Software As Device - Frank Maxwell

Software as a Device

The application of the EU-Medical Device Directive and the US-Medical Device Data Systems regulation to a private hospitals software catalog.

Software as a Device

The application of the EU-Medical Device Directive and the US-Medical Device Data Systems regulation to a private hospitals software catalog.

Introduction

Frank Maxwell

Project Manager,

Professional Services EMEA,  Acquia

Relevant Experience

14 years Professional Services Delivery (Enterprise Software)

Industries: • Pharmaceutical Clinical Applications (R&D)

• Healthcare Solutions• US: Harvard Risk Management Foundation, Brigham and

Women’s Hospital, Children’s Hospital, Florida Hospitals Network

• HSE

• NHS

Research Focus“How can software be classified as a medical device?”

US-MDDS- Medical Device Data Systems (MDDS) 21 CFR 880.6310

EU -MDD – Medical Devices Directive 93/42/EEC (MDD) with amendment M5 (2007/47/EC)

Research FocusTo apply the two regulations against the software catalogue in use by private European hospital.

• Will the outcome be different for each regulation?

• Where bespoke HIT development is involved, does HIT classification position a hospital as a medical device manufacturer?

• If the outcome is different for each regulation are there any indications as to why?

• What further research could be developed on the findings?

Point of Change - US

FDA Centre for Devices and Radiological Health made the clear statement ;

“Under the Federal Food and Drug Cosmetic Act, Healthcare Information Technology software is a medical device”

25th February 2010 Dr. Jeffery Shuran Director

Point of Change - EUIn May 2010 the UK agency Medical and Health related Regulatory Agency (MHRA) reviewed all incidents where were reported and concludes as software related issues.

Year

Percentage

2005 3.7%

2006 3.9%

2007 5.5%

2008 6.2%

Table 1: Percentage of reported incidents reported as software issues.

USFDA - Medical Device Data Systems (MDDS) 21 CFR 880.6310•15th February 2011: The new rule was announced

•18th April 2011: MDDS rule became effective

•16th May 2011: All medical device manufacturers must be registered and list their medical devices

•All manufacturers must implement a FDA compliant Quality System within 12 months of registering.

•18th April 2012: A medical device reporting system for devices must be implemented by manufacturers for their listed devices.

USFDA - Medical Device Data Systems (MDDS) 21 CFR 880.6310

• The electronic transfer of medical device data

• The electronic storage of medical device data

• The electronic conversion of medical device data from one format to another format in accordance with a preset specification

• The electronic display of medical device data

Medical Devices Directive 93/42/EEC (EU-MDD)

• 2005: EU Commission introduced amendment M5 2007/47/EC

•May 2010 : EU Commission brought the rule into force

Medical Devices Directive 93/42/EEC (EU-MDD)

“medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose

Medical Devices Directive 93/42/EEC (EU-MDD)

• Diagnosis, prevention, monitoring, treatment or alleviation of disease

• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap

• Investigation, replacement or modification of the anatomy or of a physiological process

• Control of conception

Application:EU-MDD Decision diagram. (COCIR, 2010)

Application: EU-MDD Audit Decision Matrix MDD Decision Req. MDDS Audit Question

Inclusion Condition

ExlusionCondition

1.1 Is the software a computer program?YES

No: Not MDDS

2.1 Is the software an integral part of a medical device (CE-Marked)?

NO: Standalone

Software

YES: Part of Device

3.1 Does the software drive monitor performance of ,or influence the use of a medical device? NO

Yes: MDD

4.1 Is the software performing an action on the data different form sotreage, archival, communication or simple search?

Yes No: Not MDD

5.1 Is the action for the benefit of individual patients? Yes No: Not MDD

6.1 Is the action for medical purposes? Yes No: Not MDD

End:

Decision Step 1

Inclusion Rule: "Must have YES response to continue"

Decision Step 2

Inclusion Rule: "Must have NO response to continue"Decision Step 3

Inclusion Rule: "Must have NO response to continue"

Decision Step 6

Decision Branch "Yes MDD"

Decision Step 4

Inclusion Rule: Decision Branch "Yes to Continue"Decision Step 5

Inclusion Rule: Decision Branch "Yes to Continue"

Application:US-MDDS Decision diagram for qualification of software (HIMSS Analytics, 2010)

Application: US-MDDS Audit Decision Matrix MDDS

Decision Req. Sub section MDDS Audit QuestionInclusion Condition

ExlusionCondition

1.1 Any Software Is there software involved in this product? Single Yes All No1.2 Embedded Software Is the software embedded in a electronic device? Single Yes All No1.3 Electrical Hardware Is the product electrical hardware i.e. Wirelss Device,

Modem, Communication Protcol or Combination? Single Yes All No

2.1 Is the SYSTEM intended for connection to a medical device? Single Yes All No

2.2 Is the product labeled for connection with a medical device?

Single Yes All No

2.3 Is the product advertised or promoted for connection with a medical device?

Single Yes All No

3.1 Does the SYSTEM itself control or alter functions or alter parameters of medical device? NO Yes: Not MDDS

4.1 Is the SYSTEM used in connection with active monitoring systems (i.e, monitoring to facilitate immediate clinical actions … e.g., remote alarms)?

