Linked to EAHP Statements
Section 3 - Production and Compounding: Statement 3.1, 3.2, 3.3, 3.4
Section 5 - Patient Safety and Quality Assurance: Statement 5.11
ACPE UAN: 0475-0000-22-xxx-xxx-x. xxxx.
Nowadays, customized medical devices are becoming common practice in the operation rooms. The era where one size fits all lies far behind us, and printing of medical devices is a technology that gives a new dimension in personalized treatment of patients. Today’s applications include patient specific 3D printed cutting guides, 3D planning of complex surgery, printing of anatomical models of bone structures and organs and even printing of implantable devices. Also bio-printing of tissues and organs is already explored in transplantation surgery.
As for the legislation, the Medical Device Regulation (MDR2017/745, applicable from May 2021) defines the requirements concerning customized devices and manufacturing of devices within the health institution. Specialized manufacturers have developed the expertise and knowhow of 3D printing, but with the growing quality and availability of printing equipment, printing of devices within the health institution could become common practice.
In this evolving technology, we can wonder if there is always a clear added value in the use of patient specific devices and if the sky is the limit in the clinical applications of 3D printing?
As the hospital pharmacist is responsible for quality and conformity of medical devices, there is definitely a responsibility that reaches further than control of the CE mark on the packaging. As the provider of patient therapy we will play a key role in managing just in time printing of high quality devices and assure the traceability.
After the session, participants should be able to:
- Understand the possibilities and limitations of clinical application of 3D printed devices
- Discuss the role of the hospital pharmacist according the current MDR2017/745
Educational need addressed
3D printing is an evolving technology in manufacturing of medical devices. Hospital pharmacist must be aware of the possibilities and limitations of this technology, and their changing role in the responsibility in providing high quality medical devices.
Keywords: 3D-printing, implants, surgery, MDR, hospital exemption, manufacturing, medical device