Learning objectives
To assess the effect and dimensional changes of three of the most commonly used sterilization techniques on 3D printed clinical objects (121 Autoclave, 134 Autoclave and formaldehyde) for the most common used 3D printing technologies in medicine: Fused Deposition Modeling (FDM), Selective Laser Sintering (SLS) and PolyJet™.
Background
3D Printing (3DP) models are rapidly being adopted in healthcare industry for surgical planning and tooling (3). Although in recent years first 3D/AM materials tested for medical use are timidly appearing, most of the existing materials are not tested to follow mechanical properties of living tissues, nor regulations of medical devices production to be used in clinical environment (1).
Actual 3DP surgical applications can be divided as follows:
3DP anatomical model:Obtained through imaging CT or MR and produced by 3DP technologies. Main use: train surgeons...
Findings and procedure details
We review 12 3DP materials (PLA, PLAHT, ABS 30Mi, ABS Smartfil; Nylon 680, TPE-filaflex, TPU, PP, PA6, PA12, VERO, MED610) through 3 sterilization methods: 121 Autoclave, 134 Autoclave and formaldehyde. Three ASTM D638 Type I tensiles were printed and tested (Fig 6). For each of the objects, 5 copies were made: one control specimen and one copy per each sterilization method.
Characteristics of the studied materials were summarized in the following table 1. Glass Transition temperature (Tg in ºC) is of most importance to assess...
Conclusion
Sterilization of medical objects to be used in a clinical setting may lead to deformation of the printed model if not used in proper sterilization protocol according to the material glass transition temperature (Tg) especially for heat and pressure sterilization.
Formaldehyde presents to be the most suitable sterilization method for thermoplastic polymers and photopolymer resins.
Regulations and protocols must be defined and followed to assess correct application of 3DP/AM technologies in healthcare.
Personal information and conflict of interest
J. Munuera; Barcelona/ES - nothing to disclose A. Valls; Barcelona/ES - nothing to disclose M. Ayats; Barcelona/ES - nothing to disclose P. Lustig; Barcelona/ES - nothing to disclose A. Tejo; Barcelona/ES - nothing to disclose F. Fenollosa; Barcelona/ES - nothing to disclose N. Julian; Barcelona/ES - nothing to disclose O. Navarro; Barcelona/ES - nothing to disclose L. Krauel; Barcelona/ES - nothing to disclose J. Rubio; Barcelona/ES - nothing to disclose
References
ISO 13485:2016 - Medical devices -- Quality management systems. Retrieved March 24, 2016.
UNE-EN ISO/ASTM 52900:2017 – Additive Manufacturing – General principles. Retrieved November 8, 2017.
Tejo-Otero, A., Buj-Corral, I., & Fenollosa-Artés, F. (2019). 3D Printing in Medicine for Preoperative Surgical Planning: A Review. Annals of biomedical engineering, 1-20.
Hamzah, Hairul Hisham; Saiful, Arifin Shafiee; Aya, Abdalla; Patel, Bhavik Anil (2018). "3D printable conductive materials for the fabrication of electrochemical sensors: A mini review". Electrochemistry Communications. 96: 27–371. doi:10.1016/j.elecom.2018.09.006.
"Patent#:US005121329". United States Patent and Trademark...