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  • In this Issue

    HTAHealth Technology Update

    Supporting informed decisions . . .

    Scanning the HorizonInforming Decision Makers About Emerging Medical Technologies

    Issue 5 January 2007

    A newsletter on new and emerging health care technologies in Canada

    Medical device regulation inCanada: a primer on how HealthCanada regulates medical devices.

    CyberKnife: a radiosurgery systemthat uses focused beams ofradiation, rather than a surgicalknife, to destroy tumours andother lesions.

    Ultrasound-enhanced stroketreatment: ultrasound technologiesmay improve acute stroketreatment by enhancing thedelivery of clot-busting drugs.

    Testing newborns for alcoholexposure: a biomarker in anewborns first bowel movementmay be used to identify babies atrisk for fetal alcohol spectrumdisorder.

    Interactive voice-response system:an automated telephone follow-upprogram allows clinicians to

    monitor patients recovery afterdischarge from hospital.

    New and emerging health technologyreports: a listing of recent publicationsfrom CADTH and other healthtechnology assessment agencies.

    As we launch into 2007, our fifth issue ofHealth Technology Update brings youinformation on several new healthtechnologies for the diagnosis andtreatment of disease. The Update alsointroduces an innovative system thatfollows up with patients after they gohome from hospital.

    For this issue, weve enlisted help fromDr. William Freeland, a British-trainedfamily physician who served as HealthCanadas Chief of the Device EvaluationDivision in the Bureau of Medical Devicesfrom 1992 until his recent retirement. Dr.Freeland has prepared a primer article forus on how medical devices are regulatedin Canada. We are very fortunate to beable to benefit from Dr. Freelandsexpertise in this area.

    We hope that you find this issue of theHealth Technology Update informativeand useful. And from all of us at CADTH,we wish you a happy, healthy andfulfilling New Year!

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    Sign up for complimentary future issues at https://secure.cadth.ca/index.php/en/subscribe

    Your feedback on the newsletter is alwayswelcome, as are suggestions for new

    technologies to review in future issues. Pleasesend comments to: Catherine Allison, Editor.

    E-mail:

    7

  • 2 Issue 5 January 2007

    HEALTH TECHNOLOGY UPDATE

    In vitro Diagnostic Devices

    In vitro diagnostic devices (IVDDs) includereagents, assays and equipment used forexamining specimens taken from thebody. IVDDs are regulated with a separateclassification system, but are alsodesignated as Class I, II, III and IV, based onthe degree of risk associated with theiruse. For example, a blood test that detectsbacterial meningitis is categorized as aClass III IVDD because of the risk that afalse-negative test result may cause deathor long-term disability due to delayeddiagnosis. Class IV IVDDs include donorscreening tests for transmissible virusessuch as HIV and hepatitis, which present ahigh public health risk.

    Quality Requirements

    The Medical Devices Regulations requireClass II medical devices to bemanufactured under a quality standard(ISO standard 13488:2003) developed bythe International Organization forStandardization. Class III and IV devicesmust meet ISO standard 13485:2003,which deals with both design andmanufacturing standards.

    Sign up for complimentary future issues at https://secure.cadth.ca/index.php/en/subscribe

    Medical devices are used in the diagnosis,treatment, mitigation orprevention of a medicalcondition. They include avast range of equipment,from a simplethermometer or tonguedepressor to highlysophisticated magneticresonance imaging (MRI)machines or roboticallyassisted surgicalequipment.

    In Canada, medical devices are regulatedby Health Canadas Therapeutic ProductsDirectorate and are subject to theMedical Devices Regulations under theFood and Drugs Act.

    Medical Device Regulation in Canada: A PrimerThe goal of the Medical DevicesRegulations is to ensure, to the extentpossible, that devices offered for sale inCanada are safe, effective, and meetquality standards.

    Device Licensing

    Most medical devices must have a licencebefore they can be sold in Canada. HealthCanada categorizes devices as Class I, II,III, or IV, based on the risks associatedwith their use, including the degree ofinvasiveness, duration of contact with thepatient, energy transmission hazard, andconsequences of device malfunction orfailure.

