santiago de chile validation of steam sterilizing ... · pdf fileof steam sterilizing...
Post on 23-Mar-2018
226 Views
Preview:
TRANSCRIPT
Santiago de Chile
Validation
of steam sterilizing processes
since 1998
20 Years review
Anke Carter, Cologne, Germany
international representative of the German
Society for Sterile Supply (DGSV)
➢ What is validation?
➢ Why do we need validated procedures?
➢ Which procedures should be validated?
➢ Which procedures can be validated?
➢ How is validation performed in CSSD?
➢ Preparation of validation in CSSD
➢ Brief look at the procedures of validation (PQ)
➢ What is needed to make it work?
➢ Who is responsible for validation?
➢ 20 years of validation in Germany
Validated procedures in CSSD
Validation is a documented procedure for obtaining, recording and interpreting the results
required to establish that a process will consistently yield product complying with
predetermined specifications
(EN ISO 14937:2009-Sterilization of health care products -
General requirements for characterization of a sterilizing agent
and the development, validation and routine control of a
sterilization process for medical devices)
Validated procedures in CSSD
What is validation?
Validation of reprocessing procedures is the documented proof that process reproducibly yields the intended effect
under the given site situation
for the goods defined on site
with the type of packaging used on site
with the chosen load pattern (arrangement, quantity)
Validated procedures in CSSD
What is validation?
Validation consists of:
➢ Installation qualification (IQ)
➢ Operational qualification (OQ)
➢ Performance qualification (PQ)
• Requalification (performance)
Validated procedures in CSSD
What is validation?
i.e. in Europe/Germany:
Required by law >> Medical Device Act
RKI/BfArM Guideline >> Hygienic reprocessing of medical devices
European Union:
➢ Medical Device Directive 93/42 EEC, amended by Directive 2007/47 EC
World wide:
Required by international Standards (ISO)
Validated procedures in CSSD
Why do we need validated procedures?
WHO Decontamination and Reprocessing of Medical
Devices for Health-care Facilities (2016)
Introduction
Each step of the sterile supply cycle is crucial to the good and safe use of a sterile reusable medical device/instrument during a surgical intervention. An error during any of the stages of the decontamination cycle may lead to huge costs, serious suffering and endanger the lives of patients and staff.
It is essential to have a quality assurance (QA)/management system in place which provides a framework for documentation and control. Pivotal to quality assurance is validation of each step of the reprocessing cycle;
The targets in validation of procedures according to the medical device directive are to achieve
✓ high safety in reprocessing of medical devices (cleaning, disinfection, Checking, packing, sterilisation),
✓ to protect the patients health and safety
✓ to protect the staff
✓ Validation delivers the proof of efficiency of processes and is necessary for quality assurance within the processing of medical devices.
Validated procedures in CSSD
Why do we need validated procedures?
All procedures (processes) where the end product can´t be checked for quality (i.e. because it
would be destroyed by doing so)
Have to be validated
>> Sterile Medical Devices <<
Validated procedures in CSSD
Which procedures should be validated?
According to the German Medical Device Operators Ordinance and RKI/BfArM-Guideline all steps of the reprocessing cycle must be validated
➢ Validated cleaning and disinfection
➢ Validated inspection an function control
➢ Validated packaging
➢ Validated sterilization
Validated procedures in CSSD
Which procedures should be validated?
At present the following automated procedures can be validated
➢ Steam sterilization (ISO 17665)
➢ Cleaning and disinfection (ISO 15883)
➢ Sealing of pouches (ISO 11607)
➢ Formaldehyde sterilization ( EN 14180)
➢ Ethylene oxide sterilization (ISO 11135)
➢ H2O2 Sterilization (ISO 14937)
Validated procedures in CSSD
Which procedures can be validated?
