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Qmentum Program 2009

STANDARDS

Reprocessing and Sterilization of


Reusable Medical Devices

Accredited by ISQua
Ver. 2

Qmentum Program

Published by Accreditation Canada. All rights reserved. No part of this publication may be
reproduced, or transmitted in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without proper written permission from Accreditation
Canada.
Accreditation Canada, 2008
Reprocessing and Sterilization of Reusable Medical Devices
Ver. 2

Qmentum Program

CCHSAs Standards for the Reprocessing and Sterilization of Reusable Medical Devices were prepared in
response to requests from health service organizations, regulators, and governments for a set of national
standards. They have been developed in conjunction with the Canadian Standards Association (CSA) and
incorporate many elements from existing CSA standards.
These standards contain the following subsections:

Building a high performing reprocessing service


Complying with good reprocessing and sterilization practices
Selecting, installing, and maintaining safe reprocessing equipment
Conducting safe and appropriate reprocessing and sterilization of reusable devices and
equipment
Monitoring quality and achieving positive outcomes

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Reprocessing and Sterilization of Reusable


Medical Devices
BUILDING A HIGH PERFORMING REPROCESSING SERVICE
1.0

The organization designs its reprocessing services to meet the needs of the
organization and partner organizations.
1.1

Effectiveness

The organization collects information at least annually about service volumes and
patterns of medical device use.
Guidelines
The organization collects information about service volumes in areas most associated
with medical device use and use of reprocessing services, including the operating room
and obstetrics/perinatal service or delivery areas, diagnostic imaging, and areas using
endoscopes.
The individual responsible for collecting information is clearly identified and linked directly
to the individual with overall accountability for all reprocessing activities in the
organization.

1.2
Effectiveness

The organization reviews its operational plan and the information it collects about
service volumes and equipment use to decide which sterilization and reprocessing
services are offered within the organization.
Guidelines
The organization uses mechanisms to decide on appropriate methods of sterilization or
reprocessing, including levels of disinfection or type of sterilization such as steam, liquid
chemical, or low temperature sterilization, based on the needs of the organization. The
organization also identifies staffing requirements, or requirements for new equipment.
The organization determines which services may be shared between organizations,
locations within the same organization, or contracted to external/private services.

1.3
Safety

The team works with others in the organization to limit the use of flash sterilization
to emergencies only, and never for complete sets or implantable devices.
Guidelines
Areas where flash sterilization is likely to be used in emergency situations includes the
operating room and obstetrics/perinatal services.
See CSA Standard Z314.3, 13.1, for more information on flash sterilization.

1.4
Effectiveness

The organization designates a trained and competent individual with the


accountability for coordinating all reprocessing and sterilization activities across
the organization, including those performed outside the reprocessing unit or area.
Guidelines
The individual may also be accountable for directly supervising reprocessing and
sterilization activities. It is essential that the individual possess the knowledge and training
to understand key issues in reprocessing and sterilization.
The individuals accountability for reprocessing and sterilization is clearly written, e.g.
reflected on an organization chart.
In organizations with multiple sites or locations, e.g. regional health authorities, the
designated individual is accountable for all sterilization and reprocessing activities across
all sites and locations.

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1.5
Effectiveness

The designated person reports directly to the organizations senior management


or the executive office.
Guidelines
Senior management includes, for example, the Director level or Executive.
Direct reporting to senior management may vary according to the organizations structure,
size and scope of services; however, the designated person is in a position to raise
issues regarding sterilization and reprocessing to the organizations senior management
in a timely and efficient way.

1.6
Efficiency

The organization has the right number and mix of staff to carry out its
reprocessing and sterilization activities.
Guidelines
The organization determines the right number and mix of staff based on information
collected about service volumes and equipment use, and the need for sterilization and
reprocessing in the organization. The organization may benchmark its staffing model with
other, like organizations to help determine the appropriate number and mix of staff for its
reprocessing and sterilization activities.
See CSA Standards Z314.2 and Z314.3, 6.1, for more information on staffing.

1.7
Effectiveness

Where sterilization and reprocessing services are contracted to external providers,


the organization establishes and maintains a contract with each provider that
requires consistent levels of quality and adherence to accepted standards of
practice.
Guidelines
External providers include, for example, other organizations with a centralized
reprocessing area, and third-party reprocessors or private organizations specializing in
sterilization and reprocessing services.
See CSA Standards Z314.2 and Z314.3, 4.2, for more information on sterilization and
reprocessing services provided by external providers.

1.8
Effectiveness

Where sterilization and reprocessing services are contracted to external providers,


the organization regularly monitors the quality of services provided.
Guidelines
The organization establishes and monitors minimum requirements for its contracted
services and verifies that each external provider follows accepted standards of practice,
i.e. the Canadian Standards Association.
External providers engage in quality monitoring activities, e.g. daily monitoring of printouts
and data, maintain reporting systems and data collection, and provide mechanisms to
report deficiencies such as defective wraps or items that arrive soiled. The organization
reviews copies of reports and printouts and any other documentation demonstrating the
quality monitoring performed by the external provider.

