Quality control and Innovation in cleaning and sterilisation

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

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.

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.

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

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

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

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 –…

Sterilisation : Beyond compliance, innovation • 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 • AB 101 : Bowie-Dick test that also combines an hollow challenge

AB 101: More than a Bowie-Dick test • Steam faces a : – Porous challenge : Metal – Hollow challenge : Lumen – Challenging test for increased patient safety • AB 101 means – Intelligent Ink Technology – Less interpretation – Compliance to EN ISO 11140 -4 – Completely new concept: pending Kite-Mark

Cleaning : The ever growing concern • 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 : What is clean ? • 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 : Resi. PEN protein residues test • Advanced solution for cleaning efficacy testing: – Quick : < 10 seconds – Easy-to-use: No incubation – Accurate : 1 μgram – Not harming processes : sterile swab – Broad spectrum : all proteins and their residues

Key take-aways • 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 !