medical devices Archives - Unitherm Insulation Systems

Plastic Cast: heat-moldable plastic is shaped around a patient’s limb using rivets.
Plastic Foam: polyurethane foam could stabilize trauma patients. Foam expands inside the body to prevent blood loss, and conform to the shape of injured tissue.
3-D Body Part Printing: 3-D printed implants are being created from living cells and polyester plastic; example is an ear.
3-D Printed Plastic Splint: a 3-D printed tracheal splint was implanted into a baby made from polycaprolactone, a medical plastic.
Artificial Cornea: these silicone corneas treat eye injuries or chronic inflammations. They can restore vision and are similar to a natural cornea.
Hearing Aids: a new implant directly stimulates the auditory nerve: microphone, microcomputer, stimulator, and an electrode carrier.
Spinal Implants: a cervical interbody fusion system made of machined polyetheretherketone (PEEK) rods has been approved by the U.S. FDA.
Absorbable Heart Stent: blood flow to the heart can be restored with a plastic heart stent, which can later dissolve into the body.
Vaccination patches: a skin patch containing plastic “micro needles” could possibly deliver vaccinations painlessly, replacing injections.
Plastic Heart: plastic tubes mimic heart valves to let blood in and out of plastic ventricles in an artificial heart.
Artificial Blood Vessels: these are made by coating a biodegradable, plastic mesh tube with human or animal muscle cells.
Plastic Knee Replacements: a new ceramic and plastic knee implant is to last 20 to 30 years longer than traditional knee replacements.
Hip Replacements: metal-on-metal hip replacements are declining due to new technologies and materials: ceramic polyethylene (a medial-grade plastic).
Self-healing Prosthetics: this plastic skin recognizes injury and is self healing. It has the sensitivity and flexibility of human skin and can restore its electrical and mechanical properties.
Prosthesis: plastic orthopedic devices align, correct, and support deformities, and can improve the function of movable body parts.
Plastics in Medical Implants: ethylene vinyl acetate, Proniva self-reinforced polyphenylene (SRP), Veriva polyphenylsulfone (PPSU), Zeniva (PEEK)
Bacteria-Resistant Plastics: these nonstick plastics can help ward off disease and contamination.
Polycarbonate Medical Devices: transparent medical tools are being manufactured from polycarbonate.

When we visit the doctor, most of us don’t think twice about the quality of the devices our doctors and caregivers offer us. After all, critical medical devices that keep people alive go through a rigorous testing process, right? That’s not always the case according to an alarming study published in the Archives of Internal Medicine.

For manufacturers to gain FDA approval for critical medical devices, including implants and life-sustaining devices, they must submit the product to one of two approval processes.

One is a stringent premarket approval (PMA) process that involves clinical trials and thorough manufacturing inspections. Alternatively, they can submit devices to the 501(k) process, a simpler process without human studies or manufacturing scrutiny.

The startling study focused on high-risk devices, a third of them cardiovascular devices, recalled between 2005 and 2009. Of the 113 devices studied, 80 were approved through the 501(k) process and 8 completely skipped the approval process because the FDA determined them too low-risk to test.

[Read more…]

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