LH Quảng cáo: lazijsc@gmail.com

The field of 3-D printing comes with a new set of legal questions hospitals using the technology will need to consider, said Bruce Kline, a technology licensing manager who oversees patents for new technology developed at Mayo Clinic. For starters, he said the STL file printers use are a lot like MP3 music files, in that they can be protected under copyright and require licensing to use. Copyright violations can occur if a purchased STL anatomical model file for rare disease is illegally shared ...

Nguyễn Thị Sen | Chat Online
07/09 15:27:59 (Tiếng Anh - Lớp 12)
7 lượt xem

The field of 3-D printing comes with a new set of legal questions hospitals using the technology will need to consider, said Bruce Kline, a technology licensing manager who oversees patents for new technology developed at Mayo Clinic. For starters, he said the STL file printers use are a lot like MP3 music files, in that they can be protected under copyright and require licensing to use. Copyright violations can occur if a purchased STL anatomical model file for rare disease is illegally shared with another institution that did not purchase the file from the vendor that created the file.

Under the law, if a device has a functional use it falls under patent law. If it is not functional, it falls under copyright law. Kline said most medical 3-D printing for educational models and complex anatomy evaluation currently falls under copyright. But, he said that will rapidly change in the coming years as customizable 3-D printable medical devices see wider use.

Additive manufacturing (AM) allows the creation of patient-specific devices at the point of care. Kline said an interesting fact is that these devices are FDA 510(k)-exempt if produced by a hospital instead of a medical device vendor. He said this blurs the lines between traditional vendor relationships, since the hospital can now become the manufacturer. However, if a hospital makes a device, it also becomes liable for it. He advised that it might be better for a commercial vendor to make the device for the hospital so the vendor assumes the liability of the device. Custom-made medical devices are also exempt under FDA regulations, Kline said. So, if a physician creates or modifies a device to meet the clinical needs of a specific patient’s anatomy, he said it is acceptable to use under current FDA rules. This may leave the door wide open for use of 3-D printed devices that are customized for each patient using their own 3-D imaging datasets.

It is possible printable device files may become available in the next few years to customize and print on demand. However, Kline said it will be much more difficult to enforce patents on these types of devices. He explained if someone makes one or two devices, there is no economical way for the creator of those device files to go after the user/maker of unlicensed copies of the device to claim lost profits.

(Source: https://www.dicardiology.com/)

What is the main topic of the passage?

Vui lòng chờ trong giây lát!
Lựa chọn một trả lời để xem Đáp án chính xác Báo sai đáp án hoặc câu hỏi
Số lượng đã trả lời:
A. Proposed FDA guidance for 3-D printing.
0 %
0 phiếu
B. 3-D printing of biological tissue implants.
0 %
0 phiếu
C. Early experience of printing implantable devices.
0 %
0 phiếu
D. Legal considerations regarding 3-d printing.
0 %
0 phiếu
Tổng cộng:
0 trả lời
Bình luận (0)
Chưa có bình luận nào, bạn có thể gửi ý kiến bình luận tại đây:
Gửi bình luận của bạn tại đây (*):
(Thông tin Email/ĐT sẽ không hiển thị phía người dùng)
*Nhấp vào đây để nhận mã Nhấp vào đây để nhận mã

Trắc nghiệm liên quan

Trắc nghiệm mới nhất

×
Trợ lý ảo Trợ lý ảo
×
Gia sư Lazi Gia sư