Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Tuesday, March 20, 2012

Premier healthcare alliance supports UDI for medical devices.

LINK HERE: full article at Premier webpage

Statement on legislation to require implementation of unique device identification
By Blair Childs, senior vice president of public affairs, Premier healthcare alliance
March 15, 2012
Members of the Premier alliance applaud Senators Jeff Merkley (D-OR), Michael Bennett (D-CO), Charles Grassley (R-IA) and Herb Kohl (D-WI) for introducing legislation that would require implementation of a unique device identification (UDI) system for medical devices.
UDI is the missing link to protect patient safety. Enabling healthcare providers to track medical devices electronically in the supply chain will improve the speed and accuracy of product recalls, as well as adverse event reporting. In addition to these important safety benefits, automating the now manual process of tracking of medical devices is projected to save the healthcare industry approximately $16 billion each year from greatly improved efficiencies.
Although the law requiring UDI was passed nearly five years ago with broad support from hospitals, doctors, consumer groups and patient advocates, it has been awaiting approval from the Office of Management and Budget (OMB) for more than six months. Despite urging from industry requesting that UDI be fast-tracked in the approval process, no action has been taken. While OMB delays, patients continue to face the real risks of a flawed recall or an adverse event, even though a better system exists and is ready for implementation today.
It is essential that UDI regulations move out of the OMB and into implementation immediately. Electronic tracking systems are commonplace in other industries, and have been in place since the 1970s. Today we can recall tainted dog food using standardized bar codes faster than we can medical devices, including those that are implanted in patients. It's time for healthcare to join the 21st century with a fully functioning UDI system.
About the Premier healthcare alliance, Malcolm Baldrige National Quality Award recipient
Premier is a performance improvement alliance of more than 2,500 U.S. hospitals and 81,000-plus other healthcare sites using the power of collaboration to lead the transformation to high-quality, cost-effective care. Owned by hospitals, health systems and other providers, Premier maintains the nation's most comprehensive repository of clinical, financial and outcomes information and operates a leading healthcare purchasing network. A world leader in helping deliver measurable improvements in care, Premier has worked with the Centers for Medicare & Medicaid Services and the United Kingdom's National Health Service North West to improve hospital performance. Headquartered in Charlotte, N.C., Premier also has an office in Washington. Stay connected with Premier on Facebook, Twitter and YouTube.  CONTACT:
Alven Weil
Premier healthcare alliance

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