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Medical Device Reporting

Presented by:

Dr. Joyce de Langen, Doctor of Pharmacy

Sr Solution Manager Pharmacovigilance

Elsevier Life Sciences

Date: 27th of September 2016

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Outline

• What is a medical device?

• Classification of Medical Devices

• Regulations

• Medical device adverse event reporting

• How does Elsevier support your Medical Device Development and

monitoring?

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What is a medical device?

• A medical device is "an 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, treatment/cure, mitigation or

prevention of disease in humans or animals

− Does not act through chemical actions or which does not need to

be metabolized before acting >> that means which is no drug

− Is recognized in official National Formulary or USP

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm211822.htm

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Types of Medical Devices

Capital Equipment

Instruments

Disposables &

Accessories

Implantable devices

Monitoring systems

Reagents

Computerized Medical systems

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Levels of FDA Medical Device Classification

Class I

Low Risk

Bandages, dental floss,

examination gloves

Class II

Medium Risk

Electric wheelchair,

Infusion pumps,

Class III (life-sustaining)

High Risk

Pacemakers, heart valves, brain stimulators, coronary stent

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US Approval Process for medical devices

http://www.presentationeze.com/presentations/medical-device-validation/medical-device-validation-full-details/validation-requirements-medical-

device-design-manufacture-processing/

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Medical Device Market is Growing

https://www.zionmarketresearch.com/news/global-medical-device-coatings-market

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Increase in Medical Device Revenue leads to increase in

adverse event reports for medical devices

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Origin of Medical Device Adverse Event Reports

https://www.tga.gov.au/sites/default/files/medical-devices-post-market-vigilance-statistics-2014.pdf

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US: FDA Medical device Reporting 21 CFR 803

A MDR Reportable Event is defined as:

• An event that user facilities become aware of that

reasonably suggests that a device has or may have

caused or contributed to a death or serious injury of a

patient

OR

• An event that manufacturers/importers become aware of

that reasonably suggests that one of their marketed

devices

– May have caused or contributed to a death or serious injury

– Has malfunctioned and that may potentially cause or

contribute to death or serious injury when the event would

recur

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Another few definitions…

• Becomes aware:

– An employee of the manufacturer/importer or device user facility who is

required to report medical device events has received/acquired information

that reasonably suggests a reportable event has occurred

• Caused or contributed also includes events occurring as a result of:

– Failure, malfunction, improper or inadequate design, manufacture, labelling

or user error

• Serious injury or illness includes any event that:

– Is life-threatening

– Results in permanent disability of patient or impairment of body functions

– Requires medical /surgical intervention to prevent permanent disability/

impairment

• Malfunction refers to failure of a medical device to meet its performance

specifications

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Medical Device Problems or Adverse Events

• An event whereby a medical device has, or may have, caused or

contributed to a death or serious injury.

• Includes events resulting from:

– Problems with Instructions/labeling/packaging

– Failure to work as intended/malfunction

– Improper or inadequate device design

– Manufacturing problems

– Interactions with other devices

– Defects

– Software problems

– Use errors

– Combinations of the above

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Mandatory MDR reporting requirements

Reporter What to report To whom Timelines for

reporting

Manufacturer Reports of deaths, serious

injuries and malfunctions

FDA Within 30 days of

becoming aware

Manufacturer

-Specific type of events

upon request by FDA

-Event that requires

remedial action to prevent

an unreasonable risk of

substantial harm to the

public health

FDA Within 5-days of

becoming aware

(5-day report)

Importer Reports of deaths and

serious injuries

FDA and

manufacturer

Within 30 days of

becoming aware

Importer

Reports of malfunctions Manufacturer Within 30 days of

becoming aware

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Summary of mandatory reporting requirements- Continued

Reporter What to report To whom Timelines for

reporting

Device User

facility#

Device-related Death FDA and

manufacturer

Within 10 work

days of becoming

aware

Device User

facility

Device related Serious

Injury

Manufacturer

(FDA only

when

manufacturer

is unknown)

Within 10 work-

days of becoming

aware (5-day

report)

Device User

facility

Annual summary of death &

serious injury reports

FDA January 1st of the

preceding year

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm2005737.htm#2

# hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical

facilities.

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Manufacturer MDR Requirements

• Supplemental reports are required when

-New information comes available after the submission of the initial

report

-Report within 30 days after receiving the additional/corrected

information

• Submit required information on FDA MedWatch Form 3500A or in

electronic equivalent as approved.

