Infection Prevention INLEIDING Flexibele endoscopen en CSA? 2013 VSZ Kwaliteitsgroepen
Ingenious
Solutions Transforming Health
Dirk Eraly Professional Services Infection Prevention Sterilization, Ioban, Clipper and Respirators 3M Infection Prevention Division
Endoscopie afdelingen (ook buiten ziekenhuis) Device and Controll Station
Procedures: Colonoscopy, Gastroscopy, Bronchioscpy
Reprocessing (Cleaning and Disinfection)
Special storage cupboard for flex. endoscopes
Decontamination via pre-cleaning and Automatic Endoscope Reprocessing (AER)
Rigide endoscopen
Flexible endoscopen
OK en CSA
Endoscopie afdel/privé-poli kliniek
- Minimal invasive surgical procedures
-Vele gescheiden afdelingen in verschillende disciplines autonoom van CSA, meestal ook zonder inspraak apoth -Trend naar 1 centrale unit zoals NL - Meer focus op diagnostiek en therapeutische procedures i.p.v. reprocessing - Thermisch gevoelige optische en technologische systemen - Reprocessing (reiniging en desinfection) is verantwoordelijkheid van Endoscopie afdeling en plaatselijk gereprocessed
- Rigide Endoscopen - zelfs camera kan autoclaveerbaar
- Endoscopen meestal gereprocessed met andere intrumenten in speciale trays - Decontaminatie and sterilisatie uitgevoerd in CSA of outsourced service provider
•Goed gekende richtlijnen, aanvaarde normen, vereisten en processen. •- verantwoordelijkheden meestal bij 2 personen (apotheek, hoofd CSA)
• Endoscopie technologie ontwikkelt sneller dan reprocessing mogelijkheden. • Standaarden staan nog lang niet op punt – missing links •ISO 15883-4 published in 2008 •First reprocessing guideline in 2003 •Publicaties en infectiemeldingen na endosc.procedures
4
Endoscope Reprocessing according to guidelines 1
Manual cleaning at bedside
2
Transport to reprocessing room
3
4
Leak testing
Manual cleaning: a. Immerse b. Wipe c. Brush d. Flush e. Rinse f. Dry
5 Monitoring? Is het proper genoeg? Zal de desinfectie overal aankunnen
Als het niet goed is gereinigd , correcte HLD niet mogelijk
High Level Disinfection: a. Manual b. Automated
Monito ring? Is het veilig voor volgen de patient
6
Drying & Storage
Endoscope Reprocessing according to guidelines 1
Manual cleaning at bedside
2
Transport to reprocessing room
3
4
Leak testing
Manual cleaning: a. Immerse b. Wipe c. Brush d. Flush e. Rinse f. Dry
Opportunity for Clean Trace ATP for efficacy monitoring of manual cleaning process and environment clean testing
5
6
? High Level Disinfection: a. Manual b. Automated
Drying & Storage
Chain of Arguments Every single guideline identifies manual cleaning of flexible endoscopes as critical for effective endoscope reprocessing “Meticulous cleaning must precede any sterilization or high-level disinfection of these instruments. Failure to perform good cleaning can result in sterilization or disinfection failure, and outbreaks of infection can occur “ “The most important step in the reduction of microorganisms is the manual cleaning. It is impossible to disinfect or even sterilize an inadequately cleaned instrument.“ “The objective of cleaning endoscopes and additional endoscopic instrumentation is to remove organic matter and pharmaceutical drugs, thereby leaving as little residue as possible, because disinfection or sterilisation results can be adversely affected by residues” “Effective cleaning is an essential pre-requisite to disinfection and sterilization and is vital to ensure removal of debris.”
