1. Quality control and Innovation in cleaning and sterilisation indicators Denys Dhiver Albert BROWNE Ltd.

2. History In the late 1800’s James Lister, Robert Koch and Louis Pasteur began understanding the world of microbiology and the paths of infection on patients. In 1870 Albert BROWNE began. It launched the world first chemical indicator in 1930. Then in the 80’s the Bowie-Dick pack.

3. Albert BROWNE today Dedicated >80 people team and 2,500 square metres facility Research, Development, Manufacturing and Quality team in the EU (UK) Supplying globally over 200 million indicators per year.

4. Quality control of Indicators today Indicators, are not classified as Medical Devices… yet. Quality system rely on self-certification and self-assessment of compliance to relevant standards. –E.g. EN ISO 11140-4 for Bowie & Dick test. –E.g. EN ISO 15883-5 for cleaning indicators. –ISO 9001 : Quality system

5. Quality control of Indicators today Notified body can do a testing : “Entity that has been accredited by a European Country to assess whether a product to be placed on the market meets certain preordained standards” British Standard Institute : the Kite-Mark scheme –Independent testing by a notified body –Assurance of conformity and compliance –BROWNE leader in this approach

6. Quality control of Indicators today Examples of Kite-Mark: –Bowie-Dick test pack : under Kite-Mark –TST Type 6 indicators : under Kite-Mark Are all inks the same ? No. Patented Intelligent Ink Technology

7. Quality control of Indicators : future Medical Device Directive to be replaced by a Medical Device Regulation in early 2017 Changes in the definition of medical devices : focus on more control of cleaning, disinfection and sterilisation solutions Indicators most likely to be considered as Medical Device, to be confirmed. Importance of checking compliance of independent testing today. –ISO 13485 compliance (medical device quality system) –EN ISO 11140-4 compliance –EN ISO 15883-5 compliance –…–…

8. Ensuring compliance to existing standard : huge step forward Next step : go beyond the standard, improve patient safety Bowie-Dick challenge for the sterilizer: –Compliance to standard is crucial –Beyond standard is even better AB101 : Bowie-Dick test that also combines an hollow challenge Sterilisation : Beyond compliance, innovation

9. Steam faces a : –Porous challenge : Metal –Hollow challenge : Lumen –Challenging test for increased patient safety AB101 means –Intelligent Ink Technology –Less interpretation –Compliance to EN ISO 11140-4 –Completely new concept: pending Kite-Mark AB101: More than a Bowie-Dick test

10. Cleaning never has been under such scrutiny: –New endoscopes cleaning procedures in some countries, including USA –Working item at the European standard level on level of acceptable cleaning efficacy –Dr. Spaulding (1954) : “ It is not clean, it cannot be sterile” still valid. –…–… Cleaning : The ever growing concern

11. Looking for the bugs and the dirt : beyond visual assessment –Dried soil, closed joints –Overloading, inaccurate chemistry dosing, foaming –…–… Best tool : Quick, easy to use, accurate, not harming the cleaning process, broad protein spectrum testing Cleaning : What is clean ?

12. Advanced solution for cleaning efficacy testing: –Quick : < 10 seconds –Easy-to-use: No incubation –Accurate : 1 μ gram –Not harming processes : sterile swab –Broad spectrum : all proteins and their residues Cleaning : ResiPEN protein residues test

13. Don’t take compliance for granted : ask for independent proof ! Upcoming legal changes : get prepared now ! Innovation is relevant, and help for better practices –Cleaning –Sterilisation Ask the experts Liels paldies ! Key take-aways