PINNIX Light Safety Blood Lancet

LightNix, Inc.

Snapshot
Manufacturing & delivery
Performance & use
Research & standards
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Product description Brand name and 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 1-50microliters 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 region(s) Target region for distribution/implementation (listed by country if specified)

PINNIX Light can be used in Africa, Southeast Asia, and the Federated States of Micronesia, USA. ^{Interview with representative}

Distributors/implementing organizations Organization(s) distributing/deploying this product directly to communities/individuals?"

Not available

Market suggested retail price Price per unit or service price per usage/terms (USD). Subsidies noted.

The retail price for this technology is under 0.25 USD while the list price is 0.42 USD. ^{Interview with representative}

Competitive landscape Similar products available on the market. May not be a comprehensive listing.

Other commercially available blood lancets

SDG targeted United Nations Sustainable Development Goals (SDGs) targeted with this product/application/service

Goal 3 promoting good health and well-being. Used for examination of diabetes, prevention of HIV, HCV, and HBV infection, and examination of infectious diseases such as viral hemorrhagic fever.

Target user(s) Target user/consumer base (country, income segment)

This product is meant for either untrained or trained users.

Manufacturing/building method(s) Detail regarding solution production or construction method (instructions, mass production capacity, custom made,etc...)

Being produced in Japan now. Mold production by mechanical processing without MEMS. The needle shape is processed by injection molding with the mold. ^{Interview with representative}

Product Intellectual Property Open source/IP protected (note patent)/trade secret/other?

The product is patent protected under Medical Lancet.

User Provision Model Where can the product be purchased/acquired by end users?

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

Distribution to date Number of units that have been deployed, downloads or users to date

The approximate distribution to date is 50,000.

Fields marked are sourced values that have been evaluated by the manufacturer or a third party, all others are design specifications.

Construction material

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

Disposal Method

[options list] Pending

Incineration^{interview 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)

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

N/A

Design specifications Component and Operation overview including power, portability, facility requirements, preventative maintenance and user training requirements

Material: Polylactic Acid Widths Available: 0.4 mm (30G), 0.8 mm (25G) ^{Interview with representative}

Product schematics Design and assembly illustrations

None available, though instructions for use and information regarding the fabrication process of the microlancet needle are available.

Technical support Technical support provided by

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 Availability of replacement components (in-country, by order,...)

None available

Lifecycle Disposal and warranty

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

Manufacturer specified performance targets Designer / Manufacturer specified targets

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 Findings of manufacturer evaluations or independent testing centers

Product has undergone laboratory testing and user studies, though none are officially published.

Testing organizations Independent lab, academic research centers, etc.

Not available (listed as confidential)

Safety Potential hazards / risks related to operation of this product

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 Performance of this product is improved with another technology (eg. Cookstoves and Wind-blocking skirts)

None available.

Academic research Academic research related to the product (e.g. published papers in peer-reviewed journals)

Aoyagi, S., Izumi, H., Aoki, T., and Fukuda, M. 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, 2005. Digest of Technical Papers. TRANSDUCERS’05.. Vol. 2. IEEE, 2005.

Compliance with regulations Product certifications and standards referenced by designer/manufacturer

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 Evaluation methods/protocols/guidelines referenced by designer or manufacturer.

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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Cathy Sip Clip I.V Cannulas

PINNIX Light Safety Blood Lancet

LightNix, Inc.

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