Now is the time for the Organ Procurement and Transplantation Network to change regulatory policy to effectively increase transplantation in the United States; Carpe Diem

2020 ◽  
Vol 20 (8) ◽  
pp. 2026-2029
Author(s):  
Kenneth A. Andreoni
Keyword(s):  
United States ◽  
Organ Procurement ◽  
Regulatory Policy ◽  
The United States ◽  
Carpe Diem

An Adapted Process and Organ Procurement Perspective on Heart Retransplantation for a Healthy Heart’s Third Life

2021 ◽  
pp. 152692482110246
Author(s):  
Darryl C. Nethercot ◽  
Mita Shah ◽  
Lisa M. Stocks ◽  
Jeffrey M. Trageser ◽  
Victor Pretorius ◽  
...  
Keyword(s):  
United States ◽  
Organ Procurement ◽  
The United States ◽  
Matching Process ◽  
Organ Procurement Organizations ◽  
Third Person ◽  
Adapted Process ◽  
United Network ◽  
Transplanted Hearts

As organ procurement organizations nationwide see an increased opportunity to retransplant already transplanted hearts, we would like to share the overview and process of our 2 successful cases. Heart retransplantation increased our cardiac placement rates by 2.64% and 2% in 2015 and 2019, respectively. Spread across a nation that sees over 3500 heart placements annually, a 2% increase would be substantial. Since 2009, our cases stand as the only documented heart retransplantations in the United States. However, United Network for Organ Sharing data shows that potential exists. From a facilitation perspective, we have developed a protocol to ease the matching process. From a surgical perspective, these cases had no complications and saved 2 lives, with each heart now beating in a third person. We hope that by sharing our process and success, we can familiarize fellow organ procurement organizations and transplant communities with this viable opportunity.

Variability in Pediatric Brain Death Determination Protocols in the United States

Neurology ◽  
2021 ◽  
pp. 10.1212/WNL.0000000000012225
Author(s):  
Conall Francoeur ◽  
Matthew J Weiss ◽  
Jennifer M Macdonald ◽  
Craig Press ◽  
David Matthew Greer ◽  
...  
Keyword(s):  
United States ◽  
Brain Injury ◽  
Organ Procurement ◽  
The United States ◽  
Cross Sectional Study ◽  
Neurologic Examination ◽  
National Guidelines ◽  
Cross Sectional ◽  
Organ Procurement Organizations ◽  
Death By Neurologic Criteria

Objective:To determine the variability in pediatric death by neurologic criteria (DNC) protocols between US pediatric institutions and compared to the 2011 DNC guidelines.Methods:Cross-sectional study of DNC protocols obtained from pediatric institutions in the United States (US) via regional organ procurement organizations. Protocols were evaluated across five domains: general DNC procedures, prerequisites, neurologic examination, apnea testing and ancillary testing. Descriptive statistics compared protocols to each other and the 2011 guidelines.Results:One hundred and thirty protocols were analyzed with 118 dated after publication of the 2011 guidelines. Of those 118 protocols, identification of a mechanism of irreversible brain injury was required in 97%, while 67% required an observation period after acute brain injury before DNC evaluation. Most protocols required guideline-based prerequisites such as exclusion of hypotension (94%), hypothermia (97%), and metabolic derangements (92%). On neurologic examination, 91% required a lack of responsiveness, 93% no response to noxious stimuli, and 99% loss of brainstem reflexes. 84% of protocols required the guideline-recommened two apnea tests. CO2 targets were consistent with guidelines in 64%. Contrary to guidelines, fifteen percent required ancillary testing for all patients and 15% permitted ancillary studies that are not validated in pediatrics.Conclusionsand Relevance: Variability exists between pediatric institutional DNC protocols in all domains of DNC determination, especially with respect to apnea and ancillary testing. Better alignment of DNC protocols with national guidelines may improve the consistency and accuracy of DNC determination.

