Cleaning and Sterilization of Used Cardiac Implantable Electronic Devices With Process Validation
Tài liệu tham khảo
Lamas, 1998, Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing. Pacemaker Selection in the Elderly Investigators, N Engl J Med, 338, 1097, 10.1056/NEJM199804163381602
Ohm, 1978, Patients with high-grade atrioventricular block treated and not treated with a pacemaker, Acta Med Scand, 203, 521, 10.1111/j.0954-6820.1978.tb14919.x
Bardy, 2005, Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure, N Engl J Med, 352, 225, 10.1056/NEJMoa043399
Greenspon, 2012, Trends in permanent pacemaker implantation in the United States from 1993 to 2009: increasing complexity of patients and procedures, J Am Coll Cardiol, 60, 1540, 10.1016/j.jacc.2012.07.017
Mond, 2011, The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009—a World Society of Arrhythmia's project, Pacing Clin Electrophysiol, 34, 1013, 10.1111/j.1540-8159.2011.03150.x
Baman, 2010, Pacemaker reuse: an initiative to alleviate the burden of symptomatic bradyarrhythmia in impoverished nations around the world, Circulation, 122, 1649, 10.1161/CIRCULATIONAHA.110.970483
Nava, 2013, Reuse of pacemakers: comparison of short and long-term performance, Circulation, 127, 1177, 10.1161/CIRCULATIONAHA.113.001584
U.S. Food and Drug Administration (FDA). US FDA Compliance Manuals: CPG Section 310.100, Pacemaker Reuse (CPG 7124.12). Available at: http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073891.htm Accessed January 24, 2016.
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Division of Enforcement III, Office of Compliance. Enforcement priorities for single-use devices reprocessed by third parties and hospitals. Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/000053g2.pdf. Accessed June 2, 2014.
Ryden, 1998, Re-use of devices in cardiology. Proceedings from a Policy Conference at the European Heart House, 5–6 February, 1998, Eur Heart J, 19, 1628, 10.1053/euhj.1998.1298
Kantharia, 2012, Reuse of explanted permanent pacemakers donated by funeral homes, Am J Cardiol, 109, 238, 10.1016/j.amjcard.2011.08.036
Pavri, 2012, Reuse of explanted, resterilized implantable cardioverter-defibrillators: a cohort study, Ann Intern Med, 157, 542, 10.7326/0003-4819-157-8-201210160-00004
Baman, 2012, Feasibility of postmortem device acquisition for potential reuse in underserved nations, Heart Rhythm, 9, 211, 10.1016/j.hrthm.2011.09.067
ANSI/AAMI/ISO 11135-1:2014. Sterilization of health care products—ethylene oxide— part 1: requirements for development, validation, and routine control of a sterilization process for medical devices. Available at: https://www.iso.org/obp/ui/#iso:std:56137:en. Accessed January 24, 2016.
AAMI TIR-30:2011. A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. Available at: https://global.ihs.com/doc_detail.cfm?&rid=ASA&item_s_key=00447201. Accessed January 24, 2016.
ANSI/AAMI/ISO 11737-1:2006. Sterilization of medical devices—microbiological methods—part 1: determination of population of microorganisms on product. Available at: https://www.iso.org/obp/ui/#iso:std:iso:11737:-1:ed-2:v1:en. Accessed January 24, 2016.
ANSI/AAMI/ISO 14161:2009. Sterilization of health care products—biological indicators—guidance for the selection, use, and interpretation of results. Available at: https://www.iso.org/obp/ui/#iso:std:iso:14161:ed-2:v1:en. Accessed January 24, 2016.
US Pharmacopeia and National Formulary <643> Total organic carbon. Available at: https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c643.pdf. Accessed January 24, 2016.
ANSI/AAMI/ISO 10993-10:2010. Biological evaluation of medical devices—part 10: tests for irritation and delayed type hypersensitivity. Available at: https://www.iso.org/obp/ui/#iso:std:iso:10993:-10:ed-3:v1:en. Accessed January 24, 2016.
US Pharmacopeia and National Formulary. <87> Biological reactivity tests, in vitro. Available at: http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/iras/gc-87-biolgoical-reactivity.pdf. Accessed January 24, 2016.
ANSI/AAMI/ISO 10993-5:2009. Biological evaluation of medical devices—part 5: tests for in vitro cytotoxicity. Available at: https://www.iso.org/obp/ui/#iso:std:iso:10993:-5:ed-3:v1:en. Accessed January 24, 2016.
FDA. Guidance for industry: pyrogen and endotoxins testing: questions and answers. June 2012. Available at: http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm314718.htm. Accessed August 20, 2014.
ANSI/AAMI/ISO 10993-7:2008. Biological evaluation of medical devices—part 7: ethylene oxide sterilization residuals. Available at: https://www.iso.org/obp/ui/#iso:std:iso:10993:-7:ed-2:v1:en. Accessed January 24, 2016.
Gakenheimer, 2014, Cardiac implantable electronic device reutilization: battery life of explanted devices at a tertiary care center, Pacing Clin Electrophysiol, 37, 569, 10.1111/pace.12321
Druce, 2005, Cleaning and sterilization protocol for reused cardiac electrophysiology catheters inactivates hepatitis and coxsackie viruses, Infect Control Hosp Epidemiol, 26, 720, 10.1086/502609
Druce, 2003, A decontamination and sterilization protocol employed during reuse of cardiac electrophysiology catheters inactivates human immunodeficiency virus, Infect Control Hosp Epidemiol, 24, 184, 10.1086/502190
Kirkpatrick, 2010, Reuse of pacemakers and defibrillators in developing countries: logistical, legal, and ethical barriers and solutions, Heart Rhythm, 7, 1623, 10.1016/j.hrthm.2010.04.027
Rutala, 2001, Creutzfeldt-Jakob disease: recommendations for disinfection and sterilization, Clin Infect Dis, 32, 1348, 10.1086/319997
ISO 10993-5:2009. Biological evaluation of medical devices—part 5: tests for in vitro cytotoxicity. Available at: https://www.iso.org/obp/ui/#iso:std:36406:en. Accessed January 24, 2016.
AAMI TIR 12:2010 Designing, Testing, And Labeling Reusable Medical Devices For Reprocessing In Health Care Facilities: A Guide For Medical Device Manufacturers. Available at: http://shop.standards.ie/nsai/details.aspx?ProductID=1442465. Accessed January 24, 2016.
ANSI/AAMI/ISO 10993-11:2006. Biological evaluation of medical devices—part 11: tests for systemic toxicity. Available at: https://www.iso.org/obp/ui/#iso:std:iso:10993:-11:ed-2:v1:en. Accessed January 24, 2016.
