Medical device risk based evaluation and maintenance using fault tree analysis

Biomedical Instrumentation and Technology

Volumn 41, Issue 1, 2007, Pages 76-82

  Rice, William P ^a,b  

^a Baptist Saint Anthony's Health System   (United States)

^b AAMI ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL ENGINEERING; HEALTH CARE COST; HEALTH CARE QUALITY; HUMAN; LETHAL DOSE; MATHEMATICAL COMPUTING; MEDICAL ERROR; MEDICAL INSTRUMENTATION; MEDICAL TECHNOLOGY; PROBABILITY; PUMP; RELIABILITY; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; RISK REDUCTION; SAFETY;

EQUIPMENT AND SUPPLIES; EQUIPMENT FAILURE ANALYSIS; HUMANS; MAINTENANCE AND ENGINEERING, HOSPITAL; RISK MANAGEMENT; UNITED STATES;

EID: 33847741130     PISSN: 08998205     EISSN: None     Source Type: Journal    
DOI: 10.2345/0899-8205(2007)41[76:MDRBEA]2.0.CO;2     Document Type: Review

References (14)

1. JCAHO. Comprehensive Accreditation Manual for Hospitals. Oakbrook Terrace, III: Joint Commission on Accreditation of Healthcare Organizations; 2005.
2. Baker T. Debating the medical device preventive maintenance dilemma and what is the safest and most cost-effective remedy. J Clin Eng. 2003;28:183-190.
3. Wang B. Fennigkoh and Smith model for inclusion criteria: 15-year retrospective. J Clin Eng. 2005;30:26-30.
4. Fennigkoh L, Smith B. Clinical equipment management. JCAHO PTSM Series. 1989;2:5-14.
5. JCAHO. Accreditation Manual for Hospitals. Oakbrook Terrace, III: Joint Commission on Accreditation of Healthcare Organizations; 1989.
6. ASHE. Maintenance Management for Medical Equipment. Chicago, III: American Society for Healthcare Engineering of the American Hospital Association; 1996:App-1-15.
7. Wang B, Levenson A. Equipment inclusion criteria: a new interpretation of JCAHO's medical equipment management standard. J Clin Eng. 2000;25:26-35.
8. US Food and Drug Administration, Center for Devices and Radiologic Health, Department of Health and Human Services. Manufacturer and User Facility Device Experience Database (MAUDE). Available at: http://www.fda.gov/ cdrh/maude.html. Accessed January 6, 2006.
9. Macintyre PE. Safety and efficacy of patient-controlled analgesia. Br J Anaesth. 2001;87:36-46.
10. Sullivan M, Phillips MS, Schneider P. Patient-controlled analgesia pumps. USP Quality Rev. 2004;81:1-3. Available at: http://www.usp.org/ pdf/patientSafety/qr812004-09-01.pdf. Accessed April 25, 2005.
11. ECRI. Patient-controlled analgesic infusion pumps. Health Devices. 2006;35:5-11.
12. Reid PP, Compton WD, Grossman JH, Fanjiang G, eds. Committee on Engineering and the Health Care System. Building a Better Delivery System: A New Engineering/Health Care Partnership Building a Better Delivery System. Washington, DC: The National Academic Press; 2005. Available at: http://www.nap.edu/catalog/11378.html. Accessed January 8, 2006.
13. ECRI. Health devices inspection and preventive maintenance system. 2001:25. Available at: http://www.ecri.org. Accessed January 24, 2006.
14. Malik MA. Reliable preventive maintenance scheduling. AIEE Trans. 1990;11:221-228.