# Presentation: 504271

## IEC Develops Standard for Medical Device Human Factors Design

**Ensuring a safe **
**device-user interface**

## Overview

**What is the magnitude of the use error problem?**
**Examples of device use error problems**
**The role of human factors engineering**
**IEC SC62A HFE standards activities**

## Basic Assumptions

**A flawed device-user interface can induce error**
**Warnings and instructions in the operating manual can’t fix a flawed device-user interface**

## FDA Medical Device Incident Reports:

**80,000 reports per year**
**More than 1/3 involve use error**

## To Err is Human: Building a Safer Health System

**Institute of Medicine,****National Academy of Sciences****November 1999**

## Medical Errors in U.S. each Year Result In:

**Up to 98,000 deaths**
**$29 Billion added cost**

## Anesthesia Patient Safety:20 fold improvement in 10 years

**Technological advances (pulse oximeter)**
**Standardization of equipment**
**Changes in training**

## ANSI standard for gas machines

**70% of the requirements dealt with use error**

## Slide 9

## Flow Knob with Accompanying Instructions

**Flow Knob with Accompanying Instructions**

**Turn the flow knob to the proper flow number.  Be sure the dial pointer  and is not between numbers.**

## Desirable Design Characteristics

**Operations - don’t exceed user capabilities**
**Information - Sufficient, legible and intelligible**
**Procedures - logical and intuitive**
**Operations - consistent with conventions**
**Dangerous error - designed out**
**Conditions of use - considered and addressed**

## Key safety design concepts

**make things visible**
**simplify the operation**
**avoid reliance on memory**
**avoid reliance on vigilance**
**use natural mappings**
**use forcing functions **
**make it easy to reverse an error**

## Important Statutory and Regulatory Changes

**Quality Systems Regulation/ CGMP - Design Controls (1996)**
**	****(Essentially  same as ISO 9001)**

## Design Controls

**Regulatory Language:**
**“... ****design requirements ... intended use ... needs of the user and patient.”**
**“... ****testing production units under actual or simulated use conditions.”**
**“... ****conduct risk analysis.”**

## Design Controls

**Preamble Language:**
**“... ****conduct appropriate human factors studies, analyses, and tests ...”**
**“... ****human interface includes both the hardware and software characteristics...”**

## Design Controls - Human Factors Engineering (HFE) Process

**HFE applied from concept stage to final design**
**Early Involvement of typical users is critical**
**The process is iterative **

## Human Factors Engineering Process

**Concept**
**Phase**

**Design**
**Input**

**Design**
**Output**

**Verification**

**Validation**

**HF Elements**

- Literature
- Complaints
- Observation
- Interviews

- Safety
- Environment
- Users
- Performance

- Drawings
- Mockups
- Computer
- Prototypes

- Production
- Units
- Full Usability
- Test
- Risk Assessment

- *

- *Design and Development Planning Important Here

**Human Factors Engineering Process**

- Analyses
- Expert
- Evaluation
- Rapid
- Prototyping

## Human Factors Engineering - Summary of Methodology

**Study the user population and use conditions**
**Analyze function, tasks, and hazards**
**Incorporate findings in requirements**

## Test and analyze prototypes against requirements
Test production models in simulated environment
Conduct a risk assessment

**Test production models in simulated environment**
**Conduct a risk assessment**

**Human Factors Engineering - Summary of Methodology**

## IEC SC62A WG5

**Symbols and Ergonomics**

## IEC 60601-1-6: Collateral Standard:Usability, analysis, test and validation of human factors compatibility.

## IEC 60601-1-6

**General requirements: USE ERRORS**
**USE ERRORS and their consequences shall be limited to an acceptable SAFETY level to satisfy RISK MANAGEMENT.  This shall be accomplished by applying a documented HUMAN FACTORS ENGINEERING PROCESS (e.g., Annex 8)**

## IEC 60601-1-6

**HUMAN FACTORS ENGINEERING PROCESS shall include a risk analysis.  The risk analysis shall include a description and assessment of the OPERATOR characteristics and requirements, task requirements and potential USE ERRORS.**

## IEC 60601-1-6

**General requirements for tests**
**USABILITY TESTING shall validate adequate USABILITY for the INTENDED PURPOSE of the EQUIPMENT.**

## Other International Standards

**ISO 14971-1, Risk Management Process**
**will require assessment of potential use error**
**IEC 60601-1, 3rd edition, Electromedical Equipment Standard **
**will include requirements to protect against use error**

## U.S. & International Standards

**ISO 14971-1, Risk Management Process**
**Describe intended use including any reasonably foreseeable misuse.**
**Annex A and D - questions to ask and examples of hazards**

## ANNEX 8:  AAMI HE48-1

**   ****Human factors design process for medical devices –****Part 1: Human factors engineering guidelines and preferred practices for the design of medical devices**

## Connections

- Anesthesia
- Incidents

- AAMI
- HFE Std.

- IOM
- Report

- NPSF

- ISO
- 14971

- FDA QSR
- Des. Cont’l.

- APSF

- IEC HFE
- Des. Process Std.

- IEC 60601-1
- 3rd Ed.

- AAMI
- HFE Cmte

- ANSI
- Gas Mach. Std.

## The Future

**IEC 60601-1-6  2nd edition**
**	****3 years after publication of the 1st edition - add AAMI Part 2**
**Joint IEC/ISO 60601-1-6**
**	****Begin by 2002**

## FDA Web Site

**http://www.**
**	****fda.gov/cdrh/humanfactors.html**
**	****fda.gov/cdrh/usererror.html**

## Division of Device User Programs and Systems AnalysisOffice of Health and Industry ProgramsCenter for Devices and Radiological HealthFood and Drug Administrationpbc@cdrh.fda.gov

**Peter Carstensen****Systems Engineer,****Human Factors Team Leader**