sterile u human factors webinar -...

1

3M Business Name

How can Human Factors Engineering Concepts be Applied to Medical Device Reprocessing?

Welcome!Topic: How can Human Factors Engineering Concepts be

Applied to Medical Device Reprocessing?

Facilitators: Christophe de Campeau, 3M Dorothy Larson, 3M

Speaker: Susan Klacik

For more information: www.3m.Com/3MSterileU© 3M 2015 All Rights Reserved

House Keeping

From The GoToWebinar Page:

Click on the orange box with a white arrow to expand your control panel (upper right-hand corner of your screen).

Type a question in the question box and click send.

© 3M 2015 All Rights Reserved

2

House Keeping – Continuing Education Contact Hours

Each 1 hour web meeting qualifies for:1 Contact Hour approved by the CBSPD Certification Board

1 Contact Hour approved by the IAHCSMM

1 contact hour for nursing. 3M Health Care Provider is approved by the California Board of Registered Nurses CEP 5770.

Post webinar email

Link to Course Evaluation

CE Certificate Included

Forward eMail to Others in Attendance

© 3M 2015 All Rights Reserved.

Disclosure

Susan Klacik

Educational Consultant to 3M Health Care

CSS Manager, St. Elizabeth’s Healthcare, Youngstown, OH

© 3M 2015 All Rights Reserved4

AAMI TIR55 Human factors engineering for processing medical devices


3

LEARNING OBJECTIVES


Introduce the science of human factors.

Discuss how human factors impacts medical device design.

Demonstrate how human factors relates to a CSS operation.

Introduce the science of human factors



4

A human factors engineering and design controls approach to device processing

Human Factors Engineering

Considerations in the design of the various elements of processing

Design of the device

Design of disinfection and sterile processing procedures


Photo courtesy of Sue Klacik

Duodenoscopes

Complex design

Extremely difficult to process


http://www.bing.com/images/search?q=ercp+picture+of+scope&id=BAC82997B2826007F3B0CAAC6B681D907C0B4C44&FORM=IQFRBA - Accessed on 08/20/15

Design of IFU’s

Thinking that occurs when interacting with processing instructions:

• Searching

• Comprehending

• Applying Information


Photo courtesy of Sue Klacik, Da Vinci IFU, copyright 2011

5

Physical and Material Design Characteristics that can have a significant impact on Medical Device Reprocessing

PHYSICAL

MATERIALS


Photos courtesy of Sue Klacik

Human factors engineering and design controls effect on device processing Ensure cleaning, disinfection, and/or sterilization can be performed, by including in the design:

• Processes that can be performed in real-world environments

• IFU’s that can be understood and followed

• Education, training, and competency verification that communicate the necessary information and skills.



A human factors engineering and design controls approach to device processing Design and Development Planning

Design Inputs

Design Outputs

Design Verification

Design Validation


6

Design and development planning

Cleaning and disinfection/sterilization should be at the forefront of the design, including the training materials for processing.


Photo courtesy of Rick Schultz

Design Inputs

• The physical and performance requirements of a device are used as a basis for device design

• The design needs to consider the ability of the device to be cleaned and disinfected/sterilized

• Material is able to be cleaned

• Design allows for thorough cleaning

• Clear & understandable IFU

• Processing environment


Design Validation

• Processing the device in an environment and manner that it will be processed in

• Participants representative of actual personnel, including PPE when necessary



7

Validation• Personal Protective Equipment

• Cleaning, Disinfection, Packaging, and Sterilization Validation

• Cleaning Instructions, Disinfection, Packaging & Sterilization

• Accessories

• Human Factors Validation



Validation• Personal Protective Equipment

• Cleaning, Disinfection, Packaging, and Sterilization Validation

• Cleaning Instructions, Disinfection, Packaging & Sterilization

• Accessories

• Human Factors Validation



Design Outputs

Manufacturers ensure that the design of the device and processing instructions are in compliance with standards and satisfy the design inputs resulting in a device that can be effectively and consistently processed.



8

Design Verification

Design verification is the testing and inspection of the device to verify that the design outputs meet the design inputs.

This verification includes:• Compliance to standards

• IFU clear, concise, and complete

• Processing according to IFU

© 3M 2015 All Rights Reserved.Photo courtesy of Sue Klacik

A human factors engineering and design controls approach to device processing Medical device processing is performed by and is dependent on humans and, therefore, human factors engineering needs to be considered in the design of the various elements of processing, as follows: • Design of the device to make it

possible to be cleaned• Undergo disinfection and

sterilization in real-world processing environments.




Medical device processing is performed by and is dependent on humans and, therefore, human factors engineering needs to be considered in the design of the various elements of processing, as follows:

Design of a set of processing instructions (e.g., cleaning instructions for endoscopes) that the intended processing personnel can follow successfully

Design of education, training, and competency verification for processing personnel that adequately transmits the needed information and skills.


9

Design of devices for processing

Manufacturers should take into account physical and material design considerations with respect to device performance, clinician preference and human factors. The design characteristics can have a significant impact on the ability of a device to be processed effectively and the ability of sterile processing personnel to efficiently and effectively process the device.



