FDA reveals new draft guidance for 3-D printing of medical devices

3 D printing 242x210 FDA reveals new draft guidance for 3 D printing of medical devicesThe fast-growing technology of 3-D printing may revolutionize the way medical devices, particularly knee and hip implants, are made.

Already, the 3-D printed titanium hip implant design known as  REDAPT™ Revision Acetabular Fully Porous Cup with CONCELOC™ Technology has been applauded as being a potential long-term solution for patients that are in need of hip replacement.

Recent litigation, including the eye-popping $497.6 Million verdict against Johnson & Johnson and its subsidiary, DePuy Orthopaedics, has revealed a host of potential problems with metal-on-metal hip implants. Patients are reporting experiencing adverse effects after these metal implants are installed, such as dislocations and fractures that often require revision surgery to remove and replace the device.

Following continued complaints from patients implanted with the all metal devices, it was found that the metal parts of the device may corrode inside patients’ bodies. This corrosion can lead to a type of blood poisoning known as metallosis.

As a result of these patient complaints, the metal-on-metal hip makers are facing thousands of lawsuits alleging the metal devices are responsible for the injuries.

But 3-D printing technology is showing promise, with medical technology companies such as Stryker and Smith & Nephew interested in cashing in on the market.

The FDA has given assurances that  3-D printed devices will be tested with similar standards to non-3-D printed devices. Regulators advised that mechanical testing would be used to asses the device’s build to “ensure that production processes are properly developed, conducted, controlled, and monitored to ensure devices or components are not adversely affected by fabrication orientation.”

According to the FDA, 3-D printing technology “has the advantage of facilitating the creation of anatomically matched devices and surgical instrumentation by using a patient’s own medical imaging. Another advantage is the ease in fabricating complex geometric structures, allowing the creation of engineered porous structures, tortuous internal channels, and internal support structures that would not be easily possible using traditional (non-additive) manufacturing approaches.”

Fierce Medical Devices
Righting Injustice