September 29, 2017

Strict Manufacturing Standards Protect Patients

Like all medical procedures, imaging exams offer both benefits and risks. They save lives every day and rarely cause harm. At the same time, some modalities can increase patients and healthcare professionals to ionizing radiation, which may have a direct relationship to increasing the chance of a negative biological effect from that life-saving ionizing radiation.

How does that happen? Radiation is a term for energy waves or photons that travel through the air and then through the anatomy of interest and on to an imaging receptor. Ionizing radiation used in diagnostic radiography has enough energy to potentially cause damage to our DNA via the creation of free radicals, which can cause significant damage to living cells and tissues in a process called oxidative stress.

Not all medical imaging uses radiation to produce images. Ultrasound (also called sonography) uses sound waves to view soft tissues like muscles and cartilage. Magnetic resonance imaging (MRI) uses radio waves and magnetic fields to produce images. They are great tools for soft tissue imaging, but are not always the best choice for bony anatomy.

General radiography, CT, fluoroscopy, and nuclear medicine procedures all use ionizing radiation to generate images of the body. These imaging procedures use different amounts of ionizing radiation. Standard x-rays, including chest X-rays and mammography, use relatively low amounts. CT scans, nuclear medicine studies, and fluoroscopy use higher amounts of ionizing radiation and account for most of the radiation to which patients in the U.S. are exposed.

As part of a balanced public health approach, the FDA wants to support the benefits of medical imaging exams while minimizing the risks to patients and HC employees. For example, every medical device that is used in a radiograph on humans should not exceed 1.2mm of Al equivalence. Not all products that are commercially available and used adhere to such regulations.

In 2010, the FDA’s Center for Devices and Radiological Health launched the Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging.

Through this initiative, the FDA works to promote patient safety through two principles of radiation protection:

Justification: The imaging procedure should be judged to do more good than harm to the individual patient. Therefore, all examinations using ionizing radiation should be performed only when necessary to answer a medical question, help treat a disease, or guide a procedure.

Dose Optimization: Medical imaging examinations should use techniques that are adjusted to administer the lowest radiation dose that yields an image quality adequate for diagnosis or intervention.

Manufacturers of imaging devices and equipment who sell globally, like Reina Imaging, are held to strict self-certification, including random inspections. But not all manufacturers hold themselves to the safety standards.

According to the FDA, “manufacturers are responsible for producing products that do not emit hazardous or unnecessary radiation and that comply with all applicable radiation safety performance standards.”

Manufacturers are required to self-certify their own products to be compliant with an applicable standard, based on their own quality control testing program, as described in detail by the FDA. Inspections and field tests are part of the program. Not all companies comply, which is, quite frankly, unethical at best and dangerously done without regard at worst.

Guidance documents, inspections, labeling requirements, quality assurance protocols, personnel credentialing and training, all of these cost manufacturers time and money.

But these policies, recommendations and guidelines are the only way to ensure maximum patient and operator safety and efficacy. Be certain that any medical device that comes in contact with a patient is from an ISO13485 certified medical manufacturer.

Whenever you order a product from Reina, you can be certain it has been manufactured to the most rigid requirements set by the international community. If you have questions about the safety of any of your radiological imaging equipment, accessories or devices, please call us today.