q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
April 24, 2012
Ing. J. J. J. Patijn
The value and neccessity of
validation
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Subjects
Introduction
Decontamination
Equipment
Reprocessing
Medical devices
Conclusion
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Introduction Causa
Over 15 years of experience
Independent
Innovative
Approved by manufacturers
ISO 9001:2008 certified
Affiliated with the Technical University of Eindhoven
Member of national and international normcommittees
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Mission
Being the reliable and innovative partner for:
Validation services
Validation equipment
Consultancy
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Strategy
Quality
Flexibility
Innovation
Knowledge transfer
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Innovation
Own development of hardware and software for validation
Flow and pressure module
Digital validation reports
First validation company to use alternative for the
Bowie & Dick test
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
CSSD
Goal of the CSSD is to (re)process medical devices
Result: sterile medical devices
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
What is sterile ?
Definition conform EN556
“condition of a medical device that is free from viable
micro-organisms.”
BUT
difficult to prove!
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Statistical approach
EN556
“For a terminally-sterilized medical device to be designated
"STERILE", the theoretical probability of there being a viable
micro-organism present on/in the device shall be equal to or
less than 1x10-6.”
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Decontamination equipment
CE mark conform MDD
Level of interference of Notified Body
Who is responsible for:
protocols
execution of tests
assesment of the results
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Qualification of equipment
IQ: Installation Qualification
IQ protocol in accordance between supplier and customer
OQ: Operational Qualification
OQ conform standards, e.g. large steam sterilizer EN 285
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Installation Qualification
Proof that:
the equipment is installed correctly
media are available as needed (electricity, compressed
air, steam)
Equipment can be operated safely
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Operational Qualification
Proof that:
Installed equipment has equal performance as during type
testing
E.g. large steam sterilizer:
vacuumleakage test and steam penetrationtest
conform EN285
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Result of IQ and OQ
After IQ and OQ the following statement can be made:
Installed equipment is in essence fit for intended use
E.g. the equipment can be classified as sterilizer for
medical devices or washer disinfector
All on the bases of norms and standards
NO DAILY LOADS are involved yet!
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Hospital
Responsible person: DSMH
Sterile instruments for patient and staff
Quality assurance system
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Routing of single-use
instruments in a hospital
Disposal
Hospital
Storage
Medical devices
Use on/in a patient
(Processing CSSD)
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Routing of reusable
instruments in a hospital
Disposal
Hospital
Storage
Medical devices
Use on/in a patient
Reprocessing CSSD
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Qualification of processing
PQ: Performance Qualification
PQ protocol in accordance with the DSMH
Based on norms and standards
Testing of daily loads from the hospital
PRQ: Performance Requalification
PRQ protocol in accordance with the DSMH
Combination of PQ and some tests from the OQ
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Assessment of PQ and PRQ
Assessment is done on the combination
1. Equipment
2. Process
3. Load
4. Loading configuration
5. Packaging (not for washing/disinfection)
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Performance Qualification
Proof that:
The complete processing is fit for purpose within the specific
setting of that hospital after succesfull IQ and OQ
After a succesfull PQ, production may be started
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Performance Requalification
Proof that:
The complete processing is still fit for purpose within the
specific setting of that hospital
PRQ will be executed at predefined intervals and/or in case
of process influencing changes
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Summarizing
CE mark is no proof that equipment is fit for purpose
On site IQ, OQ and PQ must be successful before production
At specified intervals and/or major changes
PRQ must be executed at least
Note: explicitly define the loads and medical devices
to be processed when writing your URS (PVE)
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Loan instruments ?
Regularly loan instruments are to be processed:
Were you involved during the selection process?
Did anyone think about compatibility with the reprocessing
procedure.....?
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
New instruments ?
Regularly new instruments are introduced at the CSSD:
Where you involved during the selection and buying process?
Do they FIT in the reprocessing procedure.....?
Most probably a common situation for a DSMH
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Reprocessing procedure
Reusable medical devices must conform ISO17664
be accompanied by:
a validated procedure for reprocessing
If available that procedure can be compared to the
procedure in your hospital
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
The procedures in practice
Reprocessing procedures are often still:
quite general
not acceptable within our criteria
not compatible with our procedures
or are not available at all....
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Do you have influence ?
YES you have !!
In what way ?
The industry is taking your questions and demands serious
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Improvement
Reprocessing procedures are becoming:
more detailed and available
adapted to commonly used procedures in the specific
region
being actually validated
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Choice of decontamination
method
compatibility with used materials
ageing of used materials
single use or re-usable
efficacy in relation to design of the device
NEW: compatibility with common practice in the region
c.q. hospital
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Examples
Flexible endoscopes:
No thermal disinfection possible
Compatibility with used chemicals must be tested
aldehydes versus peracid
How about cleaning?
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Clean or not 1 ?
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Clean or not 2 ?
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Clean or not 3 ?
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Complexity
Medical devices are getting more complex:
Smaller
longer lumen
exotic materials
electronic components
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Different designs/materials
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Flexible/hollow designs
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Compatibility
Are commonly used processes capable of reprocessing those
new and/or complex medical devices ?
NOT always......
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Example: sterilisation process
conform EN285
phase 1 deaeration and steam penetration
phase 2 sterilisation phase
phase 3 drying en equilibration of pressure
•time
•pre
ssure
•phase 1
•phase 2
•phase 3
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Norm EN285
Specify conditions in sterilisation phase (2)
Specify end result (3)
But does NOT specify phase 1 and before
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
The original "Huckaback Towel Pack"
according to Dr. J. H. Bowie and
Mr. J. Dick for steampenetration test
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Instruments
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Lumen
Lumen both sides open
Lumen one side open
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Thermocouple on non-metal
instrument
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Thermocouple on non-metal
instrument
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Thermocouple on non-metal
instrument
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Validation
Validation:
Documented procedure for obtaining, recording and
interpreting the results required to establish that a process
will consistently yield product complying with predetermined
specification
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Result
reproducibility
and
effectiveness
gives
reliability
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012
---------------------------
causa bv
horsten 1
5612 ax eindhoven
Conclusion
Validation because:
The decontamination process must be assured
Norms and standards do not cover everything
It gives a result of the day-to-day process
It brings you knowledge about your process
q u a l i t y i n v a l i d a t i o n
Eindhoven
April 24, 2012 ---------------------------
causa bv
horsten 1
5612 ax eindhoven
Thank you for your attention
![Adopting a new cleaner disinfector to optimise cleanliness ... · swab testing of multiple high-touch surfaces], ... Adopting a new cleaner disinfector to optimise cleanliness and](https://static.documents.pub/doc/80x56/5b7b44677f8b9a474a8c4f2f/adopting-a-new-cleaner-disinfector-to-optimise-cleanliness-swab-testing.jpg)
