Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals): SOR/2019-191
Canada Gazette, Part II, Volume 153, Number 13
SOR/2019-191 June 10, 2019
FOOD AND DRUGS ACT
P.C. 2019-747 June 9, 2019
Whereas, pursuant to subsection 30(1.3) footnote a of the Food and Drugs Act footnote b, the Minister of Health has taken into account existing information management systems with a view to not recommending the making of regulations that would impose unnecessary administrative burdens;
Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 30 footnote c of the Food and Drugs Act footnote b, makes the annexed Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals).
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 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 or identifier of the medical device;
- (c) the date on which the medical device incident was first documented;
- (d) the name of the manufacturer of the medical device;
- (e) a description of the medical device incident;
- (f) the lot number of the device or its serial number;
- (g) any contributing factors to the medical device incident, including any medical condition of the patient that directly relates to the medical device incident; and
- (h) the effect 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) if
- (a) the hospital does not have in its control all of the information referred to in paragraphs 2(b) and (e) 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 December 16, 2019, but if they are registered after that day, they come into force on the day on which they are registered.
N.B. The Regulatory Impact Analysis Statement for these Regulations appears following SOR/2019-190, The Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting — Hospitals).