Info über WoundStat(c) - ich werde das zeitnah noch in Deutsch zusammenfassen:
-----Original Message-----
From: Butler, Frank K., CTR [mailto:Frank.Butler@med.navy.mil]
Sent: Wednesday, December 24, 2008 12:35 PM
Subject: WoundStat Message
Forwarded FYI.
The attached message reflects safety concerns about WoundStat presented by
Dr. Bijan Kheirabadi from the U.S. Army Institute of Surgical Research at
the recent Special Operations Medical Association conference.
Dr. Kheirabadi observed that 7 of 8 animals on whom WoundStat was used in a
carotid artery bleeding model developed occlusive thrombosis and had no
blood flow 2 hours after suturing of the wound.
The implications of this study for both WoundStat and hemostatic agent
testing in general are currently under review.
Note that WoundStat currently serves as the "Last Resort" of medics' options
to stop life-threatening external hemorrhage. TCCC guidelines call for
tourniquets, Combat Gauze, and WoundStat in that order. When used
appropriately, WoundStat is the medic's last intervention to stop a casualty
from bleeding to death from external hemorrhage in a location not amenable
to tourniquet use.
V/R -
Frank
Frank K. Butler, Jr. M.D.
CAPT MC USN (RET)
Chairman
Committee on Tactical Combat Casualty Care
Einhergehend mit folgender Anweisung:
FROM
CDRUSAMMA FT DETRICK MD//MCMR-MMO-SO//
***PRIORITY***MESSAGE NOT RELEASED
****************UNCLASSIFIED****************
SUBJ: T0B-1218-002
NEW SOLDIER HEMOSTATIC DRESSINS / WOUNDSTAT / MEDICAL INFORMATION
REFERENCE: ALARACT 239/2008, NEW SOLDIER HEMOSTATIC DRESSINGS
1. THIS FRAGO DIRECTS TEMPORARY CESSATION OF USE OF WOUNDSTAT™ (WS) BY 68W
COMBAT MEDICS AND ALL OTHER PROVIDERS DUE TO NEWLY IDENTIFIED SAFETY CONCERNS
ABOUT THIS PRODUCT, PENDING FURTHER EVALUATION.
2. WOUNDSTAT™ WILL BE TURNED IN TO THE MEDICAL SUPPLY SYSTEM IMMEDIATELY.
UNIT SUPPLY PERSONNEL WILL TURN -IN WOUNDSTAT™ TO THEIR SUPPORTING MEDICAL
SUPPLY SUPPORT ACTIVITY (SSA). THE ARMY MEDICAL SSA WILL REVIEW TRANSACTION
REGISTERS AND COMPLETE 100% CONTACT WITH UNITS ISSUED WS TO ENSURE TURN-IN
OF PRODUCT. ARCENT WILL SUBMIT THE TOTAL NUMBER OF WS ISSUED AND COLLECTED
TO OTSG. THE ARMY MEDICAL SSA WILL HOLD WS UNTIL FURTHER NOTICE OR UNTIL DISPOSITION
INSTRUCTIONS ARE RECEIVED FROM OTSG.
3. DATA FROM THE US ARMY INSTITUTE OF SURGICAL RESEARCH (USAISR) SHOW THAT
WS IS ASSOCIATED WITH A HIGH INCIDENCE OF BLOOD VESSEL THROMBOSIS AND DAMAGE
TO THE VESSEL WALL. COMBAT GAUZE AND PLAIN KERLIX WERE NOT ASSOCIATED WITH
SIMILAR FINDINGS. USE OF COMBAT GAUZE IS SAFE, ACCORDING TO CURRENT STUDIES,
AND DISTRIBUTION AND USE SHOULD CONTINUE.
4. MEDICAL PERSONNEL MUST LOCATE AND EXAMINE ALL CASUALTIES PREVIOUSLY TREATED
WITH WS TO VERIFY ADEQUATE LIMB PERFUSION, IF WS WAS USED TO TREAT EXTREMITY
WOUNDS.
