med dev webinar 27052015 total

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Finding the right

Medical Device

information in Embase

Presented by Sherry Winter and Ivan Krstic

May 27, 2015

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How Embase delivers critical information needed for successful

regulatory submissions (Clinical Evaluations and Post-Market

Surveillance)

• Device performance

• Device safety – finding Device Adverse Reactions

• Comparison of device with existing devices

Agenda

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Webinar control panel:

• ‘Ask a question’ for

questions and comments

• Option for full screen view

• Q&A at the end

Need to Know

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• Adverse device effects

• Information on competitors

• Comparisons between 2 or more devices

• Quality of Life/benefit studies

• I don’t search Embase for Medical Device information

Poll – What Medical Device information do you look for

in Embase?

How does

Embase support

Medical Device

research?

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Clinical Evaluations –

Gather information for successful regulatory submissions

Scientific literature lets you:

Potentially relevant

literature identified

Literature excluded,

with reasons

Literature excluded from clinical

evaluation, with reasons

Literature retrieved for

more detailed assessment

Literature with relevant useable data

Included in the clinical evaluation by outcome: • Device performance

• Device safety

• Device comparability (if applicable)

Have more successful reg.

submissions/ acquire CE mark

Lower development costs by

avoiding a clinical trial

Find all important information on

AE’s for similar devices

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Post-market surveillance –

Companies face growing regulatory pressure

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Post-market surveillance –

Avoid missing critical information

Conduct post-market surveillance • Have you identified all adverse effects for

your device? • Are there emerging adverse-event trends in

your device or similar devices that will influence your risk management strategy?

Comply with regulatory requirements • Do you have an effective literature

monitoring solution to ensure regulatory compliance?

Medical Device adverse event reporting rising rapidly. Device Matters. 2013. http://www.devicematters.com/article/medical-device-adverse-event-reporting-rising-rapidly

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Post-market surveillance/Device Safety

With thorough monitoring of

scientific literature, you are more likely

to identify critical AE’s, preventing:

Why Embase?

• Deep indexing - >3000 med dev terms

• Adverse device effect subheadings

• Comprehensive, current

• Search for classes of drugs/devices

• Weekly alerts

• Automate content delivery – API

• Literature monitoring solution with

QUOSA

Possible fines due to non-compliance

Damage to company reputation

Likelihood of review by governmental body

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Embase and Medical Devices

Medical device-specific indexing will help preparing for a clinical evaluation or doing post-market

surveillance to run more precise searches on the coverage of medical devices in the literature.

Device Search form

Device field limits

Device subheadings

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Track adverse effects and leverage comparison data

that’s unique to Embase

Subheadings let you search for a particular product, device type or class in relation to an adverse effect, a comparison, device economics or the mention of a clinical trial

Overlap with PubMed/MEDLINE quickly shows unique content

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1

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Indexing and filters support comparison/competitive

analysis

Identify and group literature by class of devices and device types.

View all manufacturers and trade-names associated to that device class or type.

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2

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Let’s take a look in

Embase…

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Indexing medical device items

1. All medical devices for which device-related information is given in the item are

indexed. To find medical devices, the whole record is read, including “materials

and methods”.

2. A medical device is indexed using the most specific term available in Emtree to

cover the device.

3. If an appropriate specific term to index the medical device is missing from

Emtree a new term (candidate term) is proposed/used.

4. Device trade names are index.

5. Device manufacturer names and country codes are indexed.

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Indexing medical device items (cont’)

device term medical device link linked disease term

hip prosthesis adverse device effect prosthesis loosening

hip prosthesis adverse device effect prosthesis infection

6. The appropriate medical device subheadings are indexed:

• Adverse device effect

• Device comparison

• Device economics

• Clinical trial

7. If medical device links are relevant, the appropriate device (triple) link/s are

indexed (triple-indexing).

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Indexing shows what’s relevant and what might be

missing…

Manufacturer Embase Not in MEDLINE

Abbott 6,503 1,283

Beckmann 9 2

Boston Scientific 10,212 1,854

Clearstream 7 1

Heartsine 7 1

Oceana Therapeutics 7 3

Merit 155 37

Sandoz 35 11

Siemens 24,046 3,583

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Clinical Evaluations –

Gather information for successful regulatory submissions

Potentially relevant

literature identified

Literature excluded,

with reasons

Literature excluded from clinical

evaluation, with reasons

Literature retrieved for

more detailed assessment

Literature with relevant useable data

included in the clinical evaluation: Device performance

Device safety

Device comparability

(if applicable)

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Scenario: device manufacturer wants to market a new vascular stent

Goal: Find critical information needed for successful regulatory

submissions (Clinical Evaluations and Post-Market Surveillance) that

includes:

• Device Performance

• Comparison of device with existing devices

• Device Safety – finding Adverse Device Effects

Demo

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Number of records on medical

devices indexed in Embase

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Clinical performance data

('vascular stent'/exp OR 'vascular stent‘ OR 'artery stent' OR

'endovascular stent' OR 'genesis stent' OR 'aortic aneurysm

endovascular graft' OR 'arterial stent' OR 'bioresorbable vascular

stent' OR 'stent retriever‘)

AND

([cochrane review]/lim OR [systematic review]/lim OR [controlled

clinical trial]/lim OR [randomized controlled trial]/lim OR [meta

analysis]/lim)

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Device comparison (subheading)

'vascular stent'/exp/dv_dc

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Safety data

'vascular stent'/exp/dv_am OR

(('vascular stent'/exp OR 'vascular stent‘ OR 'artery stent' OR

'endovascular stent' OR 'genesis stent' OR 'aortic aneurysm endovascular

graft' OR 'arterial stent' OR 'bioresorbable vascular stent' OR 'stent

retriever‘) AND ('adverse device effect'/lnk OR 'complication'/lnk OR

'postoperative complication'/exp OR (postoperative NEXT/2

complication*) OR (complicat* or 'risk'/exp or risks) OR ‘side effect’/exp

OR (adverse OR side OR undesirable OR lack) NEXT/2 effect*))

Quick search using subheadings:

'vascular stent'/exp/dv_am

Comprehensive search using subheadings and generic terms:

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In Conclusion

Feature Embase

Search for drug/device trade name

/manufacturer name

Search using Drug or Device Search form or use results filters

Subheadings: Adverse device effect,

Device comparison, Device economics,

Clinical Trial

Select these subheadings from the Device search form

Indexing Embase has more index terms (e.g., >102K records are indexed

with stent, and it includes several narrower terms)

Triple Indexing Only on Embase.com – For example, if search for Device

comparison, the medical devices being compared are shown. Same

with Adverse device effect (not relevant for economics or clinical

trials)

Medical device manufactures rely on scientific literature to:

• Design a unique product that meets key needs

• Inform reimbursement strategies

• Comply with pre- and post-market regulations

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• Q&A will be sent to you by email and for more information and

questions please contact your regional office

• Our next Embase webinar will take place June 24, 2015 and will

focus on how Embase and QUOSA are used in pharmacovigilance

as a literature monitoring solution.

• Please click on at Embase.com for Embase training materials,

including recordings of all archived webinars from 2014 and 2015

Thank you!

Please fill out the survey that appears on your

screen after leaving the webinar.

Thank you!

Contact:

Sherry Winter, PhD

Solution Marketing Manager

s.winter.1@elsevier.com

Ivan Krstic, PhD

Product Development Manager

i.krstic@elsevier.com