Evaluation of an Affordable LED Phototherapy Device for Resource-Limited Settings

B. K. Cline1,2, H. J. Vreman3, H. H. Lou1, K. M. Donaldson1,2, V. K. Bhutani3

1D-Rev: Design for the Other 90%, Palo Alto, CA; 2Dept. of Mechanical Engineering, Stanford University, Stanford, CA; 3Div. Of Neonatology, Dept. of Pediatrics, Stanford University, Stanford, CA

Background Device Design and Specifications Conclusions

Surveys of phototherapy devices in resource-limited Illumination source Blue LEDs; 3 W; n=12 • This study demonstrates that Brilliance
settings have shown that suboptimal phototherapy is meets the 2004 AAP guideline for
Peak spectral > 40 µW/cm²/nm at 30 cm
often delivered due to limitations in the design and/or effective phototherapy2.
irradiance (recommended treatment distance)
maintenance of devices (Fig. 1). Brilliance, a LED-based
Peak wavelength 451 nm
• Brilliance yielded superior and lower
overhead phototherapy device (Table 1) developed by normalized t1/2 values than leading
D-Rev: Design for the Other 90%, USA, and Emission Spectrum 410 – 510 nm commercial phototherapy devices for the
manufactured by Phoenix Medical Systems, India, has BSA of term infants (Table 2).
Effective surface area 25 cm x 50 cm at 30 cm
low maintenance requirements (its LEDs last 30,000 A B • Brilliance also has the lowest cost of
hours, compared to 3,000 hours for typical fluorescent Irradiance ratio* 0.45 (minimum /maximum irradiance)
treatment per newborn over a 48-hour
lamps), is robust to the variable electrical power
Estimated lifetime 30,000 hours period--$0.75 per treatment (Table 3).
common to resource-limited settings, and has a low Figure 2. (A) Brilliance technical rendering, side view. Cost-of-care and variations in treatment
projected production cost (less than $135 per device). (B) Brilliance underside view consisting of 3x4 blue Power requirements 100-240 VAC; 60 W
and use time due to degenerative performance of
LEDs (attenuated for illustration).
fluorescent and halogen phototherapy
Table 1. Technical specifications of Brilliance. Irradiance was measured
with the BiliBlanket Light Meter II (Ohmeda/GE Healthcare). *measure
devices were not factored into the
of homogeneity of irradiance distribution to met IEC 60601-2-50 comparison.
Results
requirements. • Its low cost and ease of maintenance
suggest Brilliance is a potentially
Device Manufacturer Light Source Treatable Peak Irradiance Normalized
appropriate device for treating neonatal
BSA Wavelength, (Silhouette Mean ± 3-D efficacy
(% Term) Spectrum (nm) SD, µW/cm2/nm) (t1/2 in min)
hyperbilirubinemia in low-resource
A B settings.
Brilliance Phoenix Medical, LED 100 451 (410-510) 35 ± 9 63
India • Clinical trials are planned to define its
Figure 1. Sample of phototherapy devices currently used in resource- neoBLUE1 Natus Medical, LED 100 462 (420-540) 27 ± 7 80 effectiveness at resource-limited
limited settings. (A) Inefficient multi-sided phototherapy administered on
a jaundiced newborn. All three devices either lack full functionality (burnt
USA hospitals.
out bulbs) or use ineffective white fluorescent tube lights. (B) Homemade BiliLite BB 1 Olympic Medical/ Fluorescent 100 445 (400-550) 17 ± 2 117
phototherapy device using white fluorescent lights. The lights are at a far Natus, USA
MinBiliLite1 Olympic Medical/ Halogen 54 576 (350-800) 7±5 247
distance from the bed.
Natus, USA
References
Objective BiliBlanket1 Ohmeda, Halogen/ 24 533 (390-600) 21 ± 6 333 1Vreman HJ, Wong RJ, Murdock JR,
Fairfield, CT Fiberoptic Stevenson DK. Standardized bench method
To evaluate in vitro the potential efficacy and
performance of Brilliance for preterm and term Table 2. Characteristics of evaluated phototherapy devices. Irradiance was measured with the BiliBlanket Light Meter II (Ohmeda/GE for evaluating the efficacy of phototherapy
infants. Healthcare). Normalized 3-D efficacy was determined with the photodegradation rate of unconjugated bilirubin in human serum devices. Acta Paediatr 2008; 97: 308-316.
albumin (t1/2), adjusted for 3-D BSA.
Materials and Methods 2 American Academy of Pediatrics.
The in vitro efficacy of Brilliance (prototype) was 18.2 20.3 22.3 23.5 24.4 24.6 24.4 24.5 24.8 25.6 26.3 26.2 25.8 25.8 25.6 25.6 24.0 21.9 19.7 Device Cost of Treatment/ Management of hyperbilirubinemia in the
assessed according to the standardized bench method 25.7 28.4 30.4 31.7 32.4 32.6 32.4 32.4 32.6 33.4 34.6 34.7 34.4 34.3 34.3 34.1 32.3 29.9 27.4
Newborn (USD) newborn infant 35 or more weeks of
Brilliance $ 0.75
outlined in Vreman et al1. Evaluation parameters 27.1 32.0 33.1 35.4 36.7 37.3 37.5 37.8 38.3 39.3 42.0 39.6 38.2 37.3 37.5 38.2 37.1 34.5 32.0
Irradiance
gestation. Pediatrics 2004; 114; 297-316.
(μW/cm2/nm)

