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?