Firefly Phototherapy Device
DtM, East Meets West Foundation, Medical Technology Transfer Services
This device is for treating neonates with jaundice.
Firefly is an intuitive phototherapy device designed to treat newborns with jaundice in low-resource settings.
Countries: Vietnam, Myanmar, Cambodia, East Timor, Thailand, the Philippines, Malaysia, Ghana, Burundi and Haiti.
East Meets West Foundation through its Breath of Life program, MTTS for direct sales.
$350 USD to manufacture; distributed as a donation through the East Meets West Foundation. $1500 USD through MTTS
Goal 3: Ensure healthy lives and promote well-being for all at all ages
Rural health care centers treating mild to severe newborn jaundice.
Firefly is in full-scale manufacturing. All components of the Firefly have been designed to be mass-produced. Design that Matters has provided capacity development for Vietnamese manufacturer Medical Technology Transfer Services (MTTS) to assist with the sourcing of mass-produced plastic parts and in-house metal tube bending capabilities so that MTTS can mass-produce the Firefly Interview with designer
Trade secret Interview with designer
As of September 1 2014, DtM partners East Meets West Foundation and MTTS have installed Firefly phototherapy devices across Vietnam, Myanmar, Cambodia, East Timor, Thailand, Malaysia, and Ghana. These devices have already treated over 4000 newborns and will treat at least 35,000 over their lifetime. East Meets West, MTTS, and DtM continue to expand Firefly into new hospitals and countries, and seek out new distribution channels. Firefly has received its certificate of free sale from the Ministry of Health in Vietnam, a type of regulatory approval recognized by the ten ASEAN member nations. Interview with designer
Clinical trials were completed in 2012 and since then the Firefly has been used in Vietnam and the Philippines. As of February 2013, the two devices in the field have treated over 108 infants and have averted over 15 life threatening exchange transfusions. As of September 1 2014, DtM partners East Meets West Foundation and MTTS have installed Firefly phototherapy devices across Vietnam, Myanmar, Cambodia, East Timor, Thailand, Malaysia, and Ghana. These devices have already treated over 4000 newborns and will treat at least 35,000 over their lifetime. East Meets West, MTTS, and DtM continue to expand Firefly into new hospitals and countries, and seek out new distribution channels.
Component Overview
Firefly consists of a removable bassinet made from clear scratch-resistant plastic, a top light fixed at the most clinically effective height, a bottom light, and a control panel for displaying power switch, light intensity, treatment hours, and total device hours.
Key Features: No moving parts; enclosure designed toward NEMA Type 5
Dimensions (LxWxH): Overall (66 cm x 38 cm x 49.5 cm ), Top Light ( 51.6 cm x 12.5 cm x 6.3 cm), Bottom Light (64.7 cm x 38 cm x 10 cm)
Total unit mass: 11.8 kgs
Operational Overview: 2-sided light design offers top and bottom phototherapy reducing total treatment time; portable and compact nature of Firefly allows it to be used in mother’s recovery room so she can continue breastfeeding while infant receives phototherapy; single power button with single light intensity setting and fixed light distance is intented to keep the Firefly simple and to minimize risk of using it incorrectly.
See image. Additional drawings are included in the Firefly brochure available here:
Device was designed for easy and intuitive use, thus requiring minimal training and maintenance. However, medical staff require some training in proper use
Firefly was designed with minimalism in mind with few components that could require replacement. The LED lights used are expected to last for five years even with non-stop usage
The Firefly has been designed for 5 years of 24 hour operation. Its LED lights are rated to last up to 44,000 hours before requiring replacement. In addition, Firefly has no moving parts which can easily be broken, outer casings have tight seems and no holes in order to prevent most insects, dust and liquids from entering and damating the device or dimming the lights.
