FDA Notice SAM Junctional Tourniquet

SAM Junctional Tourniquet Accessory (Axilla) Strap/SAM Medical Products: Recall – Potential Clip Failure

AUDIENCE: Emergency Medicine, Critical Care Medicine, Risk Manager

ISSUE: SAM Medical Products notified customers of a voluntary recall to address a potential issue with a clip used to secure the accessory strap used for the Axilla application of the SAM Junctional Tourniquet (SJT). The company has not received any reports of patient injuries to date related to this issue nor has it been reported to fail during actual patient use.

If this piece were to fail in actual use the operator may face a potential delay in using the SJT in the Axilla area. All other indications of the SJT (inguinal hemorrhage and pelvic fracture) are not impacted by this issue.

BACKGROUND: The SAM Junctional Tourniquet has received 510K clearance for controlling inguinal hemorrhage, axilla hemorrhage, and pelvic fracture stabilization.

RECOMMENDATION: SAM Medical Products has notified customers of the voluntary recall by letter and is arranging with its customers to rapidly replace the current axilla straps with an updated version.

For more information or questions related to this notification, please contact SAM Medical Products Customer Service at 1-800-818-4726 or (503) 639-5474 or email at customerservice@sammedical.com.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm417985.htm

New Guidelines for Responders in Mass Attacks

From the New York Times:
December 7, 2013

In Mass Attacks, New Advice Lets Medics Rush In

By

WASHINGTON — Seven minutes after the authorities in Sparks, Nev., received a call one day in October that a gunman was on the loose at a local middle school, a paramedic wearing a bulletproof vest and a helmet arrived at the scene.

Instead of following long-established protocols that call for medical personnel to take cover in ambulances until a threat is over, the paramedic took a far riskier approach: He ran inside to join law enforcement officers scouring the school for the gunman and his victims.

“He met the officers right near the front door, and they said: ‘Let’s go. There are victims outside near the basketball court,’ ” said Todd Kerfoot, the emergency medical supervisor at the shooting. “He found two patients who had been shot and got them right out to ambulances.”

Federal officials and medical experts who have studied the Boston Marathon bombing and mass shootings like the one in Newtown, Conn., have concluded that this kind of aggressive medical response could be critical in saving lives. In response to their findings, the Obama administration has formally recommended that medical personnel be sent into “warm zones” before they are secured, when gunmen are still on the loose or bombs have not yet been disarmed.

“As we say: Risk a little to save a little, risk a lot to save a lot,” said Ernest Mitchell Jr., the Federal Emergency Management Agency’s fire administrator, who released the new guidelines on mass casualty events for first responders in September.

The guidelines say that such events, which have led to more than 250 deaths in the past decade, are “a reality in modern American life” and that “these complex and demanding incidents may be well beyond the traditional training of the majority of firefighters and emergency medical technicians.” They recommended that any of those first responders sent into “warm zones” focus on stopping victims’ bleeding.

The guidelines also say that first responders should be equipped with body armor and be escorted by armed police, a policy that officials in Sparks and a handful of other cities had already adopted.

The new focus on moving faster to treat victims follows an earlier shift in thinking about how quickly the police should respond.

In the 1999 shootings at Columbine High School in Colorado, where two disaffected students killed 13 people, no officers entered the school until a half-hour after the shooting began and SWAT teams arrived to respond to a highly planned attack that involved a fire bomb and other explosive devices.

After Columbine, law enforcement officials made it clear that they wanted the first officers on a scene to act immediately instead of waiting for specially trained officers with body armor and high-powered weapons.

“These events like the shootings are usually over in 10 to 15 minutes, but it often takes over an hour for everyone to get there,” said Dr. Lenworth Jacobs, a trauma surgeon who created the Hartford Consensus, which brought together experts in emergency medicine and officials from the military and law enforcement after the Newtown shooting to determine better ways to respond to mass casualties.

“We’re seeing these events in increasing frequency, and unfortunately we have to change how we approach them to keep death tolls down,” Dr. Jacobs said.

