How clean are your instruments? Pre cleaning & preparation Samuel Morais Technical Director January 25 th 2015
Overview 1. Correct Preparation will result on good cleaning results that are visible and non-visible 2. An interdepartmental responsibility 3. Aiding devices and methods for a good instrument preparation 4. Proven Protein reduction when preparation procedures are in place
Current Issues Time from point of use to decon allowing bio burden to dry. Especially in the complex nooks, crannies, lumens and other surfaces. As a direct result staff resort to cleaning with metal bristle brushes and harsh chemicals and solvents. Expensive instruments can be easily damaged. Drastically affects functionality and reduces instrument lifespan Patient safety compromised Staff safety also an important factor to consider
Protein Removal CFPP 01-01 clause 5.23 points that as an Abnormal Protein Prions are Abnormal protein is heat-stable, exceptionally resistant to enzymatic digestion and, once dried onto the instrument surfaces, very difficult to remove or inactivate by conventional reprocessing.
UK Standards recommend: CFPP 01-01 clause 6.7 Prions are hydrophobic proteins. The attachment of hydrophobic proteins to surfaces becomes less reversible if they are allowed to dry fully onto a surface. Keeping the environment around soiled instruments at or near saturation humilities (moist) prevents full attachment of hydrophobic proteins such that they are more efficiently removed by cleaning.
International Standards recommend: EN ISO 15883-2:2009 The efficacy of disinfection can be impaired if soil removal is incomplete before the start of the disinfection process. Users should be aware that some medical devices might require pre-treatment. ST79:2010 / A2:2011 6.4 Containment Immediately after use, items should be kept moist. 7.3 Pre-soaking with a specialized product (e.g. an enzymatic solution) is generally recommended.
In Summary: Pre-soaking should begin as soon as possible after an instrument is used. Rationale: Pre-soaking instruments moistens and loosens the soil, thus making the cleaning step more efficient International, UK and US standards recommend that pre preparation soaking at point of use is of paramount importance to ensure bio burden does not dry
Inter-Department Cooperation Understandably theatre staff are busy and in some cases may not give priority to decontamination protocol Small and simple steps can be taken post-procedure that will positively impact cleaning efficacy throughout the decontamination procedure and are NOT time consuming for theatre staff Important for departments to work together to improve patient safety, cut costs and prevent infection
Recommendations from leading instrument manufacturers Instruments should be soaked and primed at point of use using ph neutral to mildly alkaline (ph 11 or under) enzymatic cleaner. Lumens should be flushed at point of use
Pre Cleaning Solutions Instruments should be prepared at point of use, or as soon as possible after the procedure, We offer products to assist with the Pre Cleaning such as: Pre Soak (Foam) Spray Complex Surgical Instrument Tip Pre Soakers Humidity Transportation Bags These steps will ensure instruments retain moisture around critical instrument tips & surfaces to ensure easy cleaning when instrument is received at the decon room Once instruments arrive at CSSD they will be ready for reprocessing No more pre-soaking in CSSD time is saved, quicker turn around of instruments, meet your targets! Also protects your expensive instruments during transport AND prevents cross contamination
Pre Cleaning Options: Distal Point of Use Preparation Kit Distal Tip Soaker Dug Bag
Cleaning efficacy on utilising Tip Soakers All of the instruments that had been inserted into the Distal Tip Soaker for soaking during the 1 hour were visually clean after a 20 seconds rinse under cold water. But all of the instruments that were allowed to dry at room temperature for 1 hours visually showed soil remaining after a 20 second rinse under cold water. Soiled instrument Visually dirty after rinsing without Tip Soaker Visually clean after rinsing when using Tip Soaker
Study Results
Duck Bag Instrument humidity pack For transport and storage prior to instrument reprocessing Pre moistened ready for immediate use Enzymatic sachet included Single Use Available in different sizes
Duck Bag Use the Pre moistened transportation Bag to prevent soiled instruments from drying during transportation from point of use to CSSD. UK/International Guidelines and Instrument manufacturers recommend that the reprocessing of soiled instruments should begin within 60 minutes from end of use to ensure that soil, especially blood, does not dry on the surface of used instruments.
Choice of detergents on preparation and manual cleaning Detergents are essential in aiding the cleaning process Remember, instrument cleaning is the first and most important step in the decontamination process. if it s not clean, it can t be sterile! Cleaning will help to ensure better contact between the disinfectant and any remaining infectious agents in subsequent stages of decontamination
Pre Treatment Detergents As discussed, the cleaning process needs to begin before the instruments reach the CSSD Surgical instruments can be left unprocessed for hours after a surgery and it is during this time that soil can become denatured (insoluble and much harder to clean!) Especially on complex devices / lumens
Pre Soak Detergents This can come in the form of: Coating with an enzymatic foam spray. Tip Soaking complex instrument tips can be soaked in enzymatic detergent during transportation from point of use to SSD using a self contained transportation method to prevent cross-contamination.
Pre Treatment Detergents Soaking in a bath containing an enzymatic solution. Here the instruments can be wiped down and gross debris removed. Lumens can also be flushed.
How clean can we go?? Can 5μg or less per instrument be achieved?
XC Cycle utilising PCF technology The Medisafe XC Cycle for SI PCF and Niagara SI PCF is a cleaning cycle designed to generate unmatched levels of cleaning and disinfection for Robotic Instruments. The process includes; keeping the complex instruments moist after use and during transportation with the Medisafe Distal DUCK Tip Soaker and DUCK Bag kit. 1. Simply apply DUCK distal tip pre-soaker onto davinci instruments immediately after surgery. 2. Instruments pre-soak and stay moist during transport. 3. Load instruments in to Medisafe SI PCF and start Preparation for Automated Cleaning program that immediately precedes our time tested, ISI validated davinci program #6 for complete Automated Cleaning Process and validated Thermal Disinfection. Instruments are clean & disinfected, at or below 5μg of residual protein
Conclusion Preparation of instruments is key to ensure an efficient removal of soil Inter-departament cooperation is fundamental for pre cleaning preparation to take place and it can be easily achieved with the aid of available products in the market. Risk of Prion fixing on instrument and Protein reduction is dramatically reduced by keeping instrument moist
Remember Without appropriate instrument handling and preparation it can t be cleaned, if it is not clean, it can not be sterilized! Thank you!
References CFPP 01-01 Choice Framework for local Policy and Procedures 01-01 Management and decontamination of surgical instruments (medical devices) used in acute care. ANSI / AAMI ST79:2010 / A2:2011 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities. EN ISO 15883-1:2009 Washer-disinfectors. General requirements, terms and definitions and tests EN ISO 15883-2:2009 Washer-disinfectors. Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. EN ISO 17664:2004 Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices.