New provisions for 3D production

An expanding market and the need for clarity on regulations

Written Tuesday, by Emanuele Mortarotti

3D printing has very quickly reached impressive numbers both in terms of quantity and popularity, in particular in the last decade. In the medical field, it seems to have found one of its greatest expressions: from the creation of simple prostheses, a silicone prototype of a human heart is now in our midst.

Unfortunately, regulations pursuant to it have not kept pace with the progress made in this sector. While the costs of 3D printers decrease, patients are now able to create their own prostheses comfortably at home - or at school - beneath the guidance of the framework created by the Therapeutic Goods Administration (TGA, Australian governmental body that regulates medical devices, ed. note. ). Some believe that sooner or later, patients will even be able to "print" their own medicines in that part of the world.

 

But who is legally responsible when products produced by 3D printers turn out to be inefficient? In Australia, the TGA is proposing changes to medical devices recognized as possibly produced by 3D printers: the objective is greater safety and standard regulations for all.

Medical devices are classified from "Class I" to "Class III" depending on the level of harm they can cause to the patient. These devices are already subject to strict regulations and range from prescription glasses (class I) to vascular stents (class III).

 

While prostheses printed with 3D technology can be classified as class I devices - or low risk - technology has progressed so as to enable the production of more equipment and devices - including those in class III or high risk. If these high-level devices were to be mass-produced on a 3D printer, the regulations regarding safety, quality and performance would apply. If, however, the abovementioned devices fall under the name of "custom-made", this regulation would not be used.

 

"Customized" devices are those created ad hoc for a patient; once they were rarer, but now they are created more and more frequently. For this reason, it is necessary to ensure that these devices meet the same quality and safety standards as those produced in large numbers - and, therefore, checked piece by piece.

The legislative gap surrounding custom-made devices is not the only problem at the moment. There is also a sort of ambiguity regarding who is legally responsible for manufacturing a determined medical device. Since a slight change in a device alters the responsibilities, in the event of patient health problems (related to the use of the abovementioned device) the balance of power of "faults" would shift. Who is legally responsible, the manufacturer or the "modifier"? These are specific questions that require clear answers and detailed and thorough regulations.

What do you think? Are more transparent and comprehensible regulations necessary? Let us know by contacting Dispotech, your disposable excellence.

Emanuele Mortarotti
Author Emanuele Mortarotti

Manager

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