Quality
Glomed Devices Verified Quality
Every Glomed Devices instrument must pass detailed Quality Assurance (QA) tests before it can be sold.
Instruments are tested for:
– Material
– Workmanship
– Pattern Consistency
Critical Dimensions
We perform the following QA tests to ensure that every instrument we sell perform its function during critical surgical procedures.
Surface Inspection
All instruments are visualized for defects in material and surface finish. They must have a flawless satin finish and be free of excess lubricants and foreign substance.
Dimensions Verification
Critical dimensions are measured with calipers, micrometers, or other specialty gauges and compared to technical drawings or Glomed Devices catalog descriptions. To ensure pattern consistency selected instruments are compared to inspection samples.
Glomed Devices Quality Testing
In addition to general inspections, function tests are used to verify instrument quality.
Scissors
Cutting tests are performed on testing material. Scissors must not snag or bind when cutting appropriate layers of material. The heavier the scissors, the more layers of material they must cut. Blades must close smoothly without hesitation. Visual inspection is performed for burrs, especially on the cutting edge. Screw lock must be secure and slight amount of hinge play should exist when opened.
Forceps
Closed jaws are checked against a light source to ensure that no substantial amount of light passes through. Jaws are clamped on plastic testing material. The impression should be clean and consistent. Teeth must mesh together closely . Jaws must be properly aligned. Ratchets must engage crisply and smoothly. While engaged at the first ratchet tooth, instruments should not open when tapped lightly against the edge of a table.
Needle Holder
Jaws must close tightly so that no light shines through the front 2/3 of closed jaws tested against a light source. Must hold suture material, and pass similar tests as outlined under forceps.
Retractors
Ratchets are checked for proper holding action. Tips are verified as either sharp, blunt or semi-sharp. Ratchet mechanisms must close smoothly. Holding power is tested to make sure ratchet remain engaged during use. Ratchet teeth must align properly.
Cutting Forceps
Cutting tests are performed with the appropriate test material. Forceps must cut cleanly with the front half of the jaws. Tips must close properly from the top to the middle of the jaws.
Pins and Wire Cutters
Cutting tests are performed according to the recommended maximum capacity of each instrument.
Only after an instrument has passed our QA Inspection criteria will it be released to the market.
Glomed Devices Manufacturing
Glomed Devices instruments are manufactured from stainless steel. Stainless steel, though not truly stainless, is a high corrosion and rust-resistant material. The metal is extremely strong and durable and has the ability to form protective or “passivation” layers.
Glomed Devices surgical instruments are made from German & Japanese Stainless steel.
Heat Treatment
Heat treating makes the instruments hard and enables them to withstand rigorous use. Stainless steel is brought to a very high temperature and then cooled until it has reached the proper hardness.
Hardness is measured in units called Rockwell Hardness (HRc). A typical hardness range for needle holders is HRc 40-48. For scissors, the range is HRc 50-58.
Heat treating and steel selection are just two of the more than 80 steps required to produce surgical instruments to Glomed Devices standards. We monitor and verify the accuracy of our manufacturing process through frequent audits.