While the United States military saved thousands of lives in Iraq and Afghanistan by practicing combat medicine developed over years of responding quickly to battlefield injuries, the medical response to the bombings last April at the Boston Marathon provided a dramatic example on American soil of how lives could be saved by acting quickly.

The bombs went off near the marathon’s finish line, where many nurses and doctors were stationed to care for injured or ill runners and major hospitals were not far away. The bombing victims received medical assistance almost immediately, and while three people were killed, more than 200 others who were injured survived, including a dozen or so who had limbs amputated.

Those medical professionals were taking a risk: They did not know how many bombs there were or whether they were putting themselves in the middle of a larger attack.

The new FEMA guidelines have been embraced by state and local officials. But they have heightened concerns about the risks to first responders and about whether response times for victims would grow even longer if medics were wounded in a danger zone.

They have also raised the specter that terrorists may target the first responders as they have in Iraq. In recent years, the Qaeda affiliate there has in many instances detonated a car bomb and then, as medical personnel arrived, set off others.

But Harold Schaitberger, who leads the International Association of Fire Fighters in Washington, said his organization played a role in creating the new guidelines and strongly supported them if employed correctly. The association represents 300,000 firefighters, paramedics and others.

Trying to save victims in “warm zones,” Mr. Schaitberger said, “is a different risk for firefighters, but not more of a risk than firefighters already take in responding into a burning structure.”

Mr. Mitchell, the fire administrator, said the gunmen and terrorists who mounted attacks in the United States over the past decade rarely made targets of first responders. But, he said: “We know that this possibility does exist, and part of the training of the fire and E.M.S. is to be observant and aware and to be on the look for suspicious activity and so forth.”

Other efforts have focused on educating civilians on the need to react quickly to danger.

This year, many police departments began education efforts that urged anyone caught in a mass shooting to “run, hide or fight” instead of waiting for help.

After all, the people at the scene can often stand in for first responders before they arrive.

“In Boston, you saw that the public didn’t run,” Dr. Jacobs said. “You need for the public to have the most education about how they can help to improve the survival results.”

 

 

LEOs Saving Lives

From our Facebook page: Check out this awesome video on the Louisville Metro Police Department equipping more than 1200 officers with TacMed tourniquets and medical trauma kits. Officers have already saved four lives in the last month with the new equipment.

Link

TCCC for Law Enforcement Officers Part 1

Tactical Combat Casualty Care (TCCC) has become the standard for medical care within DOD. It is slowly being adopted by law enforcement throughout the USA as more departments are embracing the fact that the first line of medical care after a felonious assault rests with the officer. The transition in the mindset over the last 10 years is remarkable. Initially, most LEOs thought of medicine as the domain of EMS, whereas departments are currently attempting to integrate military TCCC into their protocols. For instance, use of tourniquets as a first option for extremity wounds has been accepted as a priority in civilian medicine. However, all of the lessons learned during GWOT regarding TCCC do not neatly transition to the the civilian sector. Although extremity bleeding is the most common cause of preventable death on the battlefield, chest injuries are the leading cause of preventable death for LEOs. So why do so many officers only focus on hemorrhage control when deciding what to carry in Individual First-Aid Kits (IFAKS)? It is due to the dearth of research in the field of LEO medicine and a full adoption of the research from the battlefield.

One of the first studies to address this issue was published in Prehospital and Disaster Medicine in 2009 titled “Tactical Medical Skills Requirements for Law Enforcement Officers: A 10-Year Analysis of Line-of-Duty Deaths” by Matthew D. Sztajnkrycer, MD. He concluded that “…current emphasis of TCCC on control of exsanguinating extremity hemorrhage may not meet the needs of law enforcement personnel in an environment with expedited access to -well developed trauma systems. Further study is needed to better examine the causes of preventable deaths in law enforcement officers, as well as the most appropriate tactical medical set and treatment priorities.”

It is clear that more work needs to be done, but we will explore the issue more in the following posts.