1.9
Safety

Where sterilization and reprocessing services are contracted to external providers,


the organization annually reviews each contract and records all aspects of the
contract and negotiations in its files.
Guidelines
Consult CSA Standards Z314.2 and Z314.4, 4.5.9, for more information about the review
of contracts with external providers.

2.0

The organization educates, trains, and evaluates the competency of its reprocessing
team members.

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2.1
Safety

The organization orients all staff members about safe work practices, including
patient safety, occupational health and safety, and infection prevention and
control.
Guidelines
Initial orientation addresses infection control precautions, personal protective equipment
(PPE), and principles of containment and confinement. It also covers basic microbiology
and infection control, such as the basics of microbial growth related to medical devices
and the risk of aerosol/contact transmission of infectious micro-organisms.
The orientation covers the workplace hazardous materials information system (WHMIS),
including the product identifiers of hazardous substances in the workplace; the
information on labels and materials data sheets; procedures for safe storage, use,
handling, and disposal of hazardous materials; the locations of pipes, valves, controls,
and safety devices; and procedures for emergencies.
See CSA Standards Z314.2, Z314.3 and Z314.8, 6.3 and 6.4, for more information on
staff orientation.

2.2
Safety

The sterilization team receives training about how to reprocess reusable medical
devices when they are first employed and whenever there is a change in the
sterilization process.
Guidelines
The sterilization process begins with the safe receipt of contaminated items and includes
disassembly, if appropriate; decontamination, cleaning and inspection; preparation;
packaging/wrapping; loading; operation and monitoring; unloading; correct handling after
sterilization including storage, transport, and distribution; documentation; and quality
control and quality improvement.
See CSA Standards Z314.2, Z314.3 and Z314.8, 6.3 and 6.4, for more information
regarding staff training on the sterilization process.

2.3
Safety

The teams training includes how to reprocess new devices and equipment used
in the organization.
Guidelines
For example, when new technologies for sterilization or reprocessing are purchased, the
team receives training on how to use them. Similarly, the team receives training on
devices or equipment requiring reprocessing or sterilization.

2.4
Worklife

Supervisors and staff members involved in reprocessing have completed a


recognized course in reprocessing and sterilization.
Guidelines
A recognized course includes minimum theoretical and practicum components, with a
curriculum approved by the provincial ministry or equivalent.
If a supervisor or staff member has not completed a recognized certification course, plans
to obtain this certification within a specified time frame are documented in the
organizations files.
See CSA Standards Z314.2, Z314.3 and Z314.8, 6.2, for more information on the
education requirements for staff members involved in the reprocessing process.

2.5
Worklife

The organization conducts baseline and annual competency evaluations of staff


members involved in reprocessing and sterilization.
Guidelines
The baseline competency evaluation may be completed at the time of the initial
orientation.
See CSA Standards Z314.2, Z314.3 and Z314.8, 6.4, for more information on
competency evaluation.

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2.6
Safety

The organization provides follow-up education, training, and supervision for staff
who have been involved in critical incidents or adverse events.
Guidelines
Follow-up education and training, as well as supervision, helps to reduce the likelihood of
critical incidents or adverse events recurring.

2.7
Effectiveness

The organization documents and retains records of education, training, and


competency assessments.
Guidelines
Records are retained according to the organizations policies, and applicable laws and
regulations.

3.0

The physical layout of the sterilization unit or area allows for high quality
reprocessing and the smooth flow of reusable medical devices and equipment.
3.1

Efficiency

When planning and designing the layout of the sterilization unit or area, the
organization considers the volume and types of reprocessing and sterilization
services, flow of devices and equipment, and traffic patterns.
Guidelines
See CSA Standard Z314.03-01 Appendix A for guidance for the design of sterilization
areas or units. Appendix A includes guidance for basic design considerations; design
considerations for specific areas such as receiving, preparation, and storage; work flow
and traffic control; utilities such as ventilation, temperature and humidity, and lighting;
materials such as floors, walls, partitions, doors, ceilings, and work surfaces;
handwashing/hand-hygiene facilities; emergency equipment such as eye-wash stations;
sterile storage; and housekeeping procedures.
See CSA Standards Z314.2, Z314.3 and Z314.8, section 7, to obtain more information on
the layout of the sterilization unit or area.

3.2
Safety

The sterilization unit or area limits access to the overall unit or area to unit or area
staff members, and posts clear signage limiting access at all entry points.
Guidelines
The team follows specific criteria to permit entry of other staff members under specific
circumstances, including requirements for attire, PPE, and handwashing procedures.

