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Related Experiment Videos

Calfactant sterility in multiple doses from single-use vials.

Pamela D Reiter1, Cheri Sims, Lisa Harmes

  • 1Department of Pharmacy, The University of Colorado Hospital, and School of Pharmacy, The University of Colorado, Denver, CO, USA. reiter.pam@tchden.org

The Annals of Pharmacotherapy
|August 19, 2003
PubMed
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This study found that using multiple doses from a single vial of calfactant (an exogenous surfactant) is safe for premature infants. This approach preserves sterility for up to 24 hours, offering significant cost savings.

Area of Science:

  • Neonatal Medicine
  • Pharmacology
  • Infectious Disease Control

Background:

  • Calfactant is an exogenous surfactant essential for treating respiratory distress syndrome in newborns.
  • Single-use vials of calfactant contain multiple doses, posing a potential for cost savings if sterility can be maintained after initial use.

Purpose of the Study:

  • To assess the sterility of calfactant after multiple vial entries within 12- and 24-hour intervals.
  • To determine the economic benefits of using multiple doses from a single calfactant vial.

Main Methods:

  • A prospective study involving 45 vials of calfactant used in a neonatal intensive care unit (NICU).
  • Vials were accessed using an 18- or 20-gauge needle and samples cultured at 12 and 24 hours post-initial entry.
  • Cultures were performed using MacConkey agar, blood agar, and thioglycollate broth under refrigerated conditions.

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Main Results:

  • A total of 89 samples were cultured from 45 vials.
  • No bacterial growth was detected in any samples at 24 or 48 hours post-culture.
  • All tested calfactant samples maintained sterility after 1-2 re-entries within 24 hours.

Conclusions:

  • Multiple entries into a single-use calfactant vial are safe for up to 24 hours post-initial breach.
  • This practice can be an economical method for administering surfactant to low-birth-weight infants (<1 kg).
  • Institutions are encouraged to validate these findings prior to clinical implementation.