Eric Shaver

Human Factors Professional

FDA Releases Guidance for Reprocessing Medical Devices

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Reprocessing Medical Devices in Health Care SettingsOn March 17th, the FDA announced the release of “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling’’ Guidance in the Federal Register.  This was followed by a webinar on March 24th by Elaine Mayhall, PhD and Geetha Jayan, PhD.

The Introduction notes:

This guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable medical devices. This guidance document also provides recommendations for the content and review of premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests and investigational device exemption (IDE) applications, concerning the labeling instructions for reprocessing reusable medical devices. (p. 1)

Moreover, it continues that:

…the focus of this document is to provide guidance to medical device manufacturers in the complex activities involved in crafting and validating reprocessing instructions that ensure that the device can be used safely and for the purpose for which it is intended. (p. 1)

Among other things, the Guidance outlines human factors-specific activities that should be performed during development of reprocessing instructions.  Specifically, it states medical device manufacturers should:

  1. “…develop consistent reprocessing instructions across each of your product lines.” (p. 7)
  2. “…address any known post-market human factors issues known to exist for reprocessing your device or similar devices.” (p. 7)
  3. “…validate your reprocessing instructions to insure that users will be able to successfully understand and follow them.” (p. 7)

For the latter, the guidance provides five recommendations (Note: it’s actually six; the last recommendation is actually two distinct steps) that follow the later stages of a typical human factors design and development process.  They include:

  1. “…validation study participants should be representative of the professional staff that would perform these actual reprocessing procedures.” (p. 8)
  2. “Participants may use the instructions to perform an actual or simulated reprocessing procedure or verbally describe what they would do as they read the instructions.” (p. 8)
  3. “If attributes of the use environment might affect use of the instructions and reprocessing of the device, they should be represented in the study.” (p. 8)
  4. “Observing and documenting participant behavior during testing will allow you to assess the participants’ adherence to the instructions and to identify and understand the nature of any errors or problems that occur.” (p. 8)
  5. “After using the instructions independently, you should ask the participants if they had difficulty in performing the reprocessing, and allow them to describe their experience.” (p. 8)
  6. “If you make significant changes to the instructions after testing them, you should validate the success of the changes at eliminating or reducing the problems previously identified.” (p. 8)

IEC 62366 Replaced by IEC 62366-1 and IEC/TR 62366-2

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IEC 62366-1 (2015)

[Update: 9.1.15] For a more in-depth look at IEC 62366-1, check out IEC 62366-1:2015 – More Than A Checkbox at Human Factors MD.

Last month, the IEC (International Electrotechnical Commission) published IEC 62366-1, Medical devices – Part 1: Application of usability engineering to medical devices (purchase here or here).  As noted in the Forward:

This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). (p. 4)

IEC/TR 62366-2, Medical devices – Part 2: Guidance on the Application of Usability Engineering to Medical Devices, is still in draft form and should be published in 2016.  The Forward further explains the difference between -1 and -2 by stating:

Part 1 has been updated to include contemporary concepts of USABILITY ENGINEERING, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of RISK MANAGEMENT as applied to SAFETY related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of USABILITY ENGINEERING methods that can be applied more generally to MEDICAL DEVICES that go beyond safety-related aspects of MEDICAL DEVICE USER INTERFACES. (pp. 4-5)

I first learned about the standard being divided into two parts from a presentation (.pdf) Ed Israelski, PhD gave at the HFES 2012 Symposium on Human Factors and Ergonomics in Health Care: Bridging the Gap.

I’ll post a more in-depth review of the standard after I’ve had some time to fully digest it.

Human Factors Guidance Listed in FDA 2015 Priorities

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Applying Human Factors and Usability Engineering to Optimize Medical Device Design

In 2011, the U.S. Food and Drug Administration (FDA) released their draft guidance Applying Human Factors and Usability Engineering to Optimize Medical Device Design.  

It provides the FDA’s “current thinking on this topic” and the recommendations “…are intended to improve the usability of devices to reduce use error, injuries from medical devices, and product recalls. The FDA believes that these recommendations will help control current risks and reduce future risks associated with device use” (p. 4).

The draft guidance has generated a lot of interest – and provoked numerous questions – from the medical device community.  At the 2013 International Symposium on Human Factors and Ergonomics in Health Care: Advancing the Cause, Ron Kaye, Human Factors Pre-Market Evaluation Team Leader for the FDA, noted that more than 500 comments were submitted to the Agency during the review period.

A recurring question since its release has been “When will the draft guidance be finalized?”  It looks like we have our answer.

The FDA has released the CDRH Fiscal Year 2015 (FY2015) Proposed Guidance Development and Focused Retrospective Review of Final Guidance, which includes the draft guidance on their “A-list” (…prioritized device guidance documents that the Agency intends to publish within 12 months of the date this list is published…).

It will be interesting to see if the final guidance is substantially different or not from the draft guidance.

Assessing Medical Technology from the User’s Perspective

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Operating Room Monitors

In 2008, I co-authored “Assessing Devices from the User’s Perspective” with Curt Braun.

The article focuses on the importance of using methods from the field of human factors and ergonomics to facilitate the procurement and implementation of appropriate medical technology for a health care organization.  Specifically, it identifies heuristic evaluations and usability testing.

With regard to the former, it references the Nielsen–Shneiderman Heuristics, coined by Zhang, et al. (2003).  They include:

  1. Consistency: Users should know that similar actions lead to similar results.
  2. Visibility: Users should be informed about what is going on in the system.
  3. Match: Users should have a mental model that matches the state of the medical technology.
  4. Minimalist: Users should not be exposed to unnecessary information.
  5. Memory: Users should not be required to memorize a lot of information to use the medical technology.
  6. Feedback: Users should be provided prompt and informative feedback.
  7. Flexibility: Users should have the ability to customize or create shortcuts.
  8. Message: Users should receive an informative error message.
  9. Errors: Users should be insulated from error occurrence by the design of the medical technology.
  10. Closure: Users should be informed of task completions.
  11. Undo: Users should have the ability to recover from errors.
  12. Language: Users should be presented information in an understandable form.
  13. Control: Users should not have the impression that the medical technology is in control.
  14. Document: Users should be provided help by the medical technology when necessary.

References

Shaver, E.F., & Braun, C.C. (2008, September).  Assessing devices from the user’s perspective.  Materials Management in Health Care, 30-34.

Medical Device Design and Human Factors

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Handbook of Human Factors in Medical Device Design

In 2011, CRC Press published the Handbook of Human Factors in Medical Device Design.  The book is edited by Matthew B. Weinger, Michael E. Wiklund, and Daryle J. Gardner-Bonneau and includes the following chapters:

  1. General Principles
  2. Basic Human Abilities
  3. Environment of Use
  4. Anthropometry and Biomechanics
  5. Documentation
  6. Testing and Evaluation
  7. Controls
  8. Visual Displays
  9. Connections and Connectors
  10. Alarm Design
  11. Software User Interfaces
  12. Workstations
  13. Signs, Symbols, and Markings
  14. Packaging
  15. Device Life Cycle
  16. Hand Tool Design
  17. Mobile Medical Devices
  18. Home Health Care
  19. Cross-National and Cross-Cultural Design of Medical Devices

This resource should be on the bookshelf of all human factors professionals involved in the design, development, and deployment of medical devices.  Moreover, it’s also a good resource for systems engineering and regulatory professionals.

References

Weinger, M.B., Wiklund, M.E., & Garner-Bonneau, D.J. (2011). Handbook of human factors in medical device design. Boca Raton, FL: CRC Press.