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INFECTION PREVENTION AND CONTROL


developed from 2016 to 2018 which, for the first time, allows the validation of ultrasonic cleaning devices by listening exclusively for cavitation noise.


CVDs are included within most Medstar systems and the graphs opposite show how Medstar devices perform compared to existing ‘commercial grade’ ultrasonic cleaners. In Graph 1 (existing device) the erratic nature of the sound indicates areas of low or even no activity, especially below the mean voltage.


Graph 2 by comparison shows the cavitation activity in a ‘Medstar ‘Advanced Ultrasonics device. It can be clearly seen that the regularity and intensity of the sound is totally different than that shown in Graph 1. The spikes are much shorter and the overall activity is much more consistent and condensed.


It is this intense ultrasound technology that is so effective in removing protein residue from medical devices, as measured by the in situ ProReveal method. To assess the effect on removal of bacteria, a UKAS accredited laboratory was engaged to carry out independent trials. Instruments were contaminated by the laboratory, first with Enterococcus faecium and Staphlyococcus aureus (as specified within ISO15883 annex N- “test soils and methods for demonstrating cleaning efficacy”) and then with “dirty” conditions (specified in ISO13727). They were then cleaned in a Medstar device. Since all residual protein was being removed, the question arose: was the (now exposed) bacteria also being removed by the intense ultrasound? Work is on-going, but


preliminary results suggest that intense cleaning using ‘Advanced Ultrasonic Technology’ can potentially result in disinfection without the need for any thermal or chemical methods.


Medstar devices have several other features to allow compliance with UK HTM01-01 guidance, such as the Generator Output Monitoring System- which constantly monitors the generator output and adjusts the input accordingly, thus ensuring that the system is always performing optimally. The CVD device is then used for periodic independent validation. Advanced Ultrasonics offers a tantalising alternative to thermal disinfection devices. The HTM01-01 UK guidelines are only the start of things to come and it is already widely recognised that the 5µg limit set out in the guideline is still too high. The many trials undertaken by the manufacturer have clearly shown that the Medstar range of equipment leaves no more than 0.5µg of residual protein per side on an instrument and as such renders the bacteria fully


Work is on-going, but preliminary results suggest that intense cleaning using Advanced Ultrasonic Technology’ can potentially result in disinfection without the need for any thermal or chemical methods.


exposed to the intense, very even, action of the ultrasound and enzymatic chemicals. High throughput systems are also available that would be of great benefit to single-use instrument manufacturers and SSD units alike. These systems will deliver a consistently lower residual protein count and a better log reduction than thermal disinfection devices.


References


1. John Collinge, Katie C. L. Sidle, Julie Meads, James Ironside, & Andrew F. Hill. (1996) Molecular analysis of prion strain variation and the aetiology of “new variant” CJD. Nature, 383(6602), 685. doi:10.1038/383685a0


CSJ


2. Gill, O., Spencer, Y., Richard-Loendt, A., Kelly, C., Dabaghian, R., Boyes, L., Linehan, J., et al. (2013). Prevalent abnormal prion protein in human appendixes after bovine spongiform encephalopathy epizootic: large scale survey. British Medical Journal, 347, 11.


3. See www.cjd.ed.ac.uk/sites/default/files/figs.pdf 4. Jaunmuktane, Z., Quaegebeur, A., Taipa, R., Viana-Baptista, M., Barbosa, R., Koriath, C., Sciot, R., et al. (2018). Evidence of amyloid- cerebral amyloid angiopathy transmission through neurosurgery. Acta Neuropathologica, 135(5), 671–679. doi:10.1007/s00401-018-1822-2


5. Murdoch D, Taylor, Dickinson J, Walker J T, Perrett D, Raven N D H & Sutton J M (2006) Surface de- contamination of surgical instruments – an ongoing dilemma. Journal of Hospital Infection 63: 432-438 6.Baxter, R. L., Baxter, H. C., Campbell, G. A., Grant, K., Jones, A., Richardson, P. and Whittaker, G. (2006), Quantitative analysis of residual protein contamination on reprocessed surgical instruments. J Hosp Infect, 63, 439-444.


7. Department of Health and Social Care. (2016). Health Technical Memorandum (HTM) 01-01: management and decontamination of surgical instruments (medical devices) used in acute care.. Available: https://www.gov.uk/government/ publications/management-and- decontamination-of-surgical- instruments-used-in-acute-care. Last accessed July 2018.


8. Nayuni N, Cloutman-Green E, Hollis M, Hartley J, Martin S & Perrett D (2013) A critical evaluation of ninhydrin as a protein detection method for monitoring surgical instrument decontamination in hospitals. J Hospital Infection 84 97-102


There is a clear need for a new approach to improve the cleaning of surgical devices.


74 I WWW.CLINICALSERVICESJOURNAL.COM


9. Nayuni N, & Perrett D (2013) A comparative study of methods for detecting residual protein on surgical instruments. Medical Device Decontamination (incorporating the IDSc Journal) 18 16-20


10. Perrett D & Nayuni N (2014) Efficacy of current and novel cleaning technologies (ProReveal) for assessing protein contamination on surgical instruments Chapter 22 in Decontamination in Hospitals and Healthcare Edited by Dr. J.T. Walker, Woodhead Publishers, Cambridge, U.K.


SEPTEMBER 2018


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