Scientific Advisory Committee on Health Products for Women (SAC-HPW): Agenda

Date and Time: May 16, 2019- 8:00am to 4:00pm, EST and May 17, 2019 - 8:00am to 3:00pm, EST
Location: 1600 Scott St, Holland Cross, Tower B, 2nd floor, room 2048
Chairperson: Lorraine Greaves
Secretariat: Lisa Wardell, Carl Poulin, Despina Miteva
Participants: SAC-HPW members and Health Canada employees

Day 1 – May 16, 2019:

7:30-8:00
Refreshments

8:00-8:30
Welcome and Opening remarks
Supriya Sharma, Chief Medical Advisor, Health Canada / Senior Medical Advisor for Health Products and Food Branch

8:30-9:45
Chair’s address, Introduction of Members, Review of Affiliations and Interests, Review of Agenda, Review/Approval of Terms of Reference
Chair

9:45-10:00
Break

10:00-10:30
Health Canada presentation – Regulatory Overview of Drugs and Medical Devices, and how the SAC-HPW can help inform decision-making
Therapeutics Product Directorate (TPD)

10:30-11:00
Health Canada presentation – Medical Devices Action Plan
Medical Devices Bureau (MDB), TPD

11:00-12:00
Medical Devices Regulations 101
MDB, Marketed Health Products Directorate (MHPD) and Regulatory Operations and Enforcement Branch (ROEB)

12:00-13:00
Lunch

13:00-14:00
Session #1: Clinical Evidence for Medical Devices
MDB

14:00-14:45
Session #1 –  Committee Deliberations
SAC-HPW members

14:45-15:00
Break

15:00-15:45
Session #1 – Committee Deliberations (continue)
SAC-HPW members

15:45-16:00
Closing Remarks and Adjournment for the day
Chair

Day 2 – May 17, 2019:

7:30-8:00
Refreshments

8:00-8:15
Welcome and Opening remarks
TPD

8:15-8:30
Chair’s address, Review of Agenda, Post-mortem Day 1
Chair

8:30-9:45
Session #2: Lifecycle Management of Medical Devices
MHPD

9:45-10:00
Break

10:00-12:00
Session #2 – Committee Deliberations
SAC-HPW members

12:00-13:00
Lunch

13:00-13:45
Session #3: Knowledge Translation to Patients
TPD, MHPD

13:45-14:45
Session #3: Committee Deliberations
SAC-HPW members

14:45-15:00
Closing Remarks and Adjournment of Meeting
Chair

Annex – Objectives and Questions

Session #1: Clinical Evidence for Medical Devices

Session objective:

This Session will focus on a general overview and discussion of Health Canada's review of types and levels of clinical evidence required for medical device market authorizations, including international context.

Questions:

Health Canada is currently reviewing its clinical evidence requirements related to higher-risk medical devices with the goal to more clearly define the types and levels of clinical evidence that should be provided to Health Canada to support an application for licensure.

1. Within the context of medical devices for women, are there specific clinically meaningful sex differences in trial outcomes that are not captured in traditional clinical evaluation? (i.e., What are the factors/elements that we should include/consider about women?)

Health Canada utilizes a ‘risk-based’ approach to assess the safety and effectiveness of medical devices. If a medical device has a well-established clinical history with a given device technology and has an established post-market record of safety it may be considered differently with respect to the extent of clinical evidence required for authorization.

2. Are there factors specific to women (or in general) that should be considered in defining whether or not a medical device product should be considered ‘Established Technology’? (i.e. length of time on the Canadian market, number of sales, number of clinical studies)

Health Canada is currently considering how we can best incorporate/leverage the use of Real World Evidence (RWE) into our assessment of the safety and effectiveness of medical devices for Canadians. Sources of RWE being considered include: all-comers trials, registries, post-market studies, etc. These sources of clinical evidence are often varied, complex and difficult to interpret; however, they also offer some insight into how health products perform in the real world.

3. (a) What additional types of RWE should be incorporated/leveraged into the assessment of safety and effectiveness for medical devices? (specific to women or generally)

3. (b) Are there types of medical devices that would benefit most from the use of RWE as part of the clinical evidence submitted in a license application and why? (i.e., In what situations may traditional randomized control trials/investigational testing be inappropriate or insufficient to inform about safety and effectiveness?)

Session #2: Lifecycle Management of Medical Devices

Session objective:

This session will focus on the lifecycle management of higher risk medical devices and what happens once devices are authorized and available on the market for use by Canadians. This will include issues of monitoring and surveillance, reporting of incidents, and how safety reviews may change the benefit risk profile of the currently authorized devices and/or inform pre-market requirements for future products. Mesh implants will be used as a case study to illustrate the issues.

Questions:

Health Canada includes a variety of sources of information to support the detection and assessment of potential safety risks associated with the use of medical devices in Canada. These include reports (mandatory and voluntary) of medical device incidents, the scientific literature, information sharing with foreign regulators, and information received from manufacturers. Efforts are underway to strengthen the monitoring of licensed medical devices in order to more quickly identify, communicate and act on new or increased safety concerns. Despite the limitations of the current RWE system, Health Canada is interested in hearing different perspectives on the topic and why those might be more prevalent in women, and what strategies might help overcome that.

1. What additional post-market strategies could be put in place to improve the detection of concerns related to medical device safety and/or effectiveness concerns in women?

2. (a) What other sources of information would be useful for early detection of concerns (e.g., data shared via collaboration with professional societies and/or patient groups, etc.)?

2. (b) Are there creative new ways, methods or strategies we can use to gather and better understand information about the devices being used in women so that Health Canada can be better informed of potential safety or effectiveness issues as devices are being used?

3. How could the rate and quality of medical device incident reporting (by manufacturers, hospitals, and patients) be improved/optimized?

Session #3: Knowledge Translation to Patients

Session objective:

This session will focus on the aspects of knowledge translation to patients and healthcare professionals including providing timely medical device information for informed decision making, labelling, understanding differences and unique needs of women, and enhanced communications. Breast implants will be used as a case study to illustrate the issues.

Questions:

With breast implants, patients are making a personal decision to have this device implanted either for reconstruction or esthetic/augmentation purposes. Thus, like other medical devices, the patients should be fully informed about the risks/complications as well as benefits of the breast implants and the procedure.

1. (a) Health Canada has heard from patients that there is a lack of access to information about breast implants or that it is not being communicated to them. In addition to existing communications related to breast implants, how can Health Canada improve or facilitate access to risk information for patients?

1. (b) The product information package for breast implant has a patient brochure which is a comprehensive document (over 30 pages) containing information on risks/complications and benefits including results of clinical trials of breast implants. While this may not be the optimal approach to inform on the potential risks associated with this device, what types of documents would be most useful to communicate information on these devices?

Considering that patients should be provided clear and accurate information about the risks of any proposed treatment using medical devices in order to help them reach an informed decision.

2. (a) What can Health Canada do to better inform healthcare professionals and patients so they have a better understanding about potential risks of medical devices?

2. (b) What information do you think should be provided to patients at the time of informed consent? In what format? What should the process look like? And what other communication tools might be useful to facilitate the informed consent process, as well as ongoing monitoring of devices?

Discuss current risk communication tools that Health Canada uses to inform Healthcare Providers and patients on health products safety issues e.g., InfoWatch:

3. Are these tools appropriate? What are additional ways to reach-out to patients on gender specific risk communications?