3D-printed devices such as surgical instruments and implants offer treatment advantages for ASCs and hospitals but also entail liability risks if the device isn't 'manufactured' properly, according to CNA Vice President of Underwriting Ryann Elliott.
The FDA defines a manufacturer as "any person who designs, manufactures, fabricates, assembles or processes a finished device." Therefore, the FDA may be authorized to regulate and inspect healthcare facilities creating medical devices through 3D printing.
Facilities should implement these five strategies to mitigate risks:
1. Tracking. Implement procedures to track all 3D-printed products brought into the facility. Identify which physicians have the appropriate credentials and privileges to use the products.
2. Training. Train any staff member or physicians who will manufacture or use 3D-printed products. For those who work with a 3D-printed instrument, implant or prosthetic, training should cover the device's uses, handling, sterilization and, if necessary, disposal.
3. Documentation. Document receiving the 3D-printed device and develop a tracking program to remain in contact with patients who receive the product. For example, if you discover a year after the procedure the silicone in the 3D-printed device lacked shelf life, deploy measures to notify patients. Also report and address any patient-reported adverse event.
4. Informed consent. Inform patients about who designed and manufactured their 3D-printed device, and whether it is FDA-approved. Let them know they have the right to refuse treatment with the device.
5. Protections against risk. Develop contractual protections and risk financing for those supplying the 3D-printing manufacturing tools and those operating them. If a physician creates the device onsite, make sure adequate risk transfer or financing is in place for the facility and physicians involved.
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