3.3
Safety

The physical space prevents cross-contamination of sterilized and contaminated


devices or equipment, isolates incompatible activities, and clearly separates
different work areas.
Guidelines
To prevent cross-contamination, items at an individual work station cannot be at different
stages of the reprocessing/sterilization process.

3.4
Safety

The physical space has a specific, closed area for decontamination that is
separate from other areas of the processing unit or area and the rest of the
organization.
Guidelines
Airborne microbial and particulate contamination is increased in the decontamination
area.
Organizations may refer to CSA Standard Z314.8 for specific requirements for the
decontamination area and environmental requirements including access, staff movement
within the decontamination area, and maintenance.

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3.5
Effectiveness

The organization regulates the air quality, ventilation, temperature, and relative
humidity, and lighting in decontamination, reprocessing, and storage areas.
Guidelines
The organization regulates the air quality to ensure a minimum of 10 air changes per
hour. Refer to CSA Standards Z317.2 for more information on air exchange.
Ventilation in the sterilization department is designed to prevent the infiltration of lint into
the air stream and provide directional airflow from clean areas, e.g. preparation and
sterilization areas, under positive pressure in relation to contaminated or soiled areas,
e.g. decontamination areas. Air from contaminated or soiled areas is exhausted to the
outdoors. The organization prevents the use of portable fans and heaters that can create
turbulent airflow and circulate dust or micro-organisms in the work area.
The organization closely monitors temperature and relative humidity. Temperature is
maintained between 18 and 23 degrees in all areas, and relative humidity between 30
and 60%. Each area is equipped with an alert or alarm mechanism that is activated when
temperature or humidity is outside the acceptable ranges.
Organizations seeking more specific information about the regulation of air quality,
ventilation, temperature and humidity in each areas of the reprocessing unit may refer to
CSA Standard Z317.2. More information about proper lighting is available in CSA
Standard Z317.5.

3.6
Effectiveness

The organization selects materials for the floors, walls, ceilings, fixtures, pipes,
and work surfaces that limit contamination, promote ease of washing and
decontamination, and will not shed particles or fibres.
Guidelines
Materials are flat or flush, and non-porous to limit contamination. Fixtures and pipes
above work areas are recessed and concealed.

3.7
Safety

The reprocessing and sterilization team works with others in the organization to
properly clean the sterilization unit or area.
Guidelines
The sterilization team consults with housekeeping, infection prevention and control, and
others responsible for cleaning, to establish policies and procedures for cleaning
practices, including how often the work areas are to be cleaned.

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COMPLYING WITH GOOD REPROCESSING AND STERILIZATION


PRACTICES
4.0

The team follows policies, procedures, and manufacturers instructions for the
sterilization unit or area and the reprocessing of reusable equipment and devices.
4.1

Effectiveness

The organization sets and follows policies that address the management of the
unit or area, the team, all aspects of the sterilization process, safety, infection
control, and quality control.
Guidelines
The policies include staff and management responsibilities; staff qualifications, including
training, education, and competency assessment; infection prevention and control (IPAC);
the establishment and maintenance of policies and procedures; staff health and safety;
and the requirements of subcontractors inside and outside the organization. They also
address ongoing quality assurance, including controls to ensure medical devices and
equipment are functional and sterile before being released from the sterilization area;
recall procedures; the evaluation and purchase of reprocessing equipment; and back-up
and contingency planning regarding inventory and temporary shortages.
See CSA Standards Z314.2, Z314.3 and Z314.8, clause 4.2, for more information on
policies.

4.2

When establishing or updating the teams infection prevention and control policies,
the team works closely with the organizations IPAC staff, team, or committee.

4.3

The team follows a process to establish and maintain its Standard Operating
Procedures (SOPs) for sterilization and reprocessing.

Effectiveness

Effectiveness

Guidelines
The teams SOPs address all stages of the reprocessing process, e.g. disassembly
through reprocessing and re-assembly. They also address the management and reporting
of critical incidents or adverse events, the reprocessing of devices or equipment
according to risk class and manufacturers instructions, special precautions for the
reprocessing of devices or equipment that are difficult to clean or sterilize, the reassembly
and functional testing of complex devices, offsite transportation of medical devices,
precautionary quarantine of routinely reprocessed medical devices, recall procedures,
and emergency procedures for various emergencies including sterilizer shutdowns, utility
failures or shutdowns, an emergency plan to transfer services offsite, or a large-scale
inventory loss or recall.
SOPs are sometimes referred to as policies and procedures.
See CSA Standards Z314.2, Z314.3 and Z314.8, clauses 4.3 and 4.5, for more
information on standard operating procedures.

4.4

The team writes its SOPs in a clear, concise, and consistent way.

Effectiveness

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4.5
Effectiveness

The team maintains up-to-date manufacturers information, instructions, and


recommendations for each medical device.
Guidelines
The team has manufacturers information for all medical devices, including those brought
in for evaluation and use from outside the organization.
See CSA Standards Z314.2, Z314.3 and Z314.8, clauses 4.4, for more information on
manufacturers instructions.

4.6
Effectiveness

The team documents and maintains policies, SOPs, standards of practice, and
manufacturers instructions in a manual.
Guidelines
The manual may be in written form, e.g. binders, manuals, monographs, and/or in
electronic format.
See CSA Standards Z314.2, Z314.3 and Z314.8, clauses 4.6, for more information on the
documentation of policies, SOPs, standards of practice, and manufacturers instructions.

4.7

All team members have access to the manual.


Guidelines
Copies of the manual are available in the working environment, with the master copy of
the manual in a specified location.

Accessibility

4.8

The team trains staff prior to implementing a new or amended policy, SOP,
practice standard, or manufacturers instruction.

4.9

Team leaders review and update the policies and procedures on a regular basis
and in response to critical incidents or adverse events; changes in laws,
regulations, or standards; results of internal or external audits; and new evidencebased information.

Worklife

Effectiveness

Guidelines
Critical incidents or adverse events may also be known as accidents.
See CSA Standards Z314.2, Z314.3 and Z314.8, clauses 4.5, for more information on
updating the teams policies and procedures.

4.10
Effectiveness

The team tracks changes to policies, SOPs, standards of practice, and


manufacturers instructions using a document control procedure.
Guidelines
The document control procedure helps ensure that only the most recent documents are in
use, and that obsolete versions are archived or discarded.

4.11

New and changed SOPs are approved in writing by the team leaders.

Effectiveness

5.0

The team complies with occupational health and safety (OHS) requirements to make
sure staff are safe in the reprocessing and sterilization unit or area.

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5.1
Accessibility

The reprocessing area is equipped with hand hygiene facilities at entrances to and
exits from the reprocessing units or areas, including support areas.
Guidelines
See CSA Standards Z314.2, Z314.3 and Z314.8, clauses 6.6.3 and 7.1, for more
information on hand hygiene in the reprocessing area.

5.2
Safety

The unit or areas hand hygiene facilities are equipped with faucets supplied with
foot-, wrist-, or knee-operated handles, or electric eye controls.
Guidelines
Foot-, wrist-, and knee-operated faucets help prevent the recontamination of hands.
If such faucets are not available, staff have access to single-use towels for turning off
faucets.

5.3

Staff members receive training on proper hand hygiene techniques.


Guidelines
Training on hand hygiene is multimodal and addresses the importance of hand hygiene in
preventing the spread of infections, and factors that have been found to influence hand
hygiene behaviour. Training includes recommendations on when to clean ones hands, as
well as proper hand-washing and sanitizing techniques.

Safety

5.4

Staff members have access to the supplies needed to support proper hand
hygiene, including properly supplied and functioning soap and towel dispensers or
waterless, alcohol-based hand rubs in the working environment.

5.5

Staff members apply proper hand hygiene technique before beginning and after
completion of work activities, as well as at other key points to prevent infection.

Accessibility

Safety

Guidelines
In addition to hand hygiene before beginning and after completion of work activities, staff
wash their hands after handling items contaminated or likely to be contaminated with
blood, bodily fluids, excretions, or secretions; after removing gloves; after touching the
face; before leaving the decontamination area; after using the toilet; and at any other time
specified by the organizations policies and procedures.

5.6
Safety

The team follows policies that prohibit eating and drinking, food storage, smoking,
the application of cosmetics, and the handling of contact lenses in the
reprocessing unit or area.
Guidelines
See CSA Standards Z314.2, Z314.3 and Z314.8, clauses 6.6.1, for more information on
infection control policies in the reprocessing area.

5.7
Safety

The team follows a detailed dress code while in the clean reprocessing unit or
area that addresses clothing, hair, jewelry, artificial fingernails of any form, and
covered footwear.
Guidelines
Policies related to the dress code are accessible, and staff are familiar with them. The
code specifies when attire is to be changed, for example, at the end of each shift, and
immediately if it becomes wet, grossly soiled, or contaminated with blood or other
potentially infectious matter. More information on dress codes is available in CSA
Standard Z314.3-01, clause 5.4.
See CSA Standards Z314.2 and Z314.3, clause 6.6.1.2, and Z314.8, clause 6.7.1.1, for
more information on dress codes in the reprocessing area.

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5.8
Safety

The team wears the appropriate and properly maintained personal protective
equipment (PPE) when in the decontamination work areas.
Guidelines
The appropriate PPE includes gloves that are appropriate to the task; a liquid-resistant
cover garment with sleeves, e.g. backless gown, jumpsuit, or surgical gown; and a full
face shield or a high-filtration, fluid-impervious face mask and eye protection. See CSA
Standard Z314.3-01, clause 5.4.2, and Z314.8 for more information about PPE.
See CSA Standards Z314.2 and Z314.3, clause 6.7.2.3, and Z314.8, clause 6.7.2.2, for
more information on PPE in the reprocessing area.

5.9
Worklife

6.0

The team regularly conducts workplace assessments of its sterilization and


reprocessing units or areas for ergonomics and occupational health and safety
(OHS).

The team keeps up-to-date and accessible documentation and records of its
sterilization processes.
6.1

Effectiveness

The team maintains a complete record of each sterilization cycle, including the
load control label, recording chart or printout, process-recording record, and
sterility record.
Guidelines
See CSA Standards Z314.2 and Z314.3, clause 12, for more information on
documentation and records of sterilization processes.

6.2

The record includes details of the sterilization cycle, including date and time;
exposure time; temperature; pressure; sterility test results; and the kind, quantity,
and origin of the devices sterilized.

6.3

The record allows team members to track individual items or devices associated
with a sterilizer or sterilization cycle.

Effectiveness

Safety

Guidelines
The record includes additional information that may be required for a recall action.
See CSA Standards Z314.2 and Z314.3, clause 9.5.7, for more information on the
tracking of individual devices.

6.4
Effectiveness

The organization stores and retains its sterilization records according to its
policies, and any applicable laws and regulations.
Guidelines
The organizations policies for the retention of records are developed in consultation with
its legal advisors and individuals responsible for risk management.

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SELECTING, INSTALLING, AND MAINTAINING SAFE REPROCESSING


EQUIPMENT
7.0

The organization selects, installs, and maintains reprocessing equipment so that it


is safe to use and functions according to manufacturers specifications.
7.1

Efficiency

The organization follows a process to select and purchase equipment based on


reprocessing and sterilization requirements, input from staff and service providers,
and considerations for maintenance, cleaning, and infection control.
Guidelines
The organization consults with staff from the reprocessing and sterilization unit, experts in
biomedical engineering, as well as service providers in key areas such as infection
prevention and control and the operating room, when selecting and purchasing
decontamination and sterilization equipment.
See CSA Standards Z314.2 and Z314.3, clause 7.6, and Z314.8, clause 7.5, regarding
processes to select and purchase devices and equipment.

7.2
Effectiveness

The organization has a documented preventive maintenance and cleaning


program for its decontamination and sterilization equipment.
Guidelines
The program includes regular inspection and maintenance. It also includes cleaning,
lubrication, checking for leaks, changing of filters and verification of settings and
calibration. The program covers all accessories such as sinks and brushes.
The program may be developed in-house or contracted to an external service or
organization.
See CSA Standards Z314.2, clause 13, Z314.3, clause 14, and Z314.8, clause 7.5, for
more information on preventive maintenance programs.

7.3
Effectiveness

The organization has access to a complete record of maintenance and inspection


procedures for reprocessing and sterilization devices and equipment.
Guidelines
The record includes the date on which an inspection or maintenance procedure was
initiated and completed; the name of the person who carried out the inspection or
maintenance procedure; components that were inspected and replaced, and the extent of
any maintenance procedures; when biological tests were successfully performed and the
signature of the person qualified to release the sterilizer for service following major repairs
or replacement; the signature of the person qualified to confirm that the specified
inspection or maintenance procedures have been completed by competent individuals;
and, the model, serial number, and location of the sterilizer.
See CSA Standards Z314.2, clause 13.3, Z314.3, clause 14.3, and Z314.8, clause 7.5,
for information on record keeping of maintenance and inspection procedures.

7.4
Safety

When installing reprocessing equipment, the organization follows the


manufacturers instructions and contacts the manufacturer directly for clarification
or additional information, as needed.
Guidelines
See CSA Standards Z314.2 and Z314.3, clause 12, and Z314.8, clause 7.5, for more
information.

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7.5
Safety

Before releasing a sterilizer for use, the organization completes appropriate


installation testing for sterility assurance using a process challenge device (PCD)
equipped with chemical and biological indicators.
Guidelines
Installation testing involves putting the sterilizer through at least three consecutive cycles
with a PCD. See CSA Standards Z314.1, Z314.2, and Z314.3 for more information.
The organization completes installation testing for sterility assurance: following the
installation of a new sterilizer; upon completion of major maintenance and repairs;
following construction, relocation, or environmental changes; after major changes to
packaging, wraps, or load configurations; and after unexplained sterility failures. Testing
is also completed annually. See CSA Standard Z314.3-01 Table 1 for information on the
conditions and tests for sterility assurance.
Consult CSA Standards Z314.2 and Z314.3, clause 12, for more information on
installation testing.

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CONDUCTING SAFE AND APPROPRIATE REPROCESSING AND


STERILIZATION OF REUSABLE DEVICES AND EQUIPMENT
8.0

The team properly prepares contaminated equipment for reprocessing.


