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© 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