Presentation title Date

Requirements for HFE/usability

engineering for combination products:

Recent experience from working with AAMI,

ISO/IEC and FDA

Peter Bøge

Abstract

• Usability (or Human Factors) Engineering has for a number of years been a focus area for both FDA and European authorities.

• To the requirements of the existing “IEC62366 Usability:2005” the FDA has added new with their HFE guide:2011, followed by additional guidance documents.

• Work is on-going both within FDA, as well as together with industry in AAMI and ISO/IEC, aligning and detailing requirements and guidance.

• The speech gives an overview of developments and reflects on some of the discussions with in particular FDA”

Presentation title Slide no 2 Date

Medical device regulatory framework

• EU. Medical Device Directive

• Harmonized product standards • e.g. ISO11608 pen & needle standards

• Harmonized process standards • ISO13485 QMS,

• ISO14971 Risk mgt

• ISO10993 Bio/ tox hazards

• IEC62366 Usability

• IEC 60601-1 series Electromechnical medical devices

• USA: FDA and CFRs

• Standards are recocnized in part or complete

• with or without additional requirements

Presentation title Slide no 3 Date

Presentation title Slide no 4 Date

1. What is UE/HFE? Why regulatory concern?

• Problems in hospitals: Clinicians interacting with medical devices in high-stress environments

• Problems with labelling : Percentage of people successfully completing tasks in response to questions

• What can this medicine be used for? 18%

• Who should use this medicine? 14%

• How should you keep this medicine? 7%

• When should you stop using this medicine? 6%

Source: Communication Research Institute of Australia.

Terminology: ‘Human Factors’ = ‘Usability’ = ‘Ergonomics’

• Problems in homes: Lay users interacting with medical devices in home environment

Presentation title Slide no 5 Date

1. What is UE/HFE? : The usability paradoxes

• What people say they will do, and what they then actually do, is not always the same.

• Users want more information than optimal for their achieving results. User preference often do not correlate with their achieving results.

Human factors: A vital component in product development and launch 17th June, 2002, Cynthia Drake

Affects FDA’s view on marketing studies!

• Solution: ”Usability test”

• Intended users performing real tasks, in a simulated use

• Testers who observe and record important data

Presentation title Slide no 6 Date 2. Initiatives 2000-2010

• FDA view • Adverse events more often

involved with bad usability than with technical error.

• HFE not done adequately in the industry.

• HF is closely linked to risk management.

• Preamble to FDA device GMP CFR820 mentions need for

user profiles and human factors studies

• Guidance documents from 2001

• AAMI HE 74:2001 Usability design and engineering process • recognized by FDA bas a standard. • The process content 74 was later replaced by IEC62366:2007

- convenership of work group was FDA Peter Carstensen • The product design content was replaced by AAMI HE75:2010

- also in cooperation with people from FDA CDRH HFE-office

• Enforcement: Not strict before 2010

Presentation title Slide no 7 Date

EU Medical Device Directive 2010

Created in discussions with “GHTF”, i.e. pressure from U.S.

(Global Harmonization of authorities and industry in US-EU-Japan):

“This shall include:

• reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and

• consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).”

• I.e. similar requirements.

• IEC62366 harmonized.

• Enforcement (Notified Bodies & Competent Authorities): Not in focus

ISO14971 Risk Mgt and IEC 62366 Usability Engineering

• ISO 14971:2007 (next update planned 2017) Covers use related risk, but with little guidance.

• IEC62366:2007

• ”Replaced” 14971 regarding:

• Estimating probability of Use Errors - By usability test observations

• Risk evaluation and acceptance - By usability test observations

• Verification of Risk control measure effectiveness - By usability test observations

• Allowed statistical goals (”90% performed task correctly”)

• Allowed subjective goals (”90% expressed satisfaction”)

• No rules for sample size

• No rationales required

Presentation title Slide no 8 Date

Not any more!

3. FDA initiative 2010

• April 2010: AAMI HE75:2009 ”Human factors engineering”.

• An American national standard. FDA participation.

• Touched upon some new FDA requirements briefly

• Then: CDRH, CDER & CBER: Enforcement during product review

• E.g.:

• Statistical goals not sufficient

• Subjective goals not sufficient

• Rules for sample size (min. 15 per distinct user group)

• Rationales required, e.g. root cause analysis of usability test observations, and risk analysis demonstrating absence of safety risk

• A seemingly fixed review process

• Combination products requiring HFE data in submission forwarded from CDER to CDRH HFE Office – which applies requirements quite consistently (4 people in one office).

