Promoting Patient S

Promoting Patient S

with Home Use Me

with Home Use Me

Devices Devices

Presented by Diana Rivi, MPH Presented by Diana Rivi, MPH

Public Health Analyst Public Health Analyst

Center for Devices and Radiological H

Center for Devices and Radiological H

Office of Surveillance and Biometrics (

Office of Surveillance and Biometrics (

May 2011 May 2011
 Understand what is postmarket surve

Understand what is postmarket surve

it relates to Home Use Device Initiativ

it relates to Home Use Device Initiativ

 Learn about reportable issues with ho

Learn about reportable issues with ho

medical devices. medical devices.

 Describe your role in promoting patien

Describe your role in promoting patien

medical devices used in the home. medical devices used in the home.

 Describe the steps providers and patie

Describe the steps providers and patie

report an adverse event or problem w

report an adverse event or problem w

device used in the home. device used in the home.

 Understand your role in working with 

Understand your role in working with 

assure the safety of medical devices u

assure the safety of medical devices u

home.

Objectives Objectives
What is Postmarket Surve

What is Postmarket Surve

 Monitoring medical device performanc

Monitoring medical device performanc

device is approved or cleared for mark

device is approved or cleared for mark

identify problems and safety issues th

identify problems and safety issues th

during widespread clinical and home u

during widespread clinical and home u

 Detect and evaluate problems early Detect and evaluate problems early Minimize risks Minimize risks  Address those problems that may emerge wit

Address those problems that may emerge wit

 Monitor known risks Monitor known risks
 FDA’s nationwide adverse event repo

s nationwide adverse event rep

 Relies on reports of prob Relies on reports of problems by the 

lems by the 

manufacturer manufacturer

 Manufacturers Manufacturers, Consumers Consumers an

Facilities Facilities (such as hospitals) rep

(such as hospitals) rep

MedWatch MedWatch

FDA’s Postmarket s Postmarket Sur

Sur

System: MedWa

System: MedWa
MedWatch Repor

MedWatch Repor

 Manufacturers Manufacturers must report: report:

 Deaths Serious injuries Serious injuries Malfunctions Malfunctions 

 User Facilities User Facilities must report: report:

 Deaths to FDA and to the manufac

Deaths to FDA and to the manufac

 Serious injuries to the manufacture

Serious injuries to the manufacture

 Alternative mechanism for user fac

Alternative mechanism for user fac

MedSun

 Voluntary Reporting Voluntary Reporting at 1

-800
 MedSun is a postmarket survei

is a postmarket survei

program under the MedWatch sy

program under the MedWatch sy

offers the clinical community an o

offers the clinical community an o

to participate in a to participate in a “real-time” net

net

healthcare specialists sharing ALL 

healthcare specialists sharing ALL 

about medical device problems. about medical device problems.

 Nationwide Network of 350 User 

Nationwide Network of 350 User 

What is the Medical Produc

What is the Medical Produc

Network (MedSun)

Network (MedSun)
Home Use Medical 

Home Use Medical 

Initiative Initiative
Home Use Home Use 

Medical Device Initiat

Medical Device Initiat

FDA will take the following actions to supp

FDA will take the following actions to supp

and safe use of medical devices in the ho

and safe use of medical devices in the ho

1.Establish guidelines for manufactur

Establish guidelines for manufactur

use devices use devices

2.Develop a home use device labeling 

Develop a home use device labeling 

3.Partner with home health accreditin

Partner with home health accreditin

support safe use support safe use

4.Enhance postmarket oversight Enhance postmarket oversight5.Increase public awareness and edu

Increase public awareness and edu
Top Reported Adverse Dev

Top Reported Adverse Dev

in MAUDE Jan 2010 in MAUDE Jan 2010 –Ja

Ja

(total number of events = 1103 where locat

(total number of events = 1103 where locat

states 

“home

”) 

 Invasive glucose sensor Invasive glucose sensor Implantable cardioverter defibrillators Implantable cardioverter defibrillators Ventricular (assist) bypass devices Ventricular (assist) bypass devices Tracheostomy Tracheostomy tubes and cuffs tubes and cuffs  Insulin infusion pumps Insulin infusion pumps Piston syringes Piston syringes Automatic implantable cardioverter Automatic implantable cardioverter defibrillators with cardiac resynchronizatio

defibrillators with cardiac resynchronizatio

 Peritoneal automatic delivery system Peritoneal automatic delivery system Mechanical walkers Mechanical walkers Glucose monitors Glucose monitors
What is an Adverse 

What is an Adverse 

 An event whereby a medical dev

An event whereby a medical dev

may have, caused or contribute

may have, caused or contribute

or serious injury. or serious injury.

