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.

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Background (contd)

• 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.

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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.

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The Most Frequently Asked Questions (contd)

• 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.

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The Most Frequently Asked Questions (contd)

• 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, dont 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.

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The Most Frequently Asked Questions (contd)

• 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 manufacturers 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.

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The Most Frequently Asked Questions (contd)

• 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

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The Most Frequently Asked Questions (contd)

• Hospitals cannot unilaterally designate a given
  device for veterinary use only unless the
  manufacturers 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.

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The Most Frequently Asked Questions (contd)

• 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 manufacturers 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 manufacturers 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.

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The Most Frequently Asked Questions (contd)

• 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.

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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 devices 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.

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Contact Information

• Michele Bishop
• Student-at-Law
• Trillium Health Centre(416) 259-7580 x.5618
• mbishop_at_thc.on.ca