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Imported medical devices can be potentially unsafe due to the lack of direct oversight by the Food and Drug Administration (FDA). Imported devices may carry a greater risk for users. This is why it is important to understand how imported medical devices work, the risks, and what steps can help to make them safer.
The FDA recognizes three classes of medical devices based on what controls are necessary to ensure their safety and functionality. The three classes are listed below.
Class I medical devices are allowed to enter the United States as long as the medical device’s labeling is in compliance with FDA regulations. Class I devices are not intended to support or prolong life. Examples of Class I devices include bandages, medical gloves, hand-held surgical instruments, and tools.
Class II devices are differentiated from Class I because of their medical significance and the greater risk they present. If a Class II device is determined to not work properly, it could result in serious physical injury or harm to the user.
In addition to complying with general controls, Class II devices must also conform to special controls. Devices in Class II are held to a higher regulatory safety standard than Class I devices because they are designed to perform their intended tasks without causing injury or harm to the patient or user.
Examples of Class II devices include motorized wheelchairs and infusion pumps. Class II devices also differ because they may require premarket notification. This type of special control can include labeling requirements, performance standard maintenance, and postmarketing surveillance (PMS). PMS monitors the safety of a medication or medical device after it has been released for public use. This allows for verification of the continued safety and effectiveness of the drug or device.
A Class III designation means that there is not enough information available through Class I or Class II controls to assure safety and effectiveness. These devices require premarket approval. Premarket approval uses a scientific method to study a medication or device’s effectiveness and safety prior to its release.
Class III devices are typically those that support or prolong human life. These devices play a significant role in preventing harm to human health. Some examples of Class III devices include implantable pacemakers, HIV diagnostic tests, and power morcellators.
The Coronavirus (COVID-19) pandemic caused at nationwide shortage of medical devices and personal protective equipment (PPE). In response, manufacturers and engineers across the United States had to develop new solutions quickly to keep up with the increasing demand for these life-saving products. Modern technology has provided new options to deal with this crisis. Specifically, many medical workers have been able to turn to 3D printers to address the shortage. The problem is that products that were made with this technology face obstacles before they can be considered safe for the general public.
Many places with 3D printing capabilities joined the effort to help during the pandemic. Rice University, for example, used their resources to make 3D-print face shields and had them tested for quality and approved in a relatively short period of time. Since all of the members of the development team were able to focus on the project, success came relatively quickly. Many others attempted to find solutions, however, they encountered challenges, like lack of funding and effective communication and management. These issues can lead to poor quality assurance and the development of inferior products.
PPE safety equipment is essential to health and well-being. Without adhering to proper quality controls, severe consequences can occur. One issue is the quality of medical devices that are imported from other countries. More and more complaints are arising regarding imported foreign medical devices, PPE, and testing kits.
The United States does rely on a certain amount of products supplied by manufacturers based in other countries. According to the Chinese State Council, more than 80 million counterfeit and faulty masks and 370,000 fake disinfectants have been seized. Considering those numbers, it is fair to assume that many of these defective medical products have made it into the hands of consumers.
A major problem is that so many products have entered the market that it has become a real challenge to determine which are FDA approved. One solution is to ensure that all products adhere to a standardized safety process. For example, many distilleries have converted their operations to allow for the production of hand sanitizer products. As a result, the Centers for Disease Control and Prevention (CDC) put out guidelines for how sanitizer products can be produced and distributed.
Additionally, certain tests can be performed to ensure that medical products are functioning properly. A common example is the candle test, which says that if a wearer can blow a candle out through their mask, it is not properly filtered or fitted.
COVID-19 has presented manufacturers with unique challenges. Frontline medical workers need to have access to safety supplies, like masks, face shields, gloves, and other protective gear. More advanced medical devices are also in high demand, including ICU ventilators and supporting controls systems.
The raising demand and rapid increase of production volumes of these critical supplies means increased risk. The biggest issues are the assurance of product quality and product reliability for the service. To maximize results, the manufacturing processes for medical products need to adhere to strict quality management standards. These standards should be reviewed, assessed, and approved by both quality and design engineers.
Research suggests that the biggest factors in poor quality imported products is related to mistakes in the management of reliability and quality standards. To ensure quality and safety, the bar needs to be raised higher when it comes to development and distribution standards. The problem is that it is extremely difficult to conduct inspections on the frontlines during emergency circumstances. The burden of quality and reliability assurance needs to be completed on the manufacturing and supply side before product shipment.
If a person is harmed by a dangerous imported product, they may have legal options available to them. As soon as possible, the injured victim should speak to a lawyer to discuss whether or not they should pursue a medical products liability case.
If you are suffering from negative health effects because of a faulty imported medical device, contact a Philadelphia defective medical device lawyer at Brookman, Rosenberg, Brown & Sandler. If a medical product is defective, it can cause serious harm. For more information and a free consultation about your potential case, contact us online or call us at 215-569-4000. Located in Philadelphia, we proudly serve clients throughout New Jersey and Pennsylvania, including Delaware County, Chester County, and Philadelphia County.