8.1

Safety

The team prevents the on-site reprocessing or sterilization of single-use devices


(SUDs).
Guidelines
On-site reprocessing of devices designated as single use can compromise the devices
functionality, occupational health and safety, and infection prevention and control.
If available, third party reprocessors that meet accepted standards of practice and legal
requirements may be used to reprocess SUDs.
See CSA Standards Z314.2 and Z314.3, clause 6.7.2.3, and Z314.8, clause 1, for more
information on single-use devices.

8.2
Safety

The team follows safe work practices and infection control precautions when
handling contaminated devices and equipment.
Guidelines
The team treats all devices and equipment that are received in the decontamination area
as though they are contaminated with infectious material.
See CSA Standard Z314.8, clause 8.1.1, for more information on handling contaminated
devices and equipment.

8.3
Safety

If prion contamination is suspected, e.g. Creutzfeldt-Jakob disease, the team


follows accepted guidelines from the Public Health Agency of Canada to handle,
quarantine, and incinerate the device, as appropriate.
Guidelines
Suspected prion contamination is identified by completing a risk assessment of the client
on whom the device was used.
The 2007 Public Health Agency of Canada guidelines can be accessed at
http://www.phac-aspc.gc.ca/nois-sinp/cjd/cjd_e.html.

8.4
Safety

Prior to decontamination, the team follows manufacturers recommendations to


clean and rinse equipment and devices.
Guidelines
Inorganic and organic matter (e.g. blood, protein) retained on devices can inhibit the
sterilization process by providing a medium for the growth of micro-organisms, rendering
chemical germicides inactive, or physically protecting micro-organisms from the
sterilization process.
Cleaning may be done manually or using automatic methods. Refer to CSA Standard
Z314.8-00 clause 11.4 for more information.
See CSA Standards Z314.2 and Z314.3, clause 8.2.2.1, and Z314.8, clause 10.4.1,
regarding cleaning contaminated devices and equipment.

8.5
Safety

The team follows manufacturers instructions to select and perform appropriate


cleaning methods.
Guidelines
If mechanical washing is determined to be appropriate, based on the washers
accessories, the device being cleaned, and the level of decontamination required, the
organization may refer to CSA Z134.8 Appendix E for more information on the selection
and use of mechanical washers.

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8.6
Effectiveness

The team follows manufacturers instructions and accepted standards of practice


to perform manual cleaning.
Guidelines
Refer to CSA Z314.8 for more information on manual cleaning.
See CSA Standard Z314.8, clause 10.4.2, for more information on manual cleaning.

8.7
Effectiveness

The team verifies that detergents, solutions, and disinfectants are compatible with
the devices being reprocessed, the equipment used for washing or sterilization,
and the decontamination or sterilization processes used.
Guidelines
Refer to CSA Standard Z314.8-00 clause 7.2 for selecting disinfectants.
The team may consult with others in the organization, e.g. infection prevention and
control or occupational health and safety, when selecting appropriate detergents,
solutions or disinfectants.
See CSA Standard Z314.8, clauses 10.4.3.2 and 10.8.2 for selecting compatible
disinfectants.

8.8
Safety

For each detergent, solution and disinfectant, the team follows manufacturers
recommendations for use, contact time, shelf life, storage, appropriate dilution,
testing for appropriate concentration and effectiveness, and required PPE.
Guidelines
See CSA Standard Z314.8, clause 10.8.3 for using disinfectants.

8.9
Safety

Following cleaning, and prior to additional reprocessing, the team inspects each
device for cleanliness, functionality, and defects such as breaks, chips, or cracks,
and follows up with additional cleaning or maintenance if required.
Guidelines
The team has a magnifying instrument available to inspect each device following
cleaning.
Consult CSA Standard Z314.8, clause 10.11 for more information on inspection.

8.10
Effectiveness

The team prepares each device or set of devices for sterilization according to
manufacturers instructions, including drying, lubrication, and disassembly.
Guidelines
Lubricants are compatible with the sterilization process used.
Consult CSA Standard Z314.8, clause 10.11 for more information on preparing devices
for sterilization.

8.11
Effectiveness

The team packages each device or set of devices for sterilization using an
appropriate packaging material and process.
Guidelines
Packaging is a critical component of the sterilization process. Improper packaging
materials and processes can inhibit sterilization and lead to failure to maintain sterility.
The packaging material or system allows appropriate and thorough sterilization, maintains
sterility until the package is opened for use, and permits the removal of the device without
contamination. Refer to CSA Standards Z314.10 and Z314.14 for more information on the
properties and characteristics of different packing materials.
Steps in the packaging process include inspection; set assembly, with disassembly of
multipart devices as per manufacturers instructions; wrapping; and labeling.
See CSA Standards Z314.2 and Z314.3, clause 9, for more information on packaging
devices for sterilization.
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8.12

The package or container has an externally visible chemical indicator to


differentiate between processed and unprocessed packages.