 Includes events resulting from: Includes events resulting from:

 Device failure Device failure Device malfunction Device malfunction Improper or inadequate device 

Improper or inadequate device 

 Manufacturing problems Manufacturing problems Labeling problems Labeling problems Training issues Training issues Use error Use error
Staff

Environment Environment

 Electri Electric Power, Heat, Power, Heat, 

Humidity, Humidity, Temperature, Temperature, Stability Stability

 Light, Other Devices Light, Other Devices or Electronics in or Electronics in 

home (EMI) home (EMI)

 Pets, Kids, Noi Pets, Kids, Noise 

level

Heated Humidifier

Exhalation Filter

Medication Port & Filter Pressure Va

Accessories 

Pat

Think about the De

Think about the De

and its Environm

and its Environm


Examples of Probl

Examples of Probl

With

Home Use Medical D

Home Use Medical D
What Types of Medical 

What Types of Medical 

Issues Should You Loo

Issues Should You Loo

 Defects Defects Software problems Software problems Failure to work as intended/malf

Failure to work as intended/malf

 Instructions/labeling/packaging 

Instructions/labeling/packaging 

 Interactions with other devices, 

Interactions with other devices, 

electronic equipment in the hom

electronic equipment in the hom

 Use errors Use errors Human Factors issues Human Factors issues Combinations of the above Combinations of the above
Examples of Probl

Examples of Prob

 Defects Defects

 IV pump bracket found with IV pump bracket found with 

large crack and sharp edges large crack and sharp edges

 Ventilator started smoking Ventilator started smoking  Gloves found discolored and Gloves found discolored and 

with holes with holes

 Crutches collapse Crutches collapse
Examples of Proble

Examples of Proble

 Software problems Software problems

 Vital signs monitor did not tra

Vital signs monitor did not tra

information to central station information to central station

 Software glitches with new so

Software glitches with new so

installation installation

 Virus infects device operating 

Virus infects device operating 

 Day

-light savings software con

light savings software co
Examples of Proble

Examples of Proble

 Failure to work as intended/malf

Failure to work as intended/malf

 IV pumps not infusing as programm

IV pumps not infusing as programm

 Safety mechanism on IV catheters/

Safety mechanism on IV catheters/

failing failing

 Medical bed would not maintain po

Medical bed would not maintain po

 Shower chair collapse Shower chair collapse Walker leg malfunction Walker leg malfunction Broken connector clip on patient lif

Broken connector clip on patient lif
Examples of Proble

Examples of Proble

 Instructions/Labeling/Packagin

Instructions/Labeling/Packagin

 Instructions for use (includes Instructions for use (includes 

graphics/icons/charts) graphics/icons/charts)

 Unclear Unclear Misleading Misleading  Incomplete Incomplete  Difficult to see, i.e. too small, co

Difficult to see, i.e. too small, co

 Absent Complex, i.e. written for healthc

Complex, i.e. written for healthc

and not for patient or family car

and not for patient or family car
Examples of Proble

Examples of Proble

 Instructions/Labeling/P

Instructions/Labeling/P

issues

 Packaging Packaging

 Damaged package Damaged package Missing components Missing components Sterility issues Sterility issues Device size is incorrect Device size is incorrect
Examples of Proble

Examples of Proble

 Interactions with Interactions with 

other devices other devices 

 Electrical instrument Electrical instrument 

deactivates pacemaker deactivates pacemaker

 Cell phone use interferes Cell phone use interferes 

with monitoring equipment with monitoring equipment
Examples of Proble

Examples of Proble

 Use Errors Use Errors

 Electric Electric-powered wheelchair jo

powered wheelchair jo

close to speed button close to speed button
Human Factor

Human Factor

Human Factors Human Factors –the science of 

the science of 

humans interact with technology

humans interact with technology

on the device on the device

-user interface, inc

user interface, inc

the following: the following:

