Hospital Sterilization of 3D Printed Devices

Mrs. Annie Watt1

1Steris Corporation, Lennox Head, Australia, 2STERIS Corporation, Mentor, USA

Biography:

Annie is the Senior Manager Clinical Education APAC for STERIS Corporation with over 25 years’ experience in Decontamination, Sterilization and Infection Control protocols used globally.

Annie is a Registered Nurse with post graduate certificates in Perioperative and Acute Care Nursing.

Annie’s role covers training/education to all healthcare professionals in APAC.

Abstract:

Advancements in 3D printing are revolutionizing the medical industry, allowing medical professionals to create patient-specific devices within a hospital quickly and economically. Applications vary widely from non-surgical uses such as prosthetics, dental restorations and anatomical models for pre-surgical training and patient education to surgical uses such as cutting guides for orthopaedic procedures and anatomical models used intraoperatively.

It has been demonstrated that use of patient specific 3Dprinted surgical guides, and anatomical models result in a better patient experience with less pain, shorter hospital stays and quicker recoveries.

For hospital professionals creating 3D printed devices for surgical use within a hospital, take on the role of a medical device manufacturer.

A patient-specific 3D printed device’s path to a surgical suite includes collection of patient imagery, translation of that imagery into a printable model, printing and print verification of the model, sterilization then surgical use.

Following sterilization, it is critical that the device be sterile, biocompatible, and materially compatible to ensure safe surgical use 3D printing is the process of making 3-dimensional objects from a digital file.

Biocompatibility for the 3D printed medical device must be established in accordance with the ISO 10993 series based upon the intended use and potential biological risks of the device.

Material compatibility evaluations should demonstrate that the materials and device design is compatible, and that sterilization has no impact on the device.

These 3 elements are extremely important to understand, so what processes should a hospital who is 3D printing follow, and are those processes validated?

 

 

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