Plateletapheresis: Instrumentation validation

Transfusion Science

Volumn 21, Issue 2, 1999, Pages 153-161

  Burgstaler, Edwin A ^a   Pineda, Alvaro A ^a  

^a MAYO CLINIC   (United States)

Author keywords

Plateletapheresis; Process control; Quality assurance; Validation

Indexed keywords

ARTICLE; FOOD AND DRUG ADMINISTRATION; HUMAN; INSTRUMENTATION; LEUKOCYTE COUNT; PH; QUALITY CONTROL; TECHNIQUE; THROMBOCYTOPHERESIS; VALIDATION PROCESS;

FORMS AND RECORDS CONTROL; HUMANS; HYDROGEN-ION CONCENTRATION; PLATELETPHERESIS; PROCESS ASSESSMENT (HEALTH CARE); QUALITY ASSURANCE, HEALTH CARE;

EID: 0032738465     PISSN: 09553886     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0955-3886(99)00087-9     Document Type: Article

References (13)

1. FDA Memorandum, Docket No. 91N-0450, Guideline for Quality Assurance in Blood Establishments. July 11, 1995.
2. FDA Memorandum, Guideline on General Principals of Process Validation. May, 1987.
3. Standards for Blood Banks and Transfusion Services. Bethesda, MD: American Association of Blood Banks, 18th ed. 1997:67.
4. FDA Memorandum, document #4027, Recommendations and licensure requirements for leukocyte-reduced blood products. May 29, 1996.
5. Dumont L, Dzik W, Rebulla P, Brandwein H. Practical guidelines for process validation and process control of white cell-reduced blood components: report of the Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion (ISBT). Transfusion 1996;36:11-20.
6. McCall M, Dumont L, Adams M. Required sample sizes for detecting small continuous shifts in leukocyte-reduced products. Transfusion 1997;37 (Suppl):78S (Abstract).
7. Operators Manual, Revision 1.4, Fenwal Amicus Separator. Deerfield, IL:Baxter Healthcare Corporation. March 1997:A-12.
8. Standards of Blood Banks and Transfusion Services. Bethesda, MD:American Association of Blood Banks, 18th ed. 1997:16-17.
9. COBE Spectra Apheresis System Operator's Manual for Use of Version 5.1 Software Program. Lakewood, CO:COBE BCT, Inc, October 1995:4C-10.
10. EZQC™ Training Guide, Version 2.0. Lakewood CO:COBE BCT, Inc, 1997:39.
11. EZQC™ Training Guide, Version 2.0. Lakewood CO:COBE BCT, Inc, 1997:40.
12. EZQC™ Training Guide, Version 2.0. Lakewood CO:COBE BCT, Inc, 1997:5.
13. Moroff G, Holme S. Concepts about current conditions for the preparation and storage of platelets. Transfusion Medicine Reviews 1991;V:48-59.