PRODUCT PRESENTATION - NESVE
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Product presentation
1- Why disinfect ultrasound probes?
Need and Risks?
The Spaulding classification applied to ultrasound
Probe usage Risk Disinfection Efficacy
Contact sterile tissue or the Sterilisation, if not possible
vascular system Critical High Level Disinfection HLD = ILD + Sporicidal
(ex: prostate biopsy) HLD
Contact mucous membranes (ex: Intermediate Level Disinfection Bacteria, Fungi, Mycobacteria,
Semi-Critical
œsophagus) ou Non intact skin ILD Virus
Low Level Disinfection
Contact with intact skin Non-Critical Bacteria
LLD
ultrasound probe disinfection : several departments should be aware
Ob/Gy
Vaginal probes IVF
Rectal probes Radiology
Transoesophageal probes Urology
External Probes for biopsy, block placement Anesthesia
Cardiology
Infection Risk with Ultrasound Probes
The difficulty in establishing the link between ultrasound and
infection has slowed down the publication of guidelines and the
implementation of good practices but …
Ultrasound probe with only cover and low level disinfection (LLD) =>
1-9 % of covers with leakage
28% of exams performed with a contaminated probe
HPV 7,5% and High Risk HPV 3%
4M exams give >30,000 new infections (HIV, HPV, HCV, HBV, etc.)
Case reports exist
Health and legal high risk situation
Focus on probe cover efficacy
Condom Medical Cover :
Leakage Rate Leakage Rate
Leakage rate betwen 1 and 9 % (n>2000)
CDC: Guideline for Disinfection and Sterilization in Healthcare Facilities,
2008 - USA
“A vaginal probe and all endocavitary probes without a probe cover are semicritical devices
because they have direct contact with mucous membranes (e.g., vagina, rectum, pharynx).
…, and because condoms/probe covers can fail 195, 197-199, the probe also should be high-level
disinfected. The relevance of this recommendation is reinforced with the findings that
sterile transvaginal ultrasound probe covers have a very high rate of perforations even
before use … These studies underscore the need for routine probe disinfection between
examinations…”
William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory
Committee (HICPAC)
Low level disinfection : efficacy evaluation
High Risk HPV Contamination of Endocavity Vaginal Ultrasound Probes:
An Underestimated Route of Nosocomial Infection? Oct 2012
Jeans Sébastien Casalegno, Karine Le Bail Carval, Daniel Eibach, Marie-Laure Valdeyron, Gery Lamblin,
Hervé Jacquemoud, Georges Mellier, Bruno Lina, Pascal Gaucherand, Patrice Mathevet, Yahia Mekki
10/25/12 PLOS ONE
Goal: Assess contamination on endovaginal ultrasound probes after LLD
Method: Detection of HPV via PCR
Results:
N = 217 samples before LLD and 200 samples post-LLD
Human DNA detected in 61 (28%) pre-exam samples and 36 (18%) post-exam samples
HPV DNA detected in 6 (3.0%) samples post-LLD
Conclusion = Use HLD
TEE examinations & infection risk : BELGIUM
Nosocomial outbreak of esbl-producing enterobacter cloacae among cardio-thoracic
surgical patients: causes and consequences — January 2019
A. Noël, C. Vastrade, S. Dupont, M. de Barsy, T.D. Huang, T. Van Maerken, I. Leroux-Roels, B. Delaere, L. Melly, B. Rondelet, C. Dransart, A.S.
Dincq, I. Michaux, P. Bogaerts, Y. Glupczynski
Goal: investigation of a nosocomial outbreak by Klebsiella pneumoniae affecting cardio-thoracic surgery patients
in a Belgian academic hospital (CHU NAMUR).
Method: Cases were defined based on epidemiological and microbiological investigations
Results: Over a three-month period, 42 patients were infected (ICU : 3, CTS :16, other : 3) with high mortality
rate of 40%.
All but one patient had prior to acquisition, undergone a cardio-thoracic surgical procedure, monitored by the
same TOE probe. The exclusion of the suspected probe resulted in rapid termination of the outbreak.
Conclusion : before the adverse event, use of chlorine dioxide wipes.
The study underscores the operator-dependant character of the manual disinfection processing .
Decision to switch from the use of wipes to automated reprocessor.
CTS: cardio-thoracic surgery ward
2- National & International Guidelines
Guidelines : HLD requested between each patient
PERIOD AREA INSTITUTION
BEFORE 2014 CANADA Health Canada
USA CDC
AUSTRALIA – NEW Z NHMRC (1)
2014 WALES NHS Wales
2016 SCOTLAND NHS Scotland
2017 IRELAND Health Service Executive
WORLDWIDE WFUMB (2)
AUSTRALIA ACPIC & ASUM (3)
EUROPE ECMUS (4)
EUROPE ESR (5)
UK SCoR & BMUS (6)
2018 ENGLAND Healthcare Infection Society
2019 FRANCE MOH (Ministère des Solidarités et de la Santé)
(1)National Health and Medical Research Council - (2) World Federation of Ultrasound in Medicine and Biology - (3) Australian College Infection Prevention Control & Australasian Society for
Ultrasound in Medicine - (4)European Committee for Medical Ultrasound Safety - (5) European Society of radiology - (6) Society and College of Radiographers and British Medical Ultrasound
Society 10Guidelines for transvaginal ultrasound probe disinfection between patients
• Background
• Endovaginal ultrasound probes routinely used in clinical obstetrics and gynecology
• Major pathogens of concern: HIV, HPV, CMV, enteric GNRs (E. coli, Klebsiella spp.), gonorrhea, syphilis,
Clostridium difficile
• Reported leakage rates for condoms, 0.9% -2%; probe covers, 8%-81% (relatively old studies) but more
recent study reported 9% risk of condom perforation with transrectal biopsy under ultrasound guidance
• Recommendations (post use)
• Removal of the transducer cover
• Transducer cleaning
• Transducer high level disinfection
• Application of new transducer cover
Abramowicz JS, et al. WFUMB Safety Committee. Ultrasound in Med. & Biol.; 2017;43:1076-1079.