Polling Question #1


Instrument Set DesignDesign instrument sets for disassembly and reassembly; Should be as simple and intuitive as possible.

Ease of disassembly allows for thorough cleaning.

• Staff in PPE

• Instruments prepared for manual & automatic washers

• Prevent loss



10

Amount of instruments in a setKeeping a low amount of instruments in a set prevents errors such as:

a) devices not being

reassembled correctly,

b) lost instruments,

c) wrong instruments placed in the set, and

d) confusion extending processing time.



Instrument Set Design

Design instrument sets for disassembly and reassembly should be as simple and intuitive as possible.

Ease of reassembly is also important;

• correct reassembly• prevent lost instruments• prepare for sterilization



Visual Evaluation

Visual inspection of devices during the cleaning process is a critical step in evaluating the device for:

CLEANLINESS of the device and can be challenging due to lighting conditions in the processing area and physical constraints of PPE

DEGRADATION

RINSING EFFECTIVENESS PPE effects the ability to see or feel detergent remaining on the device



11

Visual Inspection in Healthcare • Visual inspection is a critical step checking for debris & flaws

• PPE hampers visualization

• Workstation with dedicated lighting

• Have lighted magnifying glasses

• Follow AAMI requirements for departmental lighting



Design of Processing Procedures

• Decontamination area

• Prep and packaging area

• Sterile storage area



Learning in CSS

• Demonstration

• Competency with return demonstration



12

Use Error

Humans can make errors, especially if:

• The device design makes manual interactions difficult

• The processing procedure is difficult to perform


Photo courtesy of Rick Schultz

Use Error

Humans can make errors, especially if:

• The IFU is confusing or misleading

• The education and training was ineffective

Ref: www.onesourcedocs.com Accessed on 08.20.15


The Processing Procedure The processing procedure should be designed to make a device ready for reuse. The process could involve:

• Cleaning

• Disinfection

• Packaging

• Sterilization

• Storage


13

Design of Processing Instructions

General considerations for content of IFU• Comprehending

• Applying

• Content

• Images

• Language and readability

• Considerations for printed & electronic IFU


Polling Question #2


Applying

• Break the process into small manageable tasks

• Use a separate sentence for each steps

• Put the steps in the order that they should be performed

• No more than 3 actions per step


4

4 Susan Klacik, 7/30/2015

14

General considerations for content of IFU

Consistent Structure • Breaking down the main tasks into small steps

• Use the same color coding to highlight relationships among objects, concepts, or tasks

• Detailed images are helpful


Photo courtesy of Sue Klacik - Da Vinci IFU, copyright 2011

Arranging Tasks & Subtasks

• Use numbers for sequential steps

• For non-sequential steps use;– bullets

– different fonts

– different colors

– bolding



Drawings/Graphics/Pictures

• Clarify instructions

• Only essential steps

• Graphic enhancements provide emphasis



15

Comprehending

• Use text that is easy to read and understand

• Use simple terms

• Use familiar fonts like helvetica or times new roman

• Use regular writing structure

• Provide instruction

• Provide caution statements for what not to do


5

Drawings/Graphics/Pictures

• Clarify instructions

• Only essential steps

• Graphic enhancements provide emphasis



A human factors engineering and design controls approach to device processing Medical device processing is performed by and is dependent on humans and, therefore, human factors engineering needs to be considered in the design of the various elements of processing, as follows:

c) design of a set of processing instructions (e.g., cleaning instructions for endoscopes) that the intended processing personnel can follow successfully.

c) design of education, training, and competency verification for processing personnel that adequately transmits the needed information and skills.


16

Design of processing instructions

General considerations for content of IFU

• Comprehending

• Applying

• Content

• Images

• Language and readability

• Considerations for printed & electronic IFU


Education, training, and competency assessment tools• Structure of education and training

• Preparing the trainer

• Key considerations in design and training

• Competency assessment


http://www.healthmark.info/CleaningVerification/RobotArmCheck/Microsoft_Word_-_robotic_arm_policy_08_2011.pdf - Accessed on 08/20/2015

Demonstrate how human factors relates to a CSS operation


17

Department Design

Design the processing area to facilitate medical device processing• One way directional flow

• Processing tools organized

• Processing tools convenient



A human factors engineering and design controls approach to device processing Human factors engineering considerations in the design of the various elements of processing



Human factors engineering considerations in the design of the various elements of processing


18

Polling Question #3


Validation

Perform cleaning verification using ATP on instrumentation to assure instrumentation is being thoroughly cleaned



Verification

Perform product testing on instrument sets designed by the central service department and loaners instrument sets



19

Instrument IdentificationWhen possible, instrumentation should be marked using a method that is easily readable by processing personnel, who may be wearing PPE, to keep the sets together.



