CSA Z314.14-15

Preface

This is the fifth edition of CSA Z314.14, Selection and use of packaging (sterile barrier systems) in healthcare settings. It supersedes the previous editions published in 2010, 2004, and 1993 under the title, Selection and use of sterilization containers. It is one of the CSA Z314 series of Standards addressing quality systems, decontamination, disinfection, packaging, sterilization, and storage.

This Standard specifies requirements for the effective use of sterile barrier systems, including wrappers, and includes selection criteria for healthcare settings to use when purchasing these medical devices. This Standard has been revised to work in tandem with applicable requirements of CSA Z314.0, Medical device reprocessing – General requirements, and other standards in the CSA Z314 series.

Introduction

Medical devices are used in every medical procedure. Patients and healthcare professionals expect these medical devices to be safe. The safety of medical devices begins with the manufacturer and is supported by a system of national standards and government regulations that includes medical device licensing, construction and performance standards, and problem reporting systems. These systems serve as a guide for healthcare facilities and users to ensure proper care and handling is achieved every time a medical device is used.

Within this structure there are, departments, clinics, and offices located on and off site that reprocess medical devices. These areas play an essential role and face unique challenges. Unlike the medical device manufacturer, medical device reprocessing personnel work with a wide array of medical devices manufactured by different companies, these medical devices are received in varying states of cleanliness and repair. It is the responsibility of the medical device reprocessing department (MDRD) to develop standard operating procedures that provide for each step of the cleaning, inspection, and functionality testing, followed by disinfection or sterilization for each medical device. These standard operating procedures are developed using the device manufacturer’s validated written instruction for reprocessing a reusable medical device. The goal is to provide medical devices that perform as intended by the manufacturer and are safe for reuse.

Packaging is a vital step in reprocessing. The user requires knowledge of the quality and type of packaging required to maintain the sterility of medical devices. Packaging is available in many types and this Standard will address the types, quality and wrapping techniques.

This Standard is one of a series of standards to be used in conjunction with CSA Z314.0, Medical device reprocessing – General requirements, which provides a framework to establish, document, and maintain requirements for the reprocessing of medical devices as part of a quality management system. This Standard is intended to provide comprehensive requirements for the safe and reliable packaging of reusable medical devices.

Scope

1.1

This Standard defines essential elements for the evaluation, selection, inspection, and proper use of preformed sterile barrier systems, sterile barrier systems, and packaging systems. The selection criteria include minimum performance requirements to help healthcare settings choose products that are appropriate for their intended use.

1.2

This Standard applies to the following

a) reusable sterilization container systems including trays and cassettes intended for use in sterilization processes that do not rely on wrapping;

b) sterilization wraps including

i) reusable textile sterilization wrap; and

ii) disposable sterilization wrap; and

c) sealable sterilization pouches and rolls.

In addition this Standard addresses items intended to facilitate aseptic presentation such as protective organizing cases or trays that require additional wrapping or an additional method of containment for sterilization and maintenance of sterility.

1.3

This Standard sets forth requirements in the following areas:

a) policies and procedures related to the use of packaging;

b) general characteristics, selection, and purchasing of packaging;

c) evaluation of the design, performance, and labelling of packaging;

d) matching of packaging to appropriate sterilization methods and cycles;

e) testing prior to use;

i) preparation, and assembly of packaging including wrapping methods;

ii) infection prevention and control; and

iii) aseptic presentation and use; and

f) quality assurance.

1.4

This Standard does not provide requirements for

a) ongoing sterility assurance programs in healthcare settings;

b) textile gowns and packs;

c) laundering and maintenance of reusable sterilization gowns and wraps;

d) sterilizer loading and unloading; and

e) use of packaging materials after opening, for other purposes (e.g. sterile fields, transport of contaminated items).

Note: CSA Z314.0 provides requirements for quality management systems. CSA Z314.3 and CSA Z314.23 provide requirements for steam sterilization and chemical sterilization in healthcare settings. CSA Z314.10.1 provides requirements for the selection and use of sterilization gowns and drapes. CSA Z314.10.2 provides requirements for laundering of reusable surgical textiles. CSA Z314.15 provided requirements for, storage, handling, and transportation of single use and reusable medical devices.

1.5

In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the Standard.

Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.

Notes to tables and figures are considered part of the table or figure and may be written as requirements.

Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.