Installation qualification (IQ)
process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification
[ISO/TS 11139:2001, definition 2.20]
Installation qualification is based on the process development and risk analysis of the sterilizer as a medical device and pressure equipment. This should be carried out together with the manufacturer. It includes:
• the equipment complies with the specifications
• the equipment is installed correctly
Validated procedures in CSSD
How is validation performed in CSSD?
Validated procedures in CSSD
How is validation performed?
Operational qualification (OQ)
process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures [ISO/TS 11139:2001, definition 2.24]
The washer/disinfector, the sterilizer, the sealing machine
is working within given limit values and fulfills its function
OQ is carried out after IQ and shows
the washer/disinfector can wash
the sealing machine can seal
the sterilizer can sterilize
Note: there are no used/reprocessed instruments
used for OQ
Validated procedures in CSSD
How is validation performed?
Performance qualification (PQ)
process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification [ISO/TS 11139:2001, definition 2.26]
Performance qualification records that the defined cleaning,
sealing or sterilization conditions are achieved permanently and all
over the product. It includes the interaction between machine (Washer
disinfector, Sealing machine, sterilizer), process, product and confirms
that the results of the operational qualification are valid for the real
product.
Note: used/partly reprocessed instruments are checked during PQ
Validated procedures in CSSD
How is validation performed?
After all tests have been carried out the validating person evaluates the results and writes a
Validation Report
Note: The validation report must be released by the operator
Validated procedures in CSSD
How is validation performed?
Re-qualification (performance)
repeat of part or all of the validation for the purpose of confirming process reliability
The defined interval may be determined by
European or international Standards
Regulatory Authorities
risk analysis.
Note: Requalification is usually carried out yearly
Validated procedures in CSSD
How is validation performed?
Requalification shall be carried immediately
if changes or engineering work has been carried out on the
equipment and installation that could affect the performance
if review of records of routine tests of the equipment’s
performance indicate unacceptable deviation(s) from data
determined during the initial validation
if performance is unacceptable
if process conditions are changed, i.e. new products (different
to any others in use) have to be reprocessed
Note: Requalification has to be carried out immediately if relevant changes have taken place
Validated procedures in CSSD
How is validation performed?
Performance Qualification cannot be done correctly without the CSSD Staff
They know the worst case loads for cleaning/ disinfection
They know the worst case loads for sterilization
They have to make sure that all measures stated in the QM-Manual are followed to the point
Note: No validation without standardization!
Validated procedures in CSSD
Preparation for Validation
CSSD Managers and Staff need to know more about validation
In recent years Guidelines for validation have been written by experts to enable CSSD to prepare (better) for the validation procedures
Validated procedures in CSSD
Preparation for Validation
Guidelines available on WFHSS Website
Guideline for the Validation of processes in Washer/Disinfectors (WD) build according to EN ISO 15883-1 (3. issue 2008)
Guideline for validation of the sealing process (2. issue 2015)
Guideline for validation of processes in a steam sterilizer (DGKH revised in 2009, only in German)
Guideline for validation of manual cleaning and chemical disinfection (1. issue 2013)
Note: CSSD Managers and Staff can prepare validation using those Guidelines
Validated procedures in CSSD
Preparation for Validation
CSSD staff are mainly involved in the preparation of the performance qualification by
Implementing Quality management
Writing a Quality manual
Develop and write SOPs (Standard Operating Procedures) for all steps of the cycle
Recording and documentation of all procedures carried out to reprocess Medical Devices
Recording and documentation of all supporting procedures
Note: Without standardization no validation!
Validated procedures in CSSD
Brief look at the procedures of validation (PQ)
Steam sterilization –
Thermo-electrical testing – micro-biological testing
It is not possible to tell from the processed item, if a
sterilization process has achieved its intended effect, to
sterilize the goods.
That is why the sterilization process must be checked and
monitored in such a way that the intended effect can be
predicted to a very high probability. The following tests help:
Type test and validation.
Those tests of steam sterilization are mostly thermo-electrical
measuring and in certain cases micro-biological testing by
inoculation of real instruments.
