Table of Typic
cal Device R
Risk Levels
s

These lev
vels are based
d on the risks of injury ca
aused by devvice failure or user error;; they take in
nto
account both
b outcomee probability
y and severityy.

High-risk
k devices: Liffe-support, keey resuscitatio
on, critical moonitoring, eneergy emitting, and other deevices
whose failure or misuse is reasonably likely to seeriously injuree patients or sstaff.

Anesthesiia Units and Vaporizers

V Irrigatioon/Distentionn Units

Apnea Mo
onitors Laparosscopic Insuffl
flators

nhanced Coag
Argon-En gulation Unitss Lasers ((Surgical)

Aspiratorss (Emergency
y and Tracheaal) Nuclearr Medicine Syystems

Autotranssfusion Units Oxygenn Monitors annd Analyzers

Blood Preessure Units (Invasive) Patient Lifts

Capnometters Patient Warming Unnits

Contrast Media
M Injecto
ors Peritonneal Dialysis U
Units

Defibrillaators/Noninvaasive Pacemak
kers Phacoem
mulsificationn Units

Electrosurrgical Units Physiollogic Monitorrs/Monitoringg Systems

Fetal Mon
nitors Pneumaatic Tourniquuets

Heart-Lun
ng Bypass Un
nits Radiantt Warmers (Innfant)

Hemodiallysis Units Radioloogic Imaging Systems

High-Effiiciency-Filter Air Cleanerss Sterilizzers (e.g., Steaam, Ethylene Oxide)

Humidifieers (Heated) Transcuutaneous O2 aand CO2 Monnitors

Infant Inccubators Transveenous Pacemaakers

Infusion Pumps
P Ventilaators

Intra-Aorttic Balloon Pu
umps

 
P
Page 1 
 
 

Medium--risk devices:: Devices, inccluding many diagnostic innstruments, w whose misuse, failure, or
absence (ee.g., out of seervice with no
o replacementt available) w
would have a ssignificant im
mpact on patient
care but would
w not be likely
l to cause direct seriou
us injury.

Ambulato
ory ECG Reco
orders and Sccanners Enteral Pumps

Aspiratorss (Surgical, Thoracic,

T Uterrine) Lithotriipters

Blood Ban
nk Refrigerattors Noninvvasive Blood P
Pressure Unitts

Blood Gaas/pH Analyzeers Oxygenn-Air Proporttioners

Blood/Sollution Warmeers Oxygenn Concentratoors

Cardiac Output
O Units Paraffinn Baths

Centrifuges and Clinical Lab Equipm

ment Photothherapy Units

Circumcission Clamps Pulmonnary Functionn Analyzers

Computed
d Radiograph
hy Systems Radiantt Warmers (A
Adult)

Cryosurgiical Units Applications1

Scales ffor Critical A

Diagnostiic Imaging Workstations

W Speciall Care Beds (ee.g., Circle, F
Flotation)

Electrocarrdiographs Surgicaal Drills and S

Saws (Powereed)

Electrocon
nvulsive Therrapy Units Tractionn Units

Electroencephalograph
hs Treadm
mills

Endoscop
pes Ultrasoound Scannerss

1
Hemodiaalysis and Neon
natal Care Unitts

 
P
Page 2 
 
 

Low-risk
k devices: Dev
vices whose failure
f or misu
use is unlikelly to result in serious conseequences.

Alternatin
ng-Pressure Pads Operatiing Tables

Aspiratorss (Low Volum

me) Oto/Opphthalmoscoppes

umps
Breast Pu Regulattors (Low-Voolume Suctionn)

Cast Cutteers Smoke Evacuators

Circulatin
ng-Fluid Pump
ps Sphygm
momanometerrs

Diathermy
y Units (Physsical Therapy) Stimulaators (Physicaal Therapy)

Electric Beds
B Surgicaal Lights

Electric Wheelchairs
W Surgicaal Microscopees

Electronicc Scales (Gen

neral Patient Care)
C Temperrature Monitoors

Electronicc Thermometers Ultrasoonic Nebulizerrs

Examination Lights Ultrasoonic Units (Phhysical Therappy)

Fiberopticc Light Sourcces Warminng Cabinets

Intermitteent/Compressiion Units Whirlpoool Baths

 
P
Page 3