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Quality Management

Kaneko MediX, Inc. Quality Control

Management to reduce pain

Sharpness test data
JUDGEMENTDATE2010.7.22INSPECTORMI
 CHART SPEED
  2.5mm/s
 CHART RANGE
100mV (100g), 200mV (200g), 500mV (500g), 1V (1000g)
 NEEDLE SPEED
mm / min
 TEST FILM
PU (t = 0.40), PE (t = 0.05), NR (t = 0.30), Others (t =)
 SILICON
COATED / DIPPED / N / A
 ROOM TEMPERATURE
   ℃ 
KIP-OUT-002-Y1-3

Quality control of injection needles (sharpness resistance test)

I will explain the quality control of injection needles.
A general syringe has the shape shown in the photo, but there are various types such as an indwelling needle used for intravenous drip and an AVF needle used for artificial dialysis.
 The part of the needle that directly pierces a person looks the same as an injection needle, but when enlarged, the shape differs depending on the application.

syringe

syringe

The shape of the needle tip of the syringe

Lancet point shape: dialysis AVF needle
Lancet point shape:
Dialysis AVF needle
Back cut point shape: Indwelling needle
Back cut point shape:
Indwelling needle
Semi-lancet point shape: Indwelling needle
Semi-lancet point shape:
Indwelling needle

Quality control points

Needle needles are naturally inspected in a controlled room in a dust-free environment.
Doctors and nurses give injections to patients, but patients always think that injections hurt.
Tissues where humans feel pain are called "pain points".
There are about 150 pain points in 1 cm2.
In other words, there will be at least one in 1mm.It is very difficult and almost impossible to hit the injection needle to avoid this pain point.

Therefore, the point is how to produce needles that do not hurt (less pain) on the premise that "it hurts when you stab an injection needle".
Here is the point of quality control of injection needles.

Deburring before and after

before
after
≪Before≫
The pipe that becomes the injection needle is polished to form a needle shape, but just by polishing, there are small burrs (shavings) on the edge as shown in the photo.
 
 ≪After≫
A needle that reduces pain as much as possible.The edge has a needle with as little pain as possible without burrs.
To remove this burr (shavings), the main method is electrolysis, but we do not simply remove it, but proceed while managing how pain can be reduced when stabbed by a person. ..

The management is called "sharpness resistance test".
This is a method of measuring the load (penetration resistance) at that time by piercing several types of film with a needle.

Film type
No Film name
1. PE (polyethylene) t0.05 film
2. NR (natural rubber) t0.3 film
3. PU (polyurethane) t0.4 film

Full view of sharpness measuring instrument

Full view of sharpness measuring instrument
■ Puncture a needle into the puncture film ■
Record the puncture load value on the pen recorder
■ Record the puncture load value on the pen recorder ■

The injection needle is free of dust, dust, bioburden (live bacteria), endotoxin (dead bacteria), etc., as well as the amount of harmful substances such as ROHS regulation, REACH regulation and eluent test exceeding the regulation value, We manufacture products while controlling the quality of needles that are not included in the needles and that make patients feel less painful.

Kaneko MediX, Inc.
Quality Control Manager Kenji Takahisa

Kaneko MediX, Inc.
329-2703
Tochigi Prefecture, Nasushiobara City, Tsukinukizawa 342-17
TEL. 0287-36-6688
FAX: 0287-36-5827

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Manufacturing of medical injection needles
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