Feasibility of Using Existing Public and Private Data Sources for Nationwide Medical Device Post-marketing Safety Surveillance
Methods: We merged the 2013 CMS Hospital Compare CLA-BSI data with the MaxPlus™ Tru-Swab™ Positive Displacement Connector (MP) client database from CareFusion to identify hospitals using the MPs (MP hospitals) versus those not using the MPs (Comparator hospitals). MP is a newer generation of NC with enhanced patient safety engineering design features. We evaluated CLA-BSI rates associated with MPs versus Comparators.
Results: In the CMS Hospital Compare CLA-BSI database, 3,074 hospitals reported central line (CL) days >1, with 25% (n=758) hospitals using MP NCs. The MP hospitals accounted for 30% (2,923,859/ 9,887,264) of CL days, and 28% (3,017/10,864) of CLA-BSI episodes. The MP hospitals had a lower observed CLA-BSI rate (1.03 per 1,000 CL days [3,017 CLA-BSIs / 2,923,859 CL-days]) compared to Comparator hospitals (1.13 per 1,000 CL days [7,847 CLA-BSIs / 6,963,405 CL-days], P<0.0001). The univariate relative risk for CLA-BSI of MP hospitals was 0.91 (95% CI: 0.83, 0.98; P=0.02). After adjusting for hospital bed size, teaching, urban status, and geographic regions, the multivariable relative risk for CLA-BSI of MP hospitals was 0.94 (95% CI: 0.86, 1.02; P=0.11).
Conclusion: We demonstrated that it is feasible to link hospital-level data from public-private sources to support the FDA’s electronic post-market medical device safety surveillance efforts. Manufacturers should be encouraged to participate in FDA’s efforts.
Y. P. Tabak,
CareFusion: Employee and Shareholder, Salary
X. Sun, CareFusion: Employee, Salary
C. Crosby, CareFusion: Employee and Shareholder, Salary
W. Jarvis, Baxter: Consultant, Consulting fee
CareFusion: Consultant, Consulting fee
Johnson and Johnson: Consultant, Consulting fee
Gojo: Consultant, Consulting fee