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New connection method for isolating and disinfecting intraluminal path during peritoneal dialysis solution-exchange
R S Grabowy1, R Kelley, S G Richter
1Microwave Medical Systems Inc., Acton, Massachusetts, USA.
Abstract:
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 After microwave heating, the treated solution was aseptically withdrawn from the connector pair using a needle and syringe, plated in growth media, and incubated.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.
Insights
A new microwave-assisted high-temperature moist-heat disinfection method effectively reduces microbial contamination in peritoneal dialysis (PD) connectors. This intraluminal disinfection technique shows rapid, significant pathogen reduction, potentially lowering peritonitis risk.
Area of Science:
- Medical Microbiology
- Biomedical Engineering
- Infectious Disease Prevention
Background:
- Peritonitis remains a significant complication in peritoneal dialysis (PD).
- Contamination at the connect/disconnect site is a primary cause of PD-related peritonitis.
- Existing disinfection methods may have limitations in fully eradicating problematic microorganisms.
Purpose of the Study:
- To evaluate the efficacy of a novel microwave-assisted high-temperature moist-heat (HTMH) disinfection device.
- To assess the intraluminal disinfection performance at the connect/disconnect site of PD pathways.
- To determine the reduction of key peritonitis-causing microorganisms.
Main Methods:
- Connector pairs were inoculated with standardized microbial suspensions (S. epidermidis, P. aeruginosa, C. albicans, A. niger).
- Microwave energy was used to achieve HTMH disinfection of the intraluminal path.
- Surviving microbial populations were quantified using colony-forming unit (CFU) counts after incubation.
Main Results:
- The HTMH device achieved an 85°C solution temperature rise in 12 seconds.
- A tenfold microbial population reduction was observed in less than 3 seconds for all tested organisms.
- A 30-second cycle achieved >10^8 population reduction for bacteria/yeast and >10^7 for fungi.
Conclusions:
- The novel microwave-assisted HTMH method provides rapid and effective intraluminal disinfection of PD connectors.
- This technique demonstrates significant potential in reducing microbial load, thereby mitigating the risk of PD-associated peritonitis.
- The method is particularly promising against gram-negative bacteria and fungi, common causes of severe peritonitis.
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Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...