113 – Solution: Chronos & Antigermix AE1 for high level disinfection of ultrasound probes and ENT scopes
Chronos : high level disinfection of ultrasound probes
2019
for vaginal, rectal and external probes
13Chronos description
2019
Ultraviolet (UV-C) HLD
Fast Cycle (90 sec)
No consumables
No Probe Disconnection
Cycle monitoring : 3 photodiodes
Automatic Traceability : bar-code
Disinfection indicator
Webservices and Germitrac 2
Clean UV-C process, no chemicals
Easy service
Accessories
14Germitrac2
Traceability software
User
• System features
• Disinfection data
• Downloading
• Print
• Ticketing
15Antigermix® AE1 : description
Made for TEE probes and ENT scopes without channel
High Level Disinfection with
6 UV-C lamps (254 nm – 239,4 mj/cm2)
Closed chamber…
…covered with aluminium
RFID identification
2 photodiodes
And … no consumables
device installable everywhere and movable
16Antigermix® AE1 : process
High Level Disinfection*
Automatic disinfection
In 180 sec
Repeatable
Automatic traceability (labels + electronic filing)
Cycle monitoring with 2 photodiodes
No consumable
Probe immediately ready right after disinfection cycle
*: as per hygiene principle, probes must be cleaned before disinfection
174– What is the efficacy?
Compliance with HLD standards
HLD EUROPEAN STANDARDS (NF-EN)
HLD AOAC standards (US, Can, Au)
(Bacteria – Fungi – Mycobacteria –Spore)
VIRUCIDAL STANDARD HLD-DNH (ASTM)
HPV (Pr Meyers – PennState)
HLD confirmedUVC: efficacy
Susceptibility UVC radiation as an effective disinfectant method to inactivate human
papillomaviruses
Craig Meyers, et all. PLOS ONE, 2017
• Goal: transvaginal ultrasound probes can remain contaminated with HPV even when proper hospital
disinfectant reprocessing procedures are followed. Glutaraldehydes (GTA) and ortho-phthalaldehydes
(OPA) had no effect on HPV. Test of the effectiveness of high-level UVC to deactivate HPV16 and HPV18.
• Methods:
• Method based on the ASTM E1053-11, suitable for assessing virucidal activity on non porous surface
• authentic HPV16 and HPV18 virions were dried onto carriers with a 5% (v/v) protein soil or 4ppm hard water
• Efficacy testing were performed with the automated device, Antigermix AS1 device (UVC radiation at 253.7nm)
and 0.55% OPA in quadruplicate with matched input, neutralization, and cytotoxicity controls.
• Results:
• The automated Antigermix S1 device showed excellent efficacy against HPV16 and HPV18 whereas OPA
showed minimal efficacy
205– What are the scientific assesments?
Accreditations & validations
2011, Danish body
2014 & 2017, German body
Canada (Health Canada)
March 2016, Level of Scientific Proof: UV level 1+ and 2
Australie (TGA – Dpt of Health)
New Zealand (Medical Device Safety Authority)
France (ANSM, APHP Cochin, HC Lyon)
England (Public Health England /RRP)
2015, Benefit and profitability level of innovation : level 2
Scotland (NHS)
Ireland (HSE)
Denmark (Statens Serum Institut)
Germany (DGKH)
Austria (AK Hospital) Hospitals: Cochin, AKH, Hospital Infection Research Laboratory Queen Elizabeth Birmingham
Russia ( Federal Service of Healthcare)
USA (Penstate University) Supported by prestigious evaluations
Singapore (Health Care Authority)6– Compatibility
Compatibility More than 800 ultrasound probe models compatible with Antigermix PHILIPS, GE, CANON, SIEMENS, ESAOTE, HITACHI-ALOKA, BK, SONOSITE, ALPINION, SAMSUNG, MINDRAY
Conclusion
High speed :
90s or 180s
Economical:
No consommable
No decrease of medical activity due to the disinfection process
UV treatment non-corrosive for probes - preserves their functionalities
100% automatic - Traceability:
Status of each disinfection cycle
Germitrac software and self-adhesive labels
Just one click:
No special configuration. The system may be used immediately
Safety:
The UV treatment is non toxic for medical staff and patients.
No need for personal protective equiment
Environmentally friendly:
No residue, no effluentThank you
26You can also read
