High Risk Equipment and Life Support

What is Life Support Equipment? What is High Risk?

April 6, 2017

All Life Support Equipment is also high-risk equipment.  EC.02.04.01 and EC.02.04.03 now require our customers to determine what is high risk equipment.
We would like your feedback as we develop this list. We will move our updated list online for further review. If you find any of the names inaccurate or redundant, please comment.
Life Support:
Anesthesia Machine
Apheresis System
Balloon Pump, Intra-Aortic (IABP)
Extracorporeal Membrane Oxygenation (ECMO)
Heart-Lung Bypass Machine (Pump, Extracorporeal Perfusion)
Heart-Lung Bypass Heat Exchanger
Iron lung
Pacemaker, Cardiac External
Pump, Blood, Extraluminal (Roller Pump)
Ventilator / Respirator
Intermittent positive pressure breathing (IPPB) machines
Suction machine
Other High Risk Equipment:
Apnea monitor for infants (24 months and under)
Dialysis Machine
ECMO Equipment
Electrosurgical Unit (Including hyfrecators)
Heat Exchanger, Heart-Lung Bypass
Monitor, Airway Pressure
Resuscitator, Infant
Warmer, Blood / Plasma
Are these High Risk?
Ablation Unit, Ultrasonic
Aerosol tent
Air Compressor
Air Flow Gauge
Angioplasty System
Aquapheresis System
Balloon Pump, Gastrointestinal
Bed Alarm
Continuous Fluid Management Renal Replacement
Cryosurgical Unit, Cardiac
Electric nerve stimulator
Gas Outlet
Heater, ECMO
Imaging Equipment
Infusion pump
Liposuction Unit
Nebulizer, Electrostatic and Ultrasonic
Oxygen Concentrator
PCCTS Work Station
Phaco and Vietretomy System
Power Supply on Life Support Device
Pressure pads and pump
Surgical Robot
Terminal Cabinet
Tourniquet, Pneumatic
Urinary Catheterization
Vacuum, Curettage System
Ventricular Assist Device Drive Console
Warmer, Radiant, Infant
Water Treatment, Reverse Osmosis
Wax Warmer
Wound Drainage Pump
Xenon Ventilation System
We have a couple more questions.
Is there any equipment that is high-risk only when used in special circumstances?
(Quadriplegic care, home care, neonate care, etc)
Are there any ventilators or anesthesia equipment that are not high-risk?
What equipment can harm staff if it fails?
Lab Equipment
Note: Iron Lung is on the list because NIH reports that they have been reintroduced for neonatal use.

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