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Healthc Q ; 23(4): 35-38, 2021 Jan.
Article in English | MEDLINE | ID: covidwho-1040174


With the global outbreak of the COVID-19 pandemic, hospitals in Canada and around the world have been forced to consider conservation strategies to ensure continued availability of personal protective equipment (PPE) for healthcare providers. To mitigate critical PPE shortages, Sinai Health System (Sinai Health), a large academic healthcare institution in Canada, has developed and operationalized a standard operating procedure for the collection, decontamination and reuse of N95 respirators and other single-use PPE using a vaporized hydrogen peroxide decontamination method. Sinai Health has incorporated stringent quality assurance steps to ensure that the N95 respirators are successfully decontaminated without deformation and are safe to use.

Decontamination/methods , Equipment Contamination/prevention & control , Equipment Reuse , Equipment and Supplies, Hospital , N95 Respirators , COVID-19/prevention & control , Cross Infection/prevention & control , Equipment Reuse/standards , Equipment and Supplies, Hospital/adverse effects , Equipment and Supplies, Hospital/standards , Equipment and Supplies, Hospital/virology , Humans , N95 Respirators/adverse effects , N95 Respirators/standards , N95 Respirators/virology , SARS-CoV-2
Med (N Y) ; 1(1): 139-151.e4, 2020 12 18.
Article in English | MEDLINE | ID: covidwho-988787


BACKGROUND: Due to supply chain disruption, the COVID-19 pandemic has caused severe shortages in personal protective equipment for health care professionals. Local fabrication based on 3D printing is one way to address this challenge, particularly in the case of products such as protective face shields. No clear path exists, however, for introducing a locally fabricated product into a clinical setting. METHODS: We describe a research protocol under Institutional Review Board supervision that allowed clinicians to participate in an iterative design process followed by real-world testing in an emergency department. All designs, materials used, testing protocols, and survey results are reported in full to facilitate similar efforts in other clinical settings. FINDINGS: Clinical testing allowed the incident command team at a major academic medical center to introduce the locally fabricated face shield into general use in a rapid but well-controlled manner. Unlike standard hospital face shields, the locally fabricated design was intended to be reusable. We discuss the design and testing process and provide an overview of regulatory considerations associated with fabrication and testing of personal protective equipment, such as face shields. CONCLUSIONS: Our work serves as a case study for robust, local responses to pandemic-related disruption of medical supply chains with implications for health care professionals, hospital administrators, regulatory agencies, and concerned citizens in the COVID-19 and future health care emergencies. FUNDING: : This work was supported by the Harvard MIT Center for Regulatory Sciences, NIH/NCI grants U54-CA225088 and T32-GM007753, and the Harvard Ludwig Center. M.-J.A. is a Friends of McGovern Graduate Fellow.

COVID-19 , Equipment and Supplies, Hospital/standards , Personal Protective Equipment/standards , COVID-19/epidemiology , COVID-19/prevention & control , Hospitals , Humans , Pandemics/prevention & control , SARS-CoV-2
J Transl Med ; 18(1): 451, 2020 11 30.
Article in English | MEDLINE | ID: covidwho-949113


BACKGROUND: During the coronavirus disease-2019 (COVID-19) pandemic, Italian hospitals faced the most daunting challenges of their recent history, and only essential therapeutic interventions were feasible. From March to April 2020, the Laboratory of Advanced Cellular Therapies (Vicenza, Italy) received requests to treat a patient with severe COVID-19 and a patient with acute graft-versus-host disease with umbilical cord-derived mesenchymal stromal cells (UC-MSCs). Access to clinics was restricted due to the risk of contagion. Transport of UC-MSCs in liquid nitrogen was unmanageable, leaving shipment in dry ice as the only option. METHODS: We assessed effects of the transition from liquid nitrogen to dry ice on cell viability; apoptosis; phenotype; proliferation; immunomodulation; and clonogenesis; and validated dry ice-based transport of UC-MSCs to clinics. RESULTS: Our results showed no differences in cell functionality related to the two storage conditions, and demonstrated the preservation of immunomodulatory and clonogenic potentials in dry ice. UC-MSCs were successfully delivered to points-of-care, enabling favourable clinical outcomes. CONCLUSIONS: This experience underscores the flexibility of a public cell factory in its adaptation of the logistics of an advanced therapy medicinal product during a public health crisis. Alternative supply chains should be evaluated for other cell products to guarantee delivery during catastrophes.

COVID-19/therapy , Delivery of Health Care/organization & administration , Dry Ice , Mesenchymal Stem Cell Transplantation , Mesenchymal Stem Cells/cytology , Point-of-Care Systems/organization & administration , Transportation , Acute Disease , COVID-19/epidemiology , COVID-19/pathology , Cell Proliferation , Cell Survival , Cells, Cultured , Cord Blood Stem Cell Transplantation/adverse effects , Delivery of Health Care/standards , Equipment and Supplies, Hospital/standards , Equipment and Supplies, Hospital/supply & distribution , Graft vs Host Disease/etiology , Graft vs Host Disease/pathology , Graft vs Host Disease/therapy , Humans , Italy/epidemiology , Materials Management, Hospital/organization & administration , Materials Management, Hospital/standards , Mesenchymal Stem Cell Transplantation/methods , Mesenchymal Stem Cell Transplantation/standards , Mesenchymal Stem Cells/physiology , Organization and Administration/standards , Pandemics , Phenotype , Point-of-Care Systems/standards , SARS-CoV-2/physiology , Severity of Illness Index , Transportation/methods , Transportation/standards