MTTS offers a 1 year warranty for all of the products it manufactures
Illumination Source: High-power blue LEDs, 1-1.25W standard operating
Peak Wavelength Range: 455-465 nm
Lamp Duration: LEDs rated to last 44,000 hours at max temp
Average Spectral Irradiance (measured with Ohmeda Biliblanket Light Meter II) : Top Light (23 μW/cm2/nm), Bottom Light (34 μW/cm2/nm)
Effective Surface Area: Top Light (53 cm x 24 cm), Bottom Light(48 cm x 20 cm)
Irradiance Uniformity Ratio: Top Light (0.51 (IEC Compliant >0.4)), Bottom Light (0.72 (IEC Compliant >0.4))
Time Totalizer: Device run time totalizer, therapy time totalizer
Firefly data from 17 infant treatments with average initial TSB 305 μMol/L (17.8 mg/dL) yielded median serum bilirubin reduction rate of -6.7 μMol/L/hr (-0.39 mg/dL/hr). Multiple linear regression of Firefly data based on study of 66 infants in 2-sided phototherapy predicts Firefly rate of -5.3 μMol/L/hr (-0.31 mg/dL/hr) given initial TSB of 265 μMol/L (15.5 mg/dL)
A Clinical Evaluation of 17 infant treatments indicated Firefly reduces treatment time for a typical patient by at least 40% compared to state-of-the-art single-sided LED phototherapy. Reduced treatment time meant discharge from the highly infectious hospital environment after 20 hours on average instead of the typical 35 hours or often much longer in low-resource settings.
Clinical trials continue: As of July 18, 2012, local clinical trial doctors report 3 out of 55 infants treated with Firefly would have had to undergo an exchange blood transfusion if Firefly had not been available
Clinical trial was carried out at the National OBGYN Hospital in Hanoi.
Firefly cannot be used with overhead infant warmers due to the design (it can be used with side warmers). This means that it is better suited for use in warm climates or for treating term infants who have jaundice but can regulate their own body temperature.
Maisels, M.J., et al., Randomized controlled trial of light-emitting diode phototherapy. Journal of Perinatology, 2007. 27(9): p. 565-7
Johansen E. Making Human Factors Affordable for Medical Device and Global Health Startups. Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care. 2018;7(1):140–147. doi:10.1177/2327857918071036
Taylor A, Muelenaer P, Kochersberger K, Muelenaer A, Bickford L, Redican K. Innovating for global health: Study of healthcare technology failure in southern Malawi. Annals of Global Health. 2016;82(3):600. doi:10.1016/j.aogh.2016.04.575
IEC 60601-1:2005: Medical Electrical Equipment – Part 1: General Requirements
for Basic Safety and Essential Performance
IEC 60601-2-50:2009: Medical Electrical Equipment – Part 2-50: Particular requiments
for the safety of infant phototherapy equipment
American Academy of Pediatrics phototherapy standard: >30 μW/cm2/nm
Clinical evaluation of 17 infants treatments with Firefly.
Region sizes determined by phototherapy international standard IEC 60601-2-50. Measurements of device taken in center of each region with Ohmeda Biliblanket Light Meter II ™
Electrical Specifications
Power characteristics: 30W max, 24VDC input
Off-the-shelf external power supply: 60W, 90-264VAC, 47/63Hz; International medical safety approvals; 78-84% efficiency; No minimum load requirements; Class I construction is standard (ground required); Optional class II construction (no ground required); 50k hours MTBF; CEC and Energy Star Efficiency Level IV compliant; RoHS compliant; EN6100-3-2 compliance active power correction; Over voltage / over current protection; Class B emissions; UL94V-1 rated enclosure
Overheat protection: ≥65ºC
Environmental Specifications
Operating: Ambient temperature: +10ºC to +28ºC/+35ºC (tested in environment up to 28ºC, designed to treat infants in environments up to 35ºC); Humidity: 0% to 90% RH non-condensing
Transport and storage: Atmospheric pressure: 70-106kPa; Ambient temperature: +10ºC to +85ºC; Humidity: 0% to 90% RH non-condensing; Atmospheric pressure: 70-106kPa
Exclusions: Not for use inside an incubator
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