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CMS Announces Three-Year Gainsharing Pilot
Ubl |
In September, the Centers for Medicare and Medicaid Services (CMS; Baltimore) unveiled its plan for a three-year gainsharing demonstration program. Focusing on quality and efficiency improvements across the entire system of care, the program differs from earlier gainsharing arrangements that attempted to achieve savings by standardizing the use of medical devices in hospitals. But although devices are not the primary focus of the new demonstration's cost-saving initiatives, medtech industry associations remain wary.
Stephen Ubl, president and CEO of AdvaMed (Washington, DC), commended CMS for its approach to gainsharing in the latest project, but he added, "We remain concerned that some demonstrations could be designed to reduce patient treatment options or place emphasis on cost savings at the expense of what is the best therapy for the patient." [ More ]
Heart Rhythm Society Issues Recommendations on CRM Devices
Carlson |
Late last month a 15-member task force assembled by the Heart Rhythm Society (HRS; Washington, DC) issued its long-awaited recommendations on cardiac rhythm management (CRM) devices. The recommendations included specific suggestions for physicians, manufacturers, FDA, and Congress. The group called for greater transparency in postmarket surveillance, analysis, and reporting of device problems; the establishment of new systems to more quickly identify malfunctioning devices; and the development of standard notification and communication procedures for CRM manufacturers to follow when a malfunction is identified. The report also recommended that FDA no longer use the term recall in public communications about potentially malfunctioning CRM devices, as patients could interpret the word as meaning the device should be removed.
"The next step is for the Heart Rhythm Society to work with Congress, regulators, industry, patients, and other stakeholders to ensure that these recommendations will guide key policy decisions that will help heart patients," said task force chair Mark D. Carlson, MD. [ More ]
Kolodner Named Interim Healthcare IT Leader
Kolodner |
Late last month, Robert M. Kolodner, MD, joined the U.S. Department of Health and Human Services (HHS; Washington, DC) as the interim head of the Office of the National Coordinator for Health Information Technology. Kolodner comes to the office from the Veterans Health Administration in the Department of Veterans Affairs (VA; Washington, DC), where he has been serving as chief health informatics officer. He replaces David J. Brailer, MD, PhD, who served as the office's first occupant starting in May 2004.
Kolodner's appointment was welcomed by the Healthcare Information and Management Systems Society (HIMSS; Chicago). "For more than two decades, Rob Kolodner has played a critical role in helping the VA become one of the most cited and honored early adopters of healthcare information technology in general, and electronic medical records in particular," said Fred Hannett, chair of the HIMSS government relations roundtable. "What better person to charge with maintaining the momentum established by David Brailer and HHS secretary Mike Leavitt to achieve the goal of a truly interoperable nationwide health information network?" [ More ]
Advocacy Groups Seek Increased Government Funding for FDA
Thompson |
Making the case that FDA does not have the necessary resources to fulfill its mission of protecting the public health, two organizations recently emerged to lobby the Bush administration and Congress to increase yearly appropriations for the regulatory agency. The FDA Alliance (Silver Spring, MD) was formed in April, and the Coalition for a Stronger FDA (Washington, DC) was launched last month. The Medical Device Manufacturers Association (MDMA; Washington, DC) is a member of both groups, and AdvaMed (Washington, DC) is part of the coalition.
"The members of the coalition understand that a stronger FDA is critical to not only protecting the food supply, but also ensuring that the next generation of medical innovations reach the market quickly, and are as safe and effective as possible," said Tommy Thompson, coalition cochair and former HHS secretary. [ More ]
FDA Updates Guidance on Reprocessing
of Single-Use Devices
Schultz |
Late last month FDA's Center for Devices and Radiological Health (CDRH; Rockville, MD) issued updated guidance on the reprocessing of single-use devices (SUDs). Under the new guidelines, reprocessors of some SUDs that were previously exempt from submitting validation data will now be required to provide the information as part of their premarket notification (510(k)) submissions.
"The types of adverse events reported to be associated with the use of SUDs are the same types of events that are also being reported for new, nonreprocessed devices," CDRH director Daniel Schultz, MD, told the House Committee on Government Reform. He said CDRH drew its conclusions following an extensive review of all available data on reported incidents. Schultz assured the committee that the agency has a number of tools in place to monitor the safety and performance of reprocessed SUDs, and concluded his testimony by stating, "SUDs that meet FDA's regulatory requirements are as safe and effective as a new device." [ More ]
2007 MDEA Entry Deadlines Announced
The Medical Design Excellence Awards (MDEA) program is now accepting entries for its 2007 competition. Now entering its 10th year, the MDEA competition is the premier awards program for the medical technology community. The program offers recognition to manufacturers, suppliers, and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the groundbreaking innovations that are changing the face of healthcare.
To be eligible for the 2007 competition, products must be commercially available by December 31, 2006. The standard deadline for entries is December 18, 2006. The final deadline for entries (with payment of a late fee) is January 19, 2007. For additional details, including a downloadable entry form, entrants should visit the MDEA Web site at www.MDEAwards.com. [ More ]
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