Liver Transplantation for the Gastroenterologist

2015 ◽  
Author(s):  
Andreea M. Catana ◽  
Michael P. Curry
Keyword(s):  
United States ◽  
Liver Transplantation ◽  
Liver Disease ◽  
Organ Procurement ◽  
The United States ◽  
Waiting Lists ◽  
Liver Graft ◽  
Term Survival ◽  
End Stage Liver Disease ◽  
End Stage

The first liver transplantation (LT) was performed in 1963, and currently more than 65,000 people in the United States are living with a transplanted liver. In 2012, the number of adults who registered on the LT waiting list decreased for the first time since 2002; 10,143 candidates were added compared with 10,359 in 2011. LT offers long-term survival for complications of end-stage liver disease and prolongs life in properly selected patients, but problems such as donor deficit, geographic disparities, and long waiting lists remain. This overview of LT for the gastroenterologist details the indications for LT and patient selection, evaluation, liver organ allocation, prioritization for transplantation, transplantation benefit by the Model for End-Stage Liver Disease (MELD), MELD limitations, sources of liver graft, strategies employed to decrease the donor deficit, complications, and outcomes. Figures include indications for LT in Europe and the United States, Organ Procurement and Transplantation Network regions in the United States, the number of transplants and size of active waiting lists, mortality by MELD, regional disparity, patient survival rates with and without hepatitis C virus, and unadjusted patient and graft survival. Tables list LT milestones, indications for LT, contraindications for LT, minimal listing criteria for LT, criteria for LT in acute liver failure, LT evaluation process, adult recipient listing status 1A, and early posttransplantation complications. This review contains 7 highly rendered figures, 8 tables, and 46 references. 

Effect of the Opioid Crisis on the Donor Pool for Kidney Transplantation: An Analysis of National Kidney Deceased Donor Trends from 2010–2016

2018 ◽  
Vol 47 (2) ◽  
pp. 84-93 ◽  
Author(s):  
Donald F. Chute ◽  
Meghan E. Sise
Keyword(s):  
United States ◽  
Kidney Transplant ◽  
Drug Overdose ◽  
Organ Procurement ◽  
Deceased Donor ◽  
The United States ◽  
Hcv Infection ◽  
Kidney Donor ◽  
Donor Pool ◽  
Opioid Crisis

Background: The opioid crisis has led to a dramatic increase in the number of drug overdose deaths in the United States. Little is known about the effect of the opioid crisis on the kidney transplant donor pool, particularly on hepatitis C virus (HCV)-infected donors. Methods: This is a retrospective analysis of the data from the Organ Procurement and Transplantation Network from 2010 to 2016. We determined the changes in characteristics of kidney transplant donors and evaluated which changes may be directly related to the opioid crisis. Results: Between 2010 and 2016, we found a 26% increase in overall donors, including a 277% increase in the number of donors who died from drug overdose. Nineteen percent of donors who died of drug overdose had HCV infection. Donors who die from drug overdose and donors with HCV infection are younger, less likely to have diabetes or hypertension, and have favorable kidney donor profile index scores compared to average donors. Despite these favorable characteristics, HCV-infected donors appear to be notably underutilized, with substantially lower kidneys per donor being transplanted compared to HCV uninfected donors. Conclusion: The opioid crisis in the United States has substantially altered the kidney donor pool. Strategies to increase utilization of all potentially viable kidneys for transplant are needed, particularly in this era of new, highly effective, direct-acting antiviral therapy for HCV infection.

Consumer Safety

2012 ◽  
Author(s):  
David Vogel
Keyword(s):  
United States ◽  
Regulatory Policy ◽  
The United States ◽  
Pharmaceutical Regulation ◽  
Regulatory Policies ◽  
Consumer Safety ◽  
Safety Risks ◽  
European Regulatory ◽  
Drug Lag ◽  
Important Exception

This chapter analyzes European and American policies toward a range of consumer safety risks; including drugs, children's products, and cosmetics. It shows how European and American risk regulations have converged, though the dynamics through which this occurred differed substantially. Pharmaceutical regulation constitutes the most important exception to the broader pattern of increased transatlantic regulatory policy divergence. What makes this area of regulatory policy distinctive is that its political salience increased in the United States but not in Europe. Pharmaceutical regulation also represents an important exception to the dominant pattern of transatlantic regulatory policy diffusion. In this case, European regulatory policies did affect those of the United States, first by highlighting the transatlantic drug lag, and more recently by American decisions to adopt some European practices to expedite drug approvals.

