initiatives to respond to certain limitations and concerns. The MedSun pilot program, the human factors initiative, and other activities described below are examples. For the most part, their focus is general, although some include attention to pediatric issues.

MedSun

Compared to the agency’s primary spontaneous or passive event reporting program, the pilot MedSun program was created as a less inclusive but more intensive effort to better identify and understand problems with the safe use of medical devices. The program provides for more attention to close calls, more education of participating facility representatives to improve the level and quality of event reporting and analysis, and more feedback and interaction to determine the nature of device problems and close calls as a basis for preventing future problems and improving patient safety within health care facilities. These educational and feedback features offer incentives for institutional participation that are absent in the traditional program. MedSun now has a waiting list of interested facilities (FDA, 2004a). With the possible exception of certain special studies, the program will not collect denominator data that would allow the calculation and comparison of problem rates.

As shown in Table 4.4, by June of 2005, MedSun had recruited over 350 hospitals, of which 22 were acute-care general children’s hospitals and 2 were acute-care pediatric specialty hospitals. These participating facilities

TABLE 4.4 Cumulative Number of Facilities Recruited Into MedSun

 

2002

2003

June 2005

Nonpediatric hospitals with 100+ beds

57

167

307

Children’s hospitals of any size

2

8

22

Children’s rehabilitation hospitals of any size

1

2

2

Nursing homes of any size

8

19

21

TOTAL

68

196

352

NOTE: Nonpediatric hospitals with fewer than 100 beds and other types of facilities such as home health and outpatient clinics are not included. Not all sites that have been recruited have received program orientation.

SOURCE: Personal communication, Thomas P. Gross, M.D., Director, Division of Postmarket Surveillance, CDRH, June 10, 2005. Data provided by CODA, Inc.



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