Notice
Table of Approved Devices
October 21, 2013
ADVISORY: TABLE OF APPROVED DEVICES-updated 10/21/13
The following devices and categories of devices have been reviewed by OEMS. Advisories are on the OEMS web page regarding usage and restrictions, if any. As with any device operated under the license of the ambulance service, the ambulance service must ensure that the specific device is FDA approved and that their EMTs are properly trained, refreshed in their training, and have demonstrated competency under the direction of their affiliate hospital medical director, as per the manufacturer’s recommendations and usage, prior to allowing such device on the ambulance. This list will be updated as new devices are approved by the Department.
DEVICE
|
DESCRIPTION
|
APPROVAL DATE
|
RESTRICTIONS
|
Battery operated compression device
|
Battery operated CPR machine
|
January 1, 2010
|
|
Wound suction
|
device creates a gentle negative pressure to drain away exudates
|
January 1, 2010
|
|
BiPAP
|
BiPAP (Bilevel Positive Airway Pressure) provides two levels of pressure: Inspiratory Positive Airway Pressure (IPAP) and a lower Expiratory Positive Airway Pressure (EPAP) for easier exhalation
|
January 1, 2010
|
|
CPAP
|
CPAP (continuous positive airway pressure), a type of noninvasive ventilation, that delivers accurate and constant pressure
|
January 1, 2010
|
|
Autopulse™ or equivalent
|
Battery powered mechanical chest compression device
|
September 12, 2008
|
|
King LT or equivalent
|
Supraglottic device used as an alternative to tracheal intubation or mask ventilation
|
May 2008
|
May be used with approval of Affiliate Hospital Medical Director
|
Bougie
|
Rigid ETT plastic coated introducer placed blindly into the trachea to introduce the ETT over it
|
2005
|
May be used with approval of Affiliate Hospital Medical Director
|
Optical Laryngoscope or equivalent
|
Anatomically shaped laryngoscope with two separate channels: The optical channel: contains a high definition optical system. The guiding channel: holds the endotracheal tube (ETT) and guides it through the vocal cords
|
February 11, 2008
|
|
CPR Vest
|
Pneumatically powered mechanical chest compression system using air tanks
|
|
|
GlideScope ® or equivalent
|
Laryngoscope which uses optics to visualize a patient’s airway
|
November 21, 2007
|
|
Hemostatic Dressings
|
Hemostatic Dressings Only (not powders)
|
November 21, 2007
|
See Department Advisory Dated November 21, 2007 addressing EMS role
|
ADD-Vantage® System
|
Diltiazem HCl
|
July 17, 2007
|
See the Bureau of Quality Assurance and Control letter dated July 17, 2007 addressing EMS role
|
Impedance Threshold Device
|
Adjunct device, which attaches to the BVM, and increases blood flow to the heart and brain during CPR
|
September 6, 2006
|
|
CO Co-Oximeter
|
Carbon Monoxide Detection unit
|
September 6, 2006
|
|
IV Power Injector
|
IV Bolus of Medications
|
September 6, 2006
|
|
Ventricular Assist Device (VAD); (LVAD), (RVAD)
|
All
|
February 10, 2005
|
See Department Advisory dated December 15, 2011 addressing EMS transport
|
Peripherally Inserted Central Catheter (PICC) Lines
|
All
|
October 10, 2003
|
See Department Advisory dated October 10, 2003 addressing EMS role
|
Intraosseous (IO) Infusion Devices
|
Please note that any FDA approved IO device may be used as long as it is powered by hand (e.g. Jamshidi needle), drill (e.g. EZIO), or spring (e.g. BIG); but NOT if powered by a gas-driven or explosive cartridge. Standard IO is placement is in the proximal or distal tibia; if clinically necessary, Paramedics may place the IO in any site for which the device is approved, but only if they have been trained to do so and approved to do so by their Affiliate Hospital Medical Director
|
October 10, 2003
|
See Department Advisory letter dated October 10, 2003 addressing EMS role
|
Pulse Oximetry
|
Oxygen measuring device
|
Medical Services Committee August 10, 2012
|
As indicated by protocols
|
Morgan Lens
|
a sterile plastic resembling a contact lens connected to tubing that fits over the eye allowing irrigation of the eye
|
October 1, 1997
|
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99 Chauncy Street (11 th Floor), Boston, MA 02111 ● 617.753.7304 ● www.mass.gov/dph/oems
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