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a nonconformity issue that could be a contributing factor to a patient harm event. Most issues were identified through reactive surveillance, with 41.8% of product IDs reactively surveilled having a possible patient harm issue, although randomized surveillance was infrequently performed. One limitation of the study is that the coding of issues relied on coder clinical experience. Another is that although products associated with possible patient harm issues are widely used by health care facilities, it is unknown whether these issues resulted in actual patient harm.
Olfson et al. (Tue,) studied this question.