solutions for instrument cleaning, pre- preparation ... · solutions for instrument cleaning,...

www.medisafeinternational.com

Presented by Victoria Banaszak

Consumables Product Manager

Sunday January 25th

Solutions for instrument cleaning, pre-

preparation & sterilization in accordance

with International Best Practice



Overview

1. Proper Preparation Prevents Poor Cleaning

2. Flexible Endoscope Reprocessing

3. Detergents – NEW innovations

4. Monitoring your wash process – EN ISO 15883

5. Protein testing – BRILLIANT BLUE

6. A – Z of Sterility Assurance Monitoring

7. Personal Protection – Stay Safe

8. Additional OPPORTUNITIES… to be discussed.



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 easily damaged during

transport.

Drastically affects functionality and reduces

instrument lifespan

Patient safety compromised

Staff safety also an important factor to consider



UK Standards Recommend:

CFPP 01-01. page 20

“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

ALSO recommended by leading instrument manufacturers – Consult

IFUs for more info



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



Distal Duck Point of Use Preparation Kit

Distal Tip Soaker

Duck Bag

Enzyme / Neutral Foam Spray

Unique Pre Cleaning Options:



Distal Duck Kit – Point of use prep

For DaVinci Robot

Mandated in ISI IFUs

Specified in AAMI ST 79

Endorsed by IAHCSMM

Convenient Package

All MIS instruments

$500m market in USA



Distal Duck Kit

Features and Benefits:

For use with robotic instruments*

Retains moisture around distal tip – easy cleaning

Use as instrument soaker between POU (OR) and reprocessing (CSSD)

“Duck bill” is also instrument protector

Includes syringe and solution (15ml) for rear flush port (port 1)

Includes Duck Bag humidity pack to keep whole instrument / tray moist during transport

Quick and convenient to use

Can also be used with other complex instruments.



Distal Tip Soaker

A Duck for daVinci… a Duck for ALL



Distal Tip Soaker

As recommended by leading surgical

instrument manufacturers, keeping

instruments moist immediately after use

is a critical first step to effective “point of

use preparation”, safe transport and

subsequent decontamination.



Distal Tip Soaker

Features and Benefits:

Retains moisture around distal tips for easy cleaning – enzyme concentrate soaks distal tip

Recommended by leading manufacturers IFUs for keeping instruments moist between POU (OR) and CSSD (reprocessing)

Safe – Duck bill is also instrument / distal tip protector

Suitable for ALL instruments*

4 active enzymes – works at room temperature

pH Neutral – non-corrosive

Safe, quick and convenient use

No more pre –soaking in CSSD

*Check manufacturers IFU’s

MINI & MAX DUCK ALSO AVAILABLE



Duck Bag

Instrument humidity pack

For transport and storage prior to instrument reprocessing

Pre moistened – ready for immediate use

3 E-Zyme sachet included

Single Use

Available in 3 sizes: – Half DIN 420 mm wide x

430mm deep

– Full DIN 420mm wide x 670mm deep

– Double DIN



Duck Bag

Use the Pre moistened Medisafe Duck 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 30 minutes from end of use to

ensure that soil, especially blood, does not

dry on the surface of used instruments.

Simply place soiled instruments/tray inside

the transparent Duck Bag and seal to

maintain a humid environment during

transport and storage.



Enzyme / Neutral Foam Spray

•This can come in the form of:

•Soaking - in a bath containing an enzymatic solution. Here the instruments can be wiped down and gross debris removed. Lumens can also be flushed.

•Coating – with an enzymatic OR neutral foam spray.

•These processes will help to keep the instruments moist and to prevent the proteins from “fixing” to the instruments

•They can also help to prevent cross contamination!

NOTE: WHO, NICE & AORN Guidelines also recommend

instruments should not be allowed to dry



Flexible Endoscope Reprocessing

The Risks:

One of the key concerns is the drying of soil and soil residues on the internal channels of the scope during transporting to the reprocessing unit.

The current systems available on the market are - to a large extent bespoke units and therefore subject to their own internal validation, testing and protocols.

