analysing the latest developments and examining the future of wireless medical technology...

© 2013 UL LLC

Analysing the latestdevelopments and examiningthe future of wireless medical

technology and potentialopportunities for growth

Dr. Terenzio FacchinettiDirector Business Development

UL Life & Health Sci

MedTech UK - May 2014

Click t

o buy NOW!

PDF-XChange

www.docu-track.com Clic

k to buy N

OW!PDF-XChange

www.docu-track.com

http://www.docu-track.com/buy/


excellence

2

…the today winning strategy

For manufacturersHospitals & Care givers

Society

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



3

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



4

healthcare is already changing

…and continues to evolve

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Mobile devices are coming onto hospitals & non clinical healthcare

5

Apps will manage the work

Sensors & Communication will be core in Healthcare

Remote Healthcare… what is REMOTE…?

Which technologies are they replacing?

Use of Wireless and Smart Devices will be “the norm”

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

ht

Remote healthcare, Telehealth will be “the norm”

Medical Devices will work in interoperable ecosystems

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



The core of the eHealth innovation is torevolutionize patient monitoring & treatment

6

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

ht

SECTOR TECHNOLOGY & PRODUCTS

Emergency MDs, EHR-EMR-EPR for Ambulance /Flight / Working places, etc.,

OR-IC MDs, EHR-EMR-EPRImaging – Robotic - Micro/nanotechnologies

MDs, Microcameras, etc.

Diagnostics MDs, EHR-EMR-EPRHospitalized patients - Therapy andtreatment - Prescription

Prescription, Drug level control, MDs,EHR-EMR-EPR, HIT

Remote patient monitoring & treatment Post hospitalization / Chronictreatment, MDs, EHR-EMR-EPR

Self-monitoring and self-management MDs, EHR-EMR-EPR, HIT

Wellness & Rehabilitation EHR-EMR-EPR, HITPersonalized medicine - New drug anddevelopments

HIT

Research - Epidemiology HIT, Big data, Early warning,

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Disclaimer goes here

Healthcare is EVOLVING ! Healthcare is going DIGITAL

7

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

ht

Costs C

ontainement

THENEW HEALTHCARE

Under Construction

P

&

S

SAFETY

Improve Q

uality HC

R E G U L A T O R Y

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Stand Alone MD

Digital

System / PnP

System of Systems

digitization

HEALTHCARE INTEROPERABILITYINTEGRATION driven future Who integrates the best wins !

Stand Alone MD

Underwriters Laboratories Copyrights UL Copyright and not for distribution

integration

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



9

Plug&Play

interoperability

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



10

POTENTIALNEW

ENTRANTS

TODAYINDUSTRY

COMPETITORS

SUPPLIERSbargaining power

SUBSTITUTES

UL CLIENTSbargaining

power

HEALTHCAREMARKET

Health information technology (HIT) willdrive buying decisions

Healthcare will become „value“ competitive

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

ht

Start UpIT

Big vs.Flexible-Fast-High Tech

ValueProvided

OEM, Quality,Technology

Start UpIT

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Medical Device Connectivity Market (MDC)Wired hardware, Wireless hardware and Software

Forecast 20192012 - USD 3.5 bill.2019 - USD 33.5 bill. (est.)

North America: largest market due toincreasing adoption of EMRs

Transparency Market Research

11

17 bill $/year - preventable hospital readmission in USA(Center of Medicare and Medicaid)

36 bill $ (2013-2018) saving through remote monitoring(Jupiter Res. Study)

Reducing office visit (remote HC)Earlier identification of problems and interventionEmpowerment of individuals for more accurate personal health data and infoImproved forecasting of medical issues and trends

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



12‘The Challenge of Speed’ conducted by the Economist Intelligence Unit, and sponsored by Ricoh

EUROPESenior executives (Care providers and

manufacturers) across Europe

73 %• Need to adapt to changing business conditions• Need to be faster• Become better positioned due to:

-ever-increasing globalization-technological innovation,-rocketing consumer expectations

51%• Current business model will be significantly

impacted by the new technological platforms.• Technology and R&D exposed to high risk• Organizations need to change fast (71%)• Pressure is perceived (78%)

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



13

How to respond ?