TCCC_Sztajnkrycer

Triage From Afar: Star Trek and Emergency Medicine

Multiple casualties in the tactical environment or a disaster area that exceed both human and materiel resources require rescuers to triage rapidly, so the limited resources may be used for the most critical casualties. In the tactical environment, one may have to do so under fire, thereby increasing the chance of sustaining injury. In disaster zone, precious time may be wasted by attempting to access and treat vocal casualties, while delaying treatment for higher priority patients. Nonetheless, current methods for triage require rescuers to assess casualties one-on-one, delaying further the time to locate, triage and treat the most critical. A recent article in The Army Department Medical Journal succinctly captured the crux of problem noting:

Physiologic status assessment in casualties can be problematic in the military setting, where physical access to the injured individual may be complicated by terrain, weather and hostile action. Likewise, some civil sector settings may challenge first responders, particularly when victims are located remotely. The lack of a remote triage capability may therefore result in the medic attending to either a) a Soldier who is uninjured but caught in the vicinity of combat; or b) a Soldier under severe fire who has an injury that is deemed unsalvageable. Indeed, a combat medic may place himself in harm’s way to assist a Soldier who may not even be injured or may be unsalvageable. Data collected during the Vietnam War indicate that the fatality rate of US Army medics was double that seen in infantrymen.1

There is an initiative to remedy this situation within the Departments of Defense and Homeland Security. DHS, in cooperation with Boeing and Washington’s School of Medicine in St. Louise, developed a “Standoff Patient Triage Tool” in 2009 that allows a rescuer to assess pulse, body temperature and respiration. As the article from Science Daily notes, “The magic behind SPTT is a technology known as Laser Doppler Vibrometry, which has been used in aircraft and automotive components, acoustic speakers, radar technology, and landmine detection. When connected to a camera, the vibrometer can measure the velocity and displacement of vibrating objects. An algorithm then converts those data points into measurements emergency medical responders can use in their rapid assessment of a patient’s critical medical conditions.”2 Although the technology is not yet available, it is an interesting approach.

In addition to the above-mentioned, the US Army is currently seeking technologies that will allow them to have stand-off monitoring capabilities. Researchers seek to assemble a system that is functional from a human factors perspective (i.e., Soldiers will wear it and it will not hindered the mission) and useful with regard to discerning physiological signs of hemorrhage from normal combat stress. For instance, mental status and blood pressure, while useful, are unreliable indicators of hemo-dynamic stability.1 Moreover, they take time to gather. Researchers have therefor sought other “markers” that one can use to discern hemorrhage from stress. To this end, they investigated ECG readings, which can be attained remotely. Unfortunately, the readings are not sensitive enough. Another alternative is using “energy monitors” and algorithms that can detect physiological changes. The challenges are many, however. Location of monitors, for example, require Soldiers to have an uninjured limb. In the age of IEDs, this may be difficult, though researches found that in all but 6% of reported casualties an arm was viable for monitoring.

While technological challenges remain, the ability to quickly triage casualties in a tactical or civil disaster scenario is becoming more likely. Although these futuristic Star Trek device or Soldier-worn monitors lack feasibility currently, researchers are getting closer.

Article:Triage Tech
References:

1. Ryan K, Rickards C, et al. Advanced Technology Development for Remote Triage Applications in Bleeding Combat Casualties. The Army Medical Department Journal. 2011;4/5/6:61-71.

2. Department of Homeland Security. “Triage Technology With A Star Trek Twist: Tricorder-like Device.” ScienceDaily, 1 Jun. 2009. Web. 8 Nov. 2012.

