While it is true people can develop infections after surgery and even some fragments have been left behind in patients, these types of occurrences are extremely rare. The medical profession takes great precautions to keep you safe and healthy. These safety standards apply to everyone in the medical profession, from the doctors all the way down to the manufacturers of medical tools and devices.
What is Medical Molding?
Medical molding is a specific type of injection molding. Injection molding is a manufacturing process in which a specific type of plastic, called thermoplastic, is heated to the melting point then poured into molds. As the thermoplastic cools, it hardens into the shape of the mold. Medical molding is the exact same injection molding process; it is just reserved exclusively for medical tools and devices, as well as replacement body parts. Medical molding manufacturers must comply with stringent safety procedures to ensure the patient’s safety.
What Safety Precautions Do Manufacturers Take with Medical Molding?
Medical molding manufacturers in the United States are regulated by the Food and Drug Administration (FDA). These manufacturers make sterilization a top priority. This precaution starts when the manufacturers choose their suppliers. The suppliers must comply with safety regulations, as well. The manufacturers themselves operate in clean rooms, which have HEPA filtration, airflow monitoring, room pressure monitoring, and constant humidity and temperature controls. Medical molding manufacturers also use high-speed robotics and closed-loop processes. These procedures ensure that the medical parts and devices are manufactured in a highly controlled, sterile environment.
What are the Consequences for Medical Molding Manufacturers Who Don’t Comply?
Rest assured that medical molding manufacturers want to comply with all of the regulations imposed on them. Yes, it may cost them more, but in the long run it actually saves them a tremendous amount of money. In our litigious society, patients whose infractions can be traced back to the manufacturer are sure to sue, and they are highly likely to win large settlements. Not only will a jury award the patient compensatory damages, they will probably award punitive damages as well to discourage manufacturer carelessness going forward. Even if no one gets injured and sues, however, there can be major financial penalties for medical molding manufacturers who do not comply with regulations. They can be heavily fined, lose manufacturing contracts, have their license revoked, or be shut down completely.
