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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Twitter: @JjrkCh

Friday, September 30, 2011

Visual representation of the lack of meaningful regulation

Link here: Clarimed statistics expose vulnerability of 510(k) approvals.

The IOM (Institute of Medicine) on 7/29/11 stated that the 510(k) approval process was so flawed that it should be scrapped - yet that is how the FDA releases almost all orthopedic implants to the U.S. market . . . and there is currently no independent post-market registry, either!  That results in medical and legal purgatory for patients who receive failed products and higher healthcare costs for U.S. citizens. (Joleen Chambers)

Clarimed is a fabulous new company that provides meaningful data that is accessible to all stakeholders so that the U.S. can make life-enhancing decisions about medical devices.

Timeline of Orthopedic Prosthetics & Implants Approvals
Subcategory Overview
Overview of Approval Types
Supplemental FDA PMA Filings for Orthopedic Prosthetics & Implants
  • PMA supplements are required for all changes that affect safety and effectiveness of a device, unless such change involves modifications to manufacturing procedures or method of manufacture. These types of manufacturing changes require a 30-day Notice or, where the FDA finds such notice inadequate, a 135-day PMA supplement.
  • 647 supplemental filings have been approved by the FDA for Orthopedic Prosthetics & Implants.

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