Implementation of Poliovirus Containment in Poliovirus Designated Facilities—United States, 2017–2024

As the world approaches wild poliovirus eradication, effective containment measures are essential to minimize the risk of a facility-associated reintroduction into a polio-free community. Between 2017 and 2024, the United States established a national authority for containment (NAC) of poliovirus to maintain a national inventory of poliovirus materials and designate facilities to retain polioviruses. Countries with designated facilities are expected to maintain primary, secondary, and tertiary safeguards for facility containment certification. Primary safeguard requirements are assessed through audits following an ISO risk-based process. Standardized data collection and reporting tools were developed in Microsoft Access, and data were analyzed using SAS<sup>®</sup> 9.4 and R software (version 4.4.3). The NAC conducted 16 audits in three categories: gap assessment (n = 10), Stage 1 audit (n = 3), and Stage 2 audit (n = 3). The NAC found that conformance to the containment standard improved among audit categories (χ<sup>2</sup> = 94.6, 2 df, <i>p</i>-value < 0.0001). In 2024, five audits were conducted according to the revised poliovirus containment standard. Notable gaps were identified in system elements associated with risk assessment, clothing and personal protective equipment, accident/incident, and decontamination/inactivation procedures. Despite compliance with secondary and tertiary requirements, several primary containment elements continue to pose a challenge for facilities, resulting in no US-designated facility achieving full certification.

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Publication Details

Journal
Pathogens
Published
2025-12-06
DOI
https://doi.org/10.3390/pathogens14121250
Primary Topic
Viral Infections and Immunology Research
Type
article
Field-Weighted Citation Impact
0.00

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article

Implementation of Poliovirus Containment in Poliovirus Designated Facilities—United States, 2017–2024

Catriona Sinclair, Christy Ottendorfer, Patrick Vander Kelen, Cecelia A. Sanders et al.
Pathogens
Viral Infections and Immunology Research
article

Implementation of Poliovirus Containment in Poliovirus Designated Facilities—United States, 2017–2024

Catriona Sinclair, Christy Ottendorfer, Patrick Vander Kelen, Cecelia A. Sanders, Suganthi Suppiah, Emily Watson, William F. Hoffman, Lia Haynes Smith, Abena Marfo
article en

Abstract

As the world approaches wild poliovirus eradication, effective containment measures are essential to minimize the risk of a facility-associated reintroduction into a polio-free community. Between 2017 and 2024, the United States established a national authority for containment (NAC) of poliovirus to maintain a national inventory of poliovirus materials and designate facilities to retain polioviruses. Countries with designated facilities are expected to maintain primary, secondary, and tertiary safeguards for facility containment certification. Primary safeguard requirements are assessed through audits following an ISO risk-based process. Standardized data collection and reporting tools were developed in Microsoft Access, and data were analyzed using SAS<sup>®</sup> 9.4 and R software (version 4.4.3). The NAC conducted 16 audits in three categories: gap assessment (n = 10), Stage 1 audit (n = 3), and Stage 2 audit (n = 3). The NAC found that conformance to the containment standard improved among audit categories (χ<sup>2</sup> = 94.6, 2 df, <i>p</i>-value < 0.0001). In 2024, five audits were conducted according to the revised poliovirus containment standard. Notable gaps were identified in system elements associated with risk assessment, clothing and personal protective equipment, accident/incident, and decontamination/inactivation procedures. Despite compliance with secondary and tertiary requirements, several primary containment elements continue to pose a challenge for facilities, resulting in no US-designated facility achieving full certification.

PathogensVol. 14(12)
Oak Ridge Associated Universities (US), Centers for Disease Control and Prevention (US), Emory University (US), Murata (United States) (US), Oak Ridge Institute for Science and Education
U.S. Department of Energy, Centers for Disease Control and Prevention, Oak Ridge Institute for Science and Education
Openalex Percentile: Top 44%
Viral Infections and Immunology Research
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