MEDICAL DEVICE REGULATIONS AND TRADEMARK USE
Jeffrey Vincent Kostich, President
Smithers Medical Products, Inc.
North Canton, Ohio
If I could add one requirement to the successful completion of any type of medical degree, I would require that each individual take a course detailing the law regarding medical device regulations and trademark use. Additionally, I would like to see the Food and Drug Administration begin a comprehensive study in the materials used on humans in the radiation therapy/oncology departments and freestanding centers across the United States. Many centers either are not aware or choose to completely disregard the law regarding the use of medical devices on humans, and the correct use of trademarks and logos in the literature.
Believe it or not, there are guidelines that detail what is legal and more importantly what is illegal to use on humans for treatment by the medical community. I have often wondered what a hospital administrator would say to a family member of a cancer treatment patient if that family member asked why mom or dad’s treatment device was made of hazardous illegal components that came out of a hardware store. This would be unthinkable in the operating room, yet seems to be standard operating procedure at many facilities around the country. Unfortunately it will probably take a multi-million dollar lawsuit to grab the attention of medical professionals before they take the medical guidelines set forth by the FDA seriously. How would a hospital ever recover if they were the subject of an investigation report by one of the media TV reporters, reporting how a medical facility uses a product that is illegal to use indoors not to mention on a seriously ill cancer patient who is expecting the best available medical treatment available?
Any company that engages in the manufacture, preparation, propagation, compounding, assembly of processing of a device intended for use by humans, is subject to the regulations set forth and enforced by the Food and Drug Administration. This covers any device intended for use in the diagnosis of disease or other conditions, or in the cure, treatment, or prevention of disease in man or other animals. These devices are controlled on different levels based on their classification. Smithers Medical Products, Incorporated is registered with the Food and Drug Administration and has registered its products with the Food and Drug Administration. This information is not the opinion of the author, but can be found in the federal register, Department of Health, Education and Welfare, Food and Drug Administration, Medical Devices, listing.
Smithers has had an on-site inspection by the FDA where the company was praised for its manufacturing set-up and operation and for maintaining quality standards in the safe and effective production of safe, reliable, quality medical foam. At Smithers Medical Products, Incorporated, our quality assurance program details our rigid manufacturing, storing, packaging and processing standards. Detailed maintenance and calibration is performed with each batch of foaming agents poured. Our standards at SMP actually surpass the requirements laid down by the FDA. We believe in providing you, the medical expert, with the safest and most reliable product available on the market today.
It is inexcusable that some medical facilities do not follow the guidelines when considering the products they use on their patients. Many facilities have sought to make their own repositioning forms by using a dangerous, toxic and illegal foam that is sold at hardware stores intended only for outside use. This dangerous practice is not only harmful to the patient, but is in fact more harmful to the medical professionals who use the dangerous chemicals on a regular basis. These dangerous chemicals contain high levels of TDI, toluene diisocyanate. This toxic gas is a carcinogen itself. Oftentimes, some of the staff who may be told to use the product assumes that the product is safe to use, when in fact it is not. If you are not sure whether a product is safe to use, contact the safety officer at your facility, or contact the FDA directly to see if the product or its manufacturer is registered with the FDA. Ask the manufacturer if they are registered with the FDA and also ask if they have had an on-site inspection. This information will assure you that you are using a safe and effective product.
Be sure to insist that your facility use ALPHA CRADLE® brand foaming agents. “ALPHA CRADLE®” is a registered trademark of Smithers Medical Products, Incorporated. As such, SMP is the only company that provides or manufactures ALPHA CRADLE® brand customized immobilization devices. If you are approached by a representative from another company that says it sells ALPHA CRADLE® brand customized immobilization devices, buyer beware!
How sure can you be that a company that would misrepresent their product would sell you a safe and effective product. Once again, contact the FDA if you are in doubt. If you see another company offering to sell you an “ALPHA CRADLE®” please contact our office with this information. We will take the appropriate legal action to stop this type of malpractice.
I have found that trademark misuse is widespread throughout the medical community. Many times when an ALPHA CRADLE® brand customized immobilization devices is referenced in the literature, it has not been properly notated. ALPHA CRADLE® is a registered trademark of Smithers Medical Products, Incorporated. Therefore any time it is mentioned, it requires the use of a “®”, showing that it is a registered trademark. The copy should also reference the owner of the trademark (company) and their address (city, state). Regarding “ALPHA CRADLE®”, the trademark is a trademark of Smithers Medical Products, Incorporated, North Canton, Ohio.
By using the term “ALPHA CRADLE®” when you are using an inferior homemade of generic version, one is deliberately misleading the audience in the type of study that was done and misleading the audience as to the effectiveness of the products. ALPHA CRADLE®, properly used in reference, makes reference to the brand of customized patient repositioning systems that are developed, manufactured, and marketed by Smithers Medical Products, Inc. We have traced studies from the Chicago area that claimed to have used “ALPHA CRADLES®” in a clinical trial, only to find that they have never purchased “ALPHA CRADLES®”, and once contacted, admitted that ALPHA CRADLE® brand customized immobilization devices were not used in the study. This can be misleading to those reading the literature as well as unlawful. Be sure that when you mention a device in your medical report or study, that if in fact it is a device that your facility purchased, it has a legally protected name, mark or logo that you as the author are responsible for correctly notating. Companies have spent literally hundreds of millions of dollars to protect their name of a product. The medical professional that is reporting a finding has the obligation to be accurate in representing what was used in the study and whom it belongs to.
Information on correct use of trademarks, patents, and logos can be obtained from the patent office, a nearby patent attorney, or by contacting a representative of the company whose product you are using. Oftentimes companies are unaware of the study involving their product and would appreciate a copy of the article. In some instances, the company may offer to provide the samples needed to complete the study.
By properly reporting what has actually been used in a study, not only is the medical professional complying with federal law, but they are also describing the actual materials used should colleagues want to try to duplicate the study being described. Correctly using brand names of products used allows the reader to correctly understand what the author used, and the results of the use of that product. Most importantly, the medical professional should not become so unprofessional and sloppy as to mention the brand name of a product when they are only referring to a general type of device, not the brand name itself. Negative stereotypes are very difficult to overcome. The authors who have slandered companies and their brand name products should assume the responsibility of correctly and accurately using brand names, trademarks and logos.