Santiago de Chile Validation of steam sterilizing ... · PDF fileof steam sterilizing processes since 1998 ... (IQ) Operational qualification ... 20 years of validation of steam sterilizing

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)


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)


What is validation?

Validation consists of:

➢ Installation qualification (IQ)

➢ Operational qualification (OQ)

➢ Performance qualification (PQ)

• Requalification (performance)


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)


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.


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 <<


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


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)


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


How is validation performed 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



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



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



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



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



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!


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



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



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!


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.



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)



Steam Sterilization – Validation equipment



Steam Sterilization – loading for PQ





Measurements during plateau time

Steam sterilization – measuring result of probes during sterilization time





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.



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.


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


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


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)



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)



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.”


Thank you for your attention!

Any questions?

Documents

Santiago de Chile Validation of steam sterilizing ... · PDF fileof steam sterilizing processes since 1998 ... (IQ) Operational qualification ... 20 years of validation of steam sterilizing