A 12-page Executive Summary offering summary highlights for 22 Accountable Care Organizations and ACO solutions companies regarding their successes during the most recent MSSP performance year.
Kaiser Health News: 7 Things to Know About the FDA's Hidden Medical Device Database
- 5.7 million medical device injury and/or malfunction incidents bypassed FDA's public database into an alternative summary reporting system over 20 years. The FDA recently released its data.
- Blood glucose meters for patients with diabetes had the most incidents in the database
- with 2.4 million reports over the past 20 years.
- There were 2.1 million reports for bad dental implants
- 114
- 200 of which were reported last year.
- There were 176 deaths reported through the alternative summary reporting system.
- Surgical stapler-related malfunctions accounted for more than 66
- 000 previously hidden incidents since 2001.
- Breast implant injuries and malfunctions accounted for nearly half a million reports over 20 years
- including implants that leaked
- deflated or migrated.
- The FDA is replacing alternative summary reporting with the Voluntary Summary Reporting Program. Over 5
- 600 device types (87%) are eligible for summary reporting of device malfunctions.
Source: Kaiser Health News, June 27, 2019 - https://khn.org/news/five-things-we-found-in-the-fdas-hidden-device-database/