© 2020 Henry Sibun Associates Ltd (Rev 01) 27/02/2020 www.henrysibun.com

Nelson Labs Open House

“2020 The Year of Change” Leuven, 4th – 5th March 2020

Henry Sibun Introduction to Reprocessing of Medical Devices

and physical/chemical impact

© 2020 Henry Sibun Associates Ltd ISO 10993 changes and relation to MDR (Rev 01) – Nelson Labs 04/03/2020 2

1) Introduction

Introduction to Reprocessing of Medical Devices and

physical/chemical impact

1) Introduction

2) The Processing Cycle

3) Processing Cycle risk & control examples

4) Next presentations

© 2020 Henry Sibun Associates Ltd ISO 10993 changes and relation to MDR (Rev 01) – Nelson Labs 04/03/2020 3

2) The Processing Cycle

Use Care

P.O.U.

Clean

Disinfect

Dry Inspect Maint. Service

Pack / wrap

Sterilise

Transport

Store

The Processing

Cycle

P.O.U = Point Of Use

© 2020 Henry Sibun Associates Ltd ISO 10993 changes and relation to MDR (Rev 01) – Nelson Labs 04/03/2020 4

3) The Processing Cycle – risks & controls

Use: damage / misuse / blunt / residue build-up over multiple uses design, drying validation, IFU, servicing, maintain, inspection

Care P.O.U.: Not done IFU, drying validation

Clean: insufficient / can’t do / residues (microbes, cleaning chemicals) validation & verification, manual/automated

Disinfect (thermal/chemical): insufficient / damage / residues validate worst case conditions

Dry: insufficient (wet) / damage design, validation

Risks Controls

© 2020 Henry Sibun Associates Ltd ISO 10993 changes and relation to MDR (Rev 01) – Nelson Labs 04/03/2020 5

3) The Processing Cycle – risks & controls

Inspect, Maintain, Service: residues (e.g. oil), handling (bioburden) cleanroom, defined chemicals, procedure, IFU

Pack / wrap: packaging leachables, sterilant penetration, device protection design, IFU

Sterilise: insufficient, residues, chemical change, damage device / packaging validation, chemical characterisation

Transport: damage, package open validate transport

Store: package open, leachables from packaging shelf-life validation

Risks Controls

© 2020 Henry Sibun Associates Ltd ISO 10993 changes and relation to MDR (Rev 01) – Nelson Labs 04/03/2020 6

4) Next Presentations

Processing Cycle

• Sterilization of your Medical Device – Annick Gillet,

Technical Director EO Pharma – Sterigenics

• If something looks clean, is it really clean? – Dr Lise

Vanderkelen, Department Head Micro & Pharma

Services – Nelson Labs Europe

• Reprocessing Validations of reusable Medical

Devices – Alpa Patel, Principal Scientist – Nelson

Laboratories LLC