Mechanical Scope reprocessing is one continuous process during which the scope is cleaned, and then disinfected. For the most part NOT STERILIZED.




HTM 01/06 ( draft ) states that

it is “best practice” to wipe

down and flush the scope at

bedside – this ensure that no

soil residues are able to dry in

any of the channels of the

scope.

Flexible Endoscope reprocessing starts at the bed side:




• Pre mixed pH neutral enzyme/neutral

detergent and contoured sponge kit

(200ml/500ml)

• Single use prevents cross contamination

• Starts cleaning and prevents coagulation

on contact



Pre Cleaning in Summary

CFPP 01-01. page 48

“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.”



Detergents



Detergents

Most recent additions to the ever growing range:

EDA+

EDA+ is a uniquely formulated detergent,

combining highly efficient enzymes with a

mild alkaline buffer to optimise surgical

instrument cleaning. When diluted, EDA+

is safe for use on aluminium and anodised

instrument containers, delicate, complex

and robotic surgical instruments. Suitable

for use in all washer disinfectors, ultrasonic

cleaners and sonic irrigators.



Detergents

4Zyme

4E-Zyme uses a combination of four high performance enzymes. These are fully effective against, and digest ALL, residues and deposits normally found on surgical instruments and apparatus including proteins, lipids, carbohydrates and mucopolysaccharides. The introduction of an extra protease means that the enzymes work at lower temperatures.

Coming soon due to popular demand… fragranced enzyme detergent



Monitoring the wash process

Routine monitoring is required to ensure your processes consistently yield clean instruments

ISO 15883-1, 6.1.6, “WDs shall be tested periodically in accordance with a document schedule to demonstrate the continued reproducibility of the validated cycles”

For flexible endoscopes:

EN ISO 15883, HTM 2030 and the draft HTM01/06 documents all reflect the need to routinely monitor the Soil removal efficacy of your process. In general this is undertaken on a daily basis.

Added to this is the routine need to test protein residues up to an accuracy of 1ug.

Remember… if it is not clean it cannot be sterile



Test Methods listed in ISO 15883-1

Cleaning Efficacy Test 1 – SOIL TEST

– Contaminated test load shall be placed in the WD and run

through a normal wash cycle

– After completion of the wash cycle, examine the test load for

presence of residual test soil

– Test results should be recorded



Cleaning Efficacy Test 1 - Soil Test

ISO 15883-1, 6.10.2.1: “The tests for cleaning efficacy shall be

carried out using the appropriate test methods and test soils as

described in ISO 15883-5 by taking into consideration the

corresponding category of the load.”

The process challenge device should be chosen

specifically to replicate the type of instrument you are

cleaning

Must create a realistic challenge to the WD / Ultrasonic



Cleaning Efficacy Test 1 - Soil Test

Commercially available tests make this easy for staff to conduct these tests themselves.

Combination of process challenge device and cleaning efficacy indicator

Process challenge device must conform to specifications outlined in 15883-5

– i.e. devices for testing cleaning efficacy of flexible endoscopes must be…

Cleaning Efficacy Indicator must use test soil which conforms to 15883-5

Remember: The key is to test with representative challenges to your cleaning process in a consistent and reproducible way.



Valisafe CEI & Standard PCD

Container system for the Valisafe CEI

Process Challenge Device for standard/general non-lumen instrumentation.

Creates a REALISTIC & REPEATABLE challenge.

Allows quick and easy visual indication when used in conjunction with Valisafe CEI.



Valisafe CEI & PCD for MIS

Monitors the cleaning efficient of washer disinfectors & ultrasonic cleaners for MIS or other lumen devices.

PCD for MIS HP simulates cannulated instruments for MIS

Represents a difficult cleaning challenge.




Valisafe CEI & FLC

Monitors the cleaning efficient of washer disinfectors & ultrasonic cleaners for endoscopes and other fine lumen devices.

FLC conforms to specifications outlined in ISO 15883-5 for test pieces for endoscopes

Represents a realistic, difficult cleaning challenge.




