CSA Z314.22-16

1.1 This Standard a) specifies requirements for critical and semi-critical loaned, reusable medical devices; and b) applies to all health care settings and vendors that use, send, receive, transport, or reprocess loaned, reusable medical devices. 1.2 This Standard specifies requirements for a) policies and standard operating procedures (SOPs) related to loaned, reusable medical devices; b) logistics and timing; c) accountabilities and responsibilities; d) transportation; and e) required documentation. Note: Examples of the types of transactions covered by this Standard include a) health care setting to health care setting; and b) vendor to health care setting and health care setting to vendor. 1.3 This Standard does not address: a) decontamination of reusable medical devices (see CSA Z314.8); b) sterilization of medical devices (see CSA Z314.3 and CSA Z314.23); c) packaging of medical devices (see CSA Z314.14); d) storage of medical devices (see CSA Z314.15); e) single-use medical devices that accompany loaned, reusable medical devices; and f) non-critical equipment (e.g., light source) accompanying critical and semi critical devices. Note: The health care setting should ensure that equipment accompanying critical and semi critical devices go through the proper channels. 1.4 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.