The Medical Devices Regulations to The Food And Drugs Act : Implications For Canadian Hospitals

1. The Medical Devices Regulations to The Food And Drugs Act: Implications For Canadian Hospitals Michele Bishop, Student-at-law Trillium Health Centre CESO 30 April 2004

2. Background • In 1998, the federal government enacted the Medical Devices Regulations to the Food and Drugs Act. These regulations make it a criminal offence to advertise, sell, import, or donate samples of unlicenced medical devices for use on humans and animals in Canada. • The definition of Device under section 2 of the Food and Drugs Act means: • any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in: • the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, • restoring, correcting or modifying a body function or the body structure of human beings or animals, • the diagnosis of pregnancy in human beings or animals, or • the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring • and includes a contraceptive device but does not include a drug.

3. Background (cont’d) • The Medical Devices Regulations to the Food and Drugs Act classifies Medical Devices into four classes from Class I (lowest risk) to Class IV (highest risk). • Examples include: • Class I - band-aids; ultrasonic gel • Class II - contact lenses, latex gloves, x-ray devices used in radiographic mode only • Class III - indwelling catheters, IV bag, mammography devices • Class IV - pacemakers; defibrillators • Under the Regulations, Class II-IV Medical Devices must be licenced by Health Canada to be sold in Canada and only a manufacturer can apply for and obtain a medical device licence. • Class I Medical Devices are exempt from the licencing requirements under the Regulations but are not exempt from sections 19 – 21 of the Food and Drugs Act. The Food And Drugs Act and The Medical Devices Regulations cannot be contracted out of.

4. The Most Frequently Asked Questions: • Can a hospital sell an unlicenced Class II-IV medical device in Canada? • NO – it is an absolute prohibition under section 26 of the Medical Devices Regulations • The answer seems obvious, but note, section 26 also prohibits importing an unlicenced medical device. • Implications for hospitals – two-fold… • Only a manufacturer can apply for a device licence, not a Hospital – section 32.(1) of the Regulations • Do not import devices from non-Canadian manufacturers unless they have obtained device licences from Health Canada.

5. The Most Frequently Asked Questions (cont’d) … • What does “distribution without consideration” mean under the section 2 definition of “sell” in the Food and Drugs Act? • “sell” includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration “Distribution without consideration” means: “to donate or give by way of gift” • Distribution without consideration is a legal term which essentially means that a person or corporation cannot donate or gift an unlicenced Class II-IV Medical Device in Canada. • Exception: • Hospitals cannot donate medical devices within Canada, but they may export them under the conditions set out in section 37(1) of the Food and Drugs Act and under section 89 of the Medical Devices Regulations.

6. The Most Frequently Asked Questions (cont’d) … • Section 37.(1) – Conditions Under Which Exports Exempt • This Act does not apply to any packaged food, drug, cosmetic or device, not manufactured for consumption in Canada and not sold for consumption in Canada, if the package is marked in distinct overprinting with the word “Export” or “Exportation” and a certificate that the package and its contents do not contravene any known requirement of the law of the country to which it is or is about to be consigned has been issued in respect of the package and its contents in prescribed form and manner. • Implications for Hospitals… • To limit liability, don’t accept a sample Class II-IV medical devices unless proof is obtained that the sample is licenced by Health Canada. • Where a salesperson states that the sample device is a Class I device and therefore exempt from the licencing requirement under the Medical Devices Regulations, then ask for proof that Health Canada has in fact classified the sample device as a Class I device. • With respect to Exports, it may be difficult and potentially costly to determine that the export does not contravene any known law of the consignee country, particularly as regards third-world consignees.

