PMID- 31433277 OWN - NLM STAT- MEDLINE DCOM- 20200518 LR - 20200701 IS - 2326-5108 (Electronic) IS - 2326-5094 (Print) IS - 2326-5094 (Linking) VI - 17 IP - 4 DP - 2019 Jul/Aug TI - Quality Assurance Sampling Plans in US Stockpiles for Personal Protective Equipment: A Computer Simulation to Examine Degradation Rates. PG - 324-333 LID - 10.1089/hs.2019.0042 [doi] AB - Medical countermeasure stockpiles in the United States are designed to support healthcare workers and the public during public health emergencies; they include supplies of personal protective equipment (PPE). As part of typical PPE manufacturing processes, appropriate test methods are used to ensure that the devices provide adequate protective performance. At the time of manufacture, performance is often measured and weighed against an objective standard of quality, resulting in a pass or fail attribute being assigned to individual PPE items and thence to production lots. Incorporating periodic performance testing for stockpiled PPE can ensure that they maintain their protective qualities and integrity over time while in storage. There is an absence of guidance regarding how to design quality assurance programs for stockpiled PPE. The applicability of the Lot Quality Assurance Sampling (LQAS) approach to stockpiled PPE was examined in a previous study that compared and contrasted different sample sizes in recovering the true percentage of defective units in large lots in the LQAS framework. The current study carries this line of inquiry forward by integrating PPE degradation over time and comparing different sampling time intervals in recovering the true underlying degradation rate. The results suggest that product degradation is more easily detected when tested at shorter time intervals and for higher degradation rates. They further suggest that sampling interval groupings can be made based on the proficiency with which they recover the true underlying degradation rate. FAU - Dubaniewicz, Mitchell T AU - Dubaniewicz MT AD - Mitchell T. Dubaniewicz is a student researcher, Department of Bioengineering, Swanson School of Engineering, University of Pittsburgh, and was on assignment with CDC/NIOSH/NPPTL. FAU - Rottach, Dana R AU - Rottach DR AD - Dana R. Rottach, PhD, is a Physical Scientist, and Patrick L. Yorio, PhD, is a Health Statistician; both at the National Personal Protective Technology Laboratory, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Pittsburgh, PA. FAU - Yorio, Patrick L AU - Yorio PL AD - Dana R. Rottach, PhD, is a Physical Scientist, and Patrick L. Yorio, PhD, is a Health Statistician; both at the National Personal Protective Technology Laboratory, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Pittsburgh, PA. LA - eng GR - CC999999/Intramural CDC HHS/United States PT - Journal Article PL - United States TA - Health Secur JT - Health security JID - 101654694 SB - IM MH - *Computer Simulation MH - Humans MH - Lot Quality Assurance Sampling/*statistics & numerical data MH - Personal Protective Equipment/*standards MH - Public Health MH - United States PMC - PMC6823634 MID - NIHMS1054665 OTO - NOTNLM OT - Countermeasures OT - Personal protective equipment OT - Stockpile EDAT- 2019/08/23 06:00 MHDA- 2020/05/19 06:00 PMCR- 2020/07/01 CRDT- 2019/08/22 06:00 PHST- 2019/08/22 06:00 [entrez] PHST- 2019/08/23 06:00 [pubmed] PHST- 2020/05/19 06:00 [medline] PHST- 2020/07/01 00:00 [pmc-release] AID - 10.1089/hs.2019.0042 [doi] PST - ppublish SO - Health Secur. 2019 Jul/Aug;17(4):324-333. doi: 10.1089/hs.2019.0042.