Sterilization of Medical Devices: A Review

Dempsey, Donald J.; Thirucote, Ramachandran

doi:10.1177/088532828800300303

Cited by 64 publications

(43 citation statements)

References 23 publications

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“…autoclaving, gamma-irradiation, and ethylene oxide) is sorely needed, due to the limitations of these methods and the development of novel polymeric biomaterials which are usually sensitive to these methods (Matthews et al, 2001, Premnath et al, 1996. Steam sterilization damages or destroys heat-sensitive and hydrolytically labile materials (Dempsey and Thirucote, 1989); γ-irradiation may cause changes in shear and tensile strength, elastic modulus, and transparency of polymers (Dillow et al, 1999); and ethylene oxide has significant effect on molecular weight of some biodegradable polymers (Verheyen et al, 1992). Since CO 2 has a relatively low "critical temperature", it is of particular interest as a low temperature sterilization medium.…”

Section: Introductionmentioning

confidence: 99%

Supercritical carbon dioxide and hydrogen peroxide cause mild changes in spore structures associated with high killing rate of Bacillus anthracis

Zhang¹,

Dalal²,

Matthews³

et al. 2007

Journal of Microbiological Methods

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The present work examines chemical and structural response in B. anthracis spores killed by a mixture of supercritical carbon dioxide (SCCO 2 ) and hydrogen peroxide (H 2 O 2 ). Deactivation of 6-log of B. anthracis spores by SCCO 2 +H 2 O 2 was demonstrated, but changes in structure were observed in only a small portion of spores. Results from phase contrast microscopy proved that this treatment is mild and does not trigger germination-like changes. TEM imaging revealed mild damage in a portion of spores while the majority remained intact. Dipicolinic acid (DPA) analysis showed that <10% of the DPA was released from the spore core into the external milieu, further demonstrating only modest damage to the spores. Confocal fluorescent microscopy, assessing uptake of DNAbinding dyes, directly demonstrated compromise of the permeability barrier. However, the magnitude of uptake was small compared to spores that had been autoclaved. This work suggests that SCCO 2 +H 2 O 2 is quite mild compared to other sterilization methods, which has major implications in its application. These results provide some insight on the possible interactions between spores and the SCCO 2 +H 2 O 2 sterilization process.

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Section: Introductionmentioning

confidence: 99%

Supercritical carbon dioxide and hydrogen peroxide cause mild changes in spore structures associated with high killing rate of Bacillus anthracis

Zhang¹,

Dalal²,

Matthews³

et al. 2007

Journal of Microbiological Methods

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“…In this way, oxidative degradation that causes changes in the mechanical properties is avoided. However, these methods do not induce cross-linking and do not improve the wear resistance (Denpsey 1989).…”

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confidence: 99%

Increase in early polyethylene wear after sterilization with ethylene oxideRadiostereometric analyses of 201 total hips

Digas

Thanner

Nivbrant

et al. 2003

Acta Orthopaedica Scandinavica

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“…␥-Irradiation causes damage to polymers [for example, changes in shear and tensile strength, elastic modulus (4), and transparency (6)] and reduced activity in drugs, if they are incorporated for drug delivery, because of cross-linking or degradation. Steam sterilization is undesirable for biomaterials, particularly thermally and hydrolytically labile materials that cannot tolerate the temperatures required during autoclaving (7). Recently, supercritical fluid carbon dioxide has been used to inactivate viruses in bone allografts (8).…”

mentioning

confidence: 99%

Bacterial inactivation by using near- and supercritical carbon dioxide

Dillow

Dehghani

Hrkach

et al. 1999

Proc. Natl. Acad. Sci. U.S.A.

285

199

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The three most common methods of sterilization in use today are ethylene oxide exposure, ␥-irradiation, and steam sterilization. Each of these methods has serious limitations for the sterilization of some materials used in medicine, especially thermally and hydrolytically sensitive polymers by themselves and in combination with proteins. In this work, we demonstrate a potential new method of sterilization by using supercritical f luid carbon dioxide. Using this method we achieve complete inactivation of a wide variety of bacterial organisms at moderate temperatures and in the absence of organic solvents or irradiation. Sterilization is a function of both the proximity to the f luid's critical point and the chemical nature of the f luid itself. When biodegradable polymers poly(lactic-co-glycolic) acid and polylactic acid were included in the sterilization process, there was no effect on the inactivation efficiency, yet no physical or chemical damage to these thermally and hydrolytically labile materials was observed.

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Sterilization of Medical Devices: A Review

Cited by 64 publications

References 23 publications

Supercritical carbon dioxide and hydrogen peroxide cause mild changes in spore structures associated with high killing rate of Bacillus anthracis

Supercritical carbon dioxide and hydrogen peroxide cause mild changes in spore structures associated with high killing rate of Bacillus anthracis

Increase in early polyethylene wear after sterilization with ethylene oxideRadiostereometric analyses of 201 total hips

Bacterial inactivation by using near- and supercritical carbon dioxide

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