• Introduction new technologies• Improvement of core processes• New hiring• Acquisitions and client binding-

loyalty• Optimization supply chain• Data acquisition and analysis• Change in patient management• Preventive healthcare decisions

and activities• Changes in R&D‘The Challenge of Speed’ conducted by the Economist Intelligence

Unit, and sponsored by Ricoh

Problems to success• Interoperability

• Presence of various initiatives notnecessarily coordinated and in somecases conflicting

• The “right” technology(ies)

• Processes to address the newtechnology and their optimization

• Effective integration of IT systems

• Lack of clear business case andtimelines for healthcare responsible

• Little flexibility

EUROPESenior executives (Care providers and

manufacturers) across Europe

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



© 2013 UL LLC

Managing patient risk througheffective product design andintegrating risk management

in product life cycle

Terenzio Facchinetti – Richelieu Quoi

MedTech UK - May 2014

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



A Growing “Ecosystem” of Healthcare Systems

Slide 15http://www.cs.purdue.edu/homes/bertino/IIS-eHealth/images/ehealth_full.jpg

MD

EHR-EMR mHealth

SYSTEM(s)&

Interoperability

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

ht Errors in communication dueto inadequate interoperability,such as the transmission of

test results inaccurately or forthe wrong patient, do occur

and can lead to patient harm.

SAFETY !

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com

http://www.cs.purdue.edu/homes/bertino/IIS-eHealth/images/ehealth_full.jpg



RISK and RISK Levels in connected Health

Low risk(example: wellness)

16

High risk(example: remote drug intake and

therapy etc.)

• Risk and risk management in Healthcare isdifferent than in IT or communication technology

• Wireless and Conflicting systems• Coexistence• Reliability of large wireless networks• Downtime• Reboot• Wi-Fi access• Proprietary technologies and conflicting

requirements, maintenance, updates etc.• Knowledge and know-how user and supporters• Network is a dynamic entity continuously

changingDr. Terenzio Facchinetti Copyright

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



• Design Objectives• Technical Objectives• Usability Objectives• SAFETY OBJECTIVES• Security Objectives

An hypothetical CASED

r. Te

renz

io F

acch

inet

ti C

opyr

ight

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com




Safetyfreedom from unacceptable risk [ISO 14971: 2007]

Underwriters Laboratories Copyrights

Finding The Weakest Links & Emerging Properties

Examples of Safety ApplicableStandards• 60601-1• 60601-1-2 EMC• 60601-2-2-4 (infusion pumps)• 60601-1-6 (Usability)• etc.

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



RISK Harm

Hazard

Residual Risk

Hazardous SituationCause Unintended Consequences

Combination ofprobability to causeharm and its severity

The potentialcause of theharm, that posesa level of threatto life, health,property, orenvironmentType of hazards:energy,chemical,biological,operational,informational

The producer ofan effect

A circumstance in whicha person is exposed to ahazardCircumstance in whichpeople, property or theenvironment are exposedto one or more hazards

Risk remainingafter risk controlmeasures havebeen taken

outcomes that are not the onesintended by a purposeful action

RISKS - Wireless & Conflicting systems – Downtime - Proprietarytechnologies and conflicting requirements - Maintenance, updates etc., Know-how user and supporters, Interoperability (Technical, Semantic, Syntactic, etc.)– Reliability – etc.

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

ht

Consequenceof adverse

event

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Severity and Probability

Severity

Catastrophic DeathCritical Permanent impairment orlife threateningSerious Medical interventionMinor No medical interventionNegligible Inconvenience ortemporary

20

Probability scales

ISO 14971 Other

Frequent >10-3 highly likelyProbable < 10-3 and >= 10-4 will occurOccasional < 10-4 and >=10-5 may occurRemote < 10-5 and >=10-6 possible but

unlikelyImprobable < 10-6 very unlikely

Key elements (mfc)• Role and responsibilities• Risk assessment process (organized way to analyze and evaluate risk)• Risk management fit into the Medical IT system/network lifecycle• Objective evidences & documentation (testing, validation, verification)

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Hazard & Hazardous SituationSAFETY freedom from unacceptable risk [ISO 14971: 2007]

21

• What are the hazards dangerous to the system ?• How do they produce their dangerous effect ?

• What could give raise to an hazardous situation ?• What needs to happen to expose the system to hazards ?

1 hazard -> single or multiple effects/harm

1 hazardous situation/cause -> single ormultiple hazards / harm

Risk control measures: how do lower or eliminate the risk

CauseHazardHazardous situationUnintended consequences

Lowering• Probability cause/hazard• Probability of hazardous situation• Probability of Unintended consequences• Severity of unintended consequences

HARM

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Medical Device Software Recalls

Failure modes in medical device software: an analysis of 15 years of recall data by Dolores R. Wallace and D. Richard Kuhn,International Journal of Reliability, Quality, and Safety Engineering, Vol. 8, No. 4, 2001