 Device Design Device Design  Environment of Use Environment of Use  User Characteristics User Characteristics 
Human Factors Human Factors 

 User Considerations User Considerations 

 Abilities and capabilities Abilities and capabilities Expectations Expectations Familiarity with device Familiarity with device 
Issues with patient or family car

Issues with patient or family car

training and education training and education

 Training is not appropriate to audi

Training is not appropriate to audi

 Unclear Unclear  Misleading Misleading  Incomplete Incomplete 

 Training is not provided Training is not provided Training only addresses device set 

Training only addresses device set 

does not include information abou

does not include information abou

 Device maintenance Device maintenance Troubleshooting Troubleshooting Device replacement parts Device replacement parts

Human Factors Human Factors 
How Can You Help 

How Can You Help 

Assure the Safety 

Assure the Safety 

Home Use Medical Home Use Medical Devices? Devices?
Your Role Your Role

 Recognize, report, and understand 

Recognize, report, and understan

problems problems

 Identify actual and potential proble

Identify actual and potential proble

events, close calls with medical dev

events, close calls with medical dev

 Ask the end user (patient) question

Ask the end user (patient) question

device

 Include details in your report, i.e. w

Include details in your report, i.e. w

event occur, what happened, device 

event occur, what happened, devic

 Notify the manufacturer Notify the manufacturer Notify FDA via MedWatch Notify FDA via MedWatch
Why Should You Re

Why Should You Re

 Prevent future problems and 

Prevent future problems and 

your patients and families your patients and families 

 Impact the public health for 

Impact the public health for 

nation’s patients, family care

s patients, family care

and/or health care providers and/or health care providers

 Effect changes in policies an

Effect changes in policies an

procedures procedures
What Can You D

What Can You D

 Recognize, report, and understand d

Recognize, report, and understand d

problems problems

 Identify actual and potential prob

Identify actual and potential prob

adverse events, close calls with m

adverse events, close calls with m

devices devices

 Ask the end user questions about 

Ask the end user questions about 

 Include details in your report, i.e. 

Include details in your report, i.e. 

this event occur, what happened, 

this event occur, what happened, 

identifiers identifiers

 Notify the manufacturer Notify the manufacturer Notify FDA via MedWatch Notify FDA via MedWatch
When Do You Rep

When Do You Rep

 When you think a device has 

When you think a device has 

have caused or contributed t

have caused or contributed 

the following outcomes (for 

the following outcomes (for 

caregiver, staff member): caregiver, staff member):

 Death Serious injury Serious injury Minor injury Minor injury Close calls or other potential f

Close calls or other potential f
What Information Ca

What Information Ca

Report? Report?

 The event (injury) The event (injury) Place or location of the event Place or location of the event How the event occurred How the event occurred Related factors that may have c

Related factors that may have 

event

 The prescribed use of the devic

The prescribed use of the devic
 Medical procedures and follo

Medical procedures and follo

 Manufacturer information Manufacturer information Device Information Device Information Action taken to solve the pro

Action taken to solve the pro

What information Ca

What information Ca

Report? Report? cont.
How Do You Repo

How Do You Repo

Voluntary reports can be subm

Voluntary reports can be subm

calling the FDA at 1 calling the FDA at 1

-800-FDA

-1

1

mailing in the MedWatch 3500 

mailing in the MedWatch 3500 

available online at: available online at: 

www.fda.gov/downloads/Safety/M

www.fda.gov/downloads/Safety/M

DownloadForms/UCM0827

DownloadForms/UCM0827
And Remember 

And Remember 

We can’t address issues w

t address issues w

know about. know about.

Please communicate with your pro

Please communicate with your pro

with FDA. with FDA.

