Welcome to our Embase webinar!  Conducting Medical Device Safety andPerformance Assessments using Embase as     a Tool for...
Presenter               Daniel E. McLain, PhD         US AAMI Chairman TC194/WG7   President, Walker Downey & Associates, ...
From the beginning …Paracelsus (1493-1541): "All things arepoison and nothing is without poison, onlythe dose permits some...
Definition of a Medical Device Any “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or ...
Defining Device Classification LOW RISK - not intended for use in supporting or sustaining life or to be of substantial im...
ISO 10993-1 Informative                                 Flow ChartNEXT: Getting a device to market   through the FDA process
Areas where an expert opinion   can help to reduce testing     through     materialcharacterization testing and/or     NEX...
EU, USA, Japan, Australia and Canada (FM 1992)SG5/N1R8:2007 – Clinical Evidence – Key Definitions and ConceptsSG5/N2R8:200...
MEDDEV 2.7.1 rev 3Effective 2010 - Mandatory for all classes ofmedical devices to maintain their CE MarkingClinical data: ...
Clinical EvaluationThe guidance describes the procedure of how a clinicalevaluation is performed in three steps, once the ...
Clinical EvaluationEmbase.com•The Cochrane Central Register of ControlledTrials•522 Postmarket Surveillance Studies•FDA PM...
Clinical Evaluation ReportCan be 4 pages, forexample, http://www.spident.co.kr/down/estempne/Clinical%20Evaluation-EsTemp%...
Cervical OrthosisAn orthosis designed to limit cervical spine motionto varying degrees (N > 500 manufacturers).
Systematic Literature Review  1 – Define the review (PICO);Analytical PICO framework for the current CE Report            ...
Systematic Literature Review2 – Develop KEY questions;Does any single medical device “system” have a significant therapeut...
Systematic Literature ReviewGeneral search terms – Generatethe current terms;                  3 considered for search CE ...
Systematic Literature Review                 4 – Generate search strategy;Query                               Comments    ...
Systematic Literature ReviewQuery 4          4 – Generate search strategy;cervical vertebrae/exp OR       Removed AND (cer...
Systematic Literature Review4 – Generate search strategy;SpineSpine SurgeryChin Med J (China)Eur Spine J (Europe)Acta Neur...
Systematic Literature ReviewQuery 5        4 – Generate search strategy;cervical vertebrae/exp/mj OR cervical         Adde...
Systematic Literature ReviewQuery 7                    4 – Generate search strategy;cervical vertebrae/exp OR cervical    ...
Systematic Literature ReviewSample appraisal criteria for suitability (from GHTF SG5/N2R8, Appendix D, Table D1)Suitabilit...
Systematic Literature Review                                         4 – Scoring;Sample appraisal criteria for data contri...
Systematic Literature Review                                         4 – Scoring;Assigned GHTF scores for articles (see ea...
Systematic Literature ReviewAssigned GHTF scores for articles (see earlier tables for letter/number codes)                ...
ConclusionEvidentiary data are limited but available evidence does notsuggest a decreased vertebral fusion rate or increas...
Who are your stakeholders? Definition: a person, group, organization, or system who affects or can be affected by an organ...
• Q&A will be sent to you by email.• For more information on Embase and Medical Devices,  check out http://www.embase.com/...
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Medical Devices and Embase webinar - 18 Sept

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Daniel E. McLain, President of Walker Downey & Associates, Inc., an evidence-based product safety and development consultancy located near Madison, WI. presented a webinar, which showcased a soon to be released Medical Device White Paper and walked us through a clinical evaluation using Embase.

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  • When we talk about device classification, what are we talking about and what are the current methods for getting devices to market?
  • So once your device is approved. Then what?
  • Dr. McLain, I believe you have a case study to show us today. Can you please walk us through it?
  • We have come to the end of our webinar. Thank you for attending and thank you Dr. McLain for this fascinating overview of classifying and evaluating Medical Devices in relation to current regulations and to show us first-hand how Embase can support related workflows.  As well as offering deep dives into Embase, we also offer Introductory webinars and the next one is scheduled for the 27th September. You will receive a link to the webinar calendar in a follow-up email and please feel free to register for as many Embase webinars as possible. Or forward to interested colleagues. To read more on Embase and Medical Devices, you may visit our webinar page at  http://www.embase.com/info/medical-device-research. When you leave the session, a survey will pop up. Please fill out what your thoughts are regarding this webinar. In addition, you will receive the Q&A by email shortly and a link to the recording and slides. The White Paper referred to by Dr. McLain at the beginning of the webinar will be available later in the week and we will make sure you all receive a copy.  Many thanks again to you all and to our special guest Dr. McLain. We hope to meet you again soon.
