Levels of naturally occurring microorganisms on surgical instruments after clinical use and after washing.

Surgical instruments exposed to sterile body sites should be contaminated with relatively low levels of microbial contamination or bioburden; however, few studies in the literature have determined the quantitative level and types of contamination. A study was conducted at 2 clinical sites to determine the level of microbial contamination of surgical instruments after clinical use and after washing. Quantitative assays showed that bioburden levels were in the range of 0 to 4415 colony forming units per instrument after clinical use, and 88% of the instruments had bioburden levels lower than 1000. As expected, a reduction in counts occurred after washing; however, in some cases, higher counts were found on the instruments after the washing process. Although the washing procedure is effective in reducing the microbial levels deposited on the surgical instruments during use, a recontamination process occurs that results in increased counts after washing. The low bioburden level after washing consists of predominantly vegetative microorganisms that present a relatively low challenge to sterilization and disinfection systems.

Natural bioburden levels detected on rigid lumened medical devices before and after cleaning.

Controversy exists concerning the degree of microbial contamination associated with the use of rigid lumened medical devices, the efficacy of standard cleaning techniques used to remove pathogenic microorganisms from lumen channels, and whether patients are placed at risk of cross infection because of microbial contamination. In this study the level and types of microorganisms found on rigid lumened medical devices before and after cleaning in a hospital environment were investigated. The bioburden level after clinical use was found to be relatively low, ranging from 10(1) to 10(4) colony forming units (CFU) per device. After the instruments were cleaned, none of the devices studied contained bioburden levels greater than 10(4) CFU and 83% had bioburden levels less than or equal to 10(2) CFU. The bioburden present before cleaning was comprised of organisms derived from the handling of the device, from the hospital environment, and from the patient. The bioburden present after cleaning was comprised of organisms typically derived from the handling of the device and from the hospital environment. The level of bioburden per device was also related to the anatomic site where the device was used, with lower numbers of organisms found on devices exposed to sterile body sites and the respiratory tract.

Sterilization of a small caliber vascular graft with a polyexpoxy compound.

Sterilization of tissue based medical devices via cold sterilization processes has been limited to formaldehyde, glutaraldehyde, and mixtures of the same with alcohols and surfactants. The authors report the sterilization of a small caliber vascular graft with a combination of diglycidyl ether and ethanol. The sterilant contains 1-4% diglycidyl ether and 10-20% ethanol as an aqueous solution. Sterilization is achieved after exposure of the graft to the sterilant solution for a period of 7 days at an elevated temperature (30 degrees - 40 degrees C). The biologic indicator selected for efficacy studies was Bacillus subtilis niger ATCC 9372 (endospores). The grafts were inoculated with a concentrated endospore suspension and immersed in the sterilant solution for increasing time periods. After extensive rinsing over membrane filters to remove any residual sterilant, the grafts and filters were cultured in tryptic soy broth. D10 values were calculated using a fraction-negative, most probable number technique. Additionally, many representative bacteria and fungi were tested and found to be susceptible to the new sterilant developed. The diglycidyl ether/alcohol sterilant developed was found to be efficacious for sterilization of the tissue based vascular grafts tested.