Hazard analysis and risk assessment in the development of biomedical drug formulation equipment

Annals of Biomedical Engineering

Volumn 40, Issue 4, 2012, Pages 898-906

  Johnson, David H ^a   Bidez, Martha W ^b   Delucas, Lawrence J ^c  

^a and Radiation Oncology   (United States)

^b UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^c UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

Author keywords

ANSI; Failure mode effects analysis; GEIA; Hazard analysis; Risk assessment; Risk reduction; Self interaction chromatography

Indexed keywords

ANSI; FAILURE MODE EFFECTS ANALYSIS; GEIA; HAZARD ANALYSIS; RISK REDUCTIONS; SELF-INTERACTION CHROMATOGRAPHIES;

ACCIDENT PREVENTION; BIOMEDICAL ENGINEERING; BIOMEDICAL EQUIPMENT; RESEARCH; RISK ASSESSMENT;

HAZARDS;

ARTICLE; BIOENGINEERING; CHEMISTRY; FOOD AND DRUG ADMINISTRATION; HUMAN; INSTRUMENTATION; MEDICAL RESEARCH; METHODOLOGY; RISK ASSESSMENT; THEORETICAL MODEL; UNITED STATES;

BIOENGINEERING; BIOMEDICAL RESEARCH; CHEMISTRY, PHARMACEUTICAL; HUMANS; MODELS, THEORETICAL; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84862154113     PISSN: 00906964     EISSN: 15739686     Source Type: Journal    
DOI: 10.1007/s10439-011-0451-x     Document Type: Article

References (14)

1. ANSI GEIA-STD-0010. Standard Best Practices for System Safety Program Development and Execution. Tech America: Arlington, VA, 2008.
2. Bonfant, G., et al. Clinical risk analysis with failure mode and effect analysis (FMEA) model in a dialysis unit. J. Nephrol. 23:111-118, 2010.
3. Chiozza, M. L., and C. Ponzetti. FMEA: a model for reducing medical errors. Clin. Chim. Acta 404:75-78, 2009.
4. Ericson, C. A Hazard Analysis Techniques for System Safety. Hoboken, NJ: Wiley-Interscience, 2005.
5. Good Laboratory Practice Standards. Code of Federal Regulations Title 40, Part 792, 2009.
6. ISO 14971. 2007. Medical devices-application of risk management to medical devices, 2007.
7. Krouwer, J. S. An improved failure mode effects analysis for hospitals. Arch. Pathol. Lab. Med. 128:663-667, 2004. (Pubitemid 41490427)
8. Manuele, F. A. Advanced Safety Management Focusing on Z10 and Serious Injury Prevention. Hoboken, NJ: Wiley-Interscience, 2008.
9. NIOSH. System Safety and Risk Management-NIOSH Instructional Module. Cincinnati, OH: Center for Disease Control, 1998.
10. Pate-Cornell, E., and R. Boykin. Probabilistic risk analysis and safety regulation in the chemical industry. J. Hazard. Mater. 15:97-122, 1987. (Pubitemid 17114608)
11. Patel, S. M., et al. Methods of failure and reliability assessment for mechanical heart pumps. Artif. Organs 29:15-25, 2005. (Pubitemid 41601999)
12. Rosenberg, A. S. Effects of protein aggregates: an immu-nologic perspective. AAPS J. 8:E501-E507, 2006. (Pubitemid 44294011)
13. Toxic and Hazardous Substances. Code of Federal Regulations Title 29, Part 1910, Subpart Z, 2009.
14. Veterans Administration National Center for Patient Safety. The Basics of Healthcare Failure Mode and Effect Analysis. Course Notes. http://www4.va.gov/ ncps/Safety Topics/HFMEA/HFMEAIntro.doc. Accessed April 23, 2010.