October 21, 2013 advisory: table of approved devices-updated 10/21/13



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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






99 Chauncy Street (11th Floor), Boston, MA 02111 ● 617.753.7304 ● www.mass.gov/dph/oems

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