    Class I devices present the lowestpotential risk and do not require a licence.Class II devices require the manufacturersdeclaration of device safety andeffectiveness, whereas Class III and IVdevices present a greater potential for riskand are subject to in-depth regulatoryscrutiny before licensing and sale. Thecost-effectiveness of medical devices isnot considered. Surgical procedures do notrequire Health Canada licensing.

    Medicall devicee classificationn systemm Devicee Classs Riskk Exampless Licencee Requirementss Class I Lowest Surgical instruments, laboratory culture

    media A device licence is not required, but the establishment where it is made and/or distributed must be licensed.

    Class II Low Contact lenses, pregnancy test kits, endoscopes, ultrasound scanners

    Class III Moderate Orthopedic implants, glucose monitors, dental implants, hemodialysis machines

    Class IV High Cardiac pacemakers, angiography catheters, cranial shunts

    Manufacturers require a Health Canada licence before selling or advertising Class II, III and IVdevices. Annual licence renewals are required.

  • Issue 5 January 2007 3

    HEALTH TECHNOLOGY UPDATE

    it is not contrary to the best interests of the patients recruited to the trial

    the objective of the testing will be achieved.

    Formal authorization is not required touse a Class I device in a clinical trial,although full trial records must beretained. Devices must be labelled forinvestigational use only and any seriousadverse events must be reported toHealth Canada within 72 hours.

    Trial sponsors must identify allinvestigators and clinical trial sites andmust comply with Research Ethics Boardrequirements, including protocol approvaland informed patient consent. In makingtheir final decision on the application,Health Canada reviewers evaluate thestudy protocol and design, the hypotheses,the validity of the endpoints and statisticalmethods, as well as the documentationand management of the trial.

    The Special Access Program

    This program allows health careprofessionals to apply for authorizationto use medical devices that are not yetlicensed in Canada for emergency use, orif conventional therapies have failed, areunavailable or unsuitable. Therapeutic

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    Cour

    tesy

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    Number of medical device licences renewed annually by Health Canada.The regulations allow

    two instances where a

    medical device may be sold

    even though it has not met

    general safety and

    effectiveness requirements:

    investigational testing, and

    special access.

    Application Process

    The Medical Devices Regulations aresupplemented by guidance documents,which outline the safety andeffectiveness data required for each classof medical device. Licence applicationsare reviewed by Health Canada staff andlicences are issued once all requirementsare met. Manufacturers may appeal adecision if licensing is refused, or re-submit applications if additionalinformation is required.

    Modifications

    Manufacturers frequently make smallchanges to their devices. Licenceamendments are required if significantchanges are made to Class III or IV devices,and manufacturers must provideobjective evidence of device safety andeffectiveness.

    Investigational Testing in HumanClinical Trials

    Manufacturers or importers may submit aclinical trial application to use unapprovedClass II, III, and IV devices in clinical trialsprovided that:

    the life, health or safety of patients,users or other persons is not seriously endangered

    The Medical Devices Active LicenceListing (MDALL) is a searchabledatabase that lists Class II, III, and IVdevices licensed in Canada.

    Both active and archived licences maybe viewed at: A listing of Class I devices is notavailable.

    Products Directorate staff review eachindividual application to assess whetherpotential risks of using the deviceoutweigh potential benefits.

    Harmonization of Regulationwith Other Countries

    In July 1998, a new regulatory frameworkwas implemented that brought Canadasregulatory requirements closer to those of the US, the European Union, Japan, andAustralia. This framework will undergocontinual modification and fine-tuning toappropriately regulate new and emergingmedical devices.

    More information on regulations forCanadian medical devices is available at:

  • 4 Issue 5 January 2007

    HEALTH TECHNOLOGY UPDATE

    movements. Patients with extracranialtumours or lesions may need to havemetallic markers implanted to target thearea and guide treatment.

    Regulatory Status

    The CyberKnife (Accuray Inc.) was licensedby Health Canada in August 2006;1however, to date, no CyberKnife unitshave been installed in Canada. Accordingto the CyberKnife Society, there are morethan 80 CyberKnife units operatingworldwide, with about 50 in US centres.2

    Evidence

    Randomized controlled trials thatcompare patient outcomes and costs fo

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