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1.
JAMA Netw Open ; 4(10): e2128615, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1453504

ABSTRACT

Importance: The number of clinics marketing stem cell products for joint diseases, chronic pain, and most recently, COVID-19, has increased despite warnings from the US Food and Drug Administration that stem cell products for these and other indications have not been proven safe or effective. Objective: To examine bacterial infections in 20 patients who received umbilical cord blood-derived products marketed as stem cell treatment. Design, Setting, and Participants: This case series is a national public health investigation including case-finding, medical record review and abstraction, and laboratory investigation, including sterility testing of products and whole-genome sequencing of patient and product isolates. Participants included patients who developed bacterial infections following administration of umbilical cord blood-derived products marketed as stem cell treatment during August 2017 to September 2018. Data analysis was performed from March 2019 to September 2021. Exposures: Umbilical cord blood-derived products marketed as stem cell treatment. Main Outcomes and Measures: Data were collected on patient infections and exposures. The Centers for Disease Control and Prevention performed sterility testing on undistributed and distributed vials of product marketed as stem cell treatment and performed whole-genome sequencing to compare patient and product bacterial isolates. Results: Culture-confirmed bacterial infections were identified in 20 patients (median [range] age, 63 [2-89] years; 13 male patients [65%]) from 8 US states who sought stem cell treatment for conditions including pain, osteoarthritis, rheumatoid arthritis, and injury; all but 1 required hospitalization. The most frequently isolated bacteria from patients with infections were common enteric species, including Escherichia coli (14 patients) and Enterobacter cloacae (7 patients). Of unopened, undistributed products sampled for testing, 65% (22 of 34 vials) were contaminated with at least 1 of 16 bacterial species, mostly enteric. A patient isolate from Arizona matched isolates obtained from products administered to patients in Florida, and patient isolates from Texas matched undistributed product sent from the company in California. Conclusions and Relevance: Unapproved stem cell products can expose patients to serious risks without proven benefit. Sequencing results suggest a common source of extensive contamination, likely occurring during the processing of cord blood into product. Patients and health care practitioners who are considering the use of unapproved products marketed as stem cell treatment should be aware of their unproven benefits and potential risks, including serious infections.


Subject(s)
Bacterial Infections/etiology , Blood Safety/statistics & numerical data , Cord Blood Stem Cell Transplantation/adverse effects , Disease Outbreaks , Adolescent , Adult , Aged , Aged, 80 and over , Bacterial Infections/epidemiology , Bacterial Infections/prevention & control , Blood Safety/standards , Centers for Disease Control and Prevention, U.S. , Child , Child, Preschool , Cord Blood Stem Cell Transplantation/standards , Female , Humans , Male , Marketing , Middle Aged , Outcome Assessment, Health Care , Public Health Surveillance , United States/epidemiology , United States Food and Drug Administration , Young Adult
3.
Vox Sang ; 116(5): 497-503, 2021 May.
Article in English | MEDLINE | ID: covidwho-1241034

ABSTRACT

INTRODUCTION: Numerous concerns regarding maintenance of blood inventory have been raised after SARS-CoV-2 pandemic outbreak. These concerns were based on the experience of blood centres in previous pandemics where shortage of blood components was reported. The present study had tried to understand the impact of SARS-CoV-2 pandemic on blood collection and demand as well as the impact of disaster planning in maintaining an adequate inventory. METHODS: Data related to blood supply and demand were collected retrospectively using blood bank management software for pre-COVID-19 and COVID-19 time period and compared. Strategies adopted and effects of changes in existing disaster plans to maintain an adequate inventory were studied. RESULTS: A drastic fall in the red cell inventory was observed as compared to pre-COVID-19 time period was observed due to disproportionate decrease in blood collection (1/6 to 1/9 of the previous collection) and demand (1/2 of the previous demand). The buffer stock fell gradually over a period of three weeks with cancellation of planned blood donation drives. A buffer stock equivalent to 2-week inventory led to adequate inventory in the initial lockdown periods. Similar fall was observed in the platelet inventory with reduction in the blood collection but almost a proportionate reduction in the platelet demand led to adequate inventory. No increase in wastage was observed for both red cells and platelets during this period. DISCUSSION: A buffer stock of blood and blood components, strict adherence to the transfusion triggers, good coordination with the clinical staff and a prospective review of blood transfusion requests to ensure rational blood transfusion were some of the steps which helped us to successfully maintain transfusion requirements in the initial phases of the COVID-19 pandemic. Use of first-in-first-out policy prevented any wastage due to outdating of blood.


Subject(s)
Blood Banks/organization & administration , Blood Safety/standards , COVID-19/epidemiology , Blood Banks/standards , Blood Donors/supply & distribution , Blood Safety/methods , Hospitals/standards , Humans
5.
Am J Public Health ; 111(5): 860-866, 2021 05.
Article in English | MEDLINE | ID: covidwho-1140582

ABSTRACT

The COVID-19 pandemic has precipitated an acute blood shortage for medical transfusions, exacerbating an already tenuous blood supply system in the United States, contributing to the public health crisis, and raising deeper questions regarding emergency preparedness planning for ensuring blood availability. However, these issues around blood availability during the pandemic are related primarily to the decline in supply caused by reduced donations during the pandemic rather than increased demand for transfusion of patients with COVID-19.The challenges to ensure a safe blood supply during the pandemic will continue until a vaccine is developed, effective treatments are available, or the virus goes away. If this virus or a similar virus were capable of transmission through blood, it would have a catastrophic impact on the health care system, causing a future public health emergency that would jeopardize the national blood supply.In this article, we identify the impact of the COVID-19 pandemic on blood supply adequacy, discuss the public health implications, propose recovery strategies, and present recommendations for preparing for the next disruption in blood supply driven by a public health emergency.