  • Medical Devices and Embase webinar - 18 Sept

    1. 1. Welcome to our Embase webinar! Conducting Medical Device Safety andPerformance Assessments using Embase as a Tool for Completing the Clinical Evaluation Report Your host: Ann-Marie Roche Your presenter: Dr. Daniel E. McLain PhD
    2. 2. Presenter Daniel E. McLain, PhD US AAMI Chairman TC194/WG7 President, Walker Downey & Associates, Inc.Convener, ISO 10993-11: Systemic toxicity evaluation WEBSITE: http://walkerdowney.com EMAIL: dem@walkerdowney.com USA T/F: 608.827.5066 Verona, WI, USA
    3. 3. From the beginning …Paracelsus (1493-1541): "All things arepoison and nothing is without poison, onlythe dose permits something not to bepoisonous.“Note: The concept of dose is a basic principle intoxicology. The phrase, „dose makes the poison‟does capture a fundamental principle of toxicologybut the actual study of toxicology (including theclinical evaluation of a medical device) is much more nuanced andcomplex than this simple statement suggests.Take home = don‟t simply “check the box”; rather, “think outside thebox”
    4. 4. Definition of a Medical Device Any “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of diseases, or intended to affect the structure or any function of the body, and which does not achieve any of its primary intended purpose through chemical action within or on the body and which is not dependent upon being metabolized for the achievement of any of its primary intended purpose.” If the primary intended use of the product is achieved through chemical action or by being metabolized by the body it is usually a drug or biologic. NEXT: Defining your device classification
    5. 5. Defining Device Classification LOW RISK - not intended for use in supporting or sustaining life or to be of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury. Generally referred to as Class l (ls, lm). [Exempt]. MEDIUM RISK - are held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. Generally referred to as Class ll (lla, llb). [PMN/510(k)] HIGH RISK - usually a device that supports or sustains human life, is of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury (Class lll/lV) [PMA/IDE] NEXT: Getting a device to market through the regulatory process
    6. 6. ISO 10993-1 Informative Flow ChartNEXT: Getting a device to market through the FDA process
    7. 7. Areas where an expert opinion can help to reduce testing through materialcharacterization testing and/or NEXT: The device is evidential approved for analysis. market. Now what?
    8. 8. EU, USA, Japan, Australia and Canada (FM 1992)SG5/N1R8:2007 – Clinical Evidence – Key Definitions and ConceptsSG5/N2R8:2007 – Clinical Evaluation MEDDEVSG5/N3:2010 – Clinical Investigations 2.7.1 rev 3SG5/N4:2010 – Post Market Clinical Follow-Up StudiesSG5/N5:2012 – Reportable Events Suring Pre-Market ClinicalInvestigations
    9. 9. MEDDEV 2.7.1 rev 3Effective 2010 - Mandatory for all classes ofmedical devices to maintain their CE MarkingClinical data: Safety and/or performance informationthat are generated from the use of a medical device.Clinical evaluation: The assessment and analysis ofclinical data pertaining to a medical device to verify theclinical safety and performance of the device whenused as intended by the manufacturer.
    10. 10. Clinical EvaluationThe guidance describes the procedure of how a clinicalevaluation is performed in three steps, once the scopehas been defined. They are:1 - Identification of pertinent standards and clinical data;2 - Appraisal of each individual data set, in terms of itsrelevance, applicability, quality and clinical significance;and3 - Analysis of the individual data sets, wherebyconclusions are reached about the performance, safetyand presentational aspects (labeling, patient informationand instructions for use) of the device.
    11. 11. Clinical EvaluationEmbase.com•The Cochrane Central Register of ControlledTrials•522 Postmarket Surveillance Studies•FDA PMN/PMA Database•FDA MAUDE Database•Complaint Database•Etc.,
    12. 12. Clinical Evaluation ReportCan be 4 pages, forexample, http://www.spident.co.kr/down/estempne/Clinical%20Evaluation-EsTemp%20NE.pdf) or more, dependingon the device classification and the available clinical data. CASE STUDY How Embase was used for the identification and retrieval of peer-reviewed global clinical data in order to verify the requisite clinical safety and performance of a Class lll medical device.
    13. 13. Cervical OrthosisAn orthosis designed to limit cervical spine motionto varying degrees (N > 500 manufacturers).
