Equipment Donation

To ask about donating Canadian medical equipment, please feel free to contact Steve.

Introduction
The donation of medical devices to support health care services in developing countries provides a great opportunity to improve the level of care. The ongoing changes and improvements in the developed world for medical technology and equipment usually results in a turnover of medical equipment that may have several more years of useful life. It behooves us to ensure that before we retire or discard this equipment we should consider whether or not someone else could benefit from it, specifically any one of the many non-government organizations that provide medical missions to less developed health care systems.
 
In order to successfully donate medical devices the hospital must ensure compliance with the applicable Health Canada regulations. The regulations as they exist in their official form are very comprehensive and include responsibilities of manufacturers and distributors (substituted with the work hospital for this document). At first glance the regulations appear daunting and may cause an organization to shy away from such a process. This worksheet was prepared to identify only those Health Canada regulations that apply to the donating hospital of the medical devices within the context described here. In short, this worksheet will simplify the donation process while ensuring that we have satisfied the applicable regulations set by Health Canada.
 
Labeling Requirements
21 (1) No person shall import or sell a medical device unless the device has a label that sets out the following information 
(a) the name of the device;
(b) the name and address of the manufacturer;
(c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(d) in the case of a Class II or IV device, the control number;
(e) if the contents are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the device, such as the size, net weight, length, volume or number of units;
(f) the word “Sterile”, if the manufacturer intends the device to be sold in a sterile condition;
(g) the expiry date of the device, if the device has one, to be determined by the manufacturer on the basis of the component that has the shortest projected useful life;
(h) unless self-evident to the intended user, the medical conditions, purposes and uses for which the device is manufactured, sold or represented, including the performance specifications of the device if those specifications are necessary for proper use;
(i) the directions for use, unless directions are not required for the device to be used safely and effectively; and
(j) any special storage conditions applicable to the device.

(2) The information required pursuant to subsection (1) shall be expressed in a legible, permanent and prominent manner, in terms that are easily understood by the intended user.
 
Class II, III and IV Medical Devices
Prohibition
26. The hospital shall not donate or sell a Class II, II, or IV medical device unless the manufacturer of the device hold a license in respect of that device or, if the medical device has been subjected to a change described in section 34, an amended medical device license.
Refer to the Medical Device and License Listing (MDALL) on the website address http://www.hc-sc.gc.cadhp-mps/md-im/licen-eng.php
 
52 (1) The hospital shall each maintain a distribution record in respect of each device.
This is as simple as keeping a file on the equipment donated at your site and accessible.
 
Distribution Records
53. The distribution record shall contain sufficient information to permit complete and rapid withdrawal of the medical device from the market.
 
55. The hospital shall retain the distribution record maintained in respect of a medical device for the longer of
(a) the projected useful life of the device, and
(b) two years after the date the device is shipped.
The record can then be archived. (Electronic formats make this much easier these days)
 
56. Distribution records shall be maintained in a manner that will allow their timely retrieval.
The hospitals responsibility when they have been alerted to a recall is mainly to ensure that they have passed the recall on to the organization to which they donated a device. The hospital need then only ensure that they have some confirmation that the organizations received the recall.
 
Complaint Handling Records
57. (1) The hospital shall each maintain records of the following:
(a) reported complaints relating to the performance characteristics or safety of the device, including any consumer complaints, received by the manufacturer, importer or distributor after the device was first sole in Canada; and
(b) all actions taken by the manufacturer, importer or distributor in response to the problems referred to in paragraph (a)
 
(2) Subsection (1) does not apply to: (a) a retailer or
(b) a health care facility in respect of a medical device that is distributed for use within that facility.
The hospital will be required to keep a record of any complaints and any actions taken. In the context of donation these would be rare.
 
58. The hospital complaint handling and recall procedure shall enable the hospital to carry out
(a) an effective and timely investigation of the problems referred to in paragraph 57(1)(a); and
(b) an effective and timely recall of the device. (or notification of recall to the recipient of the device)
 
In this context the hospital needs only to demonstrate that they have successfully passed on the notification of recall to the organization that received the donated medical device. A confirmation of receipt of this information would satisfy that donating hospitals requirements.
Such complaints are rare in this context.