Bempu TempWatch

Target Regions

Worldwide

Target SDGs

Market Suggested Retail Price

$33.00

Target Users (Target Impact Group)

Distributors / Implementing Organizations

Bempu Health, hospitals in India, Bill & Melinda Gates Foundation, USAID

Manufacturing/Building Method

The device is currently manufactured in-house by Bempu Health.

Intellectural Property Type

Select Type

User Provision Model

The product is currently available for purchase from Bempu Health's website, Amazon, 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 in 2019

Distributions to Date Status

As of 2019, approximately 13,000 bracelets have been distributed.

Design Specifications

The Bempu Hypothermia Alert Device is a bracelet composed of a silicone band, thermistor metal cup, and plastic casing. The device contains a printed circuit board that 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 seconds 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: 9.4 x 6.6 x 6 cm; Band Weight: 9 g; Operating voltage: 2.8-3.3 V DC

Product Schematics

Technical Support

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 in 2019 The product has a warranty of 1 year and any product that does not meet selling standards will be replaced.Interview with representative in 2019 Additional training is not required for parents or nurses to operate the device.

Replacement Components

The product is one time use to ensure that the baby is protected during the entire neonatal period.Interview with representative

Lifecycle

The product can be worn on a newborn's wrist for up to 30 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

Manufacturer Specified Performance Parameters

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 one month.

Vetted Performance Status

A 2018 research paper in the Journal of Maternal-Fetal and Neonatal Medicine stated, "A total of 461 neonates were screened for hypothermia, giving 2428 temperature readings. Three hundred and eleven of 461 babies experienced hypothermia at some point. The 461 babies studied experienced 495 episodes of hypothermia in total. The sensitivity and the specificity of the bracelet in diagnosing hypothermia were 98.6% and 95% respectively. The positive and negative predictive values of the bracelet were 83.6% and 99.6%, respectively. The accuracy of the bracelet in diagnosing hypothermia was 95.8%."

Safety

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.

Complementary Technical Systems

Kangaroo care, warm clothing for neonate

Academic Research and References

Compliance with regulations

The device uses 100% hypo-allergenic medical-grade silicone, per ISO 10993 Standards. BEMPU Health Pvt. Ltd. is an ISO 13485:2016 certified company, which implies the use of good manufacturing practices for medical devices.

Evaluation methods

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. In the study from the Journal of Maternal-Fetal and Neonatal Medicine, eligible cases fulfilling inclusion criteria were given BEMPU Bracelets for a period of 24?h. A comparison was made between skin temperatures taken at the axilla by a mercury thermometer and skin temperatures taken at the wrist by the BEMPU Bracelet. Temperatures were taken every 6?h and every time the BEMPU Bracelet alarmed. Trained nurses obtained temperature measurements on newborns during their 24-h stay in the hospital step-down nursery.

Other Information

• PATH partnered with Bempu Health and has launched a multi-center study in Nepal and Bangladesh.Interview with representative in 2019
• Bempu Health has submitted to the Indian Central Government for a Health Technology Assessment.
• Bempu Health has been awarded grants from the Bill and Melinda Gates Foundation, Grand Challenges Canada, and USAID Saving Lives at Birth to develop the Bempu TempWatch.
• 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.