Explaining Regulatory Policy Divergence

2012 ◽  
Author(s):  
David Vogel
Keyword(s):  
United States ◽  
International Trade ◽  
Regulatory Policy ◽  
The United States ◽  
Business Managers ◽  
Risk Regulation ◽  
Policy Makers ◽  
European Standards ◽  
Policy Shifts ◽  
The Eu

This chapter explores several alternative explanations for the divergence in transatlantic risk regulation, and discusses the policy shifts that have taken place on both sides of the Atlantic since around 1990. The United States and the fifteen member states of the EU are affluent democracies with sophisticated public bureaucracies, substantial scientific capacities, and strong civic cultures. Their regulatory officials have access to much of the same scientific expertise and there is extensive communication among policy makers, scientists, business managers, nongovernment organizations, and citizens. The chapter shows how divergent risk regulations between the United States and the EU add to the costs of transatlantic commerce and also raise the costs of international trade as some countries adopt European standards and others adopt American ones.

scholarly journals Investigation of a Contaminated, Nationally Distributed, Organ Transplant Preservation Solution — United States, 2016–2017

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S11-S11
Author(s):  
Matthew Stuckey ◽  
Shannon Novosad ◽  
Nancy Wilde ◽  
Pallavi Annambhotla ◽  
Sridhar Basavaraju ◽  
...  
Keyword(s):  
United States ◽  
Adverse Events ◽  
Infection Control ◽  
Bacterial Contamination ◽  
Organ Procurement ◽  
The United States ◽  
Patient Harm ◽  
Preservation Solution ◽  
Public Health Action ◽  
Transplant Center

Abstract Background In December 2016, bacterial contamination of an organ preservation solution (OPS) was reported by Transplant Center A in Iowa. Annually, >20,000 abdominal organs are transplanted in the United States; OPS is used for organ storage. We investigated the scope of OPS contamination and its association with adverse events in patients. Methods We assessed infection control practices related to OPS at Transplant Centers A and B in Iowa and the local organ procurement organization (OPO). We issued national notifications about OPS contamination and requested transplant centers to report product-related concerns or potential patient harm. Among transplant recipients at Center A, we compared adverse events (fever, bacteremia, surgical site infection, peritonitis, or pyelonephritis within 14 days of transplantation) during October–December 2015 with October–December 2016, the presumed window of exposure to contaminated OPS. Isolates from OPS were characterized. Results No infection control deficiencies were identified at Transplant Centers A, B, or the OPO. In January 2017, contaminated OPS from the same manufacturer was reported by Transplant Center C in Texas. Nationally, there were no reports of patient harm definitively linked to OPS. Post-transplant adverse events at Center A did not increase between fourth quarter 2015 (5/12 [42%]) and 2016 (2/15 [13%]). Organisms recovered from OPS included Pantoea agglomerans and Enterococcus gallinarum (Center A) and Pseudomonas koreensis (Center C). Five Pantoea isolates from ≥3 opened OPS bags were indistinguishable by pulsed-field gel electrophoresis. The OPS distributor issued recalls and suspended production. The US Food and Drug Administration identified deficiencies in current good manufacturing practices at manufacturing and distribution facilities, including inadequate validation of OPS sterility. Conclusion Bacterial contamination of a nationally distributed product was identified by astute clinicians. The investigation found no illnesses were directly linked to the product. Prompt reporting of concerns about potentially contaminated healthcare products, which might put patients at risk, is critical for swift public health action. Disclosures All authors: No reported disclosures.

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