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Newborn Resuscitation Devices

Product Profile

Potential Lives Saved/Year:


~ 200,000 newborns¹

 

 

>>Read the full case study (PDF)


Problem and Proposed Intervention


Almost half of all newborn deaths are in the first 24 hours after birth, the majority resulting from birth asphyxia. This condition, manifesting as the failure of the newborn to establish breathing after birth, kills 814,000 newborns every year, accounting for almost a quarter of newborn deaths.2 Additionally, there are an estimated 1.02 million intrapartum stillbirths every year, an unknown number of them may be live born but misclassified as fresh stillbirth when no resuscitation has been provided.3 Many of these deaths could be easily prevented with basic neonatal resuscitation which requires tactile stimulation, a neonatal bag and mask, suction device, and a resuscitation training mannequin.  With this basic equipment and effective pre-and in-service training using a resuscitation training mannequin, successful newborn resuscitation can be accomplished in about 30 percent of cases that otherwise would end in death among full term babies and 5 to 10 percent among preterm births.1 For many babies born in low-resource settings, however, this basic intervention is not available. Ensuring universal access to newborn resuscitation is an essential and necessary challenge in the effort to reduce neonatal mortality.  With increased national-level attention being paid to newborn health and the advent of donor-supported initiatives to program essential newborn care, procurement of bag and mask resuscitators, suction devices, and training mannequins and their corollary training programs are the single most strategic investment on the part of countries that are interested in reducing neonatal mortality due to birth asphyxia.

Resuscitation Device product characteristics:

Product:

Self-inflating Bag and Mask Devices
 

Photo: PATH/Patrick Mckern

Suction Devices


Photo: PATH

Training Mannequin

 
Photo: Laerdal Global Health

Proposed Indication:

Positive pressure ventilation support

Used to clear the airway of the newborn to help facilitate breathing

Allows competency-based training of health workers, plus follow-up practice & supervision.

Specifications:

Resuscitator Bag: 240 ml or 500 ml size volume, specifically designed

Mask: two sizes to fit low-and normal-birth-weight babies with pressure-relief valve designed to limit the pressure

Use of bulb suction device as a mechanical source of negative pressure

Model of the baby permitting visualization of selected features of effective ventilation such as chest rise

Avg. Cost:

~$8-$100 USD

~$2-$10 USD

~$50-$1,500 USD

 




Initial Findings from Product Case Study Working Paper

 

* Note: The strengths and challenges outlined below are initial findings from a longer working paper developed to analyze the current global situation of each product.  The findings are presented below to catalyze further thinking and discussion in order to finalize a list of issues and recommendations. The full working paper texts are forthcoming.

 

 

 

Strengths

Challenges

Policy and Regulation

 

 

Global

* The Helping Babies Breath (HBB) Global Development Alliance is working to increase coverage of a quality resuscitation program, and has begun to increase product demand.

* WHO approved update to Grades of Recommendation, Assessment, Development, and Evaluation approach to newborn resuscitation was drafted in Dec 2011.

*The WHO draft Essential Medical Devices List for priority interventions for MNCH includes neonatal resuscitators (bag and mask), suction devices, and resuscitation training mannequins

* Self-inflating bag and mask device is specified by international policy guidelines as the standard, evidence-based technology for use

*Updated International purchasing guide on sources, prices and quality on high-quality, affordable resuscitation products are available to international and national purchasing agents

* WHO Essential Medical Devices List is still just a draft.  It needs to be published as a reference. 

* WHO updated Guidelines for Basic Newborn Resuscitation is still a draft. It needs to be published urgently.

National, Regional

* Newborn survival and development is often a national priority and with support from the Helping Babies Breath Global Development Alliance, national newborn resuscitation programs are being scaled up which has increased the coverage of a quality resuscitation program and the demand for newborn resuscitation devices in some countries.

* Resuscitation equipment is not systematically included in country essential device lists. 

*Newborn resuscitation equipment is often not regulated by the country medical supplies and equipment regulatory board. 4

Product Specification & Characteristics

* There is a high safety profile for bag and mask devices.

* Innovation in the product category focuses on simplification of device design and parts so that infrequent users at peripheral health centers will be better able to use the technology.

* Options exist for disposable and/or reusable devices.  Recent further development of quality hand-operated resuscitators.

*There are now available alternative options of affordable, multiple cleaning and disinfection bulb syringe suctions with excellent durability.

 

* No industry reference standards are available for newborn bulb suction devices.

* There is not standardization in mask size, or in the specifications, or in the nomenclature used to describe them.

* Quality failures occur relatively frequently, most commonly due to the quality of material used; mechanical failure during operation, mostly of valves; substandard finishing lacking precision (leakage of valves and fittings); or dust particles inside the device.

*Product selection can be complicated, given the vast array of product types, product costs, and product quality.  The selection of products should be influenced by the settings in which they will be used and the patient loads.

* It is common to reuse the single-use bulb syringe suction, which makes it likely to increase risk of infection. Only recently have affordable, multiple cleaning and disinfection options become available.

Financing, Procurement & Supply

* There is a large supplier base supporting this category of medical devices in developed/developing countries.