Valisafe CEI & FLC



Cleaning Efficacy Test 2 – Protein Test

Daily visual inspection of actual loads to assess

cleanliness of the process items

ISO 15883-1, 6.10.3.2: “When items are visually

clean one of the methods given in Annex C shall be

used to detect the presence of residual

proteinaceous contamination”

Test for protein residues performed after the daily

visual inspection

Test Methods listed in ISO 15883-1



Can you prove that your processes

are successful?

Protein residues cannot be destroyed by sterilization

alone

You cannot visually inspect for protein residues so a

test must be made



Residual Protein Testing for all Instrument Types



Medisafe’s BRILLAINT BLUE

Cost effective

Detects protein residues

within 1µ sensitivity

Accurate results within 10

seconds

No other test more sensitive

without incubation

Clear colour change when

protein is detected

Enhanced accuracy

Available with short swabs for

standard instruments and long

swabs for lumen instruments &

flexible endoscopes



NEW! - Test Complex Instruments for Protein Residue

Complex tips are hard to swab –

how can you prove they are clean?

No swabbing required – easy to

use

Fast results in 10 seconds

INSTANT – accurate protein

residue indication test

Distinctive colour change

No incubation required

No electronics required



Can you prove that your processes are

successful?

Protein testing enables both routine verification of the

efficacy of the cleaning process be it with or without

incubation and a quality control tool in those

departments such as endoscopy where manual cleaning

plays a significant role

Irrespective of whether you are working in a small dental

clinic, a CDU or ERU routine monitoring of your cleaning

phases – both manual and mechanical are critical in

providing evidence of the efficacy of your

decontamination process!



Steam Sterilization Process Control and Routine

Monitoring - How can Chemical Indicators help?

Test mechanical function of apparatus

Identification of processed and unprocessed material for

storage.

Inside a pack/container allows those using the sterile

material to check that the conditions for sterilization were

effective.

Incorporated in documentation or record systems for the

sterilization unit / patients’ notes.



Sterility Assurance Monitoring

Class 1




Class 2



Class 4/5 – Low temp. (EO,

H202, FORM)

Class 4 - steam




Class 6




Loadcheck

3.5 min

4.0min

5.3min

7min

18min Prion

EN867-5 Helix Test




Biological indicator

Monitoring (For steam and

EO 24/48 our read out)



Personal Protection – Stay Safe



Additional Opportunities…



52 Distributors Worldwide current


Questions Welcome…



52 Distributors Worldwide current



Sonic Irrigators - Manual and Auto Since 1991


Cleaning The Worlds Most Complex Instruments

Since 1991…

The Worlds First & ONLY Sonic Irrigator™



British Based Company


55

UK R & D and Manufacturing

Sales / Service / After Sales

Manufacturing /Assembly / Stores

Rand D

Logistics /Training / Finished Goods Stores / Dispatch


International Offices

World Leading Technology for Complex Instrument Cleaning / Pre Cleaning…

Medisafe UK Ltd – Parent Company

Medisafe America LLC

Medisafe Germany GmbH

Medisafe Scandianvia AS

All Products Controlled under

ISO 13485



Worldwide Presence

( 52 Dealers in past 12 months )



100 Reps for 2015 ( currently 31 )



World Leadership Team

Lawrence Dawson

Group CEO

25 Years

John Devaney

Chairman

Board

Wolfgang Drews

MD Germany

10 Years

Chris Anderson

COO / Head of Finance / Board

Victoria Banaszak

Consumables Product Manger

6 years

Olivia Blevins

Incoming President USA

12 Years

Martin Johnson

Sales Director 15 Years

Sam Morais

Technical Director 10 Years


Growth Timeline…


Now Cleaning The Worlds Most Complex

Instruments <5 μg

Est 1991 …

Re - Defining what ‘CLEAN’ Really Means!



