Influence of sterilisation methods on collagen-based devices stability and properties

• Published in: Expert review of medical devices Vol. 11; no. 3; pp. 305 - 314
• Main Authors: Delgado, Luis M, Pandit, Abhay, Zeugolis, Dimitrios I
• Format: Journal Article
• Language: English
• Published: England Informa UK, Ltd 01.05.2014; Taylor & Francis; Informa Healthcare
• Subjects: Animals; Biochemistry; Collagen - chemistry; collagen biomaterials; Contaminants; degradation rate; Devices; Equipment and Supplies; Ethanol; Ethyl alcohol; Ethylene oxide; Humans; mechanical properties; Medical devices; Peracetic acid; Prostheses and Implants; sterilization; Sterilization - methods; structural stability; tissue grafts
• ISSN: 1743-4440; 1745-2422; 1745-2422
• DOI: 10.1586/17434440.2014.900436

Sterilisation is essential for any implantable medical device in order to prevent infection in patients. The selection of the most appropriate sterilisation method depends on the nature and the physical state of the material to be sterilised; the influence of the sterilisation method on the properties of the device; and the type of the potential contaminant. In this context, herein we review the influence of ethylene oxide, γ-irradiation, e-beam irradiation, gas plasma, peracetic acid and ethanol on structural, biomechanical, biochemical and biological properties of collagen-based devices. Data to-date demonstrate that chemical approaches are associated with cytotoxicity, whilst physical methods are associated with degradation, subject to the device physical characteristics. Thus, the sterilisation method of choice is device dependent.