Technical Properties and Biological Safety of Reprocessing Technique for a Handpiece of Disposable Pulsatile Lavage Device: An Experimental Study.

Abstract

Introduction: Bony surface cleaning using a pulse lavage device (PLD) is essential for modern cementation of hip and knee arthroplasties. This costly single-use device is a medical waste and unaffordable for some patients. Reprocessing is a worldwide standard strategy to solve this problem. To determine the technical properties and biological safety of a reprocessed PLD handpiece and compare its performance under different power supplies.

Materials and methods: Eight brand-new disposable PLDs were tested for baseline technical properties (flow rate, pulse frequency, and peak pressure). Thereafter, they were reprocessed and retested for 10 rounds using two different power supplies. An adenosine triphosphate (ATP) swab test was performed on the PLD accessory parts after cleansing and disinfection. Passed-through isotonic sodium chloride solution ejected from the reprocessed PLD underwent aerobic bacterial culture. The unit costs of production were analysed.

Results: The mean flow rate of the disposable PLD (1.5±0.1 L/min) was less than that of reprocessed PLD using DC15V battery (2.5±0.3 L/min, p<0.001) and AC/DC15V3A adapter (6.1±0.4 L/min, p<0.001). The mean pulse frequency and peak pressure of the disposable PLD and reprocessed PLD using DC15V battery were not different (18.5±0.8 vs 18.8±2.5 Hz, p=0.155 and 0.37±0.04 vs 0.38±0.03 N/mm2, p=0.640, respectively), but were lower than those using AC/DC15V3A adapter (47.0±2.7 Hz, 0.45±0.03 N/mm2, p<0.001). All ATP swab tests, and aerobic fluid cultures yielded negative results. The total cost of reprocessing was 10% of disposable PLD.

Conclusion: A disposable PLD handpiece can be reprocessed without deteriorating its technical properties and used with either retrieved DC15V battery or AC/DC15V3A adapter for the power supply. As the biological safety of reprocessed and disposable PLDs was comparable, it may be clinically utilised with 90% cost reduction.