Please report. Please report.
 Postmarket surveillance an

Postmarket surveillance an

Use Device Initiative Use Device Initiative

 Reportable issues that may 

Reportable issues that may 

the home the home

 Your role in promoting pat

Your role in promoting pat

 How you can make a differ

How you can make a differ

report to FDA report to FDA

 Your role to help assure sa

Your role to help assure sa

medical devices used in the 

medical devices used in th

Summary Summary
THANK YOU! THANK YOU!
Resources for Y

Resources for Y

 Device Listing: Device Listing:

http:// http://www.accessdata.fda.gov/script www.accessdata.fda.gov/scripts/cdrh/cfdo

This database contains a listing This database contains a listing of medical devices in commerc

 of medical devices in commerc

both domestic and Fo both domestic and Foreign manufacturers. reign manufacturers. 

 FDA Patient Safety News: FDA Patient Safety News: 

http:// http://www.fda.gov/psn www.fda.gov/psn

A monthly video news show for health professionals, presents 

new product approvals, recalls, new product approvals, recalls, and safety alerts, and offe

and safety alerts, and offe

protecting patients. protecting patients. 

 Home Use Device Website: Home Use Device Website:

http:// http://www.fda.gov/homeusedevice

www.fda.gov/homeusedevice

This site provides resources an This site provides resources and safety information about med

d safety information about med

the home environment. the home environment.
Resources for Y

Resources for Y

 Human Factors Website: Human Factors Website:

www.fda.gov/MedicalDevices/Dev www.fda.gov/MedicalDevices/DeviceRegulati

iceRegulati

PostmarketRequirements/HumanFactors/uc

This site provides information on human factors design, test

This site provides information on human factors design, test

considerations for considerations for 

Healthcare professionals, manufacturers and consumers. Healthcare professionals, manufacturers and consumers. 

 Infusion Pumps Website: Infusion Pumps Website:

www.fda.gov/MedicalDevices/ProductsandMe

www.fda.gov/MedicalDevices/ProductsandMe

GeneralHospitalDevicesanSupplies/InfusionPu

This website provides information about infusion pumps, act

This website provides information about infusion pumps, act

improve pump improve pump 

safety, strategies to reduce pump safety, strategies to reduce pump-related risks, and steps yo

related risks, and steps yo

problems to FDA. problems to FDA.
Resources for Y

Resources for Y

 Luer Misconnections Website Luer Misconnections Website:

www.fda.gov/MedicalDevices/Sa

www.fda.gov/MedicalDevices/Sa

AlertsandNotices/ucm134863.h

This site provides information for healthcare professionals abou This site provides information for healthcare professionals about h

t h

different device delivery systems are mistakenly connected to 

s are mistakenly connected to 

the use of Luer connectors. the use of Luer connectors. 

 MAUDE (Manufacturer and User MAUDE (Manufacturer and User Facility Device Experie

Facility Device Experi

www.accessdata.fda.gov www.accessdata.fda.gov/scrip

/scrip

cdrh/cfdocs/cfMAUDE/search.C

MAUDE data represents reports of adverse events involving medic

MAUDE data represents reports of adverse events involving medic

consists of all voluntary report consists of all voluntary reports since June 1993, user facility s since June 1993, user facility 

distributor reports since 1993,an distributor reports since 1993,and manufacturer reports since 

d manufacturer reports since 

 Medical Device Safety Website: Medical Device Safety Website: 

www.fda.gov/cdrh/medicaldevices

www.fda.gov/cdrh/medicaldevice

One-stop for safety information with links to published safety tips stop for safety information with links to published safety tips 

patient patient

safety news programs, safety alerts, safety news programs, safety alerts, recalls recalls, and a link to report a 

, and a link to report a 
Resources for Y

Resources for Y

 MedSun Website: MedSun Website:

www.fda.gov/cdrh/meds

www.fda.gov/cdrh/meds

This site provides patient safety information via current an

This site provides patient safety information via current an

MedSun newsletter, MedSun newsletter,

educationalmaterials educationalmaterials, and search capability for MedSun ad

, and search capability for MedSun ad

 Product Classification Product Classification:

www.accessdata.fda.gov/scripts/

www.accessdata.fda.gov/scripts/

cfdocs/cfPCD/classification.cf

This database can be used to de This database can be used to determine the classification 

termine the classification 

regulations it is regulations it is

subject to. subject to.

 Warning Letters Warning Letters:

www.accessdata.fda.gov/scripts/wlcfm/re

This database contains the most This database contains the most recent manufacturer war

recent manufacturer war