Transcript
Guide for 3D Printing/Additive Manufacturing Applications in Medicine This guide is intended to help understand the potential considerations when using 3d printed models, instruments and devices in medicine. The flow chart walks you through the potential uses, providing examples. Each category and list of examples have common considerations and cautions with patient risk increasing moving to the right. Understanding how each section differs from the one before will also help identify the different considerations. NOTE: The guide provides a starting point. It is not intended to be an exhaustive list of cautions. The information has been developed by industry professionals, experienced in using 3D Printing/additive manufacturing for medical applications.
Medical Additive Manufacturing/3D Printing Workgroup
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Guide for 3D Printing / Additive Manufacturing Applications in Medicine
Data 3D Printed Model / Device Secondary Contact
Strictly Visualization
Communication
Simulation / Demo
Diagnosis / Planning
Communicating w/ patient, parents, colleagues
Testing fit + fxn of a device
Surgical Planning
(ex. Scoliosis model)
(ex. Stent deployment, implant sizing)
(ex. Pediatric cardio, conjoined twins) using complex and realistic models
Surgical Planning w/ invasive items Includes Invasive Devices / Implants (ex. CMF cases / Plate Bending / Jigs
Direct Contact (Intact Skin Barrier)
NonMucosal Surfaces External Skin Contact (ex. 3D Printed Casts, CPAP Masks, Glasses, Back Braces, Hearing Aids, Orthotics, Prosthetics)
Mucosal Surfaces Contact with mucosal tissue (ex. Dental / orthodontic applications)
Direct Contact (Open Wound)
Guide Marking w/out cutting or injection (ex.
Surgical marking guide, implant placement guide,, radiation shields/ apertures, imaging frames / fiducials, surg. inst. jigs)
Medical Additive Manufacturing/3D Printing Workgroup
Direct Contact (Open Wound+ Possible Debris)
Cutting / Drilling Guide
Temporary Implant
Removable Implants
Guide for surgical injection / instrumentation) (ex. surgical drilling guide, surgical saw guide)
Designed to be removed (ex. nasal Stents)
Permanent Implant
Nondissolvable implants Intent is to remain permanently in body (ex. Knee / Bone Implants)
Tissue / Bioprinting
Dissolvable implants
Drug Delivery
Active Ingredients, Dissolvable
(ex. Bioresorbable)
(ex. Tracheal Implant (PCL)
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Guide for 3D Printing/Additive Manufacturing Applications in Medicine CAUTIONS / THINGS TO CONSIDER Foreseeable Misuse- The device is used in a manner for which it wasn’t designed A visual-only device is brought into the operating room and used in surgery. A device which is intended for skinonly contact is placed in a patient’s open wound. A device which was designed to act as a holding aid is bent or struck with a mallet during use.
Model Accuracy
Software
Biocompatibility
The printed part won’t necessarily match the designed part dimensionallysimply calibrating the printer may not be good enough.
These procedures involve planning software which can also come under the FDA purview for safety and efficacy.
How is the device intended to be used- visualization, intact skin contact, open wound contact, contact for less than 24 hours/30days/ permanent? In addition to the printed material, consider other materials that are used in the printing process- fluids used to remove support structure, cleaning agents, cutting oils, etc. Is there debris generated during cutting? Printed material: Is it biocompatible?
Medical Additive Manufacturing/3D Printing Workgroup
Cleaning and Sterilization
Part Strength / Build Orientation
Some design features such as small gaps, crevices, etc. can trap cleaning fluids, uncured resin, cutting oils, etc. If the device is to be sterilized prior to use, these features can also make sterilization difficult.
Because most 3D printers print in layers, part strength across the layers may be different than part strength perpendicular to the layers.
Shelf Life Part strength, brittleness, etc. can change over time.
Consider the sterilization method- steam autoclave, gamma irradiation, EtOthese processes may affect dimensions, material properties, etc.
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