A WHO remit to improve global standards for medical products of human origin.

In recent decades, considerable advances have been made in assuring the safety of blood transfusion and organ transplantation. However, with the increasing movement of medical products of human origin across international boundaries, there is a need to enhance global norms and governance. These products, which include blood, organs, tissues, cells, human milk and faecal microbiota, are today crucial for health care but they also pose unique risks due to their human origin, such as disease transmission and graft failure.

Testing of tissue specimens obtained from SARS-CoV-2 nasopharyngeal swab-positive donors.

Risk for transmission of SARS-CoV-2 through allogeneic human tissue transplantation is unknown. To further evaluate the risk of virus transmission, tissues were obtained from deceased donors who had tested positive for SARS-CoV-2 RNA via nasopharyngeal swab. This study evaluated an array of human tissues recovered for transplantation, including bone, tendon, skin, fascia lata, vascular tissues, and heart valves.

Low rate of detection of SARS-CoV-2 RNA in deceased tissue donors.

Given the possibility for disease transmission, this study was performed to determine whether there is detectable SARS-CoV-2 viral RNA in the blood of deceased tissue donors. A retrospective analysis of blood samples from eligible deceased tissue donors from Oct 2019 through June 2020 was performed. Plasma aliquots were initially tested with a SARS-CoV-2 NAT Assay; positive samples were further tested using an alternate NAT and an antibody assay.

Estimating incidence of infection from diverse data sources: Zika virus in Puerto Rico, 2016.

Emerging epidemics are challenging to track. Only a subset of cases is recognized and reported, as seen with the Zika virus (ZIKV) epidemic where large proportions of infection were asymptomatic. However, multiple imperfect indicators of infection provide an opportunity to estimate the underlying incidence of infection.

The Role of Endotoxin in Sterile Inflammation After Implanted Acellular Dermal Matrix: Red Breast Syndrome Explained?

Background: Red breast syndrome (RBS) is a noninfectious erythema associated with acellular dermal matrix (ADM). The underlying cause remains unknown despite multiple suggested etiologies. No similar presentations to RBS have been reported in other anatomic regions.

A mathematical model to describe survival among liver recipients from deceased donors with risk of transmitting infectious encephalitis pathogens.

Background: Between 2002 and 2013, the organs of 13 deceased donors with infectious encephalitis were transplanted, causing infections in 23 recipients. As a consequence, organs from donors showing symptoms of encephalitis (increased probability of infectious encephalitis (IPIE) organs) might be declined. We had previously characterized the risk of IPIE organs using data available to most transplant teams and not requiring special diagnostic tests.

Transfusion-Transmitted Infections Reported to the National Healthcare Safety Network Hemovigilance Module.

Transfusion-transmitted infections (TTIs) can be severe and result in death. Transfusion-transmitted viral pathogen transmission has been substantially reduced, whereas sepsis due to bacterial contamination of platelets and transfusion-transmitted babesiosis may occur more frequently. Quantifying the burden of TTI is important to develop targeted interventions.

Evaluation of the National Healthcare Safety Network Hemovigilance Module for transfusion-related adverse reactions in the United States.

Introduction: The National Healthcare Safety Network (NHSN) Hemovigilance Module (HM) collects data on the frequency, severity, and imputability of transfusion-associated adverse events. These events contribute to significant morbidity and mortality among transfusion patients. We report results from the first systematic assessment of eight attributes of the HM.

Assessment of risk for transplant-transmissible infectious encephalitis among deceased organ donors.

Background: There were 13 documented clusters of infectious encephalitis transmission via organ transplant from deceased donors to recipients during 2002-2013. Hence, organs from donors diagnosed with encephalitis are often declined because of concerns about the possibility of infection, given that there is no quick and simple test to detect causes of infectious encephalitis.

Methods: We constructed a database containing cases of infectious and non-infectious encephalitis.

Modes of Transmission of Zika Virus.

For >60 years, Zika virus (ZIKV) has been recognized as an arthropod-borne virus with Aedes species mosquitoes as the primary vector. However in the past 10 years, multiple alternative routes of ZIKV transmission have been identified. We review the available data on vector and non-vector-borne modes of transmission and interventions undertaken, to date, to reduce the risk of human infection through these routes.

Cost projections for implementation of safety interventions to prevent transfusion-transmitted Zika virus infection in the United States.

Background: In August 2016, the Food and Drug Administration advised US blood centers to screen all whole blood and apheresis donations for Zika virus (ZIKV) with an individual-donor nucleic acid test (ID-NAT) or to use approved pathogen reduction technology (PRT). The cost of implementing this guidance nationally has not been assessed.

Study Design And Methods: Scenarios were constructed to characterize approaches to ZIKV screening, including universal ID-NAT, risk-based seasonal allowance of minipool (MP) NAT by state, and universal MP-NAT.

Continued decline in blood collection and transfusion in the United States-2015.

Background: In 2011 and 2013, the National Blood Collection and Utilization Survey (NBCUS) revealed declines in blood collection and transfusion in the United States. The objective of this study was to describe blood services in 2015.

Study Design And Methods: The 2015 NBCUS was distributed to all US blood collection centers, all hospitals performing at least 1000 surgeries annually, and a 40% random sample of hospitals performing 100 to 999 surgeries annually.

Mycoplasma hominis Infections Transmitted Through Amniotic Tissue Product.

Background: Mycoplasma hominis is a commensal genitourinary tract organism that can cause infections outside the genitourinary tract. We investigated a cluster of M. hominis surgical site infections in patients who underwent spine surgery, all associated with amniotic tissue linked to a common donor.

Transmission of Hepatitis A Virus through Combined Liver-Small Intestine-Pancreas Transplantation.

Although transmission of hepatitis A virus (HAV) through blood transfusion has been documented, transmission through organ transplantation has not been reported. In August 2015, state health officials in Texas, USA, were notified of 2 home health nurses with HAV infection whose only common exposure was a child who had undergone multi-visceral organ transplantation 9 months earlier. Specimens from the nurses, organ donor, and all organ recipients were tested and medical records reviewed to determine a possible infection source.

Use of Blood Donor Screening Data to Estimate Zika Virus Incidence, Puerto Rico, April-August 2016.

Puerto Rico has been heavily impacted by Zika virus, a mosquitoborne flavivirus that emerged in the Americas during 2015. Although most persons with Zika virus show no symptoms, the virus can cause neurologic and other complications, including fetal microcephaly. Local Zika virus transmission in Puerto Rico has been reported since December 2015.

Three Cases of Neurologic Syndrome Caused by Donor-Derived Microsporidiosis.

In April 2014, a kidney transplant recipient in the United States experienced headache, diplopia, and confusion, followed by neurologic decline and death. An investigation to evaluate the possibility of donor-derived infection determined that 3 patients had received 4 organs (kidney, liver, heart/kidney) from the same donor. The liver recipient experienced tremor and gait instability; the heart/kidney and contralateral kidney recipients were hospitalized with encephalitis.

A model to estimate the probability of human immunodeficiency virus and hepatitis C infection despite negative nucleic acid testing among increased-risk organ donors.

Background: In 2013, guidelines were released for reducing the risk of viral bloodborne pathogen transmission through organ transplantation. Eleven criteria were described that result in a donor being designated at increased infectious risk. Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) transmission risk from an increased-risk donor (IRD), despite negative nucleic acid testing (NAT), likely varies based on behavior type and timing.