Updated on February 16, 2024

·

Created on July 19, 2016

PINNIX Light Safety Blood Lancet

Upcoming Update

Pinnix light is the world's first resin lancet designed in Japan to draw blood

Developed By
  1. Lightnix
Content Partners
  1. World Health Organization (WHO)

Author

Product Description

PINNIX Light Safety Blood Lancet s a plant-derived polymer lancet needle. It is shaped like the needle of a mosquito which reduces pain and individually wrapped in sterilized packs for transportation. It is used to obtain 1-50 micro liters samples of capillary blood. Interview with representative

Information for this product was provided courtesy of the WHO’s 2016 Call for Innovative Health Technologies for Low-Resource Settings.

Target SDGs

SDG 3: Good Health and Well-Being

Market Suggested Retail Price

$0.42

Target Users (Target Impact Group)

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

Distributors / Implementing Organizations

Unknown

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.

Construction material

Mainly plastics Especially the needle part is made of Polylactic Acid : (C3H4O2)n, CAS 26100-51-6 Interview with representative

Disposal Method

Incinerationinterview with representative

Reuse prevention method

Locking mechanism

Sterilization method

Individually sealed and pre-sterilized packages

Clinical application

Blood draw

Indispensable equipment for function (Y/N)

No

Maintenance or calibration required by user at time of use? (Y/N)

N/A

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

Aoyagi, S., Izumi, H., Aoki, T., and Fukuda, M., 2005. Development of a Micro Lancet Needle Made of Biodegradable Polymer for Low-Invasive Medical Treatment. The 13th International Conference on Solid-State Sensors, Actuators and Microsystems. Digest of Technical Papers. TRANSDUCERS’05.. Vol. 2. IEEE, 2005.

Pinnix Light, “Introduction and Instructions

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.

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