Anti-Shock Garments

Treatment

• 

  Representative Product

  GLOBAL ANNUAL DEATHS ASSOCIATED WITH OBSTETRIC HEMORRHAGE

  PERCENT (%)

  NUMBER

  Maternal

  45%

  115,000

  Neonatal

  N/A

  N/A

  Stillbirth

  *

  *

  *Estimates under development

  Condition
  Anti-shock garments (ASG) may be indicated for obstetric hemorrhage in cases with blood loss above 750mL, pulse greater than 100 beats per minute, and mild hypotension. As a first step in treating shock due to hemorrhage, the ASG can reverse hypovolemic shock and reduce bleeding, buying time for complementary care.
  
  Mechanism of Action
  All ASGs compress the lower extremities, reducing the total vascular volume and redirecting blood flow to the vital organs. Pneumatic ASGs accomplish this through the use of inflatable bladders which function like blood pressure cuffs. They are relatively complex compared to non-pneumatic ASGs (NASGs).  NASGs apply similar pressure using only tightly fitting neoprene fabric. The ASG is a first resuscitative measure, followed by IV fluids, uterotonics, blood transfusion, and other measures. The device is designed to be worn until the patient’s vital signs have stabilized for 2 hours or more, including blood loss of less than 50mL/hr, pulse below 100bpm, and systolic blood pressure above 100 mmHg. ASGs are not recommended for women with a viable fetus or bleeding above the diaphragm. They are contraindicated for women with mitral stenosis, congestive heart failure, or pulmonary hypertension.
  
  Current Use in High-Resource Settings
  ASGs have come in and out of favor in emergency and military medicine. Today they are rarely used in obstetrics, although there are a few documented cases for remote rural populations.
  
  Application in Low-Resource Settings
  As of 2010, there were 2000 known cases of obstetric use of NASGs in low-resource settings.  These were part of clinical trials in Egypt and Nigeria, designed to determine the safety and efficacy of the Zoex NASG product. Current use has now spread to tertiary care settings where the NASG is first aid, buying time until definitive treatment (in the form of IV fluids, blood, uterotonics, etc.) is available. The device technically also has potential to reduce mortality during transport from one care setting to another; NASGs are used on ambulances in Tamil Nadu, India. Even in tertiary care settings, the device is not always properly cleaned or folded between uses. Widespread adoption remains a challenge due to their relative cost and complexity, but lower-cost devices have been produced with guidance from PATH.

  REPRESENTATIVE DEVICES

  MAKE

  MODEL

  PRICE*

  TECH

  STATUS

  NOTES

  Zoex

  NASG

  $160

  NASG

  Marketed

  Relatively simple, allows vaginal access

  Blue Fuzion Group

  NASG

  $55

  NASG

  Marketed

  Relatively simple, allows vaginal access

  * Prices are approximated. Actual pricing can, and will vary by marketplace and market conditions.

• CHARACTERISTICS OF REPRESENTATIVE PRODUCT

  TECHNOLOGY CHARACTERISTICS

  OPERATIONAL PARAMETERS

  POTENTIAL OPPORTUNITIES FOR IMPROVEMENT

  SKILLS

  REQUIRED

  Intended end user

  Training required

  Time required per use

  Physician, nurse

  Minutes

  Hours

  The device is relatively simple to use, but is not always cleaned or folded properly. This creates barriers to its timely use in emergency situations. Cleaning protocols must be validated.

  ENVIRONMENT/ INFRASTRUCTURE

  Power required

  Waste collection

  Complementary technologies required

  Temperature and storage

  Maintenance

  None

  None

  None

  None

  Proper washing is an important driver of product lifetime.

  The ability of the anti-shock garment to save lives depends on what other technologies are readily available to complement it. The device might, for example, be bundled with transfusion services, offering time to search for a suitable donor.

  COST

  Device Cost (Approx)

  Cost/course (Approx)

  $100-200

  <$10 assuming 40 uses

  There may be considerable opportunities for cost reduction at volume, given that NASG is similar to wetsuits, which can retail in the US for <$60.

  OTHER

  Portability

  Regulatory

  Efficacy

  <500g, but bulky

  WHO

  Randomized cluster trial

  Additional devices required for impact: ASGs only buy time for the patient to receive a definitive treatment; they are not a definitive treatment on their own. Additional technologies may include IV fluids, blood, uterotonics, etc.