The Israeli Health Ministry has established a committee to examine the wider implications of the use of 3-D printers, in light of their growing use in various medical procedures in hospitals.
The committee will address a wide range of questions and scenarios associated with the introduction of 3-D printers into the world of medicine. The panel, headed by Dr. Naftali Meidan from Beilinson Hospital, Petah Tikva, includes physicians, regulators and economists, as well as experts in law and ethics.
Online videos, widespread media coverage, TED talks, scientific articles and increased usage in medical institutions leave no doubt: 3-D printers are expected to become a significant component of the world of medicine and research for the foreseeable future. A growing number of patients are already walking around with body parts that have been created by a 3-D printer, including jaw bones, noses and various vertebrae.
Technological capabilities and the quality of printable material are improving rapidly, driven forward by the 3-D printing industry. Doctors are becoming accustomed to running simulations ahead of surgery using precise, made-to-order models, and using accessories also produced by the 3-D printers.
The current usage of 3-D printers is based on ties between hospitals and various commercial technology companies, which supply the printers and the required technical know-how.
However, health systems in Western countries, including Israel, still don’t know how to deal with this new technology, or how to incorporate it into the medical world from a regulatory perspective. The field is currently wide open and any developer or company is allowed to make 3-D printers and incorporate them into various medical procedures.
The committee, convened by Dr. Osnat Luxenburg – the medical technologies director at the Health Ministry – will discuss these topics in parallel with discussions being held in similar forums in the United States and Europe.
One of the committee’s members admits that the use of 3-D printers is logical but not without problems. “There’s a tendency to believe we can solve many problems by using these printers, which is not always true,” said Prof. Samer Srouji from the Galilee Medical Center, Nahariya. “There were also cases that ended up with complications, causing infection and harm to the patient. This area requires regulation, with protocols and clear guidelines in place,” he added.
Ethical questions relating to the medical use of 3-D printers will become increasingly challenging as the field of 3-D bioprinting starts to grow. The ultimate aim in this area is to be able to print a variety of organs and living organisms – from cartilage to eyes and livers, including improvements and adaptations.
The implementation of these ideas is still in its infancy and most experts believe it will take years, if not decades, before 3-D printers are able to print organs suitable for transplantation. The next realistic step is expected to be the printing of tissues or patches, which can be used to help repair faulty organs.
“This is a new and intriguing area. There is a clear understanding of its enormous potential, but we mustn’t be negligent regarding its regulatory and ethical aspects, blinded by our fascination for gadgets and innovation,” said another committee member, Prof. Gil Siegal, director of the Center for Health Law and Bioethics at Ono Academic College, Kiryat Ono, and a professor at the University of Virginia.
Dealing with such ethical issues today is trying to get ahead of the curve, assuming that organ-printing will happen one day, even if that day remains a long way away.
Despite the great potential benefit of these developments – including the elimination of organ-transplant waiting lists and the reduction of clinical testing on animals – many people warn of serious ethical implications.
“We can talk about several issues in this regard,” continued Siegal. “For example, replacing or renewing organs will affect the life expectancy of patients. This raises issues of resources and priorities, the retirement age and the planet’s resources. Other issues revolve around the question of what a human being is and what the boundaries are of being human. Is a person who has 90 percent of his organs made by a printer still considered a human being? Does a person with upgraded, printed organs with improved capabilities still qualify as human? These questions will only become more important as the area advances and develops.”
Srouji currently uses parts made by 3-D printers to help reconstruct facial bones and jawbones. “We’ve used printers in the past to reconstruct and repair patients’ faces – whether they suffered combat wounds in Syria or were oncology patients who had to have their jaws removed. But our approach is still very conservative and we prefer to use this solution as a last resort,” he said.
Two years ago, Beilinson Hospital conducted a joint project with 3-D printing companies, in which models of human hearts were printed, based on CT scans of patients ahead of complex surgery. “The experiment focused mainly on the valves, with the aim of understanding how much this area could contribute to a prior understanding of what was expected in the surgeries themselves,” said Prof. Ran Kornowski, chief of cardiology at Beilinson Hospital and president of the Israel Heart Society.
“We also later ordered the printing of organs with different degrees of stiffness, according to different degrees of calcification,” he added. “Amazing things are being done today, especially regarding skeletal and cranial bones. For now, though, we must distinguish between gimmicks and the value a patient receives. In this regard, we are still at a relatively early stage.”
From a regulatory viewpoint, the status of the printers is still unclear: 3-D printing was never defined as a medical technology and its usage includes a wide range of other services. Consequently, officials in the Health Ministry were never in any rush to draw up regulations.
The fact the printers produce customized items rather than predefined products also makes the issue more complicated, meaning the committee will have no shortage of items on its agenda.
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