New connection method for isolating and disinfecting intraluminal path during peritoneal dialysis solution-exchange procedures.

Microbiological data have been collected on the performance of a new method of isolating and disinfecting the intraluminal path at the connect/disconnect site of a peritoneal dialysis (PD)-exchange pathway. High-temperature moist-heat (HTMH) disinfection is accomplished by a new device that uses microwave energy to heat the solution contained in the pressure-tight inner lumen of PD connector pairs between the transfer-set connector-clamp and the bag-connector break-away seal. An 85 degrees C (S.D. = 2.4 degrees C, n = 10) rise in solution temperature is seen in 12 seconds, thus yielding temperatures under pressure well over 100 degrees C with starting temperatures of 25 degrees C. Connector pairs were prepared by inoculation of a solution suspension containing at least 10(6) colony-forming units (CFU) of a test micro-organism. Approximately 0.4 mL of solution was contained within the mated connector pair. Using standard D-value determination methods, data were obtained for surviving organisms versus five exposure times and a positive control to obtain a population reduction curve. Four micro-organisms (S. epidermidis, P. aeruginosa, C. albicans, and A. niger) recognized to be among the most prevalent or problematic in causing peritonitis were tested. After microwave heating, the treated solution was aseptically withdrawn from the connector pair using a needle and syringe, plated in growth media, and incubated. Population counts of CFUs after incubation were used to establish survival curves. Results showed a tenfold population reduction in less than 3 seconds for all organisms tested. A 30-second cycle time safely achieves a > 10(8) population-reduction for bacteria and yeast organisms, and a > 10(7) population reduction for fungi. One potential benefit of using this new intraluminal disinfection method is that it may help reduce peritonitis resulting from the even more problematic pathogens such as the gram-negative bacteria and fungal organisms.

Effectiveness of microwave moist-heat intraluminal disinfection of CAPD connectology.

Studies were performed to quantify the microbial population reduction achieved with the Peritoneal Dialysis Moist Heat Device (PDM-1). This microwave method is used to disinfect the inner lumen of connectors used in the exchange process for continuous ambulatory peritoneal dialysis (CAPD). The microwave heating technique was evaluated on different connector systems containing a suspension of 10(6) microorganisms. The most prevalent and most problematic peritonitis-causative microorganisms were tested. After heating, the degree of disinfection was measured by enumerating bacterial colonies of the treated suspension. D-value determinations were then performed. The D-value for spores of A. niger was found to be 7.1 seconds for one type of connector system. Two other connector systems containing different intraluminal solution volumes were also tested using spores of A. niger and D-values were determined to be 7.6 seconds and 9.5 seconds, respectively. Other organisms tested were determined to have D-value times shorter than that for A. niger. Rapid heating of the solution contained within the CAPD connectors is a key characteristic of the microwave technique since temperatures rise high enough for destruction of microorganisms while leaving the plastic safe to touch. Thus, this technique is a safe and effective method for providing intraluminal disinfection.

Moist heat intraluminal disinfection of CAPD connectors.

A moist heat technique for disinfecting the inner lumen of commercially available connectology used in the exchange process for Continuous Ambulatory Peritoneal Dialysis (CAPD) was evaluated. Moist heat was generated by a device (PDM-1) that directed microwave energy to heat a sample solution containing a concentration of 10(6) microorganisms inside a pair of mated plastic CAPD connectors. Microorganisms tested included those most prevalent and most problematic in causing peritonitis. Testing, performed according to F.D.A. approved standards, involved heating a sample solution and then placing the sample solution into vials which were then sealed and incubated. Absolute determination of growth versus no growth was measured by macroscopic observation. Positive control samples were performed in the same manner but were not exposed to heat. Negative controls were performed in the same manner in the absence of test organisms. At temperatures of approximately 100 degrees C a D-value of 6.6 seconds was determined using the organism found the most thermoresistant. A cycle time of 54 seconds appeared sufficient to achieve a 10(6) population reduction of all microorganisms tested. The moist heat technique offers a safe, effective method for disinfection of the inner lumen of CAPD connectors.