Nanotechnology

Safety Concerns Using Nanotech In The Medical Field

Nanotechnology is an advanced technology that has the potential to be used in a wide selection of FDA-regulated products. Including foods, medical goods, and cosmetics. Nanomaterials, produced using nanotechnology, are measured in nanometers equivalent to about one-billionth of a meter.

So very small that they can’t be seen with a microscope. All these nanomaterials may have different chemical, physical, or biological properties compared to their usually-scaled equal substances used in many products regulated by FDA.

FDA has long encountered the blend of guarantee, risk, and uncertainty that accompanies emerging technologies. Nanotechnology isn’t unique in this aspect. The Nanotech changes in chemical, biological, and other attributes that make nanotechnology applications do come with safety concerns.

Recognizing nanotechnology remains a top FDA priority. The FDA is observing the evolving science and has a strong research agenda to help evaluate the effectiveness and safety of products using nanotechnology.

Strong science is vital to the FDA’s ongoing review of the products it monitors. FDA is spending in a nanotechnology regulatory science program to improve further the scientific capabilities, including producing specific data and tools to identify properties of nanomaterials and assess the impact they may have on products.

Generally, the agency believes the current framework for security assessments adequately robust and flexible to be suitable for a variety of materials, including nanomaterials.  FDA is keeping a science-based and product-focused regulatory policy to regulate products using this emerging technology appropriately.

Legal standards criteria vary among different product-categories that FDA manages.  FDA will regulate nanotechnology products under current statutory authorities, in accordance with the legal standards applicable to each kind of merchandise under its jurisdiction.

The agency is taking a sensible approach to evaluating each product on its own merits and doesn’t make broad, general assumptions about the safety of nanotechnology products.

How Safe Is Nanotechnology?

Should we ever be concerned about the potentially toxic effects of exotic (and recently invented) nanomaterials?

Most medical care provider’s main goal is keeping patients alive by all means available! It has been the means of thinking on an emotional level.

Why do we spend so much time, energy, and resources in our labs attempting to ascertain whether using carbon nanotubes to treat leukemia or glioblastoma (an aggressive form of brain cancer) may increase the risk of another cancer?

First, we are currently dealing with cancer patients already; second, the worst-case scenario is that carcinogenesis may happen to some of them decades from. In the meantime, there are all these so little, so seriously sick right now.

In the context of medical uses of nanotechnology, we need to create tools for clinicians to save lives. We don’t believe many people would dispute this as an urgent and worthwhile task.

However, we should also develop safe medicines and instruments. No clinician, regulatory authority, or host will support a technology that isn’t “safe.”

That’s the reason there are strict rules that govern the approval of new products for medical use. This is something that a lot of medical experts that develop nanomaterials but are concerned with development are liable to overlook.

The challenge then becomes who explains “security” and how.

Usually, what is safe and what’s not is a relative concern. For me, bungee jumping is obviously not safe. For many others, it is not only safe but also fun.

In the modern interventional medical clinic, virtually every treatment plan is “dangerous.” Radiation treatment, surgery or chemotherapy all risks with several adverse side-effects. However, this is what we learn to work with and what we have available.

It’s the famous risk-benefit balance that clinical practice is based on. A patient walks into the clinic with critical symptoms or has been detected with malignancy, the risk of destroying healthy cells, and collateral damage, the danger is immediately balanced with the benefit of eradicating the tumor.

This is the undeniable fact that a lot of nano workers in toxicology (generally environmental or occupational health) neglect or ignore when they believe nanotechnology in medicine.

An experienced clinician explained: “Kostas, water may be an intoxicant if you do want to use and see it that way.” That announcement has resonated so vividly with us since then we’ve attempted many times to answer the question: “is water safe?” Well, inhalation of excessive amounts of water can kill us. It’s called drowning.

The risk of drowning stands quite high, typically in the United Kingdom, at 450 deaths annually. Additionally, excessive oral intake of water may result in water intoxication. Really, a condition called dilutional hyponatremia results from drinking excessive amounts of water and can lead to brain damage and stroke.