* More options for affordable, quality devices have recently become available.

* Tube and mask devices, which require the user to blow into the tube, were previously developed as a low-cost alternative to bag and mask devices and may be useful in environments where self-inflating bags are not available, affordable, or functional.5

* Evidence that increased demand in 2010-2011 has led to increased product branding and availability.

* Resuscitators are manufactured in multiple locations worldwide with regional concentrations. Most manufacturers indicate that they have worldwide distribution capabilities.

* Laerdal Global Health has committed to continuing to provide the NeoNatalie innovative, affordable equipment, which includes a mannequin, bag and mask, and suction bulb, to all 68 MDG countries on a not-for-profit basis through 2015.

* Complicated supply chain problems such as expiry dates and cold chain do not apply to these products.

* UNICEF country offices often act as a distribution channel by providing support for the supply of devices at the country level. 

* Countries often do not prioritize newborn resuscitation equipment needs among many other conflicting priorities.

* Difficulty procuring high-quality, affordable resuscitation equipment.

* Resuscitation equipment is more likely to be available in tertiary and district hospitals than in lower-level health facilities and is almost nonexistent in home deliveries.

* A self-inflating bag and mask device is often too costly for low-resource settings. Only recently have affordable, quality devices become available.

* Manufacturing of tube and mask devices is severely limited, making them a less feasible option for low-resource settings.

* Even when equipment is available, it may not be readily accessible in the delivery room.

* With countries relying on international and regional procurement, delays in delivery, custom clearance and additional tariffs and customs costs pose a challenge.

* Price variations among seemingly similar products are enormous. While sourcing cheap products may be tempting, attention to quality is imperative.

* In-country manufacturing is limited and most procurement is international/regional, increasing lead times and potential for delays in delivery.

* Low-resource settings face a lack of appropriate companies, agents, and distributers to procure and supply the necessary commodities, institute repairs, replace spare parts, or get new equipment.

* There are major barriers that delay distribution: inadequate logistics coordination, planning, and budgeting.

Service Provision (Rational Use)

* In 2010, the AAP launched Helping Babies Breathe (HBB), a simplified evidence-based resuscitation training program to address the lack of neonatal resuscitation skills in resource-limited areas.

* A Global Development Alliance (GDA) has been established to roll out the HBB curriculum.

* The studies so far have indicated that HBB training results in significant improvement in resuscitation knowledge and skills. However, the studies also showed that developing competency skill in newborn resuscitation with bag and mask is complex and requires adequate time for instruction and possibly mentoring 6

 

* Poor resuscitation skills are common among health providers at all levels of delivery in low-resource settings.

* Even when equipment is available, many health care providers are unable to use it effectively.7

* Most pre-service institutions lack the necessary resuscitation equipment for hands-on training by the students. There is limited or no time dedicated to practice or refresh skills, and no post-training system to maintain skills.

* There is low exposure to asphyxia cases and inadequate use and retention of resuscitation skills by health workers in peripheral centers.

* There is a lack of provider procurement awareness of the suitable sizes of the self-inflating bag and masks and appropriate negative pressures required with the use of suction machines.

* Providers sometimes exhibit poor motivation for maintaining quality of care including appropriate maintenance of resuscitation commodities.

Demand

*There is high demand for resuscitation devices among health providers and health facilities. The HBB Global Development Alliance (GDA) has increased demand for such devices.

* Pregnant women and the community often lack awareness that asphyxiated babies could be saved by appropriate resuscitation equipment and skills. Having this awareness could empower pregnant women and communities to support newborn resuscitation interventions.




[1] SN Wall et al. Neonatal resuscitation in low resource settings: what, who, and how to overcome challenges to scale up. International Journal of Gynecology and Obstetrics, (107) 2009, S47-S64.

[2] Black R, Cousens S, Johnson HL, et al. Global, regional, and national causes of child mortality in 2008: a systematic analysis. Lancet. June 2010;375(9730):1969–1987.

[3] Lawn J, Shibuya K, Stein C. No cry at birth: global estimates of intrapartum stillbirths and intrapartum related neonatal death. Bulletin of the World Health Organization. 2005;409–417.

[4] Helping Babies Breathe Global Development Alliance. Multi-Country Rapid Newborn Resuscitation Assessment for the UN Commission on Commodities for Women’s and Children’s Health. January 2012 (unpublished report). 

[5] Wall S, Lee ACC, Niermeyer S, et al. Neonatal resuscitation in low-resource settings: What, who, and how to overcome challenges to scale up? International Journal of Gynecology and Obstetrics.2009;107:S47–S64. 

[6] Singhal N, Lockyer J, Fidler H. Helping Babies Breathe: Global neonatal resuscitation program development and formative educational evaluation. Resuscitation. 2012;83:90–96. 

[7] Ricca J. Assessing the quality of care for prevention, identification, and management of maternal and newborn complications at the time of birth: Results from 5 country facility surveys. Presented at: MCHIP meeting with USAID, September 2011. Available at: http://www.mchip.net/sites/default/files/MCHIP%20QoC%20panel%20presentation%20for%20APHA%20October%2028%20FINAL%20(2).pdf. Accessed February 15, 2012.