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 After microwave heating, the treated solution was aseptically withdrawn from the connector pair using a needle and syringe, plated in growth media, and incubated.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.

Detection of air emboli in radiographic contrast media by microwave radiometry.

To evaluate the efficacy of a microwave radiometry system in detecting in-line air emboli in radiographic contrast media, air emboli ranging in volume from 0.1 to 0.005 ml were introduced into ionic (ioxaglate) and nonionic (iohexol) contrast media at 22 or 37 degrees pumped at flow rates of 16.7, 180 or 300 ml/min through polyvinlychloride tubing with an inner diameter of 0.100 inches (2.54 mm) over which was fitted a radiometer antenna connected to a Microwave Medical System F+ radiometer and a computerized data acquisition system. A total of 400 determinations were run, with 10 replicate determinations for each unique set of experimental conditions. The success of air emboli detection was not significantly related to contrast media (p = 0.73) or contrast temperature (p = 0.68). Embolus volume (p < 0.0001) and pump speed (p < 0.0001) were significant factors affecting system performance. The system could reliably detect small (0.005 ml) emboli in both ionic and nonionic low-osmolar contrast media.

Early detection of extravasation of radiographic contrast medium. Work in progress.

Microwave radiometry is a passive and noninvasive technique that allows quick detection of subcutaneous temperature changes. The feasibility of this technique for differentiating normal intravenous infusions of radiographic contrast medium from extravasations of contrast medium was tested in anesthetized dogs. Room-temperature and heated ionic and nonionic contrast media were administered at flow rates ranging from 0.2 to 9.9 mL/sec by means of a power injector. On the basis of these experiments, an algorithm to adjust for extravasation detection thresholds as a function of injection flow rates was developed. With this algorithm, results showed a false-positive rate of 0% at all infusion rates and false-negative rates of 2%, 2%, and 4% at pump speeds of 0.2, 1.0, and 9.9 mL/sec, respectively. The times of these extravasation "alarms" corresponded to maximum extravasated volumes, respectively, of 4, 6.5, and 8 mL. Microwave radiometry has clinical potential for early detection of extravasation of contrast medium administered with power injectors.

Rapid in-line blood warming using microwave energy: preliminary studies.

The management of massive blood loss resulting from trauma or surgery necessitates rapid transfusion capability. Hypothermia secondary to shock, transfusion, and prolonged surgical procedures significantly increases morbidity and mortality in these patients. Transfusion at high flow rates frequently exceeds the warming capacity of conventional blood-warming devices, whose inherent resistance also limits the maximal flow rates. Microwave ovens are capable of blood warming, but have been associated with unacceptable hemolysis. We have investigated the possibility of using microwave energy to provide rapid in-line blood warming. Fresh blood from 10 human subjects was warmed from an average of 18 degrees C to temperatures ranging from 37 to 39 degrees C at flow rates from 250 to 500 mL/min. Laboratory analysis of free plasma hemoglobin, haptoglobin, hematocrit, hemoglobin, and electrolytes showed no difference between heated and control samples. LDH was elevated in those samples warmed repeatedly, but remained within the normal range. These data indicate the potential for further investigation utilizing properly controlled microwave energy for in-line blood and fluid warming.

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.

Spatial resolution measurements for passive microwave radiometry using a tissue-equivalent phantom.

A tissue-equivalent "hot" line source phantom is described for assessing spatial resolution in passive microwave radiometry systems. LSFs were measured for two rectangular waveguide antennas connected to a 4.7-GHz radiometer. The normalized LSFs and corresponding modulation transfer functions were found to be independent of line source temperature, but dependent upon antenna size, orientation, and line source depth.

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.