Posting notices for comprehension• Use text that is easy to read and

understand• Use simple terms• Use familiar fonts like helvetica

or times new roman • Use regular writing structure • Provide instruction• Provide caution statements for what

not to do



3

Protocol Application• Break the process into small

manageable tasks

• Use a separate sentence for each steps

• Put the steps in the order that they should be performed

• No more than 3 actions per step

AFTER ATTACHING THE CORD, TURN ON THE LITE SOURCE

Attach the cord tothe light source. Turn the light sourceon.


1


Slide 57


20

Protocol arrange tasks & subtasks

•Use numbers for sequential steps

•For non-sequential steps use

– bullets

– different fonts

–different colors

–bolding

Make sure the stopcocks don’t leak. This can be done by turning the stopcock into the locked position.If it leaks, replace it. Also check the stopcock plug to be sure it is in the housing.

1. Check the stopcocks for leak-tightness.2. Turn the stopcock plug to the locked position. 3. If stopcocks leak, replace stopcock plug.



Language

• Clear language

• Short direct sentences

• Positive terms

• Familiar terms

• Number steps with familiar numbers

Don’t give out any of the code blue scopes without first checking to see if they are working first.

Test laryngoscope blades and handles before dispensing!



Policies & Procedures

Processing personnel should be able to easily follow

Design procedures to enable;

• Searching

• Comprehending

• Applying information


21

Posting Considerations

Use non-shiny or matte-finish paper laminate

- White space

- Readability



Education, training, and competency assessment tools

• Structure of education and training




Ref: www.3M.com/infectionprevention Accessed on 08.20.15


Education, training, and competency assessment tools• Structure of education and training






22

Case Study


Human Factors

Complex design

Complex IFUs

Multiple types of scopes

Requiring over 120 steps



CLEANR Study found employees experienced problems related to reprocessing

75% felt pressure to work quickly while reprocessing

37% observed procedural delays due to reprocessing

53% reported discomfort due to working with scopes

13% had problems with lungs, sinuses, or breathing

27% were bothered by odors or fumes

50% had physical discomfort or bothersome symptoms

Citation: Ofstead et al., Gastroenterology Nursing, 2010© 3M 2015 All Rights Reserved.

23

Results from Ofstead’s 2014-2015 Research- Egregious breaches found in over 50 scope processing facilities

- No brushing or flushing of endoscope channels

- Enzymatic cleaner improperly diluted

- Reuse of dirty/damaged brushes and basins

- Improperly prepared HLD (no temp, no MEC, short exposure times

- No drying

- Lack of training and competency testing

- Dedicated staff did a better job

-Highest quality when IAHCSMM specialist in charge

Ref: IAHCSMM Conference 05/03/15, Ofstead Taking a Closer Look at the Dirt on Flexible Endoscopes© 3M 2015 All Rights Reserved.

Human Factors

• Constant interruptions

• Staff turnover

• Pressure to turn scopes

• Personnel in PPE’s

• Inadequate training

• Noxious fumes

• Physical discomfort including muscle strain from repeat activities



Human Factors Resolve

• Review unnecessary interruptions for elimination

• Purchase additional scopes to reduce turn-around

• Have minimum types of scopes

• Review PPE with staff to find type more functional



24

Human Factors Resolve• Implement training/competency programs

• Have all IFU’s readily available

• Utilize formal training programs, standard setting organizations and

enlist the expertise from all manufacturer involved including;

- Scope

- Detergent

- HDL/sterilizer

- AER

- Automatic flushers

- Quality assurance products



• Use only dedicated staff for processing flexible endoscopes

• Require certification for staff processing flexible endoscopes

• Investigate the use of automated processes such as flushing aids; If manual HDL consider purchase of AER



Implement Safe Use of HDL

• Keep covered

• Use fume hoods

• Provide proper environmental air flow, exchanges and

temperature

• Use HDL with low noxious fumes


25

Human Factors ResolvePhysical DiscomfortReview the layout of the processing area

for ease of processing• Supplies conveniently located

• Short distance between activities

• Check lighting to prevent eye strain

• Check level of counters and sink depth

• Environmental temperature



Key Leanings

• Applying human factors concepts to medical device processing results in medical devices to be designed for thorough cleaning and sterilization.

• The design of IFUs are a key factor to enable a healthcare facility to properly process medical devices.

• The concepts from the AAMI TIR on Human Factors provide guidance to a central service department or area for workplace design and departmental communication.


Questions?


26


THANK YOU!

NEXT LIVE WEBINAR

Date: October 15, 2015

Title: Ask the Experts

ReferencesAAMI TIR55:2014 Human factors engineering for processing medical devices. Association for the Advancement of Medical Instrumentation.

Ofstead, IAHCSMM Conference May 3, 2015 Taking a Closer Look at the Dirt on Flexible Endoscopes

Ofstead, et al., Gastroenterology Nursing, July/Aug 2010 – Vol 33 – Issue 4 – p 304-311

The Society of Gastroenterology Nurses & Associates 2010. Abstract accessed 08.20.15;

http://journals.lww.com/gastroenterologynursing/Abstract/2010/07000/Endoscope_Reprocessing_Methods__A_Prospective.8.aspx

oneSOURCE: www.onesourcedocs.com, accessed on 08.20.15


sterile u human factors webinar -...

Documents