Codes & Standards - Purchase
Medical devices are used in nearly every medical procedure and both patients & health care professionals expect these medical devices to be functionally and microbiologically safe. The safety of medical devices begins with the manufacturer and is supported and maintained by a system of national standards and government regulations that includes medical device licensing, construction and performance standards, and problem reporting systems.
Safe storage of single use and reusable medical devices is necessary to protect these devices from damage. Traditionally single use and reusable medical devices have been stored in sterile storage areas associated with operating room medical device reprocessing, and storage areas within the health care setting. However with the regionalization of health care services and the increased use of contract services as well as the purchase of single use sterile medical devices, health care settings have begun to use centralized facilities such as warehouses or on-site storerooms for the storage of single use and reusable medical devices. In these facilities, shipping containers of medical devices are opened or unpacked, and medical devices are stored in open inventory (split case), bins, or totes until needed. These facilities also pick medical devices and repack them into bins, totes, or case carts for transportation to the point of use. Off-site storage is also provided by some contract reprocessing and laundry services. These trends have resulted in the need to address warehouses that store and distribute open inventory.
This Standard, when used in conjunction with CSA Z314.0 Medical Device Reprocessing - General Requirements, provides a framework to establish, document, and maintain requirements for the reprocessing of medical devices as part of a quality management system, as well as other important requirements.
- Provides a common set of specifications for health care settings, storage facilities, off-site reprocessors, and warehouses that do open inventory (both third party and health care setting owned) as well as for materials management consultants to use when contracting for, arranging, and managing the storage of medical devices
- Covers physical and functional requirements for storerooms, and other storage facilities that provide open-inventory (split-case) storage of single use, reusable single use or reusable medical devices
- Details environmental conditions for storage and transportation
- Clearly outlines personnel considerations such as staff qualifications, orientation, education and occupational health & safety
- Covers emergency procedures