Canada Gazette, Part I, Volume 152, Number 24: Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals)
June 16, 2018
Food and Drugs Act
Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
For the Regulatory Impact Analysis Statement, see the Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting — Hospitals).PROPOSED REGULATORY TEXT
PROPOSED REGULATORY TEXT
Notice is given that the Governor in Council, pursuant to section 30 footnote a of the Food and Drugs Act footnote b, proposes to make the annexed Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals).
Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Bruno Rodrigue, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health, Holland Cross, Tower A, Ground Floor, Suite 14, 11 Holland Avenue, Address Locator: 3000A, Ottawa, Ontario K1A 0K9 (email: LRM_MLR_consultations@hc-sc.gc.ca).
Ottawa, June 7, 2018
Assistant Clerk of the Privy Council
Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals)
1 The Medical Devices Regulations footnote 1 are amended by adding the following after section 61.1:
Provision of Information Under Section 21.8 of the Act
62 (1) For the purposes of section 21.8 of the Act, hospitals are the prescribed health care institutions that shall provide information that is in their control to the Minister about a medical device incident.
(2) The following prescribed information about a medical device incident that is in a hospital’s control shall be provided to the Minister in writing within 30 days after the day on which the medical device incident is first documented within the hospital:
- (a) the name of the hospital and the contact information of a representative of that hospital;
- (b) the name of the device and its identifier;
- (c) the name of the manufacturer of the device;
- (d) a description of the medical device incident;
- (e) the lot number of the device or its serial number;
- (f) any contributing factors to the medical device incident, including any medical condition of the patient that directly relates to the medical device incident; and
- (g) the result of the medical device incident on the patient’s health.
(3) A hospital is exempt from section 21.8 of the Act in respect of the reporting of information referred to in subsection (2) that is in its control about a medical device incident if
- (a) the hospital does not have in its control all of the information referred to in paragraphs 2(b) to (d) in respect of the medical device incident; or
- (b) the medical device incident involves only a medical device that is the subject of an authorization issued under subsection 72(1) or 83(1).
(4) The following definitions apply in this section.
hospital means a facility
- (a) that is licensed, approved or designated as a hospital by a province in accordance with the laws of the province to provide care or treatment to persons suffering from any form of disease or illness; or
- (b) that is operated by the Government of Canada and that provides health services to in-patients. (hôpital)
medical device incident means an incident related to a failure of a medical device, a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use that has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were it to recur. (incident lié à un instrument médical)
(5) For the purposes of the Act, medical device incident has the same meaning as in subsection (4).
Coming into Force
2 These Regulations come into force on the day that, in the sixth month after the month in which they are published in the Canada Gazette, Part II, has the same calendar number as the day on which they are published or, if that sixth month has no day with that number, the last day of that sixth month.