Health Canada seizes unauthorised injectable drugs, medical devices

AbstractIntroductionHealth Canada is committed to the modernization of the use of real-world data (RWD) and evidence (RWE) to support regulatory decisions. As such, telephone interviews with stakeholders, including government decision makers, health technology assessment (HTA) producers, industry, and patients, to understand their experiences with and perspectives on how to enhance RWE use for medical devices were performed.MethodsThirty-four semi-structured telephone interviews with forty key informants were conducted. Transcripts were reviewed independently by one individual to identify, define, and categorize key concepts and were verified by a second reviewer.Key FindingsThere are expectations for Health Canada to provide a framework and guidance on RWE use, identify relevant outcomes for data collection and criteria for data quality, conduct post-market surveillance more systematically, and partner with HTA organizations to develop methods for RWE generation. Stakeholders interviewed support the RWE use for regulatory decisions and HTA recommendations. Moreover, robust scientific methods for RWE generation will be critical to ensure that relevant questions are asked and rigorous statistical analyses are done to answer them. Patients are likely to consent to share their anonymized or de-identified medical information for nonprofit purposes.ConclusionsKey concepts from the interviews centered on the current and future RWE use for medical devices, considerations for the organizational, medical, scientific, and legal aspects and privacy issues of RWD collection or RWE generation, and options to implement the use of RWD and RWE. Our study findings will help inform the development of an RWE framework for regulatory decisions and HTA recommendations.

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MEDICAL DEVICE RECALLS IN CANADA FROM 2005 TO 2015

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462317000824 ◽

2017 ◽

Vol 33 (6) ◽

pp. 708-714

Author(s):

Anna R. Gagliardi ◽

Julie Takata ◽

Ariel Ducey ◽

Pascale Lehoux ◽

Sue Ross ◽

...

Keyword(s):

Medical Device ◽

Medical Devices ◽

Class Ii ◽

Type I ◽

Intermediate Risk ◽

Class Iii ◽

Potential Harm ◽

Risk Class ◽

New Class ◽

Health Canada

Objectives: Medical devices are ubiquitous in modern medical care. However, little is known about the epidemiology of medical devices in the healthcare marketplace, including the rate at which medical devices are subject to recalls or other advisories. We sought to study the epidemiology of medical devices in Canada, focusing on device recalls. In Canada, a recall may signify a variety of events, ranging from relatively minor field safety notifications, to removal of a product from the marketplace.Methods: We used data from Health Canada to study medical device recalls in Canada from 2005 to 2015. We analyzed the risks of medical device recalls according to the risk class of the device (I lowest; IV highest) and the hazard priority of the recall (Type I highest potential harm; Type III lowest potential harm).Results: During a 10-year period, there were 7,226 medical device recalls. Most recalls were for intermediate risk class (Class II, 40.1 percent; Class III, 38.7 percent) medical devices. Among recalled devices, 5.0 percent were judged to have a reasonable probability of serious adverse health consequences or death (Type I recall Hazard Priority classification). While the number of medical devices marketed in Canada is not known, over a similar 10-year period, 24,849 new Class II, II, and IV medical device licenses were issued by Health Canada.Conclusions: Several hundred medical device recalls occur in Canada each year. Further research is needed to characterize the nature of medical device recalls, and to explore how consumers use information about recalls.

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Roles and Rules of Some Regulatory Agencies around the World during COVID-19 Pandemic

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2021/v33i34a31838 ◽

2021 ◽

pp. 178-187

Author(s):

Aseel Bin Sawad ◽

Fatema Turkistani

Keyword(s):

Drug Administration ◽

Medical Devices ◽

Regulatory Agencies ◽

European Medicines Agency ◽

Cure Models ◽

The Us ◽

The World ◽

Us Fda ◽

Health Canada ◽

Official Sources

Objective: Collecting and synthesizing relevant data on COVID-19 from official sources of some different regulatory agencies around the world. Methods: The information and actions related to responding to the COVID-19 situation were collected from the websites of some regulatory agencies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada (HC), Swiss Agency for Therapeutic Products (Swissmedic), and the Australian Therapeutic Goods Administration (TGA). Results: All the regulatory agencies help in expediting the development of COVID-19 treatments and medical devices. These agencies also developed an international regulatory collaboration to develop cure models for the pandemic. While some of the agencies conduct the COVID-19 testing, like the US FDA, the others do not. The agencies also differ in their approaches towards resolving the pandemic. FDA and EMA are more aggressive in a way that they prioritize more testing and hospitalization coverage. However, as of the 22nd of June 2021, the FDA authorized the highest number (388) of diagnostic COVID-19 test kits followed by TGA (128), and EMA (88). Conclusions: Although the regulatory agencies differ in their approaches towards resolving pandemic COVID-19, all regulatory agencies help in expediting the development of COVID-19 treatments and medical devices.

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Ultrastructural changes in murine lymphoma cells exposed to ultraviolet-A radiation

Proceedings, annual meeting, Electron Microscopy Society of America ◽

10.1017/s042482010008482x ◽

1991 ◽

Vol 49 ◽

pp. 104-105

Author(s):

Delma P. Thomas ◽

Dianne E. Godar

Keyword(s):

Medical Devices ◽

Blood Cells ◽

White Blood Cells ◽

Consumer Products ◽

Ultrastructural Changes ◽

Ultraviolet A ◽

Uv Spectrum ◽

Lymphoma Cells ◽

Murine Lymphoma ◽

Transmission Electron

Ultraviolet radiation (UVR) from all three waveband regions of the UV spectrum, UVA (320-400 nm), UVB (290-320 nm), and UVC (200-290 nm), can be emitted by some medical devices and consumer products. Sunlamps can expose the blood to a considerable amount of UVR, particularly UVA and/or UVB. The percent transmission of each waveband through the epidermis to the dermis, which contains blood, increases in the order of increasing wavelength: UVC (10%) < UVB (20%) < UVA (30%). To investigate the effects of UVR on white blood cells, we chose transmission electron microscopy to examine the ultrastructure changes in L5178Y-R murine lymphoma cells.

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Bacterial biofilm behavior in water-supply lines of dental units

Proceedings, annual meeting, Electron Microscopy Society of America ◽

10.1017/s0424820100124811 ◽

1992 ◽

Vol 50 (1) ◽

pp. 882-883

Author(s):

B.D. Tall ◽

K.S. George ◽

R. T. Gray ◽

H.N. Williams

Keyword(s):

Water Supply ◽

Medical Devices ◽

Biofilm Formation ◽

Bacterial Biofilm

Studies of bacterial behavior in many environments have shown that most organisms attach to surfaces, forming communities of microcolonies called biofilms. In contaminated medical devices, biofilms may serve both as reservoirs and as inocula for the initiation of infections. Recently, there has been much concern about the potential of dental units to transmit infections. Because the mechanisms of biofilm formation are ill-defined, we investigated the behavior and formation of a biofilm associated with tubing leading to the water syringe of a dental unit over a period of 1 month.

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