Manual cleaning is one of the most challenging parts of flexible endoscope decontamination, is prone to human error and shows low compliance „Practice audits showed that manual cleaning and drying before storage were insufficient. Strict adherence to reprocessing procedures ended the outbreak.“ Aumeran et al Multidrug-resistant Klebsiella pneumoniae outbreak after endoscopic retrograde cholangiopancreatography. Endoscopy 2010;42:957-9
„This multisite study documented extensive nonadherence with reprocessing guidelines when manual reprocessing methods were useed.“ • 57% Did not brush all channels & components • 55% Did not dry with forced air • 22% Tested for leaks using sudy water • 16% Skipped air purge after detergent flush • 14% Did not flush with alcohol • 10% Skipped final wipe down Ofstead et al Endoscope reprocessing methods: a prospective study on the impact of human factors and automation. Gastroenterol Nurs 2010;33:304-11
Monitoring of the cleaning efficacy of the manual cleaning improves the process quality of the endoscope reprocessing „ Increased efforts and resources should be directed to improve compliance with these guidelines.” Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011
„Strict adherence to reprocessing procedures ended the outbreak. [...] Regular audits to ensure rigorous application of cleaning, high-level disinfection, and drying steps are crucial to avoid contamination.” Aumeran et al Multidrug-resistant Klebsiella pneumoniae outbreak after endoscopic retrograde cholangiopancreatography. Endoscopy 2010;42:957-9
„ There is need for a rapid audit tool for ongoing quality assurance monitoring that would allow facilities to proactively assess compliance with the manual cleaning phase of flexible endoscope reprocessing Alfa et al The adenosin triphosphate test is a rapid an reliable audit tool to assess manual cleaning adequacy of flexible endoscope channels. AJIC 2012
„ As soon as simple practicable methods to check the effectiveness of the cleaning process are available, they should be included in the guideline.“ Heeg P Reprocessing endoscopes: national recommendations with a special emphasis on cleaning-the German perspective. J. of Hospital Infection 2004; 56:23-25
Meest geraadpleegde bronnen in Vlaanderen • Hoge Gezondheidsraad HGR.8355 mei 2010 – Aanbevelingen inzake het onderhoud van flexibel warmtegevoelig endoscopisch materiaal en de preventie van infecties
• ESGE-ESGANA (Euro Soc Gastrointest endosc) – Cleaning and disinfecting in gastrointestinal endoscopy 2008
• SFERD (NL Stuurgroep flex endosc Reinig en Desinfect) – kwaliteitshandboek
• ISO 15883- 4 (met link naar ISO 15883-1 en 5) –
Enkele belangrijke uitreksels:
Vlaams Agentschap Zorg en Gezondheid • Eisenkader met nalevingstoezicht waarvan flexibele endoscopen als 1 van de 6 focussen internistisch zorgtraject kritische diensten • Basis : juridische erkenningsnormen en Internationale guidelines of gevalideerde en haalbare standaarden • Vertaling eisenkader naar inspectie instrument • Opgesteld in samenwerking met professionals (verenigingen) • Probleem: financiering Federaal, audit & toezicht Vlaams!
Multisociety guideline (2011) / Robert Koch Institute 11 professional organizations (ASGE)
Essential
Classification of instruments and recommendation on reprocessing requirements and essential steps. Classification (Spaulding): CRITICAL-objects which enter normally sterile tissue or the vascular system or through which blood flows should be sterile.
SEMICRITICAL-objects that touch mucous membranes or skin that is not intact require a disinfection process (high-level disinfection[HLD]) that kills all microorganisms but high numbers of bacterial spores.
NONCRITICAL-objects that touch only intact skin require low-level disinfection.
1.Pre-cleaning: at the point of use Manual 2. Leak Test 3.Cleaning: meticulously clean the entire endoscope and brushing and flushing of all channels. Use enzymatic detergents. 4.High level disinfection- manual or automatic at decontamination area 5. Drying 6. Storage
Automatic 2.Leakl Test 3.Cleaning: Immerse endoscope in detergent, brush and flush all channels. Use enzymatic detergents. 4. Automated Endoscopy Reprocess or: includes cleaning and high level disinfection stage, rinsing and drying . 5. Storage
Weak points
- does not distinguish between observational and therapeutically use of an endoscope. - therapeutically used endoscopes are evaluated as semi-critical which is wrong by definition. ~1/3 of all procedures use therapeutically applied instruments.
Evaluation
The recommended processes are not based on well-designed studies, but on available technology status and industry input. The evidence is only based on the absence of case reports. It is confirmed that this may underestimate the true incidence of pathogen transmission. Confirmed: UNRESOLVED ISSUE REQUIRING FURTHER STUDY Microbiologic surveillance testing after reprocessing; Detection of non-environmental pathogens; Indicator of faulty in reprocessing equipment, inadequate solution, or failed human process.
