices are safe and effective and FDA could require necessary longer-term post-market studies as a condition of approval. FDA can’t do that for catheters cleared as Class II devices through the 510k process.
These implanted devices are left in patients for years, but long-term safety and efficacy data are lacking. Even if you think the short-term safety data are adequate, I’m sure you will agree that long-term implants need long-term data to determine the lifespan of these catheters.
Reliance on MAUDE reports to establish the safety profiles of these devices is unacceptable. As you all know, MAUDE reports are voluntary and usually underreport the occurrence of adverse events. MAUDE reports can be used to eventually identify risks associated with a device, but do not provide an accurate assessment of the prevalence of each risk. The only way to ensure long-term safety data for these devices is to keep them at Class III.
As a Class III device, the FDA should require controlled clinical studies that directly compare implanted blood access devices to alternatives, such as more temporary devices or surgical blood access techniques. Implanted catheters regulate blood flow, but that flow is irregular compared to other techniques. Though implanted catheters can be used quickly for hemodialysis, that benefit does not warrant LONG-TERM use because better alternatives are available. Other techniques have become more popular for vascular access for hemodialysis because they avoid device failure and infections that occur with implanted catheters. In the future, new catheters may prove to be superior to those currently on the market, but that would require data from clinical trials. That’s why the Class III designation is needed.
We agree that implanted catheters should remain an option for patients requiring hemodialysis. However, currently available clinical evidence does not prove safety and effectiveness for the number of years these devices are in the human body. Special controls are not enough to ensure safety and effectiveness for the wide variety of devices included in the down classification being considered.
Class III devices must be reviewed through the PMA process, which by law is required for implanted life-saving or life-sustaining devices. Without a PMA, these catheters will not be adequately tested to make sure they can save lives, and that their failure won’t kill or seriously harm patients.