QUALITY ASSURANCE
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; records are kept usually up to 5 years, depending on the medico-legal requirements of each country.
Essential elements of quality management systems
Documentation and record-keeping: of all stages of the decontamination cycle should include the following aspects:
ñ Personal protective equipment (PPE) for the following procedures (see also section on PPE):
– Instrument cleaning: waterproof gown, hair cover, visor, closed footwear, heavy-duty gloves
– Inspection, assembly, packing/wrapping: hair cover, clean lint-free uniform
– Sterilization area: clean uniform, hair cover, heat-resistant gloves, closed footwearñ Sterilizer monitoring: use of biological and chemical indicator controls.
ñ Product sterility release criteria: parametric release to ensure that the processed medical device has met the validate process parameters.
ñ Record-keeping: all activities should be documented and maintained for the requisite (national legal period) length of time.
ñ Device and process tracking and traceability: manual or computerized system for tracing and tracking to enable tracing from the patient back to the processor in the event of a medical device recall. ñ Storage and transport. ñ Preventative maintenance procedures, schedules and contracts. ñ Procedural or material change standards and policies.
ñ Infection prevention and control within the decontamination facility:
– Hand hygiene
– PPE
– Dress code and personal hygiene
– Safe sharp disposal
– Incidents and reporting
– Waste management
– Ventilation control testing using air movement detection
– Environmental cleaning
Occupational health and safety (OH&S): policies and procedures (see section on OH&S).
Education and training: internal and external staff (see section on Education). ñ Numeracy, literacy and dexterity are essential to perform the duties required.
ñ Effective and appropriate training and assessment programmes must be put in place to assist staff development.
Risk management: ensures that non-conformances, incidents and errors are identified promptly, investigated, evaluated and documented.
Knowledge of international and European standards: relevance to quality management systems ñ International Standards Organization (ISO): ISO 13485 (2003) relates to medical devices, quality management systems and requirements for regulatory purposes.
Auditing: periodic auditing where inspections are made of the processes, procedures and staff in the department.
ñ Audits can be detailed and conducted by the departmental manager or by an independent person within the health-care facility or by local government agencies.
What should quality assurance include?
ñ QA includes Implementation of a recognized QA system. ñ Resources and training. ñ Policies and procedures. ñ Regular service and validation of sterilization and decontamination equipment. ñ Tracking and traceability of process and medical devices from the processor back to the patient. ñ Good Manufacturing Practice (GMP) requirements:
– Guard against litigation
– Promote customer confidence
– Continuous evaluation
– Risk evaluation
– Ongoing evaluation and treatment of risksñ Successful service is based on understanding and co-operation. ñ Positive process:
– Enables to see issues as challenges and not problems
– Creates a learning and supportive role and not a climate of blame
Validation
Validation usually applies to equipment or procedures used for reprocessing medical devices. Each step of the decontamination cycle will require validation as part of the QA programme and will be addressed in each relevant section. While it is accepted that not all sterilization service departments (SSDs) will be able to achieve such high standards of validation, best practice is the aim of this document.
Validating a process consists of systematically carrying out the process in a specific manner in order to improve it by planning: establish temporary programmes and checklists, validation protocols with criteria for acceptance/rejection, resource needs and risk analysis.
Evaluation of sterilizing methods
The ISO 9001[1](general quality) and European norm (EN) ISO 13485[2](quality of the installation and maintenance of health products) standards make it possible for a facility to evaluate its system and to guide the steps for its improvement. In the case of sterilization, the sterilization assurance level [SAL] 10-6should be ensured so that the sterilization process generates a product or service according to its predetermined validated specification and in keeping with established quality characteristics.
Note: The European standard, EN 46001 1997[3][4], defines that a medical device determined to be “sterile” should reach a SAL of 10-6 colony-forming units (cfu) when it undergoes a validation process.
A common requirement of ISO 13485, the European Central Manufacturing Standards (CMS), and the United States (US) GMP and Food and Drug Administration (FDA) is the use of validated processes as mentioned above.
Validation of the sterilizer process
The validation process consists of verifying in a certified and clearly documented manner that a process meets the requirements for which it was designed. In the case of sterilization, labelling a health product with the word “sterile” is only permissible when a validated sterilization process has been used.
Validation should consist of the following:
ñ Installation qualification (IQ) ñ Operational qualification (OQ) ñ Performance or process qualification (PQ)
ñ Documentation
ñ Microbiological performance qualification (MPQ) ñ Validation report and certificates
In this way, the sterilization process can demonstrate in a documented manner that the parameters of temperature, time and pressure reached throughout the process were within the validated parameters determined by three consecutive successful cycles.
Installation qualification (IQ): Is a process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification[1].
IQ consists of verifying that the equipment has been adequately installed and is safe to operate following the manufacturer’s specifications and the standards applied in each country.