• The CDER/CBER reviewer will then add additional requirements, - in a less consistent way (many reviewers in several divisions)

Presentation title Slide no 9 Date

2010-2011: Clarification of FDA requirements and gap analyses

• Info from FDA review letters, AAMI and informal contacts in ISO/IEC

• E.g. AAMI 2 day ”HFE Course”

• Faculty includes both CDRH and CDER

• Excellent as training and as informal FDA contact

• FDA requirements were NOT documented in a normal way

• in regulation, standard or FDA guidance: Unusual, confusing and problematic

• => AAMI inner circle drafted a suggestion for a FDA guide and handed over – very discreetly. Then after some months:

• CDRH: HFE Guide:2011

• Formalized the CDRH requirements (NOT the additional CDER/CBER)

• Is still the most accurate description of FDA requirements

• 2011: AAMI asked ISO/IEC to update IEC62366 ”Usability”

• To align with FDA requirements

• (I am member of this IEC62366 work group)

• Hard work => New IEC62366 edition expected 2014

Presentation title Slide no 10 Date

4. Issues discussed with CDRH in the IEC group

1. How to do criticality assessment of Use Errors?

• Use errors will happen. Not all Use Errors lead to harm. Depends on the chain-of-events / scenario.

• CDRH: Accept this in principle. CDER : Less accept: Problem.

2. How to handle “Abnormal Use”

• E.g. not changing a single-use needle

• FDA accepts this in principle, but needs rationales.

• But rationales cannot be obtained from usability test : Problem.

3. Worst case scenarios in ”summative” usability validation, e.g. lack of training?

• CDRH: Should be ”realistic”. CDER: Should be worst case: Problem.

4. Instructions For Use (labelling) as part of the “User Interface”

• CDRH: Manufacturer is the expert in user interface design.

• CDER: They are experts too and will define improvements: Problem. Solution: Involve early, in particular in Instructions For Use

5. Clinical trials with usability end points

• CDRH: Only infusion pumps and only if high safety risk

• CDER: No rules, but has been requested for even simple single use prefilled pen. Problem

Presentation title Slide no 11 Date

1. Clarify interface between Usability and Risk Mgt.

2. Avoid additional burdens.

3. Provide practical how-to

4. Align industry- FDA CDRH HFE-office

• The FDA person Molly Story is expert in HFE, not in Risk Mgt, but improving

• She is representing CDRH in both AAMI and IEC, and editor of the FDA HFE Guide: Key person in alignment

• CDRH intent is to postpone release of final HFE guide until after IEC62366 has been agreed, and incorporate most of IEC62366 and only add “few” requirements

5. Align CDRH and CDER

• has recently initiated workshops to align:

Potentially closing the present gap in requirements.

6. Final draft end 2013 – new edition 2014

Presentation title Slide no 12 Date

4. Objectives in IEC group

• CDER FDA–2012–D–1005. Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication Errors http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM349009.pdf

• Is the “CDER HFE guide”, but:

• Focus on medication errors (differentiation)

• No reference to the additional actual additional CDER requirements (e.g. worst case scenarios)

• Pharma industry has objected to new burdens, but

• Risk analysis: Points to ISO14971. Good!

• Usability: Points to CDRH HFE Guide and EC62366: Good!

• I.e. internal FDA alignment.

Presentation title Slide no 13 Date

2013: Status and recent developments

• FDA proposes Rule On Symbols for medical devices and biological products

• to allow symbols without accompanying explanatory text - current U.S. regulation does not.

• to harmonize with the European Commission.

• only accept symbols that have been listed in ISO15223-1. Problem

• Only accept symbols that have been usability validated. Good.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm348700.htm

• FDA has released draft guidance for home care devices Dec.2012. Points to IEC62366 and HFE Guide

• AAMI supporting guidances:

• Usability and post market surveillance. Final.

• Usability for Home Care devices. Final

• Usability: Contextual Inquiry. Draft

• Clinical trials with usability end points. Draft

• Assurance cases: Final.

Presentation title Slide no 14 Date

2013: Status and recent developments

6. Europe recent regulatory initiatives: Differences and similarities

1. EU has no specific usability initiatives, but has implemented general additional Risk Mgt. requirements (EN ISO14971:2012 Annex Z), e.g.

1. Manufacturer must design out risk as much as possible, before using labelling

2. Manufacturer must balance all identified risks against benefits of the device in a risk benefit analysis (”The Clinical Evaluation”).

3. Manufacturer cannot reduce risk scoring by warnings in the Instructions For Use

4. Standards or often not sufficient, and manufacturer must make a case, why they are in the particular case

2. Differences in EU and FDA usability initiatives

1. EU is moving away from harmonized standards - FDA towards them

2. EU focus on risk in general - FDA on usability related risk (for home use devices often the same thing)

3. EU focus on the IFU - FDA focus on training supported by IFU, video or apps.

3. Similarities

1. Standards or good, but often not sufficient

2. Focus on the manufacturer ”proving” / making a case of safety - Which means that many design decisions now needs documented rationales

Presentation title Slide no 15 Date

Conclusion: The way ahead

1. Still major challenges for the industry, to comply to the new regulatory usability expectations

2. Industry and FDA CDRH is working together to produce practical ways in which to comply

3. CDRH and CDER seem to move towards alignment .

Thank you!

Presentation title Slide no 16 Date