Import Alerts: Understanding Medical Device Requirements For Overseas Use
A medical device is anything designed to be utilized for the relief of patients in various health-related situations. Medical devices help patients in overcoming disease and illness, enhancing their quality of life and assisting healthcare providers in diagnosing and treating patients. Medical technology is constantly evolving, resulting in improved diagnostic and treatment methods and greater patient satisfaction. The development of medical devices is driven by advances in medicine, such as genomics, molecular biology, computer science, and immunology.
Manufacturers must determine whether their devices fall into one of the following classifications based on the Food and Drug Administration’s (FDA) regulations. These classifications are: Class I devices, which are the most advanced and sophisticated; Class II devices, which are generally considered safe but might have some negative effect; and Class III devices, which include several therapeutic devices that might cause serious adverse effects. There are three categories of medical devices: therapeutic devices, safety devices, and surgical devices. Each category has different levels of regulation depending on the potential hazard they pose to patients.
As a result of the significant advancements made in medical technology over the past two decades, devices in these categories are more commonly used than ever before. According to the American Society of Clinical Pathologists, it is estimated that healthcare professionals will require more than 100 new medical devices by the year 2021. This pace of adoption is unprecedented, especially given the fact that in years past, only one new device was approved every year. In addition, there are many challenges that doctors and other professionals facing this rate are faced with.
One challenge that medical devices in this category are faced with is the FDA’s radiation-emitting electronic drug product (R ie EMRP). The FDA has not approved this product, despite the manufacturer having been in business for more than 30 years. However, R ie EMRP units have been prohibited from use in clinical trials due to concerns regarding the potential for severe radiation exposure. The device may increase the risk of tumors or growths in the body, as well as increasing the lifetime risks of some patients. The classification also includes blood borne pathogens, such as hepatitis B and C viruses, cytomegalo virus, Epstein-Barr virus, and HIV. While there are studies currently in progress to test the efficacy of radiation-emitting electronic medical devices on humans, these tests are not conclusive at this time.
Next on the list is the medical devices in the three classes known as class 2. These devices are commonly used by healthcare professionals, particularly those in the emergency room, to manage minor emergencies. RSIE devices are required to be installed by medical facilities in order to maintain patient care standards. This device class also includes non-thermal monitors used to assess the heart function of individuals, such as the pulse oximeter. As noted above, all medical devices are required to be approved by the FDA, but class 2 devices must undergo rigorous testing before being released into the marketplace.
In addition to the three classes mentioned above, there are also a few devices that fall into the class of class III, which are largely considered to be elective devices. Examples of this category include implantable cardio-respiratory devices, such as the Atripla, and pacemakers. It should be noted that although the pacemaker was originally developed for the treatment of cardiovascular disease, it is now widely used to treat other medical conditions such as cerebral palsy, arrhythmia, diabetic retinopathy, and spinal cord injuries. Although many individuals may consider these particular devices unnecessary or burdensome, research has shown that pacemakers have significant benefits for patients who need them, and are often a lifesaver.
Finally, the last two categories, class IV and V, fall between the classification of traditional medical devices and those marketed for non-medical purposes. This includes items such as ovary valves, defibrillators, dialysis machines, endoscopes, liver flukes, kidneys, stomach stapling devices, synthetic hips, and artificial heart valves. Many of these devices are no longer sold in the United States, and it is important to review the documentation provided by your prospective supplier to determine whether the device will be classified as one of these devices. While ovaries and dialysis machines were once classified as medical devices, changes in the law have made it more difficult for these devices to be sold to consumers, and this is your responsibility if you are purchasing an ovary or dialysis machine for your personal use.
As outlined above, there are a number of differences between the various classes of medical devices. The import alert that you must complete for each item will help ensure that you understand the requirements that must be met for shipment to the United States. To learn more about the requirements that must be met for shipment to the United States, complete an import alert request form today.