United States Code of Federal Regulations, Title 21, Volume 1, Part 3, Section 3.2 (e), Definitions.
PharmaLive.com. Special reports: drug-delivery review and outlook. 2010.
Conroy S. The industry’s Trifecta: drugs, devices and biologics. MD&DI; 2009. www.devicelink.com/mddi. Accessed 31 Jan 2011.
Kereiakes DL et al. Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients undergoing multilesion and multivessel intervention. JACC Cardiovasc Interv. 2010;3(12):1229–39.
Caixeta A et al. Clinical follow-up 3 years after everolimus- and paclitaxel-eluting stents. JACC Cardiovasc Interv. 2010;3(12):1220–8.
Serruys PW, Waksman R, Onuma Y, editors. Vascular restoration therapy, EuroIntervention supplement. 2009;5 Suppl F. Supplement is entitled and dedicated to the theme of vascular restoration therapy and initial devices.
Serruys PW et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009;373:897–910.
MedMarket Diligence report #C245, worldwide market for drug-eluting, bare and other coronary stents. 2009;2008–2017.
Lambert BJ. Sterilisation: material compatibility challenges and guidance for combination products. European Medical Device Technology. 2010;21–25.
ISO/TS 11139:2006. Sterilization of health care products—vocabulary. 2006.
Favero MS. Sterility assurance: concepts for patient safety, in disinfection, sterilization and antisepsis: principles and practices in healthcare facilities, chapter 12. In: Rutala WA, editor. Association for Professionals in Infection Control and Epidemiology. DC.: Washington; 2001. p. 110–9.
Lolas AG. US FDA, Center for Drug Evaluation and Research, Regulatory Approaches for Novel Processing and Innovative Products, invited presentation at the 15th International Meeting on Radiation Processing. London: September 2008.
ANSI/AAMI ST67:2011. Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "STERILE". See Annex A, Background and historical application of sterility assurance.
ANSI/AAMI ST67:2011. Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "STERILE". See Annex B, Examples of terminally sterilized products and sterility assurance levels that have historically been selected.
ISO TC 198. ISO/Draft International Standard, Aseptic processing of health care products, Part 7: Alternate processes for atypical medical devices and combination devices.
AAMI TIR 17:2008. Compatibility of materials subject to sterilization. 2008.
AAMI TIR37:2007. Sterilization of health care products—radiation—guidance on sterilization of human tissue-based products. The need for tissue product sterilization drove the development of this document. 2007
Jarvis WR, Epidemiology Branch. Nosocomial outbreaks: the Centers for Disease Control’s Hospital Infections Program Experience, 1980–1990. In: Martone WJ, Garnder JS, editors. Proceedings of the 3rd decennial international conference on nosocomial infections. Am. J. Med 1991;91 Suppl 3B. p. 101S–106S.
Jarvis WR. Centers for Disease Control and Prevention, Hospital Infections Program on-site outbreaks investigations, 1990–1999: how often are germicides or sterilants the sources. In: Rutala WR, editor. Disinfection, sterilization and antisepsis: principles and practices in healthcare facilities. Washington, DC: Association for Professionals in Infection Control and Epidemiology; 2001.
Higashi JM, Marchant RE. Implant infections. In: Recum AFV, editor. Handbook of biomaterials evaluation: scientific, technical, and clinical testing of implant materials. Philadelphia: Taylor & Francis; 1999. p. 493–506.
RTI, Proven Record of Safety, Sterilization Process. http://www.rtix.com/safety/sterilization-processes. Accessed 30 Jan 2011.
ISO 14937:2009, Sterilization of health care products—general requirements for characterization of a sterilizing agent and the development, validation, and routing control of a sterilization process for medical devices. See introduction. 2009.
ANSI/AAMI ST67:2003. Sterilization of health care products—requirements for products labeled “STERILE”. 2003.
ISO 11137-1 Sterilization of health care products—radiation—part 1: requirements for development, validation, and routine control of a sterilization process for medical devices.
