Authors' objectives:

The objectives of this review are to assess the efficacy and safety of perioperative blood salvage (PBS) systems and their anticipated benefit; and to propose a CCAM (Classification Commune des Actes Medicaux/Common Classification of Medical Procedures) status for the technique and a legal status for the blood product in order to identify the appropriate vigilance systems.

Authors' results and conclusions: (i) Quality of the blood product: washed and unwashed red blood cells obtained by PBS are viable and their oxygen transport capacity is preserved. (ii) Efficacy of PBS: the volume of allogenic blood transfused is reduced by 20-87% when using PBS. Efficacy depends on the type of surgery and increases with the amount of blood lost. Data on the impact of PBS on length of hospital stay and reduction in postoperative bleeding are contradictory. (iii) Risks related to PBS: contamination of blood product storage packs has been reported but it has not caused infection in patients. Fatal gas embolism has been reported. In all cases, it has been related to non-compliance with procedures for use. (iv) Status and vigilance system: in the current CCAM, PBS is defined as a "complementary professional procedure" always associated with a surgical procedure. It is never an "isolated procedure". Health professionals' expectations with regard to the status of the technique and the restrictions imposed by vigilance systems and legal authorisations were reviewed. (v)Regulatory aspects: PBS is covered by a circular (Jan. 1997) which states Good Practice but does not mention the schedule for biological controls, standards, nor blood product specifications.

Authors' recommendations: PBS with washed blood should remain a CCAM professional procedure. The committee deciding on state reimbursement for procedures (CHAP Commission de Hiwrarchisation des Actes Professionnels) has to decide whether it will be "a procedure linked to a surgical procedure", an "isolated procedure", or a "full-scale procedure". PBS with unwashed blood should not retain complementary status but should be included in the CCAM with the reservation that its place in postoperative blood saving after surgery has not yet been clarified. PBS blood product cannot be included under health products nor under labile blood products, and does not necessitate a specific status. The vigilance systems associated with the procedure and the PBS product are: medical device vigilance for incidents related to single-use medical devices (SUD), and the nosocomial infection notification system and/or system for reporting care-related adverse events for incidents related to PBS blood products.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.has-Sante.fr/

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: France

Organisation Name: Haute Autorité de Santé

Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;

Contact Name: has.seap.secretariat@has-sante.fr

Contact Email: has.seap.secretariat@has-sante.fr

Copyright: Haute Autorite de Sante/French National Authority for Health (HAS)