Validated procedures in CSSD
Brief look at the procedures of validation (PQ)
The correlation between steam of a certain temperature present for a certain period of time and the resulting killing effect on micro-organisms is common knowledge in steam sterilization. That is why it is possible to verify that a certain method achieves the intended sterilization effect by physical measuring and by proving the existence of sterilization conditions on the goods to be sterilized.
This proof is furnished by temperature measuring (thermo–electrical testing)
Validated procedures in CSSD
Brief look at the procedures of validation (PQ)
Steam Sterilization – Validation equipment
Validated procedures in CSSD
Brief look at the procedures of validation (PQ)
Steam Sterilization – loading for PQ
Validated procedures in CSSD
Brief look at the procedures of validation (PQ)
Measurements during plateau time
Steam sterilization – measuring result of probes during sterilization time
Validated procedures in CSSD
Brief look at the procedures of validation (PQ)
Validated procedures in CSSD
Brief look at the procedures of validation (PQ)
Steam sterilization – additional microbiological test, if
Surfaces difficult to reach by steam where temperature probes cannot be placed because they are difficult to access.;
Sterilization goods, that would be geometrically changed if temperature probes would be installed in such a way that the result of the measuring would be false
Sterilization goods which don‘t allow to say whether it was steam or air at the measuring point, e.g. long lumen with thermal properties, such as little heat passage resistance and little thermal mass
Sterilization goods, where no condensate is expected on the surface to be sterilized.
Validated procedures in CSSD
Brief look at the procedures of validation (PQ)
Steam sterilization – additional microbiological test, if
In general, it is also possible to verify the existence of sterilization conditions on the goods by biological indicators. Biological indicators are artificially contaminated test bodies with a known resistance against the method to be tested. If you breed the bio-indicators after sterilization you can see if there are still micro-organisms growing.
If there is growth, the sterilization method was not effective.
Validated procedures in CSSD
What is needed to make it work?
To validate proceduresgood cooperation between manufactures, CSSD and
Technical department is compulsory
Validation is very complex and depending on correct preparation and performance
of everyone involved
Validated procedures in CSSD
Who is responsible for validation?
The Hospital or the Central Service operaters are responsible for validation
There has to be profound knowledge about the procedure of validation
Validation has to be a part of the education for CSSD Managers and staff!
Technical equipment
Well trainedStaff
Quality management
Reproducibleprocesses
Validated reprocessing of Medical Devices
Validated procedures in CSSD
20 years of validation of steam sterilizing processes
Back in 1998 most CSSD ignored the requirement (because they did not know how to fulfill it)
Only when the authorities started to check the workin CSSD it was noticed that almost everyone carried on as always
In 2003 the first CSSD was shut by the authorities because work was not carried out as required by law
That left a shock for a lot of responsible people and the “validation of sterilization madness” started..
Everyone wanted to validate at once and at that time without proper preparation (no SOPs or QM)
Validated procedures in CSSD
20 years of validation of steam sterilizing processes
That did not fulfill the requirements, but it took quite a while to notice
Only after the second issue of the RKI/BfarM-recommendation was published in 2012, thingschanged and started to go the right way.
Validation of steam sterilization within thereprocessing cycle.
2017 over 98% of steam sterilizing processes are validated procedures (in healthcare)
Validated procedures in CSSD
20 years of validation of steam sterilizing processes
More importantly it was realized that sterilization can only work on a clean instrument, so the following quote from KRINKO/BfArM recommendation was noted and now not just the Sterilization process is validated but also other prior reprocessing steps
“For reprocessing of a medical device, the sum of all the automated and manual processes involved (individual process steps that complement each other) contribute to reaching the respective reprocessing goal. Hence, inadequately validated individual steps (processes) may reduce the quality of the reprocessing results in equal measure as the failure to observe standard operating instructions.”
top related