1. The FDA sends out letters to health care providers detailing issues with devices. Review one of the letters listed below. In 3 paragraphs provide summary of the letter from the FDA. Include the following in your summary
- Device name & use
- SAEs and AEs reported (type and number)
- Common reported problem(s)
- Other complication (if applicable)
2. The FDA also provides recommendations for use to health care providers. Select one of the recommendations from the letter you chose and discuss in 2 paragraphs what the manufacturer could have done during the design, testing, or manufacturing of the device to eliminate the issue.
- SynCardia Systems – TAH-t Companion 2 Driver System (C2) and Risk of Mortality and Stroke – Letter to Health Care Providers (8/17/2018) (Links to an external site.)
- Feeding Tube Placement Systems – Letter to Health Care Providers (1/11/2018) (Links to an external site.)
- Device Failure Associated with Getinge’s Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers (11/1/2018) (Links to an external site.)
- Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers (3/8/2019) (Links to an external site.)
- https://www.fda.gov/medical-devices/letters-health-care-providers/programmable-csf-shunts-and-magnetic-field-interference-implanted-hearing-devices-letter-health-care – Letter to Health Care Providers (7/16/2019) (Links to an external site.)
FDA Letters to Health Care Professionals regarding medical devices can be found at:
https://www.fda.gov/medical-devices/medical-device-safety/letters-health-care-providers
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