WESTCHESTER REGIONAL

EMERGENCY MEDICAL ADVISORY COMMITTEE

POLICY STATEMENT

Supercedes/Updates: New

No. 04 - 03

Date: April 19, 2004

Re: Use of Absorbable Hemostatic Agents

Pages: 2

Printable version (pdf)

Use of Absorbable Hemostatic Agents By Certified EMS Agencies

PURPOSE

To provide EMS agencies with regional guidelines on the appropriate possession and use of hemostatic agents for hemorrhage control.

BACKGROUND

Brought first into use through the United States Military, the United States Food and Drug Administration (FDA) has regulated absorbable hemostatic agents since the late 1970s. Addressed separately from surgically used vascular constricting agents under regulation number 21 CFR §878.4490, “Absorbable hemostatic agent and dressing, “ these agents are defined as “a device intended to produce hemostasis by accelerating the clotting process of blood.” Within the past decade these agents have been commercially developed for use by civilian emergency medical services. Recent studies presented in medical journals have found that the use of these hemostatic dressing can improve survival and decrease bleeding associated with lethal vascular and soft tissue injuries.[1]

AUTHORIZATION

Any Westchester Regional certified EMS agency wishing to include the use of hemostatic agents among other tools for hemorrhage control may do so under the advice and consent of their Agency Medical Director. Any absorbable hemostatic agent purchased and supplied on an EMS unit must be approved by the FDA for that purpose.

TRAINING

The NYS DOH EMT and AEMT curriculums do not include instruction on the use of hemostatic agents for hemorrhage control. The EMS agency, in conjunction with the Agency Medical Director, shall create a training program to familiarize all the members/employees of that agency with the indications for and use of the agent as per the FDA approved manufacturer’s instructions[2], as well as emergency treatment for exposures to non-injured areas and accidental ingestion. Application of the agents will be consistent with the direction of care for hemorrhage-control found in the current NYS DOH BLS protocols.

STORAGE

The certified EMS agency must ensure that the hemostatic agent is stocked and stored in accordance with manufacturer recommendations.

Issued and Authorized by:

Dr. Nicholas DeRobertis, MD, FACEP

Chair, Westchester Regional Emergency Medical Advisory Committee