Needle Decompression Location Reviewed

We have discussed the changing thoughts regarding the sign and symptoms of Tension Pneumothorax in the past (see here: Rethinking Tension Pneumothorax). Although this study was broad, it did not address in detail the implications of different locations of one of the more popular treatments of tension pneumothorax: needle decompression. Due to an increased incidence of iatrogenic effects of improper needle placement, one of the recent topics of discussion among TCCC trainers has centered around locations (i.e., anterior vs lateral) of needle placement. Improper anterior placement in the mid-line direction can led to severe vascular injuries. Some have advocated for moving the primary location for needle insertion to the lateral location to mitigate iatrogenic effects. This location, however, raises other issues, specifically chest wall thickness in comparison to the anterior location, even as needles have increased in length.

A recent study published* in Academic Emergency Medicine seeks to answer one of the questions that have emerged from the debate by identifying the optimal site of needle insertion with respect to anterior wall thickness limitations. The results are interesting. Average chest wall thickness at the right side anterior second intercostal space, lateral forth and fifth mid-axillary locations were 46.4 mm, 53.8 mm and 63.7 mm, respectively. When considering the one factor of chest wall thickness as it relates to successful penetration of the plural space, the researchers concluded, the anterior location is superior. Furthermore, attempting to overcome the increased chest wall thickness at the lateral mid-axillary locations by using a longer catheter is risky, for it increases the risk of damaging surrounding vascular structures.

While this study does not address the larger issue of practitioners misplacement at the anterior location, it does illicit and attempt to answer an important question of impulsively changing training doctrine to emphasize the lateral location.

*Anterior Versus Lateral Needle Decompression of Tension Pneumothorax: Comparison by Computed Tomography Chest Wall Measurement by Sanchez, Leon, MD, MPH, et al. Academic Emergency Medicine 2011; 18:1022-1026 by the Society for Academic Emergency Medicine

SOFTT Added to TCCC Instructions

The SOF Tactical Tourniquet has always been TCCC approved, but until recently, it has been overlooked when it comes to official TCCC instructions and guides. Here is the link to the most recent Care Under Fire PowerPoint produced by the TCCC board that outline the instructions. Furthermore, the second link below has many other training aides for all phases of tactical medicine.

CUF Link

General TCCC Links

How to:One-handed Tourniquet Application

A principal learning objective taught in many tactical medical training programs is self-application of tourniquets. Although reports from current battlefields estimate the frequency of one-handed application at less 1/10 of 1% (o.oo1), it is still a valuable drill for those working alone (i.e., law enforcement officers). Unfortunately, the technique taught is often incorrect, as most disregard the fact that if one is applying a tourniquet to one’s limb, the limb is probably injured. Therefore, as the video demonstrates, one ought to train for real-world application.

Importance of Training Forward Life Saving Procedures and Future Blood Protocols

In a recent article published in the Journal of Trauma Injury, Infection, and Critical Care, the authors analyzed the effect of life-saving interventions (LSI) performed by combat medics and other forward providers. The medical practitioners in the study were arranged in an EMS style hierarchy under a medical director, with the majority of medics trained to the EMT-B level, in addition to supplemental training in TCCC-approved LSI procedures. Additionally, they analyzed outcomes with an eye toward the applicability of more advanced care in the form of Remote Damage Resuscitation protocols. As summarized below, they found that forward deployment of blood products would be beneficial if the logistical and scope-of-practice concerns could be addressed. In the limitations section of the study, they concede that certain biases might have affected the outcome. They note, for instance, “[t]he differential impact of transport time from point-of-injury to surgical facility arrival is worth considering.” Time from injury to point-of-injury treatment, time between request for evacuation to arrival of transportation, and time from extraction to the study facility all affected the outcomes, some of which were unknown in retrospect.

Although the authors did acknowledge in the conclusion that LSI need to be performed sooner, they unfortunately continued to argue that their notional blood protocol would have been beneficial. This is despite the fact that the majority of LSI were preformed by PA-level practitioners or higher, which is the major concern, because that indicates that urgent and priority patients were evacuated without LSI. It is difficult to surmise why LSI were not performed sooner, due to the nature of record keeping and retrospective studies. Perhaps tactical considerations dictated transport before treatment, or casualties deteriorated during evacuation. Nonetheless, early treatment is paramount, so training might possibly the more important to allocate resources to than blood protocols. Technology is an exceptional adjunct to the basics, but medics must have a foundation upon which to build.