ISO 15883-4
Part of the 15883 Series - 7 parts (frequently refers to other parts especially 1 & 5) In scope • Part of the decontamination process that takes part in the Washer-Disinfector (WD) / Automatic Endoscope Reprocessor (AER) / High Level Disinfector (HLD) Out of scope • Manual cleaning – some minor references • Storage cabinets • Endoscopes that can be steam sterilised – covered in 15883:2
ISO 15883-4 Standard Broken down into following broad sections
• • • • • • • •
Performance requirements Mechanical and process requirements Testing for conformity Documentation and inspection Information to be supplied by the manufacturer Summary of activities covered Summary of test programmes Methods for microbiological evaluation
ISO 15883-4 General observations • Much emphasis on qualification and installation of WD – WD manufacturers responsibility • Recommended routine tests after installation described in detail - incl cleaning efficacy and disinfection performance – Frequency not recommended – Apart from input water quality – at least annual micro test – Chemical concentration testing (if not automatic)
• Process control very important – Time / temperature / chemical concentration
ISO 15883-4 (2008) Essential
Requirements and tests for washer disinfector employing chemical disinfection for thermolabile endoscopes. Main focus: - Perfomance requirements - Mechanical and process requirements - Testing for conformity
Performance requirements: 1) leak testing (where appropriate) 2) cleaning (which may include several stages) 3) disinfecting 4) final rinsing 5) purging of rinse water 6) drying (when appropriate)
Weak points - few or no guidance on essential process steps like manual cleaning or storage -7 different test soils are listed to prove the efficacy of the process -only a surrogate and 2 representative devices have to be tested to demonstrate cleaning efficacy -disinfection performance qualification and routine testing are mentioned but not specifically described Evaluation
It is obvious that the standard is based on input from manufacturers and lacks in reference to profound data. The efficacy of processes is not evidence based.
Leverage Clinical Research for Guideline Influence
•Vele professionele groepen • betrokken
Meer studies nodig , data infecties, wat zijn de risico‘s veiligheid patient
Clean Trace for Endoscopy Surface test Monitors the exterior of bending section of the distal end.
1.
Water test
2. Dip
Data Transfer and Analysis
3.
Monitors the interior of the suction biopsy channel via validated flushing method. Defined threshold is 200 RLUs Downloads Endoscope specific data and generates a trend analysis. Validate the process. Web based or CD-Rom based.
3M™ Clean-Trace™ ATP swabs
ATP waterswabs Surface ATP Swabs
ATP proteïnetest Water ATP Swabs
Controle Omgeving ziekenhuis CSA
NGi Luminometer Heat Block S
Controle was-en desinfectiefase En flexibele endoscopen
Surgical Instruments
Online Software
PC Based Software
Gevalideerde levels na manuele cleaning
Gevalideerde levels na manuele cleaning
Protein Test
Gebaseerd op ISO 15883 ninhydrinetest )
3M Clean Trace does allow fast real time monitoring of the manual cleaning process to ensure appropiate manual cleaning before automatic processing of the endosope „ The results of our simulated-use study support the application of the ATP method [ 3M CT] as a reliable means of monitoring manual cleaning efficacy on a “realtime” basis for channels of flexible endoscopes.“ Alfa et al Validation of adenosine triphosphate to audit manual cleaning of flexible endoscope channels. AJIC 2012, in press
„ We recommend that the ATP test [3M CT] be used after manual cleaning as an audit tool to confirm adequacy of cleaning (ie, removal of both patient-derived organic materials and bioburden). Alfa et al The adenosin triphosphate test is a rapid an reliable audit tool to assess manual cleaning adequacy of flexible endoscope channels. AJIC 2012 in press
„ ATP [3M CT] is likely to be the superior routine monitoring system for its practical, real-time and quantitative evaluation capabilities in clinical settings. Fushimi et al Comparison of adenosin triphosphate, microbiological load, and residual protein as inbdicators for assessing the cleanliness of flexible gastrointestinal endoscopes. AJIC 2012, in press
Vragen - discussie • Wie is verantwoordelijk voor de reprocessing van flex.endoscopen en hoe worden deze ingevuld? • Zijn er geschreven procedures die in Com.Ziekenhuishygiëne worden goedgekeurd en hoe dikwijls worden die herzien?
Vragen - discussie • Worden er nog flex.scopen volledig manueel geprocessed en waarom? Plan om dit te elimineren? • Welke zijn de werkpunten op vlak van structurele indicatoren (lokalen, veiligheidsmiddelen, autom reproc, transportkar, compartimentering lokalen,
Vragen - discussie • Welke controles worden er uitgevoerd bij de behandeling van flex scopen en wie voert ze uit? Frekwentie? Wat bij positief resultaat? • Is er zicht op de training en opleiding van het personeel – welke opleiding (intern, extern)
Vragen - discussie • Welke aspecten van de reprocessing zouden onder toezicht van de CSA idealiter moeten komen. (nu opleiding bij endoscopie verplegenden) – hoe best samenwerken?
