207646 Linking Healthcare Facilities, the US Food and Drug Administration (FDA) and Manufacturers Collaborate in a Proactive and Preventive Patient Safety Operation

Monday, November 9, 2009

Carmella Simmons, MS, RN, FNP , MedSun, Social & Scientific Systems, Inc., Silver Spring, MD
As a result of increasing pressure to provide safe, high quality health care despite growing fiscal constraints and economic stress, health care administrators are challenged to identify novel approaches and efficient, timely tools to enhance their institutional operations. One example is the ability to utilize medical product safety information available from both inside and outside their organizations.

With input from the clinical community, FDA designed and implemented an enhanced post-market surveillance system known as the Medical Product Safety Network (MedSun). The FDA and its contractor, Social & Scientific Systems, Inc., enrolled a sample of 350 hospitals and other facilities to report through a confidential, on-line system about problems seen with medical devices, human cells, tissues and related products.

MedSun has provided the FDA with important information which has contributed to numerous patient safety actions including recalls. It has offered a venue for participating sites to receive substantial feedback to learn about experiences of other sites through newsletters and meetings, and to work with the FDA and manufacturers to address problems reported. MedSun has provided a supported Community of Practice for those who serve as MedSun Representatives, including risk managers, biomedical engineers and clinical staff. Moreover, it has established a mechanism for healthcare facilities to work in an efficient, timely and collaborative way to improve patient safety locally and nationally.

Learning Objectives:
Discuss a novel approach to utilize medical product safety information.

Keywords: Medical Devices, FDA

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: My experience working in the MedSun Project with Representatives and the FDA has provided me with the expertise to present this content.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.