    14. 14. Systematic Literature Review 1 – Define the review (PICO);Analytical PICO framework for the current CE Report Comparison or Intervention orPatient Population Intermediate Patient-Oriented Treatmentof Interest Outcome Outcomes Comparisons MeasurementsPatients undergoing Time to full ambulation, Post-fusion spinespinal surgery for Success rate, failure rate of fusion, duration stabilization with avertebral fusion and rate, adverse events of of stabilization, quality system or componentreceiving a treatment, incidence, of life/satisfaction, vs. other system or“stabilization device” as and/or frequency of concurrent disease or component vs. otherpart of the overall additional surgeries condition with potential treatmentprocedure. to affect the outcome
    15. 15. Systematic Literature Review2 – Develop KEY questions;Does any single medical device “system” have a significant therapeuticdistinction in terms of spinal stabilization or surgical healing outcomescompared to any other “system” for the treatment of spinal stabilization?Does any “component of a system” have a significant therapeuticdistinction in terms of spinal stabilization or surgical healing outcomescompared to any other similar “component of a system” for thetreatment of spinal stabilization?Do patients being treated with “any one system” have a significanttherapeutic distinction in terms of successful or unsuccessful clinicaloutcome for these systems?What are the reported occurrences of successful or unsuccessfulclinical outcomes for the systems?
    16. 16. Systematic Literature ReviewGeneral search terms – Generatethe current terms; 3 considered for search CE ReportSpine, Spinal Fusion, PLIF, TLIF, ALIF, Device Component 1 VBR (few/many)Vertebra, Vertebral Resection Device Component 2BodyIntervertebral, Replacement ImplantInterbodyCervical, Lumbar Arthrodesis WDA (replaces actual client name) Corpectomy Competitor CompaniesDefinitions: PLIF - posterior lumbar I/F, TLIF - transforaminal lumbar I/F, ALIF -anterior lumbar I/F, “Device Component” replaces actual device componentname for purpose of confidentiality
    17. 17. Systematic Literature Review 4 – Generate search strategy;Query Comments ResultsQuery 1cervical vertebrae/exp OR Initial build of primary 41,422cervical vertebrae OR cervical search query for focus onatlas/exp OR cervical atlas OR cervical spine/vertebraecervical spine/exp OR cervicalspine OR atlas/exp OR atlas
    18. 18. Systematic Literature ReviewQuery 4 4 – Generate search strategy;cervical vertebrae/exp OR Removed AND (cervix 165cervical vertebrae OR cervical OR cervical). All Query 4atlas/exp OR cervical atlas OR results are appended tocervical spine/exp OR cervical the CE Report (Authors,spine OR atlas/exp OR atlas Journal, and Title).AND (vertebra OR vertebraeOR vertebral OR intervertebra*OR atlas) AND (halo ORhalovest OR halo vest) AND(crown OR crowns OR ring ORrings OR tong OR tongs ORapparatus)
    19. 19. Systematic Literature Review4 – Generate search strategy;SpineSpine SurgeryChin Med J (China)Eur Spine J (Europe)Acta Neurocuropehirurgica (Wien) (Europe 1.5)Clin Orthop Relat Res (USA)Z Orthop Unfall (German)Zentrabl Chir (German)Acta Chirurgiae Orthopaedicae et Traumatologiae Cechosl(Czech)Archives of Iranian Medicine (Iran)Hong Kong Journal of Emergency Medicine (HK)Zhurnal voprosy neirokhirurgii imeni N. N. Burdenko (Russia)Etc.,
    20. 20. Systematic Literature ReviewQuery 5 4 – Generate search strategy;cervical vertebrae/exp/mj OR cervical Added explosion 36vertebrae OR cervical atlas/exp/mj OR (exp) and majorcervical atlas OR cervical spine/exp/mj OR (mj) terms, andcervical spine OR atlas OR atlas/exp/mj year limitationsOR atlas AND (vertebra/exp/mj OR vertebra AND [specifiedOR vertebrae OR vertebral OR intervertebra* search years]/pyOR atlas/exp/mj OR atlas) AND (halo ORhalovest OR halo vest) AND (crown/exp/mjOR crown OR crowns/exp/mj OR crowns ORring OR rings OR tong OR tongs ORapparatus/exp/mj OR apparatus) AND[specified search years]/py
    21. 21. Systematic Literature ReviewQuery 7 4 – Generate search strategy;cervical vertebrae/exp OR cervical Removed Query 6 AND 1vertebrae OR cervical atlas/exp OR cervical (stabilization ORatlas OR cervical spine/exp OR cervical immobilization) andspine OR atlas/exp OR atlas AND (vertebra added evidence-basedOR vertebrae OR vertebral OR intervertebra* medicine terms asOR atlas) AND (cervix OR cervical) AND (halo additional limitationsOR halovest OR halo vest) AND (crown OR AND ([cochranecrowns OR ring OR rings OR tong OR tongs review]/lim OROR apparatus) AND ([cochrane review]/lim [controlled clinicalOR [controlled clinical trial]/lim OR trial]/lim OR[randomized controlled trial]/lim) AND [randomized controlled[specified search years]/py trial]/lim)
    22. 22. Systematic Literature ReviewSample appraisal criteria for suitability (from GHTF SG5/N2R8, Appendix D, Table D1)Suitability Criteria Description Grading SystemAppropriate device 4 – Scoring; Were the data generated from the D1 Actual device device in question? D2 Comparable device D3 Other deviceAppropriate device application Was the device used for the A1 Same use same intended use (e.g., A2 Minor deviation methods of deployment, A3 Major deviation application, etc.)?Appropriate patient group Were the data generated from a P1 Applicable patient group that is P2 Limited representative of the intended P3 Different population treatment population (e.g., age, sex, etc.) and clinical condition (i.e., disease, including state and severity)?Acceptable report/data collation Do the reports or collation of R1 High quality data contain sufficient R2 Minor deficiencies information to be able to R3 Insufficient information undertake a rational and objective assessment?
