Bempu Hypothermia Alert Device
This is a bracelet which detects hypothermia.
The Bempu Hypothermia Alert Device is a bracelet that uses a sophisticated algorithm to identify hypothermia from continuous temperature measurement at the wrist of a newborn. Information for this product was provided courtesy of the WHO’s 2016 Call for Innovative Health Technologies for Low-Resource Settings
The device is currently available in India and Nigeria. The devices is targeted for distribution in Africa and South Asia.
The list price is $15 USD and the market price is $21 USD.
Axillary thermometers, High-end vital systems, Tummy-toe hand touch technique (a simple temperature gauging trick taught to parents in low resource areas where parents touch their newborn’s hand/foot and compare the temperature to their belly), ThermoSpot
Goal 3: to improve and promote good health.
Newborns at risk of developing hypothermia
The device is intended to be used on newborns weighing 0.8 – 3.6 kg. Monitoring is done by nurses in understaffed clinics and parents at home.
The device is currently manufacture in-house by Bempu Health. Bempu Health is able to make 4k units per month. There are currently plans to hire a larger manufacturing team and redesign the device so that up to 40k units can be manufactured per month.
Bempu Health is in the process of receiving a patent for the device’s temperature monitoring algorithm.
The product is currently available for purchase from Bempu Health’s website, pharmacies, and other distributors. Bempu Health is currently working with the Indian government to provide the device for free or subsidized costs for newborns at government hospitals. Bempu Health is also working to develop public-private partnerships for the device where NGOs and public organizations are used as distribution channels.^(Interview with representative)
As of June 2016, approximately 1500 bracelets have been distributed in over 150 centers in 19 states and 1 territory across India.^(Interview with representative)
LEDs, audio alarm w/dB level, etc.
temperature, oxygen saturation, HR, etc.
The Bempu Hypothermia Alert Device is a bracelet composed of a silicone band, thermistor metal cup, and plastic casing. The devices contains a printed circuit board which holds an algorithm that logs temperatures and
alarms when the newborn reaches an unhealthy temperature.The device uses orange, blue, and light LED indications to communicate the device state. When the baby is warm a blue light blinks every 30 seconds to indicate that the baby’s temperature is normal. When the baby’s temperature is low, an orange light blinks once every five second and an alarm sounds for one minute and repeats every 5-15 minutes to indicate that the baby needs warmth. When the band is not being worn it will switch into an off mode that is indicated by a white light blinking every 30 seconds.
The Bempu bracelet is water resistant and should be regularly cleaned while in use. All wipes that are suitable for baby use can be used for cleaning.
Package Dimension: 110mm X 27mm;
Band Weight: 9g;
Operating voltage: 2.8-3.3V DC
The device does not require preventative maintenance. Bempu Health has a customer care line that directly connects the customer to product engineers. If the engineers cannot assess the problem over the phone, courier pick-up will be arranged so that the engineer team can discover the root of the problem. A new device would then be sent out to the customer.^(Interview with representative) The product has a warranty of 1 year and any product that does not meet selling standards will be replaced.^(Interview with representative) Additional training is not required for parents or nurses to operate the device.
The product is one time use to ensure that the baby is protected during the entire neonatal period.^(Interview with representative)
The product can be worn on a newborn’s wrist for up to 28 days. Once the product has reached its end-of-life, the LED indicator will show the white light for one full day and then go dark. The device has a shelf life of 3 years.^(Interview with representative)
Bempu Health has performed internal durability tests and it was concluded that the device works in extreme heat or cold and in temperatures that quickly drop and rise over a period of time. The bracelet can keep an infant protected from hypothermia 24/7 for up to 4 weeks.
A study performed across 27 NICUs and 16 homes in India reported high doctor and parent satisfaction with the Bempu bracelet. A recent accuracy and utility study reported that in a sample size of 43 babies, there were 120 True Positives, 12 False Positives, and a 91% Positive Predictive Value. A study is currently being conducted in Pondicherry, Tamil Nadu. Results as of June 2016 report 98% device sensitivity, 92% device specificity, 78% positive predictive value, and 99% negative predictive value for the detection of mild hypothermia (cold stress). 7 other clinical studies have recently started or are scheduled to start in late 2016.
BJ Medical College, Jawaharlal Institute of Postgraduate Medical Education and Research, Indira Gandhi Institute Of Child Health Hospital, Jayanagar Hospital General
The bracelet should not be attached too tightly to the infant’s wrist. The device should not be sterilized or submerged under water. The device is radiation free.
Kangaroo care, warm clothing for neonate
A study was recently completed in June 2016 and the results are expected to be published in a peer reviewed journal in the near future.^(Interview with representative)
The device uses 100% hypo-allergenic medical-grade silicone, per ISO 10993 Standards. The device is in the process of receiving the CE Mark.
In developing the Bempu Hypothermia Alert Device, temperature readings were taken over 4 studies in 2 different hospitals with approximately 400 newborns. Wrist and core temperature was correlated (r=0.7). This correlation informed the algorithm used in the current product.
Bempu Health also performed usability studies with doctors and parents to evaluate ease of use. In the doctor study, 67% of doctors used the device in their clinics or prescribed for home use to parents, 89% of doctors who used the device observed at least one case of hypothermia in the home or clinical setting, and 89% of doctors who used the device recommended it to be used in their practice. In the parent study, 86% of families used the device in the NICU or postnatal wards and 84% of families continued use of the device in their home. 100% of the mothers who used the device used corrective care.
PATH has recently partnered with Bempu Health and has launched a multi-center study in Nepal and Bangladesh.^(Interview with representative)
Bempu Health has submitted to the Indian Central Government for a Health Technology Assessment and expects to receive HTA approval in the near future.
The Bempu Hypothermia Alert Device is currently a 2017 nominee for the Design to Improve Life Award.
Expert advisors have suggested that the price range is relatively high for a single-use device intended for low-resource settings. Expert advisors have also expressed concern about whether designers have considered risks associated with misuse or mishandling of the product.
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