The following steps should be taken:
ñ Verify the correct installation of connections: water, steam, electricity, compressed air, ventilation, etc. This process verifies that the different parameters meet the manufacturer’s specifications and the regulations that apply. ñ Verify the correct operation of the equipment’s different security functions, according to standards.
ñ Confirm that the machine is equipped with the adequate technical documentation, i.e. installation plans, technical/operational user manual, etc.
Operational qualification (OQ): A process of obtaining and documenting evidence that the installed equipment operates within predetermined limits when used in accordance with its operational procedures4. This consists of verifying that the sterilizer’s different measurement and control elements function correctly and within the ranges specified by the manufacturer. Furthermore, it aims to verify that the temperature distribution in the chamber is uniform and within the parameters designated by the country standards. To achieve this, the following steps should be taken for a pre vacuum autoclave:
ñ Calibration of the regulation and control elements ñ Carry out a cycle with the vacuum test ñ Carry out a cycle with the Bowie-Dick test
ñ Implement three thermometric tests in an empty chamber in order to obtain the temperature profile at all
points of the chamber
For a displacement autoclave
ñ Calibration of the regulation and control elements
ñ Implement three thermometric tests in an empty chamber in order to obtain the temperature profile at all
points of the chamber
Note: This is the crucial phase of fine-tuning the process during which its robustness and reliability should be demonstrated when facing the worse-case scenario.
Performance qualification (PQ): A 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 a product meeting its specification.
Note: This final phase examines the replicability of the process, the precise training and qualifications for its operators, including work instructions that are definitive and put into action.
The quality of the process is demonstrated by carrying out three thermometric tests for each type of load and obtaining the temperature profile at all points for each one.
Validation of loads for sterilizers
It is important to validate the process at all points (especially where contamination may occur). These include cleaning, inspection, wrapping and packaging, and the loading and unloading of medical devices. These parameters are validated by PQ and documentation of the evaluation criteria should be checked by the user.
Technique and material
Documented evidence contributes to a high degree of safety of the process, during which the following aspects should be taken into account: ñ Position of the articles within the load
ñ Packaging of the load ñ Selected cycle ñ How to unload ñ Repeated three times
Components of sterilization validation
Audit
This process is designed to demonstrate, document and confirm that the equipment meets the performance specifications according to its specific design and technical characteristics following its installation in the place of use.
Certification to operate
This process demonstrates that a review of the equipment has confirmed its ability to produce acceptable products when operated according to the specifications of the process. The following will have to be demonstrated:
ñ Certification of the equipment ñ Test of the effectiveness of the equipment ñ Monitoring of the equipment’s operational routine ñ Validation if an alteration in the routine is identified
Types of sterilizers and methods of validation
Validation of the sterilization process by dry heat
Ensure that sterilization by dry heat is adequate, safe and effective. The validation process to demonstrate evidence of sterilization by dry heat will guarantee that this is always carried out in the same way and with the same quality. The purpose is to guarantee the pre-established parameters for sterilization by means of dry heat.
Technique and material
The validation of this process consists of meeting the minimum stages and evaluation criteria by the user. Furthermore, documented evidence contributes a high degree of safety to this process during which the following aspects should be taken into account:
ñ Equipment quality: the electrical installations (voltage), structure, dimensions and ventilation should be confirmed.
ñ OQ: confirmation that all components of the equipment function according to the operation manual and maintenance instructions. Similarly, a report of the most common parts replaced and the technical service carried out should be generated.
ñ PQ: verification of the established physical parameters, types of packaging, types of loads and their registries, types of materials (quantity and volume), arrangement of the materials within the chamber and its capacity, and the adequate use of registries for chemical indicators.
Validation of the sterilization process by steam
Sterilization by moist heat should be validated in order to guarantee the safety, adaptation and effectiveness of the process. The validation process to demonstrate evidence of sterilization by moist heat will guarantee that this is always carried out in the same way and with the same quality. The purpose is to guarantee the preestablished parameters for sterilization by means of moist heat.
All of these verifications can be defined by IQ, OQ and PQ as described above.
IQ: this consists of verifying that the equipment has been adequately installed and is safe to operate according to the manufacturer’s specifications and the standards applied in each country. The following steps should be taken:
ñ Verify the correct installation of connections: water, steam, electricity, compressed air, ventilation, etc. This process verifies that the different parameters meet the manufacturer’s specifications and the regulations that apply.
ñ Verify the correct operation of the equipment’s different security functions according to published standards.
ñ Confirm that the machine is equipped with the adequate technical documentation, i.e. installation plans, technical/operational user manual, etc.
