COVID-19 guidance for reporting medical device shortages: Background

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Organization: Health Canada

Date published: 2021-03-17

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About the guidance document

This guidance document supports Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (Interim Order No. 2).

The Minister of Health approved Interim Order No. 2 on March 1, 2021, to address the unprecedented demand and urgent need for medical devices to treat, diagnose and protect Canadians against COVID-19. This guidance covers sections 14 to 18 of the interim order. It remains in effect as long as the interim order is in effect.

Under Interim Order No. 2, manufacturers and importers must report medical device shortages to Health Canada for devices on the List of medical devices: Notification of shortages (specified medical devices).

A specified medical device is a device that is either:

  • set out in the list of medical devices or
  • part of a category of medical devices that is set out in that list

This guidance document includes new regulatory requirements for manufacturers, importers and distributors of COVID-19-related devices under Interim Order No. 2.

The guidance is intended to help manufacturers, importers and distributors meet their regulatory obligations. It outlines their responsibilities concerning the mandatory reporting of medical device shortages. Medical device shortages that were reported under the previous Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 do not need to be reported again.

About medical device shortages and reporting

A medical device shortage occurs when a manufacturer of a medical device is unable to meet Canadian market demand for the device or its components, accessories or parts. This does not apply to a situation in which the manufacturer is also the manufacturer of a substitute medical device, component, accessory or part and is able to meet demand for it in Canada.

There are 2 types of shortages:

  1. actual, when the current supply can't meet current demand
  2. anticipated, when the future supply can't meet projected demand

Manufacturers and importers must:

  • report a medical device shortage
  • provide a shortage status update if there is a change in the shortage information submitted
  • report an end of a medical device shortage

Section 18 of Interim Order No. 2 allows the Minister of Health to compel manufacturers, importers or distributors that import or sell medical devices in Canada to provide information within their control about a shortage or potential shortage when:

  • there's a shortage of the device in Canada or the device is at risk of going into shortage
  • the information is necessary to establish or assess:
    • the existence of a shortage or risk of shortage
    • the reasons for a shortage or risk of shortage
    • the effects or potential effects on human health of a shortage or
    • measures that could be taken to prevent or alleviate a shortage
  • the manufacturer, importer or distributor will not provide the information without a legal obligation to do so

When requested by Health Canada, manufacturers, importers and distributors must provide additional information about a shortage in an acceptable or electronic format within a specified time limit. We will only require that the information be submitted with less than 24 hours' notice if we have reasonable grounds to believe that there is a serious and imminent risk of injury to human health. The information that may be requested will not include personal information on a patient, user or other person whose health or safety may be adversely affected by the medical device being in shortage. Privacy considerations are defined in section 3 of the Privacy Act.

This guidance document also provides some guidance on how to voluntarily report a medical device shortage that does not fall under the interim order.

Everyone has a role to play

Manufacturers and importers

Manufacturers and importers have a key role to play in preventing and reducing the impact of medical device shortages. They can control the volume of medical devices in the supply chain and can take steps to resolve a medical device shortage when one occurs. They are also in the best position to communicate to customers about the availability of their devices.

When a manufacturer experiences a shortage of a critical medical device it sells, we expect the manufacturer will take all necessary measures to resolve the shortage as quickly as possible.

Distributors

Distributors may also be impacted by medical device shortages and have information about the availability of devices they sell. Although they are not required to report a medical device shortage, they may be contacted by Health Canada to provide information about a shortage or potential shortage under certain conditions. These are outlined in section 18 of the interim order.

Provincial/territorial governments and health care authorities

Provincial and territorial governments and health care authorities also have an important role to play in preventing and mitigating critical medical device shortages. They can:

  • conserve and reallocate stock within regions or provinces to where it is most needed and collaborate to share supply
  • identify and secure additional supplies of medical devices from other vendors or another provincial or territorial government
  • identify and secure other compatible, substitute medical devices

Government of Canada

The federal government administers the Food and Drugs Act, Radiation Emitting Devices Act and Medical Devices Regulations.

We do not provide or control the supply of medical devices in Canada or have the authority to compel a manufacturer to supply a device. We work with stakeholders across the medical device supply chain to help determine the details and status of a shortage. We also coordinate and facilitate information sharing.

When it comes to medical device shortages, Health Canada depends on early reporting of anticipated or actual shortages to help us:

  • prevent or manage impacts related to medical device shortages
  • work with industry to identify mitigation strategies
  • inform the procurement of medical devices for Canada

Depending on the situation, our options include:

  • prioritizing the review and approval of regulatory applications received from manufacturers (for example, an application to authorize or import an acceptable compatible device)
  • expediting the process for issuing Medical Device Establishment Licences (MDELs)
  • permitting the importation and sale of medical devices that do not fully meet Canadian regulatory requirements, but are manufactured to comparable standards to help address device shortages
  • working with international regulators to identify other manufacturers and to share needed safety and manufacturing information
  • helping health care professionals and institutions get access to compatible substitute medical devices on an emergency basis (for example, the Special Access Program can be used to provide access to unlicensed alternative medical devices)

As part of the Government of Canada's response to COVID-19, the Public Health Agency of Canada is working with other government departments to procure bulk shipments to facilitate access to much-needed medical devices. These include ventilators, testing swabs, reagents, test kits and personal protective equipment.

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