NO Yes: Not MDDS

5.1 Does the SYSTEM convert medical device data? Yes: Goto Decision 8NO: Goto Decision 5

Inclusion Rule:

Inclusion Rule:

Inclusion Rule:

Inclusion Rule:

Minimal Inclusion Questions

Decision Step 1

Inclusion Rule:

Decision Step 3

Decision Step 4 : Data Quality Phase

"Must have one YES response to continue"

"Must have one YES response to continue"

Decision Step 2

"Must have NO response to continue"

"Must have NO response to continue"

Decision Branch "Yes or No to Continue"

Software Catalogue

Software Title Function Publisher Integration CE Marking Customisation

Enterprise HIS

Hospital Information System:

• Theatre Clinical Notes• Patient Impant & Consumable Trace• Patient Admissions & Scheduleing• Care Plans:- (Nursing, Physio, Sports Med, Cardiology, Radiology)• Document Scanning & Clinical GP Reports• Adhoc Reporting

HICOM Ltdw w w .hicom.co.uk

• GE Centicity RIS PACS• MS Dynamics Finance• Perkin Elmer Scope• GE MUSE ECG• GE Centicity RIS PACS NO

Entire Bespoke Design

MUSE® Cardiology Information System

ECG Diagnostic Monitor:

• ECG screen that closely resembles traditional paper ECG formats • HL7 Interface options for ADT, orders, across all electronic records • Display that provides access to demographics, interpretive information, and historical c

GE Healthcarehttp://w w w .gehealthcare.com

• Enterprise HIS

YES NO

Smith and Nephew Arthroscope

• Integrated System 1 • 560 Series 3-CCD High Definition Camera System• (VGA, HD-SDI, S-video, DVI, Composite, MP3)

Smith & Nephewhttp://global.smith-nephew .com/us/15236.htm

• Enterprise HIS• GE RIS PACS YES NO

Quantum Payrole Management System Quantum Pyarolehttp://w w w .qss.ie/

NO NO NO

Microosft Dynamics Financial Management and ERP Solution Microsoftw w w .microsoft.com

• Enterprise HISNO YES

Healthdedge Sterile Managenet , Serialisaiton and LabelingHealthedgew w w .healthedge.ie • Enterprise HIS NO NO

Results Summary

Regulation Enterprise HIS MUSE®

Cardiology Smith&Nephew

Arthroscope QuantumMicroosft Dynamics Healthdedge

EU-MDDYes

MDD6.1

YESPart of device

2.1

YESMDD 3.1

NONot MDD

5.1

NONot MDD

5.1

Yes MDD6.1

US-MDDSYes

MDDS9.1

NONot MDDS

2.3

NONot MDDS

3.1

NONot MDDS

8.1

NONot MDDS

2.3

NONot MDDS

2.3

Results Summary

• Will the outcome be different for each regulation? Significant Yes – Where is the harmonisation

that was intended

• Where bespoke HIT development is involved, does HIT classification position a hospital as a medical device manufacturer? Yes

Results Summary

• What further research could be developed on the findings?

1.The evaluation of complementary regulation, standards and guidelines? GAMP ?2.The implications to software evaluation and selection?3.Comparison across vendors of similar products?4.Private versus public institutions?5.What about the software found at GPs

Results US-MDDSReq.

ResultsEnterprise

HIS

ResultsMUSE®

Cardiology Information

System

ResultsSmith and Nephew

ArthroscopeResults

Quantum

ResultsMicroosft Dynamics

ResultsHealthdedge

1.1 Yes Yes Yes Yes Yes Yes1.2 No Yes Yes No No Yes1.3

No No Yes No No Yes

2.1Yes Yes Yes No No No

2.2No Yes Yes No No No

2.3No Yes Yes No No No

Not MDDS Not MDDS Not MDDS

3.1NO Yes Yes N/A N/A N/A

Not MDDS Not MDDS

4.1

NO N/A N/A N/A N/A N/A

5.1NO N/A N/A N/A N/A N/A

6.1Yes N/A N/A N/A N/A N/A

7.1N/A N/A N/A N/A N/A

8.1 N/A N/A N/A N/A N/A

9.1Yes N/A N/A N/A N/A N/A

10.1Yes

ManufacturerN/A N/A N/A N/A N/A

NO N/A N/A N/A N/A N/A

Harmonised Standards

Thank you

Email: [email protected]

[email protected]

Linkedin:http://ie.linkedin.com/in/frankmaxwell