8.13

The team places an internal chemical indicator in each package or container,


according to the organizations quality control processes, to verify that sterilizer
penetration has occurred.

Effectiveness

Effectiveness

Guidelines
Refer to CSA Z15882 for more information about chemical indicators.

9.0

The team operates the sterilization equipment and conducts the sterilization safely
and accurately.
9.1

Safety

The team uses its most complex or challenging pack or container to verify that all
devices can be sterilized.
Guidelines
See CSA Standards Z314.2 and Z314.3, clause 12, for more information.

9.2
Effectiveness

The team follows the SOPs, the sterilizers operating manual, and manufacturers
instructions for devices and equipment when loading the sterilizer.
Guidelines
For more information on loading the sterilizer, consult CSA Standards Z314.2 and Z314.3,
clause 10.1.

9.3
Effectiveness

An appropriate team member verifies the configuration of the load before


beginning the sterilization.
Guidelines
Indications of acceptable loads are identified in the sterilizers operating manual and in
the organizations written SOPs. The appropriate team member verifies that the load does
not contact the interior surfaces of the sterilizer chamber.

9.4

The team follows manufacturers instructions while operating the sterilizer.


Guidelines
The team follows manufacturers instructions for both the sterilizer and the devices being
sterilized.

Safety

For CSA guidelines for operating the sterilizer, consult CSA Standards Z314.2 and
Z314.3, clause 10.2.

9.5
Effectiveness

Following the sterilization cycle and before unloading, the appropriate team
member verifies that the required parameters have been met.
Guidelines
This verification includes checking the recording chart or printout and signing in the
designated place. Refer to the Annex of CSA Z314.3 to monitor extended cycles.
It also includes verifying that the workspace is free of any items waiting for sterilization to
avoid cross-contamination.
CSA Standards Z314.2, clause 10.5, and Z314.3, clause 10.3, contain more information
on verifying the sterilization cycles following sterilization.

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9.6

During unloading, the team inspects all packs, including the results of external
chemical indicators.

9.7

The team repeats reprocessing for any items with a damaged pack or seal, or
those that are compressed, torn, wet, or have been dropped on the floor.

Effectiveness

Effectiveness

Guidelines
See CSA Standards Z314.2 and Z314.3, clause 11.3, for more information.

10.0 The team prevents the contamination of reprocessed devices.


10.1
Effectiveness

The reprocessing unit or area has an appropriate area for the storage of sterilized
medical devices.
Guidelines
The appropriate area is large enough to prevent crushing or damage to packages. In
addition, it is protected from moisture contamination, dust from adjacent areas and
ventilation systems, and vermin.
The use of closed shelves may help with storage of devices and equipment, in particular
those that are infrequently used. If open shelves are used, devices are stored away from
the floor, ceiling, window sills, sinks, and outside wall.
Refer to CSA Z314.15 Sections 5 and 6 for more information about appropriate storage
areas.
For more information on the sterile storage area, see CSA Standards Z314.2 and Z314.3,
clause 11.2.

10.2

The organization limits and monitors access to the storage area to appropriate
team members.

10.3

When cleaning the sterile storage area, staff members minimize the amount of air
turbulence and excess moisture.

Accessibility

Effectiveness

Guidelines
Damp, rather than dry, dusting or sweeping is performed whenever possible. Dry cleaning
is done carefully with a chemically treated dry mop or a vacuum cleaner equipped with an
exhaust filter, rather than a broom.
CSA Standard Z314.15, as well as the charts in CSA Z314.8 and CSA Z314.3, contain
more information about air and other parameters in the sterile storage area.
See CSA Standards Z314.2 and Z314.3, clause 7.5, for more information on cleaning
requirements for the sterile storage area.

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10.4

The organization maintains the integrity of each sterile package.


Guidelines
Items that have been properly decontaminated, wrapped, sterilized, stored, and handled
will remain sterile indefinitely, unless the integrity of the package is compromised. The
integrity of the package is based on: the type of wrapper used; the method of sealing the
package; the type of shelving used, including open or closed; the method and frequency
of handling; the method, frequency, and conditions of transportation; the environmental
conditions of the storage area, e.g. temperature, humidity, ventilation, cleanliness; and,
control and monitoring of access to storage areas.

Safety

For more information on maintaining the integrity of the sterile package during storage,
consult CSA Standards Z314.2 and Z314.3, clause 11.3.

10.5
Effectiveness

Trained team members follow established procedures for handling and distributing
sterile devices.
Guidelines
The organization has and follows specific procedures to maintain sterility during
transportation between sites or locations.
See CSA Standards Z314.2 and Z314.3, clause 11.4, on distributing and transporting
sterile devices and equipment.

10.6

The team transports sterile devices and equipment using clean, enclosed, or
covered carts and bins, or plastic bags.