Background: To analyze casualties from the Camp Eagle Study, focusing on
life-saving interventions (LSI) and potentially survivable deaths.

Methods: Retrospective cohort of battle casualties from a forward base engaged in urban combat in Central Iraq. Medical support included emergency medicine practitioners and combat medics with advanced training and protocols. LSI were defined as advanced airway, needle or tube thoracostomy, tourniquet, and hypotensive resuscitation with Hetastarch. Cases were assessed retrospectively for notional application of a Remote Damage Control Resuscitation protocol using blood products.

Results: Three hundred eighteen subjects were included. The case fatality rate was 7%. “Urgent” (55) or “priority” (88) medical evacuation was required for 45% of casualties. Sixty-one LSI were performed, in most cases by the physician or PA, with 80% on “urgent” and 9% on “priority” casualties, respectively. Among survivors requiring LSI, the percentage actually performed were airway 100%; thoracostomy 100%; tourniquet 100%; hetastarch 100%. Among nonsurvivors, these percentages were 78%, 50%, 100%, and 56%, respectively. Proximate causes of potentially survivable death were delays in airway placement and ventilation (40%), no thoracostomy (20%), and delayed evacuation
resulting in hemorrhagic shock (60%). The notional Remote Damage Control Resuscitation protocol would have been appropriate in 15% of “urgent” survivors
and in 26% of nonsurvivors.

Conclusion: LSI were required by most urgent casualties, and a lack or delay in their performance was associated with increased mortality. Forward deployment of blood components may represent the next addition to LSI if logistical and scope-of-practice issues can be overcome.

(J Trauma. 2011;71: S109–S113)

Standard Gauze versus Hemostaic Agents: A New Look

A recent article published by the Academic Emergency Medicine journal found that when compared to standard gauze, hemostatic agents showed no improvement in hemorrhage control and prevention of re-bleeding. The findings indicated that the training is the the most important aspect of hemorrhage control. Obviously, hemostatics have their place, but they are not magic fairy-dust to be sprinkled on wounds, hoping for the best outcome. Moreover, it is clear that the basics saves lives, as the gauze and hemostatics were under direct pressure for five minutes. Finally, the study reveals the difficulties in accessing certain wounds–cavity versus puncture–with gauze and other delivery methods that ought to be considered.

(It should be noted that this study was funded by the US distributor of Celox, Sam Medical, but conducted by an agency within the Department of the Navy.)

Full Study
Littlejohn Hemostatic Comparison AEM 2011

Abstract

Objectives: Uncontrolled hemorrhage remains one of the leading causes of trauma deaths and one of
the most challenging problems facing emergency medical professionals. Several hemostatic agents have
emerged as effective adjuncts in controlling extremity hemorrhage. However, a review of the current literature
indicates that none of these agents have proven superior under all conditions and in all wound
types. This study compared several hemostatic agents in a lethal penetrating groin wound model where
the bleeding site could not be visualized.

Methods: A complex groin injury with a small penetrating wound, followed by transection of the
femoral vessels and 45 seconds of uncontrolled hemorrhage, was created in 80 swine. The animals
were then randomized to five treatment groups (16 animals each). Group 1 was Celox-A (CA),
group 2 was combat gauze (CG), group 3 was Chitoflex (CF), group 4 was WoundStat (WS),
and group 5 was standard gauze (SG) dressing. Each agent was applied with 5 minutes of manual
pressure. Hetastarch (500 mL) was infused over 30 minutes. Hemodynamic parameters were recorded
over 180 minutes. Primary endpoints were attainment of initial hemostasis and incidence of
re-bleeding.

Results: Overall, no difference was found among the agents with respect to initial hemostasis, rebleeding,
and survival. Localizing effects among the granular agents, with and without delivery mechanisms,
revealed that WS performed more poorly in initial hemostasis and survival when compared to
CA.