Linked Life Data

12415513

Source:http://linkedlifedata.com/resource/pubmed/id/12415513

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2002-11-4
pubmed:abstractText
Blood banking and the manufacture of blood products have been relatively outside the influence of regulatory authorities. Several developments contributed to a revision of this environment. The transmission of acquired immunodeficiency syndrome by blood products changed the perception of blood product safety and also spawned litigation and governmental inquiries. The blood banking industry has embraced, with varying degrees of enthusiasm, the principles of systematic quality management and good manufacturing practice, which has created a substantial subindustry and has contributed to a disproportionate focus on product quality. Conventional market forces have also gradually penetrated the traditional blood economies. The public and political focus has resulted in regulatory and policy efforts being concentrated on inappropriate areas. Several of the safety efforts can be arguably described as cost-ineffective while diverting attention and resources from more important issues. An improved integration into mainstream public health policy and incorporation of objectively measured risks into regulatory policy would do much to enhance the quality of the transfusion system. This can be achieved if regulators themselves are overseen through a process that ensures performance and accountability against objective and predefined standards. A further beneficial outcome from this approach could be the harmonization of blood safety and policy measures, the need for which is being felt increasingly worldwide.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:month
Oct
pubmed:issn
0887-7963
pubmed:author
pubmed:copyrightInfo
Copyright 2002, Elsevier Science (USA)
pubmed:issnType
Print
pubmed:volume
16
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
273-82
pubmed:dateRevised
2005-11-16
pubmed:meshHeading
pubmed:year
2002
pubmed:articleTitle
The regulatory pendulum in transfusion medicine.
pubmed:affiliation
Blood Products Group, Therapeutic Goods Administration, Australian Commonwealth Department of Health and Aged Care, Woden, Australia. albert.farrugia@health.gov.au
pubmed:publicationType
Journal Article, Review