Health Canada on Medical Device Shortages

Key points:

• Medical device shortage reporting is mandatory for products included in the appropriate list of vitally important medical devices,
• For all other medical devices, shortage reporting can be performed on a voluntary basis,
• The most important aspect clarified regarding medical device shortages relates to the availability of substitute medical devices – ones that could be used to replace those subject to shortages.

Regulatory Background

The measures and regulatory requirements described in the present Health Canada guidance were implemented by Interim Order No. 2, a special act used to introduce new rules within the shortest period of time. The authority acknowledges the increasing need for medical devices during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus” and public health emergency associated thereto. According to the aforementioned regulation, the parties responsible for medical devices marketed in Canada (e.g., manufacturers and importers) shall duly notify about shortages of medical devices included in the appropriate list. The authority is entitled to request additional information to be provided within a period of time indicated in such a request. It is also important to mention that medical device shortages that have already been reported under the previous Interim Order are not subject to reporting once again under the new framework. 

A medical device shortage occurs when a medical device manufacturer fails to meet increasing demand, provided there are not medical devices that could be used instead (substitute devices). The concept of a medical device shortage covers not only medical devices themselves but also any parts, components, or accessories thereto. 

According to the guidelines published by Health Canada, medical device shortages can be divided into two categories: 

1. Actual, when the current supply can’t meet current demand;

2. Anticipated, when the future supply can’t meet projected demand. 

Obligations on Medical Device Shortage Reporting

Health Canada states that medical device manufacturers and importers are obliged to submit electronic reports on shortages related to medical devices included in the appropriate list. The authority also mentions that the manufacturer and importer are allowed to coordinate their actions in the sphere of reporting to avoid the submission of similar reports. In particular, a manufacturer is entitled to authorize an importer to file a medical device shortage report on its behalf, provided the information to be reported by both parties is the same. In such a case, a manufacturer shall provide the authority with the appropriate authorization form. 

The authority also mentions that voluntary medical device shortage reporting could be applied in case of shortages related to medical devices that are not included in the appropriate list. In particular, voluntary reporting could take place in the following cases: 

• The shortage is likely to create a patient or user safety issue in Canada,
• A substitute device, component, accessory, or part is not readily available in Canada,
• The shortage is national in scope. 

The Health Canada guidelines on medical device shortage reporting cover the most important aspects related to the way such reports should be filed by the parties involved in the supply of medical devices. For instance, the document describes the reporting timelines, namely:

• 5 business days from the day the shortage has been identified for the first time, 
• 2 business days to provide updated information, and 
• 2 business days to inform about the end of the shortage. 

In order to determine whether a particular shortage is subject to reporting, the manufacturer or sponsor shall evaluate whether they are able to overcome the shortage and meet the demand within 30 days from the date the shortage has been identified for the first time. This approach also applies in the case of back-ordered medical devices. However, if a manufacturer or importer fails to resolve such a back-order within 30 days, it should be reported as a medical device shortage. 

Upon receipt of a medical device shortage report, the regulating authority will get back to the manufacturer with the request to provide additional information on the matter. In particular, the authority will also ask about a substitution available for a medical device subject to a shortage. 

According to the document, an acceptable substitution stands for: 

• A Class I device that’s sold or imported by an authorized Medical Device Establishment License (MDEL) holder, 
• A Class II to IV device that’s licensed by Health Canada,
• Any device that’s authorized for sale or import under another interim order made under section 30.1 of the Food and Drugs Act.

A medical device shortage report should be submitted by the manufacturer even if a substitute device manufactured by another manufacturer is available on the market. In such a case, Health Canada will contact other manufacturers to clarify the situation with substitute devices that could potentially be used as a replacement for the one subject to a shortage. 

According to the guidelines, there is no need to file a medical device shortage report if the responsible party can confirm and demonstrate that there is a substitute device manufactured by the same manufacturer, and such substitute device is not subject to shortage itself. 

If a report submitted by the manufacturer or importer meets the definition of a medical device shortage, and if the same manufacturer provides no substitute device, the appropriate medical device storage notice will be published online in order to: 

• Notify healthcare institutions about potential or existing supply gaps, 
• Assist healthcare professionals and patients in the decision-making process with regard to medical devices to be used, and
• Mitigate the impact caused by a medical device shortage on patient care in general. 

The information about medical device storage contained in the appropriate report will be used by the regulating authority for managing the particular case, developing and improving the strategies to be applied to mitigate shortages, and also planning the procurement of medical devices for state needs. 

The same approach applies in the case of voluntary shortage reports filed with regard to medical devices that are not included in the appropriate list of vitally important medical devices. In particular, the authority will use the information contained therein to identify potential shortages. 

It is also important to mention that in accordance with the Interim Order No.2, the Minister of Health is entitled to require any party involved in the manufacturing and supply of medical devices (e.g., a manufacturer, importer, or distributor) to submit additional information related to existing or potential medical device shortage that could take place. 

In summary, the present guidelines published by Health Canada describe the most important aspects related to medical device shortage reporting. In particular, the authority outlines the responsibilities of the parties involved and also indicates the applicable timelines. 

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Sources:

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/shortages.html