So is water toxic? Surely it’s not “safe.” If we ban or heavily regulate swimming or shipping or punting because the chance of drowning rises dramatically, when on water. Should we manage the convenience of water in our homes, because it can potentially kill?

What if we attempt to extrapolate about the protection of carbon nanofibres in bike frames and our tennis rackets? How toxic are they? Are we ready to balance the risks from exposure to such new nanomaterials against the benefits of useful products we get in exchange?

So, if you read or hear about a nanoparticle being poisonous, dangerous, unsafe, our advice is to ignore the sensationalism and concentrate on the use to which technology or that substance will be put. If gold or carbon nanomaterials are utilized in medicine, they’ll be subject to a battery of tests and a set of inspections. Approvals to maximize the security of their individual. These can include clinical trials lasting to determine the safety and efficacy of such technologies. So that you can be certain that problems will become apparent.

Having said that, we think patients in a severe condition might want to try less proven hazardous technologies, and if at all possible, these should be made available to them. Increasing the life span of a person with a brain tumor by six months can be such a substantial achievement, it may justify using “unsafe ” technologies.

The same technology is used as an additive in the drink our child likes to consume or as a window cleaning product, then we might wish to be careful and minimize all risks. Better still, we might support them to give up fizzy drinks altogether.

Among the most difficult challenges of the human condition is sharing our different realities. What’s safe for one may be harmful to others. What might be dangerous for an NGO with an environmentalist “fact” might be a safe, important tool for a neurosurgeon and or oncologist in their clinical “reality.” Radiation is just such a case.

Let us avoid arguing when it comes to talk about the safety of nanotechnology. Try to exchange facts, and bear in mind that water can kill and can intoxicate. No nano-substance will be completely “safe.” Whether we select to use it will depend on the application.

FDA’s Action on Nanotechnology

The acting Commissioner of Food and Drugs imposed FDA’s Nanotechnology Task Force with issuing a report to discover regulatory strategies. That would allow the continuing expansion of nanotech safe, innovative, and useful FDA-regulated products. That report included the safety of nanoscale materials.

The Nanotechnology Task Force was required to identify and suggest strategies to deal with any policy or knowledge gaps that exist to enable the agency better to assess the safety features of FDA-regulated products that include nanoscale materials. The Nanotechnology Task Force published the report on July 2007, and among other things. The report presented suggestions to the Commissioner for actions the agency can take in. Furtherance of its mission to protect and promote public health.

Since this report published, FDA issued some guidance papers on topics regarding the use of nanotechnology in FDA-regulated products. As guidance documents do not form or grant any rights for or on any person. Do not work to bind FDA or the public, they do describe FDA’s current thinking on a subject.

FDA’s Strategy For Management of Nanotechnology Products

FDA will proceed to improve nanotechnology products under its current statutory and regulatory authorities. In accordance with the legal standards applicable to each kind of product under its jurisdiction. FDA plans to ensure predictable and transparent regulatory pathways grounded in the best available science to improve nanotech safety concerns.

  • FDA doesn’t make a definite judgment that nanotechnology is naturally harmful or safe. They intend their regulatory approach to be adaptive, flexible and to take into account the specific features. The consequences of nanomaterials in the biological context of each item and its usage.
  • Particular strategies for each product area will vary based on the statutory authorities. The issues and scope included in the product-specific supervision documents indicate this approach.
  • FDA’s nanotechnology regulatory science research profile centers on interpreting interactions of nanomaterials with biological systems; and on the competence of testing strategies for assessing efficacy, safety, and quality of products containing nanomaterials.
  • FDA’s regulatory policy approach is consistent with applicable overarching U.S. government policy principles and encourages advanced under appropriate oversight.

The industry remains responsible for ensuring that its products meet with all applicable legal requirements. Including criteria for security, in spite of the emerging nature of a technology associated with the production of a product.

FDA supports industry to discuss with the Agency early in the product development process to address any questions. Related to nanotech safety, effectiveness, or other characteristics of products. That carry nanomaterials, or about the regulatory status of those products.

Initial consultations with FDA facilitate a common understanding of the particular regulatory and scientific concerns for nanotechnology products.

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