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Presented by: Pat Quinn September 16, 2015
Presentation outline Introduction Accreditation Qmentum update CSA Standards: What they are and how they are
written Overview of Z314 series (Reprocessing series) News! Summary
Accreditation Canada - Qmentum Sterilization Standards Working Group formed with
representation from across Canada Objectives were:
To provide expertise in the area of sterilization To provide input on the revisions to the standards
Working group reviewed the standards line by line and made many revisions
Accreditation Canada - Qmentum Timelines:
Working group review standards (February 2015) Confirm revised version of standards (March 2015) Review revised standards (April 2015) National consultation (July 2015) Working group review consultation results (August
2015) Finalize standards based on feedback (Aug-Sep 2015) Prepare standards for release (Sep-Oct 2015) Release revised version of standards (Jan 2016)
Accreditation Canada - Qmentum Revised Qmentum standards won’t be used until 2017 Once new reprocessing standards are in place,
organizations who are evaluated against the reprocessing standards will not be evaluated against the reprocessing content in the IPC standards
Small organizations without an MDR who may reprocess will be surveyed using the reprocessing content in the IPC standards. All others will use the reprocessing standards
Accreditation Canada - Qmentum Changes to the standards include:
A new title New standards structure Common content (intro, glossary) Comparison with new CSA standards and other national
and provincial standards Wording was changed throughout to align with CSA
standards References were updated to reflect current CSA
documents
CSA Z314 series overview Included in this
presentation: Z314.0-13 Z314.8-14 Z314.14-15 Z314.3-14 Z314.15-15
Omitted from this presentation Z314.10.1-15 Z314.10.2-15 Z314.23-12 Z314.22-10
What are CSA Sterilization Standards? Z314 series are used in healthcare settings Addresses quality systems, decontamination,
disinfection, packaging, sterilization and storage A guide for healthcare facilities and users to ensure
proper care and handling is achieved every time a medical device is used
Developed through a consensus standards development process approved by the Standards Council of Canada
Who writes the standards? Developed and maintained by the Technical
Committee on Sterilization Committee is made up of volunteers representing
varied viewpoints and interests Committee consists of the following interest categories:
General Interest (professional associations, academic, scientific etc), Government and/or regulatory authority, Producer Interest (manufacturers, distributors etc), User Interest (third party reprocessers, laundries etc), User Institutional (end users usually in a health care setting)
Which standards apply to me? Standards apply to all healthcare facilities regardless of
size To be used in conjunction with manufacturers
instructions for use and standard operating procedures
Z314 series is made up of nine documents that follow the reprocessing flow of a medical device from point of use until ready for the next use
Z314.0-13 Medical device reprocessing – General requirements
• Quality Management System • Evaluation and purchase of reusable medical
devices and reprocessing equipment • Personnel • Work areas and design • Reprocessing principles • Process verification, monitoring, and adverse
events • Storage
Z314.8-13 Decontamination of reusable medical devices
Z314.14-15 Selection and use of packaging (sterile barrier systems) in health care settings
Z314.3-14 Effective sterilization in healthcare settings by the steam process
Z314.23-12 Chemical sterilization of reusable medical devices in health care facilities
Z314.15-15 Storage, transportation and distribution of single use and reusable medical devices
End Users
Z314.10.1-15 Selection and use of gowns and drapes intended for use in healthcare settings
Z314.10.2-15 Laundering of reusable gowns, drapes and wrappers
Z314.22-10 Management of loaned, reusable medical devices
Name decoder Example: Z314.14-15
“Z314” identifies reprocessing standards “.14” is a numerical identifier “-15” is the 2 digit year that the standard was revised or
reaffirmed last
Standards are revised or reaffirmed every 5 years
Language “Shall” – a requirement
A provision that the user is obliged to satisfy in order to comply with the standard
“Should” – a recommendation Is used to express a recommendation or that which is
advised but not required “May” – an option
Is used to express an option or that which is permissible within the limits of the standard
“Can” Is used to express possibility or capability
Z314.0-13 Medical device reprocessing – General requirements
Z314.0-13 Medical device reprocessing – General requirements
General requirements from all other standards moved into Z314.0
All other standards must be used in conjunction with this document
Because all general information is in one place, easier to maintain other documents.