Effectiveness

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MONITORING QUALITY AND ACHIEVING POSITIVE OUTCOMES


11.0 The team tracks sterilized loads and performs appropriate recalls, as needed.
11.1
Effectiveness

The team follows policies and procedures for inventory control of sterilized
devices.
Guidelines
The teams policies include documentation of the sterilization load indicator for tracking
purposes; documentation of the sterilization date for rotation purposes, e.g.
first-in/first-out; adequate spacing of packages; and easy visibility and retrieval of
packages.

11.2
Safety

The sterilized packages are clearly identifiable and distinguished from nonsterilized items.
Guidelines
The organization has processes and structures to prevent the use of a non-sterilized item
from being released and used on clients.
See CSA Standards Z314.2, clause 10.5, and Z314.3, clause 10.3, for more information.

11.3
Safety

The team is able to track all sterilized items in storage or transported to client care
areas, units, or other organizations.
Guidelines
Tracking ensures that the necessary items can be identified in the case of a recall.
CSA Standards Z314.2 and Z314.3, clause 9.5, contain more information on tracking
sterilized items.

11.4
Safety

Guidelines
Traceability is particularly important for neurosurgical and ortho-spine devices, to quickly
identify and prevent the transmission of Creutzfeldt-Jakob Disease.

11.5
Safety

The team follows accepted standards of practice to identify when there may be a
problem with sterilization and when a recall may be necessary.
Guidelines
CSA Standards Z314.2 and Z314.3, clause 12, contain detailed guidelines on tracking
and recall of medical devices.

11.6
Safety

The team follows an established procedure to recall sterilized items that may have
been compromised.
Guidelines
The procedure for recall is in writing and identifies the circumstances for issuing the recall
order; the staff authorized to issue a recall order; the procedure to be followed when recall
is necessary; and the staff responsible for reporting on the execution of a recall order.

11.7
Safety

The organization maintains a dedicated bank of neurosurgical and ortho-spine


devices.

For each recall, the team issues a written, complete notification to all areas of the
organization that use reprocessed medical devices that identifies the items to be
recalled and the actions needed to recall the items.

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11.8

The team issues a complete and written report of all recalls.


Guidelines
A complete recall report identifies the circumstances that prompted the recall order;
specifies the corrective action taken to prevent recurrence; and, states the percentage of
devices actually located in the recall, i.e. in terms of the total number of items intended to
be recalled.

Effectiveness

11.9

The team follows a policy to retain recall orders and reports in its files.

Effectiveness

12.0 The team has an integrated approach to quality and risk management for its
reprocessing and sterilization services.
12.1
Effectiveness

The team has a documented quality management system for its reprocessing and
sterilization services that integrates principles of quality assurance, risk
management, and continual improvement.
Guidelines
The quality management system addresses quality assurance for reprocessing activities,
staff education, and requirements for written policies and procedures.
See CSA Standards Z314.2 and Z314.3, clause 4.5, for more information on the quality
management system.

12.2
Effectiveness

As part of the quality management system, the reprocessing team engages in an


annual review of reprocessing and sterilization activities, with formal reports
provided to the organizations senior management.
Guidelines
The annual review may include random audits of reprocessing and sterilization activities,
documents and records.

12.3
Accessibility

The quality management system documents are accessible to staff and team
members.
Guidelines
CSA Standards Z314.2 and Z314.3, clause 4.3, contain more information on the quality
management system documents.

12.4

As part of its quality management system, the team trains staff to identify, assess,
prioritize, reduce, and communicate risks in the reprocessing unit or area.

12.5

The team monitors compliance with policies and procedures, safe work practices,
and OHS requirements in the reprocessing unit or area.

Safety

Safety

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12.6
Effectiveness

The team verifies and documents the quality of reprocessing services provided in
other areas, or by contracted services or subsidiaries.
Guidelines
For example, the reprocessing of endocopes is often done outside the centralized
reprocessing unit or area. Reprocessing conducted outside the centralized reprocessing
unit or by external services meet the same standards as the rest of the organization.

12.7

The team identifies, investigates, evaluates, and takes appropriate corrective


action for deviations from normal operating procedures or safe work practices,
including critical incidents/accidents and adverse events.

12.8

Team leaders review the quality management system regularly.

Effectiveness

Guidelines
This review may be called an internal audit. It is performed by a knowledgeable and
trained individual to verify the continuing effectiveness of the system.

Effectiveness

CSA Standards Z314.2 and Z314.3, clause 4.3, contain more information on reviewing
the quality management system.

12.9
Effectiveness

The team participates in periodic audits.


Guidelines
Audits may be completed by external bodies or objective internal individuals. Audits are
completed at regular intervals and are comprehensive and systematic.

12.10 The team identifies areas for improvement and makes appropriate changes or
improvements.
Effectiveness

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Reprocessing and Sterilization of Reusable Medical Devices