ThermoSpot

Target SDGs

Market Suggested Retail Price

$0.50

Target Users (Target Impact Group)

Household, Community

Distributors / Implementing Organizations

Maternova, Teaching Aids at Low Cost

Competitive Landscape

Direct competitors include Bempu TempWatch.

Manufacturing/Building Method

ThermoSpot is manufactured at small capacity in the United Kingdom.

Intellectural Property Type

Select Type

User Provision Model

ThermoSpot is available for purchase in packs of 25 on the Maternova website. The product is also distributed by Teaching-aids at Low Cost (TALC). TALC typically distributes to NGOs, hospitals, and health clinics in African countries.Interview with distributor in 2018

ThermoSpot is included in an integrated neonatal kit that is being distributed through the national Lady Health Worker program in Pakistan as a part of a clinical study. ThermoSpot is also being distributed to mothers in Kenya as a part of a clinical study that is investigating the relationship between the use of neonatal toolkits and neurodevelopment. Both studies are sponsored by The Hospital for Sick Children.

Distributions to Date Status

Maternova has distributed tens of thousands of Thermospots.Interview with representative in 2018 TALC has distributed 179 ThermoSpot packages since 2013.Interview with distributor in 2018

Design Specifications

The ThermoSpot is a liquid crystal temperature indicator in the form of a flexible plastic disc (12 mm) that sticks directly onto the newborn's skin. If the infant's temperature is between 36.5ºC (97.7ºF) and 37.5ºC (99.5ºF), the black disk changes to a green smiling face to indicate that the temperature is within a normal range. If the baby's temperature drops below 36.5ºC, the smile begins to fade until the disk turns black at 35.5ºC. ThermoSpot can be used for 7-10 days consecutively and can be reused once cleaned with soap and water if it is attached to the skin with surgical tape.

Product Schematics

Technical Support

A warranty is not included with purchase of ThermoSpot. The product is not intended to be serviceable.Interview with representative in 2018

Replacement Components

There are no replacement components available. Maternova recommends for the user to simply replace the sticker once it no longer works.Interview with representative in 2018

Lifecycle

The thermometer can be reused for up to 1 year if stored in a cool, dark location away from direct sunlight when not in use.

Manufacturer Specified Performance Parameters

The ThermoSpot performs reliably and accurately within an operating tolerance of ± 0.5? Celsius.

Vetted Performance Status

Astudy with 180 observations that was conducted in an urban Indian slum reported that the ThermoSpot sensitivity and specificity for the detection of hypothermia (axillary temperature below 35°C) were 88% and 97% respectively when compared to digital electric thermometers. However, a study conducted in Zimbabwe with a total of 2787 thermometer readings reported that the sensitivity and specificity detection of hypothermia was 18% and 100% respectively. A study conducted at a rural hospital in Malawi reported that ThermoSpot readings were in agreement with rectal temperature measurements taken with a low-reading glass-mercury thermometer in 99 of 100 measurements across ten newborns. An additional study conducted in Malawi with 162 children suffering with severe acute malnutrition reported that the specificity of the ThermoSpot was consistently above 94% and that 93% of mothers were satisfied with the device. Data from a study conducted in Uttar Pradesh, India showed that there was no effect on neonatal mortality when the ThermoSpot was integrated into the newborn care package. For a study in Nepal, sensitivity and specificity of ThermoSpot in detecting moderate hypothermia was found to be 97.8% and 99.8% respectively.

Safety

The site that is chosen on the newborn must be cleaned with alcohol before the ThermoSpot is attached.

Complementary Technical Systems

None.

Academic Research and References

Compliance with regulations

CE marked.

Evaluation methods

ThermoSpot performance was evaluated through a study amongst premature or low-birth-weight babies in a hospital in rural Malawi. In 100 paired measurements comparing the ThermoSpot reading with that of a low-reading glass-mercury thermometer, the device correctly identified hypothermia in every case (2 out of 100 measurements). The ThermoSpot falsely identified hypothermia on 1 occasion. (sensitivity = 100%, specificity = 95%)

Other Information

ThermoSpot was featured in a 2012 report from PATH on technologies for maternal infection.

ThermoSpot has been featured in the World Health Organization's Compendium of Innovative Health Technologies for Low-Resource Settings.

USAID also published a report on the study conducted in Uttar, Pradesh India.

Expert advisors have questioned whether scaling up production has been considered and suggest that manufacturer should consider focusing on creating demand either by partnering with local distributors/NGOs or contracting with larger international and national organizations. Expert advisors also expressed concern about whether designers have considered risks associated with misuse or mishandling of ThermoSpot.