PINNIX Light Safety Blood Lancet

Target SDGs

Market Suggested Retail Price

$0.42

Target Users (Target Impact Group)

Household, Small and Medium-sized Enterprises, Public Sector Agencies

Distributors / Implementing Organizations

Unknown

Regions

Africa, Southeast Asia

Countries

Micronesia (Federated Sates of), United States

Manufacturing/Building Method

It is being produced in Japan now. The process used is mold production by mechanical processing without MEMS. The needle shape is processed by injection molding with the mold. ^{Interview with representative. Information on the manufacturing can also be found in a presentation by the manufacturer's authorized agent}

Intellectural Property Type

Patent

User Provision Model

The product is subsidized and can be purchased/acquired directly through the manufacturer, hospital/clinic, national/international distributor, direct sales, and government agency.

Distributions to Date Status

The approximate distribution to date is 50,000.

Design Specifications

Pinnix light is a single-use automatic lancet with a needle material made from polylactic acid. The product comes in two dimensions, Width 0.4 mm (30G equivalent) and 0.8 mm (25G). It is a controlled medical puncturing device with a Japanese Medical Device Nomenclature (JMDN) code: 37243002 and a device approval number : 22300BZX00293000. '

Product Schematics

Technical Support

No technical support is listed, as LightNix, Inc. states that PINNIX Light is easy to use compared to the standard lancet for minimally skilled health workers.

Replacement Components

None

Lifecycle

Single-use only, though shelf life of the technology is 2 years. ^{Interview with representative}

Manufacturer Specified Performance Parameters

The benefits:

- Eco-Friendly: Made with biodegradable materials

- Painless: Due to its mosquito-inspired shape

- Disposable: Locks automatically after use, reducing the danger of infection

- Individually wrapped: Clean and convenient to take anywhere

Vetted Performance Status

Product has undergone laboratory testing and user studies. The product is proven to be sterile after a 14-day culture extract test for sterility was conducted

Safety

The product is individually pre-sterilized sealed packaging for finger pricks. The lack of a blade also prevents sharps injuries and the locking mechanism prevents hazardous reuse. It is possible to prevent the secondary infection, such as HIV and HBV. The biodegradable polymer needle doesn’t leave the garbage of contaminated medical equipment. ^{Interview with representative}

Complementary Technical Systems

None

Academic Research and References

Compliance with regulations

Approved by Pharmaceuticals Affairs Act in Japan, registered by FDA in the Philippines (MDR-02482), approved by Health Sciences Authority in Singapore (DE0016347), FDA in USA (3010183441), and FDA in Thailand (JPN5904571). Compliant with ISO7864:1993-05-15 Sterile hypodermic needles for single use ^{Interview with representative}

Evaluation methods

Laboratory testing and user studies to ensure product compliance with regulations

Evidence has been collected to meet the following standards:

– ISO10993-1:1997: GLP test

– ISO 11137-1,2:Sterilization of health care products-Radiation Part 2 : Establishing the sterilization dose 7 Method 1 : dose setting

– ISO7864:1993-05-15 Sterile hypodermic needles for single use

– ISO10993-1:1997

Other Information

None.