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



IEC 62304 SW Lifecycle & Process

Software developmentprocess

Software configurationmanagement process

Software risk-management process

Software problemresolution process

Software maintenanceprocess

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

ht

oversee thereleased product

Repeatable, predictable methodologies that improveproductivity and quality of software deliverables

identify hazards arising fromfailure of software to perform

as specified

identify and maintain theconfiguration(s) of software

deliverables and to document them

to identify, analyzeand resolve any gaps

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



The Health IT Sociotechnical System&

Their Safety Impact

24

Stakeholder Safety Impact / SectorDevelopers Design & DevelopmentVendors R&D, Production, SalesOrganizations Implementation Heterogeneous

experience & expertizeUsers Heterogeneous experience &

understandingPatients Heterogeneous understandingTechnology Disrupting solutions

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com




Mobile ApplicationsMobile Medical ApplicationsFDA & MMA

„DEVICE“ asdefined under

Section 201(h) ofFederal FD&C Act

Not meeting this„DEVICE“ definition

of „device“

FDAnot regulated



Meeting „DEVICE“definition, but low

risk to public

FDAEnforcement

discretion



Meeting „DEVICE“definition, posing

risk to public

FDAApps are defined

as MMAMMA Guideline

applies

25Dr. Terenzio Facchinetti Copyright

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



WIRELESS HEALTHCAREWireless Health - mHealth - remote healthcare

26

WAN LAN NAN-NFC

Connectivity Integration Interoperability

DEVICE to Device M2MRemotely InstallationRemotely Updates

Sends Various CommandsOrganize and Monitor devices operations

Systems

INTENDED USE of a type of MD INTENDED USE of a type of system

SAFETY & EFFECTIVENESS

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Mobile Health (mHealth)• Mobile Health or mHealth emerged as a sub-segment of eHealth, the

use of information and communication technology (ICT) for healthservices and information.

MobileHealth

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Trends (Devices and Infrastructures)• The development of smarter and robust devices and infrastructures has

helped to increase the awareness and growth of eHealth.

• Smaller and compact mobile devices which are technologically versatileare helping to ship the way healthcare is delivered.

MobileHealth

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Trends (Technological Advancement)• Wireless Technology Road Map

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Key wireless technologies for mHealth

Bluetooth andBluetooth Low

Energy

Low power andshort range

Well establishedtechnology

Wi-Fi 802.11

Mainly802.11b/g/n ISM

2.4GHz band

Very few802.11a/n 5GHz

band

ZigBee

Offers meshtopology betweendevices (many-to-

many)

NFC / RFID

Very low power

Short range

3G HSPA+

Offer high speedand bandwidth for

WWAN

4G LTEThe Future

Offer very highspeed

Multiplebandwidth for

WWAN

Use of IP address

• Bluetooth is the commonly used technology in the WPAN / BAN setup

• Wi-Fi, 3G HSPA and 2.5G EGPRS seems to be the primary wirelesstechnologies used in the WWAN setup

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Bluetooth Health Device Profile (HDP)• Bluetooth Special Interest Group (SIG) incorporates Bluetooth Health Device

Profile (HDP), these are profiles to further enhance user connectivity.

• Bluetooth SIG mandates the usage of the IEEE 11073-20601 for HDP

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Bluetooth Industry Scheme - Scope• Bluetooth Devices require both Bluetooth Qualification and Regulatory

Type Approval

Bluetooth Devices

End Product &SubsystemComponent

Other Devices

Qualification Program

Bluetooth Logo /License

Test Plan / Test casesEvaluation

Regulatory ApprovalPermission to use

Spectrum & Sell in aregion

R&TTE, FCC, MDDetc…

Global MarketSell Devices LegallyUse Bluetooth Logo

Legally&

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Key mHealth Segments

• Wireless body area network (WBAN) devices has given rise to these keymarket segments:

WearableSensors

Sports andFitness

HomeMonitoring

and AssistedLiving

RemotePatient

Monitoring

• WBAN – is a subset of WPAN.• BAN very limited coverage• Only a person’s body.• Network app dealing with

specific person and not entiresurroundings

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



The Cloud (Wireless Accessibility)• Introduction and emerging use of Cloud OS, a browser based OS that

provides access to multiple internet based apps.