Kowalski JB, Morrison RF. Sterilization of implants and devices. In: Ratner BD et al., editors. Biomaterials science: an introduction to materials in medicine. San Diego: Elsevier Academic; 2004. p. 754–9.
ISO 11135-1: 2007. Sterilisation of healthcare products, ethylene oxide, part I: requirements for development, validation and routine control of a sterilisation process for medical devices, Annex B, Conservative determination of lethal rate of the sterilization process—Overkill approach. 2007.
Hemmerich KJ, et al. Sterilization methods stand the test of time. Medical Device and Diagnostic Industry. 2004;26(8). http://www.mddionline.com/article/sterilization-methods-stand-test-time. Accessed 30 Jan 2011.
ISO 11135-1: 2007. Sterilisation of healthcare products, ethylene oxide, part I: requirements for development, validation and routine control of a sterilisation process for medical devices. 2007.
Phillips C. The sterilizing action of gaseous ethylene oxide II. Sterilization of contaminated objects with ethylene. AM J HTO. 1949;50:280–8.
Silverman J. Radiation processing: the industrial applications of radiation chemistry. J Chem Ed. 1981;58:168–73.
ANSI/AAMI/ISO 14937:2009. Sterilization of health care products—general requirements for characterization of a sterilizing agent and the development, validation, and routing control of a sterilization process for medical devices. 2009.
Committee for Proprietary Medical Products (CPMP) Decision Trees for the Selection of Sterilisation Methods (CPMP/QWP/054/98). Annex to note for guidance on developmental pharmaceuticals (CPMP/QWP/155/96).
Matthews IP, Gibson C, Samuel AH. Sterilisation of implantable devices. Clin Mater. 1994;15:191–215.
Mendes GCC, Brandão TRS, Silva CLM. Ethylene oxide sterilization of medical devices: a review. Am J Infect Control. 2007;35:574–81.
Lindboe WG, Hayakawa K. Comparative terminal sterilization. J Parenter Sci Technol. 1993;47(3):138–41. This article addresses moist heat sterilization of pharmaceuticals.
Serruys PW, Ong ATL, Piek JJ, et al. A randomised comparison of a durable polymer everolimus-eluting coronary stent with a bare metal coronary stent: the SPIRIT first trial. EuroIntervention. 2005. p. 58–65.
Oberhauser J, Hossainy S, Rapoza R. Design principles and performance of bioresorbable polymeric vascular scaffolds. EuroInterv Suppl. 2009;5(Suppl F):F15–22.
The XIENCE V® everolimus eluting coronary stent system instructions for use, p. 53. 2010. http://www.abbottvascular.com/us/ifu.html. Accessed 30 Jan 2011.
Loo JSC, Ooi CP, Boey FYC. Degradation of poly(lactide-co-glycolide) (PLGA) and poly(l-lactide) (PLLA) by electron beam radiation. Biomaterials. 2005;26(12):1359–67.
Güven O. The use of size exclusion chromatography in the studies of crosslinking and chain scission in polymers. In: Güven O, editor. Crosslinking and scission in polymers. Dordrecht: Kluwer Academic; 1990. p. 39–250.
ISO 11137-1:2006. Sterilization of health care products—radiation—part 1: requirements for development, validation and routine control of a sterilization process for medical devices. Clause 8, Process Definition. 2006.
AAMI TIR 33:2005. Sterilization of health care products—radiation—substantiation of a selected sterilization dose—method VDmax. 2005.
AAMI TIR 40:2009. Sterilization of health care products—radiation—guidance on dose setting utilizing a modified method 2. 2009.
Lambert BJ, Tang FW. Rationale for practical medical device accelerated aging programs in AAMI TIR17. Radiat Phys Chem. 2000;57(3–6):349–53.
ICH Q1A (R2). Stability testing of new drug substances and products. 2003.
J. Kulla J, et al. Sterilising combination products using oxides of nitrogen. Medical Device and Diagnostic Industry. 2009;31(3). www.mddionline.com/article/sterilizingcombination-products-using-oxides-nitrogen. Accessed 30 Jan 2011.