• Implement a complaint procedure to ensure that complaints are

evaluated to determine whether the complaint represents in fact an

event which should be report under 21CFR803

• Develop, maintaine, implement MDR Standard operating procedures

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Medical Device Non-compliance issues during FDA Inspections

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FDA- Sent warning letters to 12 Medical Device Companies

http://www.massdevice.com/fda-sends-warning-letters-12-medical-device-companies/

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Poll: Multiple adverse events on different days in same

patient with same device

How you report adverse events involving the same patient and

same device but occurring on different days?

A) Submit one report describing all occurrences of the reportable

event in the patient.

B) Submit one report describing all the reportable events in the patient

for each day the event occurred.

C) Submit one report describing the reportable event for the patient

for each occurrence

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Poll: Multiple adverse events on different days in same

patient with same device

How you report adverse events involving the same patient and

same device but occurring on different days?

A) Submit one report describing all occurrences of the reportable

event in the patient.

B) Submit one report describing all the reportable events in the patient

for each day the event occurred.

C) Submit one report describing the reportable event for the patient

for each occurrence

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EU Directives for Medical Devices

• Active Implantable Medical Device Directive

AIMD 90/385/EEC

• Medical Device Directive MDD

93/42/EEC

• In Vitro Diagnostic Device Directive

IVDD

98/79/EC

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Stakeholders Medical Device Marketing

• Manufacturing Medical device Manufacturers Subcontractors

• Local entities implementing MDD at national level in each EU member state

Competent authorities

• Organizations that are authorized to perform audits manufacturers QMS and test/assess the compliance of medical devices

Notified bodies

• Any Manufacturing company that has no affiliate in EU Authorized

representatives

• Companies distributing Medical Devices in EU Distributors

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Post-marketing Surveillance (PMS) of Medical Device

Reporting in EU

• Implementation of PMS is required for all Medical devices sold in EU

• PMS should include a systematic review and analysis of

postproduction information including:

– Clinical follow-ups

– Quality complaints

– Customer feedback,

– Vigilance

– New scientific Information

– Literature

• Manufacturers need to develop proactive plans for PMS

• Systematic record management of PMS data

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Vigilance Reporting for Medical Devices in EU

• Notification of Competent Authorities about Incidents occurring with

medical devices

• Qualified Representative to submit Medical Device Incident Reports

Incident is defined in the EU Medical Device Regulatory Documents as

• Any Malfunction or deterioration in the characteristics and/or performance

of a device, including also insufficient labeling, insufficient instructions for

use , that may lead to the death of a patient or to a serious deterioration of

his/her health

• Any technical or medical reason in relation to the characteristics or

performance of a device leading to systematic recall of devices of the same

type

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Software as Medical Device

• Software becomes a medical device when the

manufacturer or supplier intends for the software to be

used in:

– Diagnosis

– Prevention

– Monitoring

– Treatment or alleviation of disease

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Examples of events with Software Medical Devices

• Software problems

– Vital signs monitor did not transmit information to

central station

– Software glitches with new software installation

– Virus infects device operating software

– Day-light savings software considerations

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Software verification and validation is an essential tool for

ensuring medical device software is safe.

http://medicaldeviceacademy.com/category/software-verification-and-validation/

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Literature as source of MDR reportable events

…..Reports of deaths or serious injuries. You must

submit a report to us, and a copy of this report to

the manufacturer, as soon as practicable, but no

later than 30 calendar days after the day that you

receive or otherwise become aware of information from

any source, including user facilities, individuals,

or medical or scientific literature, whether

published or unpublished, that reasonably suggests

that one of your marketed devices may have caused or

contributed to a death or serious injury. …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=803&showFR=1

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How does Elsevier R&D Life Sciences Portfolio support

MDR Reporting?

Embase supports Medical Device Development and PMS

Quosa PV support triage and review of literature to identify reportable events

Journals like Smart Health

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Introducing QUOSA PV : Elsevier’s GxP-compliant PV-

solution for literature management

Conference

Documents

Online literature

database

Journal RSS

Feeds

PSURs

ICSRs

OTHER

SAFETY &

COMPLIANCE

REPORTS A combination of software and services that allows customers to

reduce risk, remain compliant and ensure that workgroups have

the latest scientific literature

Supervisors

Track deadlines

And bottlenecks

• Automatic alerts import

• Article deduplication

• E2B case data export

• Document listing

exports in Vancouver

format for PSURs

Administrators

View all aspects of

the review process

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Embase supporting Medical

Device Development and Post

Marketing Surveillance

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Thank you!

For more information about

Embase and Quosa PV visit also

https://www.elsevier.com/rd-

solutions

Dr. Joyce de Langen

Sr Solution Manager Pharmacovigilance

j.delangen@elsevier.com