7. The Most Frequently Asked Questions (cont’d) … • The definition of “Medical Device” under section 1 of the Medical Devices Regulations states that a medical device does not include any device that is intended for use in relation to animals. • Does this mean that a Hospital can sell an unlicenced medical device for veterinary use only? • YES, if: • The manufacturer’s specifications indicate that the device can be used on animals • The device is sold for the specific purpose it was intended to be used on animals • Compliance with section 19-21 of the Food and Drugs Act can be satisfied: • Section 19 – Prohibited Sales of Devices • No person shall sell any device that, when used according to directions or under such conditions as are customary or usual may cause injury to the health of the purchaser or user [includes animals] thereof.

8. The Most Frequently Asked Questions (cont’d) … • Section 20(1) – Deception, etc, Regarding Devices • No person shall label, package, treat, process, sell or advertise any device in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its design, construction, performance, intended use, quantity, character, value, composition, merit or safety. • Section 20(2) – Devices Labelled or package in Contravention of the Regulations • A device that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1). • Section 21 – Where Standard Prescribed for Device • Where a standard has been prescribed for a device, no person shall label, package, sell or advertise any article in such a manner that it is likely to be mistaken for that device, unless the articles complies with the prescribed standard

9. The Most Frequently Asked Questions (cont’d) … … • Hospitals cannot unilaterally designate a given device for veterinary use only unless the manufacturer’s specifications indicate that the device can be used on animals. • It may be time-consuming and burdensome to determine compliance with section 19 – 21 of the Food and Drugs Act, examples: • Directions for use of the device no longer exist and the manufacturer has gone out of business; • Prescribed standards for the device cannot be determined; • Prescribed standards for the device can be determined, but who will test the device to ensure operating compliance with the prescribed standards and how much will it cost; and/or • It might not be possible to fulfill or determine the Labelling Requirements under section 21 of the Medical Devices Regulations.

10. The Most Frequently Asked Questions (cont’d) … • If Class I medical devices do not require a licence, can they be sold or donated by a hospital within Canada? • YES, however, several requirements under the legislation must be satisfied. Examples: • Current proof from Health Canada that the device is in fact a Class I device must be obtained. • The manufacturer’s specification for the device must be obtained and it must be determined that the device is performing as per those specifications under section 21 of the Food and Drugs Act and under s.12 of the Medical Devices Regulations. These requirements necessitates testing by a person qualified to diagnose a device against the manufacturer’s specifications and to determine if the device meets the Safety and Effectiveness requirements under section 10-20 of the Medical Devices Regulations. • Implications for Hospitals… • Time-consuming and s potentially costly venture.

11. The Most Frequently Asked Questions (cont’d) … • Can a licenced Class II-IV medical device be sold or donated by a Hospital within Canada? • YES, however, several requirements under the legislation must be satisfied. Examples: • A copy of the current device license issued by Health Canada in respect of the device must be obtained. • It must be determined if the manufacturer obtained a Quality System Certificate under s. 32(1) of the Medical Devices Regulations and whether or not the Certificate has expired (a Quality System Certificate is valid for only 3 years from the date of issuance under section 32.2 of the Regulations. • If the Quality System Certificate has expired, a new Quality System Certificate must be obtained. This requires the device to be diagnosed by a person qualified under section 32.1(a) and (b) of the Regulations.

12. What you can bring to the table … • Propose sending a Communiqué to all physicians and health care providers not to accept sample Medical Devices unless the sales representative can produce a copy of the Device Licence and proof of classification as issued by Health Canada. • Propose obtaining legal advice to ensure that all standard RFIs, RFPs, RFQs and other procurement contracts negotiated by Materials Management contain clauses obligating a vendor to comply with the legislation and produce at a minimum: • Current Device Licences in respect of Class I-IV Medical Devices; and • Proof of a medical device’s classification as determined by Health Canada • Consider performing an audit to identify all devices purchased after the 1998 enactment of the Regulations and follow-up with vendors to determine whether steps are being taken to comply with the licencing requirements under the legislation. • Designate an individual or group to remain hyper-vigilant in respect of any recall notices and to act on them promptly by removing the device from use.

13. Contact Information: Michele Bishop Student-at-Law Trillium Health Centre(416) 259-7580 x.5618 mbishop@thc.on.ca