Published online September 1, 2008
PEDIATRICS Vol. 122 No. 3 September 2008, pp. 550-555 (doi:10.1542/peds.2007-2729)

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ARTICLE

Iatrogenesis in Neonatal Intensive Care Units: Observational and Interventional, Prospective, Multicenter Study

Amir Kugelman, MD^a, Esther Inbar-Sanado, MD^a, Eric S. Shinwell, MD^b, Imad R. Makhoul, MD, PhD^c, Meiron Leshem, MD^d, Shmuel Zangen, MD^d, Orly Wattenberg, RN^b, Tanya Kaplan, RN^c, Arieh Riskin, MD^a and David Bader, MD, MHA^a

^a Department of Neonatology, Bnai Zion Medical Center
^c Department of Neonatology, Rambam Health Care Campus, B. Rappaport Faculty of Medicine, Technion, Haifa, Israel
^b Department of Neonatology, Kaplan Medical Center, Rehovot, Israel
^d Department of Neonatology, Barzilai Medical Center, Ashkelon, Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva, Israel

OBJECTIVES. The goals were to determine the incidence of iatrogenic events in NICUs and to determine whether awareness of iatrogenic events could influence their occurrence.

METHODS. We performed a prospective, observational, interventional, multicenter study including all consecutive infants hospitalized in 4 NICUs. In the first 3 months (observation period), the medical teams were unaware of the study; in the next 3 months (intervention period), they were made aware of daily ongoing monitoring of iatrogenic events by a designated "Iatrogenesis Advocate."

RESULTS. The numbers of infants admitted to the NICUs were comparable during the observation and intervention periods (328 and 369 infants, respectively). There was no difference between the 2 periods with respect to the number of infants of <1500 g, hospitalization days, or mean daily occupancy of the NICUs. Although the prevalence rates of iatrogenic events were comparable in the observation and intervention periods (18.0 and 18.2 infants with iatrogenic events per 100 hospitalized infants, respectively), the incidence rate decreased significantly during the intervention period (3.2 and 2.4 iatrogenic events per 100 hospitalization days of new admissions, respectively). Of all iatrogenic events, 7.9% were classified as life-threatening and 45.1% as harmful. There was no death related to an iatrogenic event. Eighty-three percent of iatrogenic events were considered preventable, of which 26.9% resulted from medical errors in ordering or delivery of medical care. Only 1.6% of all iatrogenic events were intercepted before reaching the infants, and only 47.0% of iatrogenic events were corrected. For younger and smaller infants, the rate of iatrogenic events was higher (57% at gestational ages of 24 to 27 weeks, compared with 3% at term) and the iatrogenic events were more severe and harmful. Increased length of stay was associated independently with more iatrogenic events.

CONCLUSIONS. Neonatal medical teams and parents should be aware of the burden of iatrogenesis, which occurs at a significant rate.

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Key Words: iatrogenesis • iatrogenic event • medical error • NICUs

Abbreviations: IE—iatrogenic event • IP—intervention period • OP—observation period • LOS—length of stay

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Accepted Dec 13, 2007.

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