RESEARCH POSTER PRESENTATION DESIGN © 2012

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• Obstetric shock as a consequence of Post-partum Hemorrhage is one of main causes of maternal mortality.

•Active Management of Third Stage Labor (AMSTL)has great impact in reducing maternal mortality.

•Non-pneumatic Anti-Shock Garment ( NASG) is a health technology identified in WHO Medical devices and e-Health solutions Compendium of innovative health technologies for low-resource settings(2011).

• Health Technology Assessment is a tool for evidence based decision making on uptake of technology in public health system.

• This HTA on NASG is expected to measure the health impact of NASG.

Introduction

Objectives

Findings from Cost-Effectiveness Analysis

• Clinical Factor considered for analysis - Difference in Mortality

• Considering same device use without disposal in 40 patients, total number of NASGs required annually equals to 1006.

Regulatory Status and Patent Status Review

• NASG is difficult to be applied along with “sari”, which is most common customary clothing for women in India.

• Cultural constraints and stigma associated with requirement for application of NASG may act as obstacle in successful acceptance of this health technology.

PRIMARY OBJECTIVES :

•To evaluate clinical effectiveness of NASG with systematic review of literature.

•To conduct cost-effectiveness analysis on NASG.

•To review regulatory and patent aspects associated with NASG .

• To review social aspects associated with NASG .

• To review safety aspects associated with NASG.

•To review current market status of NASG.

SECONDARY OBJECTIVE :

• To make recommendations based on results of HTA on uptake of NASG in Emergency Response Systems.

National Health Systems Resource Centre- New Delhi,India Vatsal A Chhaya, Jitendar Kumar Sharma, Mohammad Ameel, T Sundararaman

Healthcare Technology Assessment for Non-Pneumatic Anti Shock Garment for Obstetric Shock Prevention

Findings from Systematic Review of Literature

Introduction of NASG

•Sources for Literature Search – Cochrane database of systematic review , PUBMED and ScienceDirect and other publicly available information by organizations like WHO,UNICEF •Methodological Quality Assessment – Critical Appraisal Skills Programme( CASP) tool for randomised trials was used for assessing quality of study. •Bias identified in Study : Most of studies were published by same author. However, it did not affect outcome of review significantly.

Cost Threshold in INR

Total no. Of NASG

needed

Cmax Cmin Cost/Life saved = (Total no. Of NASG needed / Cmax) x Cost Threshold )

Cost/Life saved = (Total no. Of NASG

needed / Cmin) x Cost Threshold )

₹ 500.00 1006 12479 483 ₹ 40.31 ₹ 1,041.41 ₹ 1,000.00 1006 12479 483 ₹ 80.61 ₹ 2,082.82 ₹ 1,500.00 1006 12479 483 ₹ 120.92 ₹ 3,124.22 ₹ 2,000.00 1006 12479 483 ₹ 161.23 ₹ 4,165.63 ₹ 2,500.00 1006 12479 483 ₹ 201.53 ₹ 5,207.03

Current MRP ₹ 3,000.00 1006 12479 483 ₹ 241.85 ₹ 6,248.45

Social Aspects

• NASG is not formally regulated in India due to lack of Medical Device Regulatory Board.

• NASG is not FDA or CE certified which are international medical device regulatory standards.

• NASG is now off-patent and produced in several different locations.

• However, there is similar device filed as US patent 3933150 which is for general trauma and uses pressurized gas for increasing venous blood flow to victim’s heart. This was patented in 1974.

Safety Aspects • NASG has no documented adverse events after its application and use.

• However, NASG must not be removed by lay person, but by the experienced clinician only.

Current Market Status

• International Manufacturer(s) – ZOEX Corporation(Portland, OR), Blue Fusion ( Hong Kong) etc.

• Indian Manufacturer – VISCO –a rubber product manufacturing company

• Indian distributer – PATH FINDER

• Price of NASG in International Market – USD 54$ , 120 $

• Price of NASG in Indian Market – INR ₹ 3000

Recommendations/Conclusion

• Given the outcomes of this HTA; NASG could be beneficially included in Emergency Maternal and Obstetric Care( EMOC) Management.

References

1. Miller S et al., First aid for obstetric haemorrhage: the pilot study of the non-pneumatic anti-shock garment in Egypt, BJOG 2006.Vol. 113:424–9.

2. Sutherland T et al. Use of the Non-Pneumatic Anti-Shock Garment (NASG) for Life-Threatening Obstetric Hemorrhage: A Cost-Effectiveness Analysis in Egypt and Nigeria. PLoS ONE 2013;Vol. 8(4): e62282.

3. Turan J et al. Positive effects of the non-pneumatic anti-shock garment on delays in accessing care for postpartum and postabortion hemorrhage in Egypt and Nigeria.Int J Women’s health .2011. Vol.20 (1).91-8.

4. Kausar et al.Nurses in low resource settings save mothers’ lives with non-pneumatic anti-shock garment. Am J Matern Child Nurs.2012. Vol.37(5) 308-16.

5. Fathalla, MF, Non-atonic obstetric hemorrhage: effectiveness of the non-pneumatic anti-shock garment in Egypt.ISRN Obstet Gynecol, 2011;vol 2011, article ID 179349; doi 10.5402/2011/179349

6. Pathfinder International , Non-pneumatic anti-shock garment (NASG) : a unique first aid device for obstetric hemorrhage and hypovolemic shock 2012

7. WHO (World Health Organization.) WHO Recommendations for the Prevention and Treatment of Postpartum Hemorrhage. Geneva, Switzerland; 2012.

8. http://www.who.int/medical_devices/innovation/compendium_med_dev2011_5.pdf.

Synthesis Table of Reduction in Mortality due to NASG

Study Number

Study Authors

Reduction in mortality by NASG

application (M1% to M2%)

Absolute number of women without

NASG (A = X * M1%)

Absolute number of women with

NASG(B=X* M2%)

Decrease in Mortality (A-B=C)

rounded off

1 Miller S et al. 3.2% to 1.0% 1288.192 402.56 885

2 Sutherland T et al. 2.3% to 1.1% 925.888 442.816 483 Cmin

16% to 8.7% 6440.96 3502.272 2938

3 Turan J et al 20% to 6% ( EAO ,not death)

8051.2 2415.36 5636

4 Kausar et al. 8.5 % to 2.3% 3421.76 925.888 2496

5 Fathalla et al. 4.4 % to 2.9%(EAO) 1771.264 1167.424 604

6 Pathfinder Study 58.5% to 27.5% 23549.76 11070.4 12479 Cmax

• Non-pneumatic Anti-shock Garment is a medical device made up of Neoprene Rubber .

• It has 9 articulated segments that are wrapped sequentially around the legs, pelvis and abdomen and fastened with Velcro.

•Courtesy : World Heallth Organization and Pathfinder International ,India

• The foam ball over the abdomen is provided for additional compression so as to pressurize aorta to affect blood flow.

•NASG applies circumferential counter pressure to compressed areas.

•Blood flow from these areas will be diverted in direction of heart, lungs and brain, thereby reversing the obstetric shock symptoms.

• Total Number of Obstetric Shock cases per year = x=40256