A doctor in Raleigh, North Carolina was indicted for the extreme misuse of a medical device in addition to Medicare fraud and making and using materially false Healthcare Documents.  Many of the patients were misled by thinking the medical device, was sterile and was used for the first time during their surgery. A balloon sinuplasty often called an “angioplasty for the nose”, is an innovative procedure used for the treatment of chronic sinusitis.

                                               Source: https://cedars-sinai.org

The indictment against the doctor notes the reuse of a single-use medical device. The device was often used multiple times and sometimes reused on the same day.  Medical device companies must innovate and plan with not only patient safety in mind but also regulatory requirements and brand equity.  Compliance labeling for medical devices involves a number of identification standards from Unique Device Identification (UDI) to the Global UDI Database (GUDID), which can only ensure that the product is in compliance from production until use.

The Food and Drug Administration (FDA) is “responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”

Source: https://www.usa.gov/federal-agencies/food-and-drug-administration

 It is the FDA that requires certain labeling compliance to ensure the traceability of products and monitoring of their use.  In this particular case, the FDA is working closely with other government agencies to identify and understand the effects of this misuse.

Pragmatyxs works closely with our medical device partners to uphold all regulatory labeling requirements for the health and safety of consumers, and the solutions we support will continue to change to meet the rigors of FDA compliance.