• Mobility has become the prime reason for cloud adoption.• Allows apps and data to be stored on the internet instead of local hard drive

Body / Personal Area Network

Cloud Environment

Private / Internal Cloud

Hybrid Cloud

Public Clouds

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Wireless & Medical Devices Regulations

Management Standard

ISO 13485 QualityManagement System

ISO 13485 QualityManagement System

ISO 14971 Application ofrisk management to

medical device

ISO 14971 Application ofrisk management to

medical device

RegulatoryRequirements

FDA CFR 21 part 11 /part 820 / part xx

FDA CFR 21 part 11 /part 820 / part xx

European MedicalDevice Directive93/42/EEC• EMC Directive

2004/108/EC

European MedicalDevice Directive93/42/EEC• EMC Directive

2004/108/EC

FCC CFR 47 part 15 /part 18 / part xx

FCC CFR 47 part 15 /part 18 / part xx

R&TTE Directive1999/5/EC• EMC Directive

2004/108/EC• Low Voltage

Directive, 2006/95/EC

R&TTE Directive1999/5/EC• EMC Directive

2004/108/EC• Low Voltage

Directive, 2006/95/EC

MedicalDeviceProduct

Standards

IEC 60601family

IEC 60601family

IEC 61326IEC 61326

Telecommunication

Standards

ANSI C63.18ANSI C63.18

ANSI C63.19ANSI C63.19

ETSI• ETS 300339• ETS 300683• ETSI EN302

195-1

ETSI• ETS 300339• ETS 300683• ETSI EN302

195-1

IEEE 802.XIEEE 802.XProcess StandardsIEC 62304 Medical DeviceSoftware – Software lifecycleprocesses• Development and

maintenance of a safesoftware system

IEC 62304 Medical DeviceSoftware – Software lifecycleprocesses• Development and

maintenance of a safesoftware system

Finalizing &marketing of

WirelessMedical Device

Product

Must meetrequirements

Requires



Affects Approval

RegulatesCompliance

Affects Approval

Affects Approval

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Wireless Medical Devices Concerns• Information Integrity

- Assurance that the information presented is unmodified by unwanted interceptors orinterference.

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Wireless Medical Devices Concerns• Security

- Is the wireless technology easily accessed and decoded by unauthorized persons inits transmission?

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Wireless Medical Devices Concerns• Radio Frequency (RF) Performance

- Characteristics of the radio element normal and extreme operating conditions withregards to its sensitivity and susceptibility.

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Wireless Medical Devices Concerns• Electromagnetic compatibility (EMC)

- Can the system withstand interference from otherelectrical or electronic equipment and environments?

• Immunity testing is carried out on devices, equipment, orsystems to test performance degradation in the presence ofan electromagnetic disturbance

• Emissions Testing - Radiated and conducted emissionsare measured to verify that a product cannot cause harmfulinterference with other electrical or electronic equipment andcommunication networks.

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Wireless Medical Devices Concerns• Wireless Safety

- Radio Frequency exposure to the human body, the rate at which electromagneticradiation is absorbed the biological tissue.

• SAR evaluation is applicable to cover the RF safety as defineby the FCC and R&TTE. This process involves near fieldmeasurement of the e-field in biological tissue.

• Other methods such as calculations or numerical modelling canbe used.

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Wireless Medical Devices Concerns• Coexistence

- How does the device operate when amongst other devices of similar device nature.

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Wireless Medical Devices Concerns• Interoperability

- Device to device interaction and exchange of data.

• Organisation Such as Continua Health Alliance has setup an programto assist with medical device interoperability

• They are looking at the technology used

• The way in which data is sent

• Device-to-device interaction

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Continua Certification Scheme - Scope• Medical Devices require both Continua Qualification and Regulatory Type Approval• For device supporting WAN the appropriate certification must be addressed

Medical DevicesEnd Product &

SubsystemComponent

Other Devices

QualificationProgram (PAN)

BluetoothLogo

RegulatoryApprovalPermission to

use Spectrum &Sell in a regionR&TTE, FCC,

MDD etc…

Global MarketSell Devices

LegallyUse ContinuaCertified Logo

Legally

&

ZigBeeLogo

USBLogo

QualificationProgram (WAN)

GCF

PTCRB

ContinuaCertification

Test Hardware /Software E-2-E PAN

devices

InteroperablePath

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Regulatory Approvals - North America FCC 47 CFR &• Federal Communications Commission (FCC) regulates products that use the

radio spectrum and certification is a mandatory process for radio products

• The FCC promotes efficient use of the radio spectrum:• Develops technical standards for radio frequency equipment (intentional or

unintentional)• The Code of Federal Regulations “Title 47: Telecommunications” defines the technical

standards applicable to different types of equipment• FCC defines the rules and procedures required to commercialize and operate the

equipment in North America.

• Essential requirements:• EMC, unintentional emissions• RF, intentional emissions• RF safety, maximum exposure to electromagnetic fields

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Regulatory Approvals - European R&TTE Directive• The Radio Equipment and Telecommunications Terminal Equipment (R&TTE)

Directive – 1999/5/EC• Establishes the regulatory framework for placing wireless devices on the market.