Z314.0-13 Medical device reprocessing – General requirements
Information on: Quality systems Personnel qualifications Manufacturers instructions for use Evaluation and purchase of medical devices Workplace design General reprocessing principles
Z314.8-14 Decontamination of reusable medical devices
Z314.8-14 Decontamination of reusable medical devices
Diagram provides an overview of the steps covered within the standard and references for each step (6)
Introduces qualification testing for decontamination equipment (IQ, OQ, PQ) (6.2)
Z314.8-14 Decontamination of reusable medical devices
Parameters of each washer-disinfector cycle now must be verified by printed or electronic method (e.g. printout) (7.3.5.6.1)
New requirement for commercially available tests to provide weekly verification of cleaning efficacy in washer-disinfectors (7.3.5.6.2)
Guidance on intermediate and low level disinfection using pre-moistened wipes. (8.2.4.3)
Z314.8-14 Decontamination of reusable medical devices
Requirement for documentation when performing manual high level disinfection (8.2.6.2) name of the agent; dilution; date and time prepared; expiry date; and name of employee who prepared the solution
Z314.8-14 Decontamination of reusable medical devices
New section on ultrasound transducer probes (section 12)
Previously combined with flexible endoscope section Requirement for policies and procedures followed
outside the MDRD (i.e., reprocessing areas for ultrasound probes) are consistent with the policies and procedures established within the MDRD (12.1.8)
Z314.14-15 Selection and use of packaging (sterile barrier systems)
Z314.14-15 Selection and use of packaging (sterile barrier systems)
New document covering all methods of packaging. Formerly only one standard dedicated to packaging
(rigid sterilization containers) Information on single use wrappers, reusable wrappers
and peel pouches scattered throughout multiple documents making it difficult for users to find
All packaging information will eventually be removed from other Z314 series documents
In-line with ISO 11607 packaging documents
Z314.14-15 Selection and use of packaging (sterile barrier systems)
Definitions Sterile barrier systems – minimum packaging that
prevents ingress of micro-organisms and allows aseptic presentation of the product at the point of use
Protective packaging – a packaging configuration designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use
Packaging system – the combination of the sterile barrier system and protective packaging
Z314.14-15 Selection and use of packaging (sterile barrier systems) Sections include:
General requirements for all packaging systems; Pouches and rolls; Wrappers (single- and multiple-use); and Sterilization trays and container systems
Annexes: Guidance for the purchase of sterilization container
systems; Information to be supplied by the manufacturer; and, Properties of sterilization wrappers
Z314.14-15 Selection and use of packaging (sterile barrier systems)
General Requirements (4.3.2) Validation is required for all packaging systems and
shall demonstrate: Compatibility with the intended sterilization process and
parameters (preconditioning, air removal, sterilant penetration and evacuation, and, if applicable, aeration
That the ingress of micro-organisms can be prevented through sterilization, handling, distribution, transportation and storage
Ability to meet the required physical properties for materials and closures
Z314.14-15 Selection and use of packaging (sterile barrier systems)
General Requirements for all packaging systems and accessories shall: Be made of known and traceable materials Be non-toxic Be able to facilitate aseptic presentation Provide protection to the point of use Be able to resist deterioration during storage Be compatible with the labelling system Have manufacturers instructions for reprocessing
reusable packaging and accessories
Z314.14-15 Selection and use of packaging (sterile barrier systems)
General Requirements for all packaging systems and accessories shall: Be compatible with the labelling system Have manufacturers instructions for reprocessing
reusable packaging and accessories Shield sharp items to protect user from injury and the
medical device from damage Allow for easy identification of contents Be stored in a controlled environment to maintain
cleanliness and fitness for use
Z314.14-15 Selection and use of packaging (sterile barrier systems)
Packaging system performance testing Before any packaging system is used in a healthcare setting for
the first time, it shall be evaluated for its performance Sterile barrier systems or packaging systems must maintain
their integrity without holes, tears or seal ruptures through handling, distribution and transportation before and after sterilization
Z314.3-14 Effective sterilization in health care settings by the steam process
Z314.3-14 Effective sterilization in health care settings by the steam process
Chemical indicators Must be placed in the innermost pouch when double
pouches are used (8.6.3.3.2) Must be placed in each level of multi-layered containers
(8.6.3.3.2) If releasing packages based on physical parameters and
chemical indicator results (e.g., no B.I.), the chemical indicator must be Class 5 or 6 (8.6.3.3.3)
Z314.3-14 Effective sterilization in health care settings by the steam process
Chemical indicators Table B.1 outlines recommendations for placement of
CI’s
Z314.3-14 Effective sterilization in health care settings by the steam process
Biological indicators BI Process Challenge Devices (PCD’s) must be used with
a full load daily to test each type of sterilization cycle (8.6.4.1) Gravity 132-135˚C Gravity 121˚ C Dynamic air removal 132-135˚C IUSS 132-135˚C (wrapped or unwrapped)