Focus Pre Cleaning / Cleaning

1. Specialised Equipment for Cleaning Complex / Robotic Instruments

2. New Unique XC cycle achieve highest level of cleaning result ( 5μg )

3. New ‘patented’ Duck products ‘Point of use’ pre cleaning IFU / Legislation

Additionally…

Validation Products

Sterility Assurance

Wash Monitoring

To…

Hospital Market

Surgery Centres



Unique Washers Combining Ultrasonic’s

Supported by IAHCSMM CE Program

Specified in top Instrument manufacturers IFU’s

Specified for DaVinci Surgery for all three platforms EndoWrist - XI and SS



PCF ( as seen in ISI IFU )

The worlds ONLY Sonic Irrigator™

First machine for use with DaVinci

Only Machine with Thermal

Disinfection option…


All MIS instruments


Endorsed by IAHCSMM

$25m market in USA



PCF ( as seen in ISI IFU )

Medisafe SI PCF is the ONLY solution for All-In-One automated reprocessing.

Our New XC (Xtra Clean) program reproduces the manual pre-cleaning steps recommended above

(Primes Primary Flush Port, Soaks for 30 minutes, Flushes Primary Flush Ports & Secondary Flush Ports

for 20 seconds, Spray Tip & Entire Instrument, Brush, Rinse) all completely automatically!

At the conclusion of the XC program, the user is able to inspect the instruments (step 9) before the

program continues with the appropriate Washer Disinfector cycle.

No other system on the market offers these capabilities and user fl exibility!

A true ALL-IN-ONE, automatic process.

Intuitive Surgical SI Single-Site Reprocessing Instructions Appendices;

PN 552268-01 Rev B; page A-4

Cleaning Validations Summary

Product

Automated Washer/Disinfector Ultrasonic Bath with Flushing

Belimed Medisafe STERIS® Belimed

WD290 SI PCF Caviwave® Pro UW-565

Single Site Instruments and

Accessories • • • •

Medisafe America LLC, 9423 Corporate Lake Drive, Tampa FL, 33634, T: 1-877-444-6334 F: 1-800-692-5205 www .medisafeamerica.com

New IFUs

JUST RELEASED

(Primes Primary Flush Port, Soaks for 30 minutes, Flushes Primary Flush Ports & Secondary Flush Ports

Automated Washer/Disinfector Ultrasonic Bath with Flushing



Niagara Si Series

The worlds ONLY Sonic Irrigator ™

combo washer disinfector

First WD for use with DaVinci

Fastest Cycle


All MIS instruments


$250m market in USA



PCF Pro 60 / Pro 120 ( new for 2015 )



Duck™ ‘Point Of Use’ PRE cleaning

Patent Pend - Specified in IFUs ( ISI Point of Use Prep )

Outlined in ST79

Uses un-productive transport time between OR and CS cleaning instrument…



Duck Range – Point of Use

For DaVinci Robot



Endorsed by IAHCSMM

Convenient Package

All MIS instruments

$500m market in USA



Distal Duck Kit ( as outlined in ISI IFU )

Distal Duck Kit

Point of Use Preparation Kit keeps instruments moist for prolonged periods after usage.

Our unique patented Duck Kit includes a ready-to-use Duck Soaker, pH-neutral enzymatic cleaner for

priming and a Duck Bag that prevents soiled instruments from drying after usage and during transport.

Available in ALL in One Duck Kit, #M20400 (5-Distal soakers, 1-Duck bag, 1-100ml of 4zyme and 1-15ml syringe)

OR Economical Distal Duck Soaker Dispenser Box, #M20413 (250 Duck soakers only)

Distal Duck Kit #M20400

Ready to use - No mixing

Dispenser Box #M20413 - 250 vials

Ready to use - No mixing

Watch the Distal Duck IFU video here

New IFUs

JUST RELEASED

Medisafe America LLC, 9423 Corporate Lake Drive, Tampa FL, 33634, T: 1-877-444-6334 F: 1-800-692-5205 www .medisafeamerica.com


IAHCSMM Educational Video



Distal Tip Soaker



Other Related / Unique Products



Medisafe Detergents



Scope Pre Clean

(Neutral and Enzymatic)

(200ml and 500ml)



‘Patented’ - Distal Check

Outlined in AAMI ST 79

Instrument ‘Clean Test’

IAHCSMM Referenced

Convenient Package worth $10m


Cleaning The Worlds Most Complex Instruments

Since 1991…

The Worlds First & ONLY Sonic Irrigator™



Equipment and Consumables for partnership


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