OQ: This consists of verifying that the sterilizer’s different measurement and control elements function correctly and within the ranges specified by the manufacturer. Furthermore, it aims to verify that the temperature distribution in the chamber is uniform and within the parameters designated by the country standards. To achieve this, the following steps should be taken for a pre vacuum autoclave:
ñ Calibration of the regulation and control elements ñ Carry out a cycle with the vacuum test. ñ Carry out a cycle with the Bowie-Dick test
ñ Implement three thermometric tests in an empty chamber in order to obtain the temperature profile at all
points of the chamber
For a displacement autoclave
ñ Calibration of the regulation and control elements
ñ Implement three thermometric tests in an empty chamber in order to obtain the temperature profile at all points of the chamber
PQ: This procedure documents and verifies that the parameters of temperature, pressure and case-fatality reached within the load throughout the sterilization process are within the criteria defined by national standards. The quality of the process is demonstrated by carrying out three thermometric tests for each type of load and obtaining the temperature profile at all points for each one.
Technique and material
This validation should be carried out by confirming the quality of the following elements:
ñ Environment. The installations should be verified. The physical area includes the structure itself, climate control dimensions, and installed networks of steam and compressed air. With regard to the hydraulic installation, water hardness should be noted. With regard to the electrical installations, the voltage, protective devices, installation to the source itself, and quality of the steam should be observed.
ñ Equipment: The structure for the installation of the autoclave should be confirmed, including its physical adaptation, integration, and ventilation near the doors of the autoclave, and minimum distances between walls and the equipment in order to facilitate maintenance.
ñ OQ. The existence of an operational manual should be confirmed, as should a registry of the most commonly replaced parts, information registered by the technical service, and a voucher that certifies the operation of the equipment.
ñ PQ. This should be evaluated by assessing effectiveness and efficiency. Established physical parameters, types of packaging, types of loads and their registries, types of materials (quantity and volume), the arrangement of the materials within the chamber and its capacity, and the adequate use of registries for biological and chemical indicators should all be confirmed.
In pre-vacuum autoclaves, three cycles should be checked with the Bowie-Dick test, followed by three complete cycles with biological and chemical controls during three consecutive days and with loads.
In gravitational autoclaves, the test should be carried out with an empty chamber. A frequent problem is that preventive maintenance is not carried out on machines and the most common attitude is to wait until equipment failure occurs and then take action. To prevent equipment failure, regular servicing at least once a year is recommended.
Validation of sterilization by ethylene oxide (ETO)
Validation should be determined and provided by the manufacturer of ETO autoclaves (see above-mentioned section on QA).
Technique and material
This validation should be carried out by confirming the quality of the following elements:
ñ Environment. The installations should be verified. The physical area includes the structure itself, climate control dimensions, and the need for an installation to extract environmental gas toward the exterior. Furthermore, the electrical installations, voltage and protective devices should be observed.
ñ Equipment. The structure for the installation of the autoclave should be confirmed, including its physical adaptation, integration, ventilation and minimum distances between walls and the equipment in order to facilitate maintenance. The existence of a device to measure the quantity of residual ETO in the environment should be confirmed also.
ñ OQ. The existence of an operational manual should be confirmed, including a registry of the most commonly replaced parts, information registered by the technical service, and a voucher that certifies the operation of the equipment.
ñ PQ. This should be evaluated by assessing effectiveness and efficiency. Established physical parameters, types of packaging, types of loads and their registries, types of materials (quantity and volume), the arrangement of the materials within the chamber and its capacity, and the adequate use of registries for biological and chemical indicators should all be confirmed.
Three complete cycles should be confirmed with biological and chemical controls during three consecutive days and with loads.
Validation of hydrogen peroxide plasma
Technique and material
This validation should be carried out by confirming the quality of the following elements:
ñ Environment. The installations should be verified. The physical area includes the structure itself, climate control dimensions, and the need for an installation for extraction toward the exterior. Furthermore, the electrical installations, voltage and protective devices should be observed.
ñ Equipment. The structure for the installation of the autoclave should be confirmed, including its physical adaptation, integration, ventilation and minimum distances between walls and the equipment in order to facilitate maintenance.
ñ OQ. The existence of an operational manual should be confirmed, including a registry of the most commonly replaced parts, information registered by the technical service, and a voucher that certifies the operation of the equipment.
ñ PQ. A microprocessor should be used to evaluate the physical parameters. In addition, a test package has been developed for the specific biological and chemical indicators. It consists of a plastic tray with a restricted dissemination opening that ends in a closed compartment containing both indicators. The chemical indicator indicates that hydrogen peroxide, an essential part of the sterilization cycle, has been introduced into the sterilization chamber. The biological indicator consists of a paper strip containing 106 spores of Bacillus subtilis var. Niger in a Tyvek® bag.
The physical parameters should be confirmed with a test package, followed by three complete cycles with biological and chemical and controls, during three consecutive days and with loads.
Summary of validation activities of all machines
ñ Create a multifunctional validation team ñ Plan the approach and define the requirements ñ Identify and describe the processes
ñ Specify the parameters of the process and the desired outcome ñ Create a master validation plan ñ Select the validation methods and tools ñ Create validation protocols
ñ Carry out IQ, OQ and PQ and document the results ñ Determine continuous process controls
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