include light potency (emissions wavelength range and 25.6 29.9 33.9 38.1 40.1 40.7 40.9 41.0 41.6 42.3 42.7 41.4 39.2 38.3 38.7 39.6 38.8 36.6 33.5 neoBLUE $ 10.60

peak in nm), intensity (irradiance in µW/cm2/nm), 0 to 10 BiliLite BB $ 7.20

Acknowledgments
25.8 36.0 35.3 39.8 42.0 43.0 43.3 43.2 43.6 44.6 45.1 44.4 42.9 42.1 41.8 41.1 39.5 37.2 35.0

treatable body surface area (BSA) comparable to term 27.4 32.6 37.6 42.4 45.3 46.9 47.4 47.2 47.4 48.6 49.8 49.8 48.2 46.8 45.2 43.8 42.1 42.0 39.2 10 to 20 MinBiliLite $ 8.70
infants and in vitro photodegradation rate of bilirubin 27.7 32.6 37.0 41.8 44.8 46.6 46.9 46.9 47.3 48.4 49.3 49.0 46.7 44.7 43.4 42.6 41.4 39.3 37.3
20 to 30 BiliBlanket $ 12.10 This research was supported in part by NCIIA
in aqueous human serum albumin solution at 37ºC 25.8 33.0 35.1 39.8 42.9 44.5 44.3 44.3 44.9 45.2 45.0 43.6 41.5 40.1 39.5 39.3 38.3 36.2 33.6
Grant 6885-09.
30 to 40 Table 3. Cost assessment of affordability.
(t1/2 in min). The latter is considered to be an index of 27.2 32.0 36.1 39.5 41.6 42.2 42.3 41.4 43.3 43.0 42.3 40.7 38.9 37.6 36.6 36.1 35.2 33.4 31.4
Illumination source lifespan and a 48-hour
in vitro efficacy for phototherapy devices. The 27.8 31.6 34.5 36.8 38.2 38.7 38.9 38.9 38.5 38.7 38.8 38.0 36.4 34.9 33.5 32.7 32.1 30.2 28.0
40 to 50
treatment time standard were factored
amortized cost of treatment per newborn for all 50 to 60 into the retail value of each device to
24.2 26.6 28.3 29.3 29.7 29.7 29.6 30.0 30.7 31.4 31.7 30.9 29.2 27.5 26.1 24.8 23.5 21.6 19.4
approximate cost.
devices was calculated based on a 48-hour treatment
time standard. Figure 3. Irradiance footprint with baby silhouette for Brilliance .