• European CE marking Directives – Self declaration

• Who is responsible for ensuring compliance?• The person placing the product on the market• Not necessarily the product manufacturer

• The end host product must meet the essential requirements:• Article 3.2 – Radio• Article 3.1b – EMC• Article 3.1a - Safety, including RF Human Exposure to Electromagnetic Field

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



• Technical specs std• Process std• Safety std• System eng.

Integration of Medical devices into IT Network

46

Stand aloneMD

Proprietarynetworkedmedicaldevices

MD linked tohospitalnetwork

MD Plugand Play

Dr. Terenzio Facchinetti Copyright

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com




THE CLINICAL ENVIRONMENTexample „the ICE“

47

ICE Supervisor

Ext.Interface

NCNetwork Controller

DataLogger

Interface

MDInterface

MD

APP APP APP

INTERFACE

Adaptation from ASTM 2761-09

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Systems & Components…

Slide 48

…every “component” could be a “system” and…

every “system” could be a “component” of an evenbigger “system”

Dr. Terenzio Facchinetti Copyright

networks use cases 2 components

Layers of complexity

use cases 1

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Disclaimer goes here 49

SYSTEMCollectionof parts

behaviour

Safety System Approach

SAFETY & SYSTEMSAFETY - freedom from unacceptable risk

No behaviour

?

?

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



Interoperability &”System” approach

http://www.telemedicineinsider.com/

Acute Care Telemedicine

(Highly IntegratedSystems) (Highly Distributed Systems)

http://www.dailymail.co.uk/news/article-2032378/Space-age-sickbay-diagnoses-disease-need-tests.html

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

ht

Safety is a “System-level property”A collection of safe devices does notmake them necessarily a safe system.

“component(s)” and“components

capabilities” mustsatisfy “systemsrequirements”

Is the SystemSafe?

New EmergingSafety

Properties

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com

http://www.telemedicineinsider.com/

http://www.dailymail.co.uk/news/article-2032378/Space-age-sickbay-diagnoses-disease-need-tests.html




PRIORITIES

51

• Need for standardization• Align incentives, expectations, roles and responsibilities.• Drive Patient safety with systems approach to design

and implementation• Focus on human behavior first• Improve regulatory clarity• Streamline clinical workflow to improve return on investment• Remove barriers with shared continuous learning

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com




CONTRIBUTING TO SOLUTIONS

52Dr. Terenzio Facchinetti

AAMI-UL 2800

Underwriters Laboratories Copyrights

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



AAMI-UL 2800 in the “big picture”

53

ClinicalScenario

InteroperableScenario

System Safety /Interoperability

Connectivity /Interoperability (HL7, IEEE.

Continua, etc…)

Enabling Technologies (Wi-Fi,Bluetooth, Zigbee, Ethernet, etc…)

AAMI-UL 2800

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



…but: “Who is Responsible”

Copyright © 2013 UL LLC

54

The “Manufacturer” of anyproduct which is1

1) section 201(h) of the Federal Food Drug & Cosmetic(FD&C) Act it will be regulated by the FDA

Preamble5 Comment #4“…In fact the new regulation is less prescriptive and gives the

manufacturer the flexibility to determine the controls that arenecessary commensurate with risk.

The burden is on the manufacturer, to describe the types anddegree of controls and how those controls were decidedupon…”

“an instrument, apparatus, implement,machine, contrivance, implant, in vitroreagent, or other similar or relatedarticle…

• intended for use in the diagnosis ofdisease or other conditions, or in thecure, mitigation, treatment, orprevention of disease… or

• intended to affect the structure or anyfunction of the body of man or otheranimals…”

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



FDA & FDASIAFDASIA = Food and Drug Administration Safety & Innovation Act

- FDA- ONC- FCC

- Strategy & Recommendations for HIT- Risk-based regulatory framework- Including mobile medical applications- Promoting innovation- Protects patient safety- Avoid regulatory duplication- Health IT Safety Center

55

FUNCTIONALITIES

o Admin-HIT - Lowrisks, no MD - nooversight

o Health Mgm-HIT -MD with low risk– no oversight

o MD-HIT –Oversight

Dr.

Tere

nzio

Fac

chin

etti

Cop

yrig

htClic

k to buy N

OW!PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com



56

Medical Device Engineering is Evolving

THANK YOU !

[email protected]+49 162 262 1912

S A F E T Y

Click t

o buy NOW!

PDF-XChange


k to buy N

OW!PDF-XChange

www.docu-track.com

mailto:[email protected]



analysing the latest developments and examining the future of wireless medical technology...

Documents