Notice

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

---

Contact MDB Enquiries

May 31, 2006

Our file number: 06-112393-523

To: All manufacturers, importers and distributors of medical gas piping systems including headwalls, articulating arms, ceiling columns and terminal units.

Subject: Application of Section 5 of the Medical Devices Regulations to medical gas piping systems.

Application

This notice affects:

• manufacturers, importers and distributors of medical gas piping systems including headwalls, articulating arms, ceiling columns and terminal units.

Definitions

As defined in the Medical Devices Regulations:

"manufacturer" means a person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf.

Context

Medical gas piping is exempt from the requirements of the Medical Devices Regulations under section 5 which states:

These Regulations do not apply to a medical gas piping system that is assembled on site at a health care facility and permanently built into the structure of the facility, if

1. the system meets the requirements of National Standard of Canada CAN/CSA-Z305.1, Nonflammable Medical Gas Piping Systems, as amended from time to time; and

2. a certificate of compliance with that standard has been issued by a testing agency that meets the requirements of National Standard of Canada CAN/CSA-Z305.4, Qualification Requirements for Agencies Testing Nonflammable Medical Gas Piping Systems, as amended from time to time.

Recently, Health Canada has been asked by interested stakeholders to consider whether or not headwalls, articulating arms, ceiling columns and terminal units could be considered as part of the medical gas piping system. Health Canada has engaged manufacturers and distributors of these products in consultations and has discussed the application of United States law with the United States Food and Drug Administration (FDA) to these types of products. Additionally, Health Canada officials have toured hospital facilities to gain a better understanding of the use of these products in the healthcare setting.

Section 5 was originally included in the Regulations after carefully considering the health and safety issues related to gas piping systems, the applicable laws in Canada and other jurisdictions, the role of national standards, third party testing and certification with respect to these systems in Canada, and that gas piping systems are installed within the walls of hospitals at the time of construction.

Based on the information gathered during these recent consultations, Health Canada concludes that headwalls, articulating arms, ceiling columns and terminal units are a component part of a medical gas piping system. As such, they are subject to applicable laws, standards and certifications as mentioned above applicable to medical gas piping. Effective the date of this notice, Health Canada will consider these products to be exempt from the requirements of the Medical Devices Regulations provided that their sale, distribution and installation is accomplished in accordance with the requirements set out in section 5 of the Regulations.

Additional information

For additional information on medical gas systems, please contact the following:

Device Licensing
Medical Devices Bureau
Therapeutic Products Directorate
Room 1605, Statistics Canada Main Building
Tunney's Pasture, Address Locator 0301H1
Ottawa, Ontario
K1A 0K9

Phone: (613) 957-7285
Fax: (613) 957-6345
E-mail: device_licensing@hc-sc.gc.ca