    23. 23. Systematic Literature Review 4 – Scoring;Sample appraisal criteria for data contribution (from GHTF SG5/N2R8, Appendix D, Table D2)Data Contribution Criteria Description Grading SystemData source type Was the design of the study T1 Yes appropriate? T2 NoOutcome measures Do the outcome measures O1 Yes reported reflect the intended O2 No performance of the device?Follow-up Is the duration of follow-up long F1 Yes enough to assess (whether) F2 No duration of treatment effects and identify complications?Statistical significance Has a statistical analysis of the S1 Yes data been provided and is it S2 No appropriate?Clinical significance Was the magnitude of the C1 Yes treatment effect observed C2 No clinically significant
    24. 24. Systematic Literature Review 4 – Scoring;Assigned GHTF scores for articles (see earlier tables for letter/number codes)REF No. D A P R T O F S C 1 3 3 2 3 2 2 2 2 2 2 1 1 1 3 2 2 2 2 2 3 3 3 2 2 1 1 2 1 1 4 1 1 1 3 2 1 1 2 1 5 3 3 2 3 2 2 2 2 1 6 3 1 2 3 2 2 1 2 1 7 1 1 1 1 2 1 1 2 1 8 1 1 2 3 2 2 2 2 2 9 3 2 2 3 2 2 1 2 1 10+ 3 3 2 2 2 2 2 2 2
    25. 25. Systematic Literature ReviewAssigned GHTF scores for articles (see earlier tables for letter/number codes) 4 – Scoring;REF No. D A P R T O F S C 1 3 3 2 3 2 2 2 2 2 2 1 1 1 3 2 2 2 2 2 3 3 3 2 2 1 1 2 1 1 4 1 1 1 3 2 1 1 2 1 5 3 3 2 3 2 2 2 2 1 6 3 1 2 3 2 2 1 2 1 7 1 1 1 1 2 1 1 2 1 8 1 1 2 3 2 2 2 2 2 9 3 2 2 3 2 2 1 2 1 10+ 3 3 2 2 2 2 2 2 2
    26. 26. ConclusionEvidentiary data are limited but available evidence does notsuggest a decreased vertebral fusion rate or increasedincidence of re-operation when spinal stabilization devicesare employed. On the contrary, in all evidential data, rarelywas there discussion of adverse or dissimilar clinicaloutcomes for the various comparisons made. The quality ofthe evidence on effectiveness is a key component, but notthe only component, in making decisions about clinicalpolicies, or device effectiveness. Additional factors toconsider include acceptability to physicians andpatients, the potential for unrecognized risks, theconsequences of deferring decisions until better evidencebecomes available, and applicability of the evidence topractice and regulation. For the current deviceapplication, the benefits appear to continue to outweigh the
    27. 27. Who are your stakeholders? Definition: a person, group, organization, or system who affects or can be affected by an organizations actions Embase
    28. 28. • Q&A will be sent to you by email.• For more information on Embase and Medical Devices, check out http://www.embase.com/info/medical-device- research• Our next Embase webinar is on September 27th (4PM CET).• Go to www.trainingdesk.elsevier.com/embase for all training related materialsPlease fill out the survey that appears on yourscreen after leaving the webinar.

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