5. EXPIRATION DATE CANNOT BE DETERMINED.
-----Original Message-----
From: Butler, Frank K., CTR [mailto:Frank.Butler@med.navy.mil]
Sent: Wednesday, December 24, 2008 12:35 PM
Subject: WoundStat Message
Forwarded FYI.
The attached message reflects safety concerns about WoundStat presented by
Dr. Bijan Kheirabadi from the U.S. Army Institute of Surgical Research at
the recent Special Operations Medical Association conference.
Dr. Kheirabadi observed that 7 of 8 animals on whom WoundStat was used in a
carotid artery bleeding model developed occlusive thrombosis and had no
blood flow 2 hours after suturing of the wound.
The implications of this study for both WoundStat and hemostatic agent
testing in general are currently under review.
Note that WoundStat currently serves as the "Last Resort" of medics' options
to stop life-threatening external hemorrhage. TCCC guidelines call for
tourniquets, Combat Gauze, and WoundStat in that order. When used
appropriately, WoundStat is the medic's last intervention to stop a casualty
from bleeding to death from external hemorrhage in a location not amenable
to tourniquet use.
V/R -
Frank
Frank K. Butler, Jr. M.D.
CAPT MC USN (RET)
Chairman
Committee on Tactical Combat Casualty Care
Einhergehend mit folgender Anweisung:
FROM
CDRUSAMMA FT DETRICK MD//MCMR-MMO-SO//
***PRIORITY***MESSAGE NOT RELEASED
****************UNCLASSIFIED****************
SUBJ: T0B-1218-002
NEW SOLDIER HEMOSTATIC DRESSINS / WOUNDSTAT / MEDICAL INFORMATION
REFERENCE: ALARACT 239/2008, NEW SOLDIER HEMOSTATIC DRESSINGS
1. THIS FRAGO DIRECTS TEMPORARY CESSATION OF USE OF WOUNDSTAT™ (WS) BY 68W
COMBAT MEDICS AND ALL OTHER PROVIDERS DUE TO NEWLY IDENTIFIED SAFETY CONCERNS
ABOUT THIS PRODUCT, PENDING FURTHER EVALUATION.
2. WOUNDSTAT™ WILL BE TURNED IN TO THE MEDICAL SUPPLY SYSTEM IMMEDIATELY.
UNIT SUPPLY PERSONNEL WILL TURN -IN WOUNDSTAT™ TO THEIR SUPPORTING MEDICAL
SUPPLY SUPPORT ACTIVITY (SSA). THE ARMY MEDICAL SSA WILL REVIEW TRANSACTION
REGISTERS AND COMPLETE 100% CONTACT WITH UNITS ISSUED WS TO ENSURE TURN-IN
OF PRODUCT. ARCENT WILL SUBMIT THE TOTAL NUMBER OF WS ISSUED AND COLLECTED
TO OTSG. THE ARMY MEDICAL SSA WILL HOLD WS UNTIL FURTHER NOTICE OR UNTIL DISPOSITION
INSTRUCTIONS ARE RECEIVED FROM OTSG.
3. DATA FROM THE US ARMY INSTITUTE OF SURGICAL RESEARCH (USAISR) SHOW THAT
WS IS ASSOCIATED WITH A HIGH INCIDENCE OF BLOOD VESSEL THROMBOSIS AND DAMAGE
TO THE VESSEL WALL. COMBAT GAUZE AND PLAIN KERLIX WERE NOT ASSOCIATED WITH
SIMILAR FINDINGS. USE OF COMBAT GAUZE IS SAFE, ACCORDING TO CURRENT STUDIES,
AND DISTRIBUTION AND USE SHOULD CONTINUE.
4. MEDICAL PERSONNEL MUST LOCATE AND EXAMINE ALL CASUALTIES PREVIOUSLY TREATED
WITH WS TO VERIFY ADEQUATE LIMB PERFUSION, IF WS WAS USED TO TREAT EXTREMITY
WOUNDS.
5. EXPIRATION DATE CANNOT BE DETERMINED.
"Bellum omnium contra omnes."
Krieg von Allen gegen Alle.
