Full article reprinted from 'The Gray Sheet" - July 20, 2009
Medical device manufacturers are trying to prevent the creation of a National Medical Device Registry as proposed in a health care reform bill introduced in the House July 14.
The device registry requirement is buried within America's Affordable Health Choices Act of 2009 (H.R. 3200), introduced July 14 by Rep. John Dingell, D-Mich., and the chairmen of three House committees with jurisdiction over health policy.
The registry would list devices by type, model and serial number or other unique identifier. It is intended to help HHS assess the post-market safety and effectiveness of all class III devices, and all class II devices that are implantable, life-supporting or life-sustaining, according to the bill.
The registry, to be established by HHS, would link data provided by manufacturers to FDA with outcomes data from multiple sources.
The outcomes data would be drawn from Medicare claims data, patient survey data, electronic health records, and standardized analytic files maintained by CMS and the Department of Veterans Affairs. It could also come from private databases, such as pharmaceutical purchase and insurance claims data.
The registry data and analyses would be made available to the public without revealing private patient data or proprietary information, the bill states.
The bill also authorizes HHS to require device makers to submit "such other information as is necessary to facilitate post-market assessments of device safety and effectiveness and notification of device risks."
Registry Could Cover "Every Staple And Suture"
According to AdvaMed staff, the devices covered in the proposed registry might include "every staple and every suture," as well as thousands of life-supporting or life-sustaining devices, such as defibrillators or stents.
AdvaMed CEO Stephen Ubl said July 15 the data captured by the registry would be "too broad," of questionable utility and "redundant with existing FDA post-market authorities and initiatives."
Elaborating further, Tara Federici, AdvaMed VP, technology and regulatory affairs, said that meeting the data requirements for the registry would be "expensive for the manufacturer, expensive for the hospital and for the provider, assuming they get around to filling in this data."
Federici acknowledged that registry data on certain devices can be useful.
"I don't think we would dispute that," she said.
But she added that several device types already have registries, including drug-eluting stents and left ventricular assist devices.
AdvaMed also points to the FDA's Sentinel Initiative and the MedWatch adverse event reporting program as existing sources of data.
Federici questioned the utility of the proposed all-encompassing registry. "Why do we need this data? What is the utility, and what does the data serve? How is it helping patients or providers make better decisions?"
Although government-mandated registries to monitor and learn about real-world experiences with medical technology are not new, the breadth of the device registry proposed in the House bill is unprecedented.
Currently, CMS uses the National Oncologic PET Registry (NOPR) to assess the impact of positron emission tomography on cancer patient management. And just two weeks ago, the Agency for Healthcare Research and Quality announced plans to create a registry for orthopedic devices, drugs and procedures (1 'The Gray Sheet' July 13, 2009).
In addition, lawmakers in the House are considering the National Knee and Hip Replacement Registry Act, which would create a nine-year knee and hip replacement registry within the Agency for Healthcare Research and Quality.
- Sue Darcey
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