Subject(s)
Blood Safety/standards , COVID-19 , Civil Defense/standards , Public Health , Public Policy , Delivery of Health Care , Humans , United States
6.
Am J Public Health ; 111(2): 247-252, 2021 02.
Article in English | MEDLINE | ID: covidwho-937313

ABSTRACT

In April 2020, in light of COVID-19-related blood shortages, the US Food and Drug Administration (FDA) reduced the deferral period for men who have sex with men (MSM) from its previous duration of 1 year to 3 months.Although originally born out of necessity, the decades-old restrictions on MSM donors have been mitigated by significant advancements in HIV screening, treatment, and public education. The severity of the ongoing COVID-19 pandemic-and the urgent need for safe blood products to respond to such crises-demands an immediate reconsideration of the 3-month deferral policy for MSM.We review historical HIV testing and transmission evidence, discuss the ethical ramifications of the current deferral period, and examine the issue of noncompliance with donor deferral rules. We also propose an eligibility screening format that involves an individual risk-based screening protocol and, unlike current FDA guidelines, does not effectively exclude donors on the basis of gender identity or sexual orientation. Our policy proposal would allow historically marginalized community members to participate with dignity in the blood donation process without compromising blood donation and transfusion safety outcomes.


Subject(s)
Blood Donors/ethics , Blood Safety/standards , Blood Transfusion/standards , COVID-19/epidemiology , Donor Selection/standards , Sexual and Gender Minorities/statistics & numerical data , COVID-19/therapy , COVID-19/transmission , HIV Infections/transmission , Health Policy , Homosexuality, Male/statistics & numerical data , Humans , Male , Transgender Persons/statistics & numerical data , United States
7.
Vox Sang ; 116(5): 497-503, 2021 May.
Article in English | MEDLINE | ID: covidwho-889823

ABSTRACT

INTRODUCTION: Numerous concerns regarding maintenance of blood inventory have been raised after SARS-CoV-2 pandemic outbreak. These concerns were based on the experience of blood centres in previous pandemics where shortage of blood components was reported. The present study had tried to understand the impact of SARS-CoV-2 pandemic on blood collection and demand as well as the impact of disaster planning in maintaining an adequate inventory. METHODS: Data related to blood supply and demand were collected retrospectively using blood bank management software for pre-COVID-19 and COVID-19 time period and compared. Strategies adopted and effects of changes in existing disaster plans to maintain an adequate inventory were studied. RESULTS: A drastic fall in the red cell inventory was observed as compared to pre-COVID-19 time period was observed due to disproportionate decrease in blood collection (1/6 to 1/9 of the previous collection) and demand (1/2 of the previous demand). The buffer stock fell gradually over a period of three weeks with cancellation of planned blood donation drives. A buffer stock equivalent to 2-week inventory led to adequate inventory in the initial lockdown periods. Similar fall was observed in the platelet inventory with reduction in the blood collection but almost a proportionate reduction in the platelet demand led to adequate inventory. No increase in wastage was observed for both red cells and platelets during this period. DISCUSSION: A buffer stock of blood and blood components, strict adherence to the transfusion triggers, good coordination with the clinical staff and a prospective review of blood transfusion requests to ensure rational blood transfusion were some of the steps which helped us to successfully maintain transfusion requirements in the initial phases of the COVID-19 pandemic. Use of first-in-first-out policy prevented any wastage due to outdating of blood.


Subject(s)
Blood Banks/organization & administration , Blood Safety/standards , COVID-19/epidemiology , Blood Banks/standards , Blood Donors/supply & distribution , Blood Safety/methods , Hospitals/standards , Humans
10.
Vox Sang ; 115(6): 488-494, 2020 Aug.
Article in English | MEDLINE | ID: covidwho-26729

ABSTRACT

Plasma provided by COVID-19 convalescent patients may provide therapeutic relief as the number of COVID-19 cases escalates steeply worldwide. Prior findings in various viral respiratory diseases including SARS-CoV-related pneumonia suggest that convalescent plasma can reduce mortality, although formal proof of efficacy is still lacking. By reducing viral spread early on, such an approach may possibly downplay subsequent immunopathology. Identifying, collecting, qualifying and preparing plasma from convalescent patients with adequate SARS-CoV-2-neutralizing Ab titres in an acute crisis setting may be challenging, although well within the remit of most blood establishments. Careful clinical evaluation should allow to quickly establish whether such passive immunotherapy, administered at early phases of the disease in patients at high risk of deleterious evolution, may reduce the frequency of patient deterioration, and thereby COVID-19 mortality.


Subject(s)
Blood Specimen Collection/methods , Coronavirus Infections/blood , Pneumonia, Viral/blood , Blood Safety/methods , Blood Safety/standards , Blood Specimen Collection/standards , COVID-19 , Coronavirus Infections/immunology , Coronavirus Infections/therapy , Humans , Immunization, Passive/methods , Immunization, Passive/standards , Pandemics , Pneumonia, Viral/immunology , Pneumonia, Viral/therapy
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