Controversies in transfusion medicine

Je, Menitove

doi:10.1046/j.1537-2995.1993.33593255607.x

Cited by 19 publications

(11 citation statements)

References 3 publications

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“…Using the pharmaceutical manufacturing framework, blood manufacturers were now being cited for failures of process control and quality assurance. 9,15,18 In 1992, the FDA further classified blood and blood products as pharmaceuticals, placing them under 21CFR 210,211. [19][20][21] These sections of the CFR outline current good manufacturing practices (CGMPs).…”

Section: Regulatory and Quality Initiativestrends In Transfusion Medimentioning

confidence: 99%

“…As a result, blood banking and transfusion medicine, which had been focused on patient care through clinical consultation, evolved into a blood manufacturing industry. 9 Blood donors were also seen differently, as the source of transfusion transmitted disease and risk. 10 The public lost faith in the safety of the blood supply and in the government's oversight over blood banks.…”

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confidence: 99%

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Regulatory and Quality Initiatives—Trends in Transfusion Medicine

Roseff

2005

Lab Med

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Section: Regulatory and Quality Initiativestrends In Transfusion Medimentioning

confidence: 99%

mentioning

confidence: 99%

Regulatory and Quality Initiatives—Trends in Transfusion Medicine

Roseff

2005

Lab Med

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“…However, the flexibility to limit the costs of autologous blood for donor screening, testing, and handling of these units depends on the recognition that auto logous blood procurement is a medical service for these pa tients [37], While a recent publication [38] endorsed this approach, it is counter to the policies of regulatory agencies that now regard blood as a drug, subject to the standards of good manufacturing practices [39]. Perhaps the greatest de gree of cost savings can be achieved by hospital-based auto logous blood procurement, as detailed in table 1.…”

Section: Cost-effective Considerationsmentioning

confidence: 99%

Autologous Blood Procurement in the Surgical Setting: Lessons Learned in the Last 10 years

Brecher¹,

Goodnough²,

Monk³

1996

Vox Sanguinis

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The percentage of blood transfused yearly that is autologous has increased substantially over the last 10 years. While autologous blood is regarded as a standard of care in many elective surgical settings, the increasing safety of allogeneic blood and the expense of autologous blood procurement have raised questions regarding the appropriate roles of autologous blood in blood conservation strategies. We therefore review current activities and emerging questions that arise from this maturing arena.

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“…From Birkmeyer et al, Ref 67. autologous blood testing if cross-over is not practiced; cross-over of unused autologous blood; and/or procurement of autologous blood from a hospital-based program. However, the flexibility to limit the costs of autologous blood for donor screening, testing, and handling of these units depends on the recognition that autologous blood procurement is a medical service for these patients (78); this approach runs counter to regulatory agencies that now regard blood as a drug, subject to the standards of good manufacturing practices (79). Perhaps the greatest degree of cost savings can be achieved by hospital-based autologous blood procurement, in which donor screening and blood testing policies can be modified (77), rather than acquisition of these blood units from the regional blood center.…”

Section: Cost-effective Considerationsmentioning

confidence: 99%

Blood Transfusion and Blood Conservation: Cost and Utilization Issues

Goodnough¹,

Bodner²,

Martin

1994

Am J Med Qual

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Approximately 12 million red blood cell units are transfused to nearly 4 million patients annually in the United States (1). The conservation of blood has historically arisen from awareness that the inventory of this resource is limited (2), as well as the knowledge that blood transfusion carries a risk (3). Estimates of current blood transfusion risks (4-12), and the costs of transfusion complications (13-17), are summarized in Table 1. In addition, emphasis on the costs of health care has raised issues related to the costs of blood transfusion (18, 19). Finally, recent guidelines have emphasized that in the elective transfusion setting, no blood transfusion is a desirable outcome (20, 21). Furthermore, these guidelines along with consensus conference recommendations (22) have emphasized that if blood is to be transfused, autologous (the patient's own) blood is preferable to allogeneic (from an anonymous, volunteer donor) blood. Thus, the costs of blood conservation, for which an increasing array of technologic procedures and products have become available (Table 2), have also become an issue (23). The purpose of this review is to provide an overview of emerging data on the cost-effectiveness of blood and blood conservation interventions in order to help identify areas important for future investigation.

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Controversies in transfusion medicine

Cited by 19 publications

References 3 publications

Regulatory and Quality Initiatives—Trends in Transfusion Medicine

Regulatory and Quality Initiatives—Trends in Transfusion Medicine

Autologous Blood Procurement in the Surgical Setting: Lessons Learned in the Last 10 years

Blood Transfusion and Blood Conservation: Cost and Utilization Issues

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