CSA Z314.22-10 (R2015)

This is the second edition of CSA Z314.22, Management of loaned, reusable medical devices. It supersedes the previous edition, published in 2004 under the title Management of loaned, shared, and leased medical devices. It is intended to be used with the CSA Z314 series of Standards pertaining to the reprocessing of medical devices.

Scope

1.1

This Standard specifies requirements for the lending of (a) critical and semi-critical reusable medical devices; and

(b) single-use medical devices, such as implants, that a company and are intended to be used with the loaned, reusable device. This Standard applies to all health care facilities and vendors that provide, use, transport, or maintain loaned, reusable medical devices.

1.2

This Standard specifies requirements for

(a) policies and procedures related to the lending and trial of medical devices;

(b) accountabilities and responsibilities;

(c) staff qualifications, orientation, education, training, and other personnel considerations;

(d) transportation between organizations;

(e) quality assurance;

(f) emergency procedures; and

(g) required documentation.

Note: Examples of the types of transactions covered by this Standard include

(a) health care facility to health care facility; and

(b) vendor to health care facility and health care facility to vendor.

1.3

The following areas are not addressed in this Standard:

(a) decontamination of reusable medical devices (see CAN/CSA-Z314.8);

(b) maintenance;

(c) sterilization of medical devices (see CSA Z314.2 and CSA Z314.3); and

(d) single-use medical devices other than those that accompany and are intended to be used with a loaned, reusable device.

1.4

In CSA standards, “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 (nonmandatory) to define their application.