What does it take? A case study of radical change toward patient safety.
BACKGROUND
Adopting a human factors engineering approach to patient safety requires a radical behavioral shift from "blame and shame," which emphasizes further training, to systems thinking, which also emphasizes improved system design. A medical device manufacturer appeared to initiate this radical shift after exhibiting the traditional approach for years.


METHODS
The research focused on a patient-controlled analgesia device. A qualitative case study methodology was used to study events in the period from the device's introduction (1988) until the start of the behavioral change (May 2001). Data on 50 relevant events were analyzed. The tabular summary was analyzed for evidence of the prerequisites predicted by punctuated equilibrium theory, and the graphical time line was analyzed for evidence of vertical alignment across levels.


RESULTS
Radical behavioral change was preceded by a critical 9.5-month period with three characteristics: new corporate leadership, perceived poor corporate performance, and aligned disruptions occurring within a relatively short time at almost every level in the external environment in which the company operated.


CONCLUSIONS
These findings are consistent with punctuated equilibrium theory, according to which organizations can experience long periods of resistance to change followed by fast revolutionary change (approximately two years). The findings also have implications for when and how to introduce patient safety policy interventions to "tilt the playing field" and thereby increase the likelihood that such reforms will succeed.
Vicente
Kim J
KJ
Department of Mechanical and Industrial Engineering, University of Toronto, Toronto, Ontario, Canada. vicente@mie.utoronto.ca
D016058:Analgesia, Patient-Controlled / Q000295:instrumentation*; D018795:Device Approval; D019544:Equipment Failure Analysis; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D006804:Ergonomics; D033161:Government Regulation; D006801:Humans; D007221:Industry / Q000458:organization & administration* / Q000592:standards; D008137:Longitudinal Studies; D008508:Medication Errors / Q000517:prevention & control*; D008510:Medication Systems, Hospital / Q000592:standards; D019982:Organizational Case Studies; D009936:Organizational Innovation; D011639:Public Opinion; D036301:Qualitative Research; D011786:Quality Control; D013597:Systems Analysis; D014481:United States; D014486:United States Food and Drug Administration