Z314.3-14 Effective sterilization in health care settings by the steam process
Biological indicators Routine loads can be released on specific cycle physical
parameters and a class 5 or 6 CI PCD or physical parameters and a BI PCD (8.7.1)
Implant loads must be quarantined until the results of a BI PCD test are known. If the implant must be released before the BI results are available, risk assessment shall include evaluation of a class 5 CI from the BI PCD (8.7.2)
Z314.3-14 Effective sterilization in health care settings by the steam process
Installation Qualification (IQ) (8.3) Verifies that sterilizer is installed correctly Performed by the sterilizer manufacturer (or designate)
following installation of the sterilizer Requirement of manufacturer to provide
documentation, drawings showing utility and space requirements and checklists to be completed as part of the equipment installation
Z314.3-14 Effective sterilization in health care settings by the steam process
Operational Qualification (OQ) (8.4) Verifies that sterilizer functions as it was intended to Performed by the sterilizer manufacturer or health care
facility after IQ and before the sterilizer is put into use Requalification must take place annually and after:
Major sterilization repairs Sterilizer relocation Environmental changes (e.g., HVAC changes) Unexplained sterility failures Interruptions to steam supply or major boiler repair
Z314.3-14 Effective sterilization in health care settings by the steam process
Performance Qualification (PQ) (8.5) Verifies that conditions are suitable to achieve
sterilization (product testing) Performed by health care facility for regular and
extended cycles on products and loads that represent the greatest challenge
PQ must also be performed after changes in: Packaging material Set or load configuration Modification to specific cycle variables
Z314.15-15 Storage, transportation, and distribution of single use and reusable medical devices
Z314.15-15 Storage, transportation, and distribution of single use and reusable medical devices
Title has been changed from Warehousing, storage, and transportation of clean and sterile medical devices
New document provides a common set of specifications for health care settings, storage facilities, off-site reprocessors, and warehouses
Clear definition of “transportation” (off-site) and “distribution” (on-site)
Z314.15-15 Storage, transportation, and distribution of single use and reusable medical devices
Sterile storage areas have been identified as: Tier 1 – Sterile storage areas associated with OR and
MDR areas including 3rd party/off site reprocessors Tier 2 – Storage areas within the health care setting Tier 3 – Warehouse areas that store and distribute open
inventory
Z314.15-15 Storage, transportation, and distribution of single use and reusable medical devices
For Tier 1 and 2 storage areas, higher requirements for: personnel training and education environmental conditions (i.e., temp, RH, ventilation) environmental cleaning storage conditions
Z314.15-15 Storage, transportation, and distribution of single use and reusable medical devices
Tiers 1 and 2 storage areas shall meet the requirements of CAN/CSA-Z317.13 during construction, renovation, and maintenance activities occurring within or in close proximity to the health care setting. Tier 3 storage areas should consider the applicability of this Standard (8.7.9)
The word “partition” has been removed from this document as no evidence to support the use of a partition to contain contaminates
Z314.15-15 Storage, transportation, and distribution of single use and reusable medical devices
Tier 1 storage areas (8.10) Adjacent to sterilization areas and dedicated to the
storage of clean and sterile supplies – e.g., SPD Clean supplies should be stored separately from sterile Access should be limited to personnel whose duties
require them to be there
Z314.15-15 Storage, transportation, and distribution of single use and reusable medical devices
Shelving: (8.4.1) Consideration should be given to solid top shelving The use of solid plastic liners is appropriate for the top
and bottom shelves.
Z314.0-13 Medical device reprocessing – General requirements
• Quality Management System • Evaluation and purchase of reusable medical
devices and reprocessing equipment • Personnel • Work areas and design • Reprocessing principles • Process verification, monitoring, and adverse
events • Storage
End Users
Proposed Z314 Integration In the coming year the technical committee is
pursuing a proposal to integrate the Z314 series as one all-encompassing MDR standard or “code”
Benefits: More nimble to use and easier to maintain Even small communities health care settings need all the
sections Users surveyed so far have indicated support for an all-
encompassing standard Great resource even for those acquiring new technology
Proposed Z314 Integration Suggestions for content:
a table depicting the reference changes should be developed. This would assist those currently referencing the old Z314 documents in their policies and SOPs to help with their revisions
Add in more rationales for requirements Make the code useful for all groups potentially by adding
subsections to address these groups Add informative content on personnel certification to
clarify terms, etc
What do you think of the proposal to integrate the standards into one all-encompassing code?
Summary CSA standards work as a complete system of
documents written by experts from varied viewpoints and interests
Focus on patient safety Increased focus on quality systems Many changes to existing documents. Users are
strongly encouraged to get to know them.
Questions?