Bentec Medical, founded by Briant Benson, a specialty medical device company, announces the first “ultra clean” medical products made of technologically advanced Polyvinyl Alcohol (PVA) material. This advanced biomaterial is lint free, latex free, nontoxic, highly absorbent, biocompatible and biodegradable making it an “Eco Friendly” material. Coastal PVA, a sister company of Bentec Medical, supplies the PVA products that are used during the ultra cleaning process of silicon wafers by such semiconductor manufacturers as NASA, Intel, IBM and Motorola. Bentec Medical is taking this advanced ultra clean material from the semi‐conductor industry clean rooms, which are up to 10,000 times cleaner than a hospital operating room, and bringing it to the healthcare field. The Bentec Medical Dr. Clean products are dedicated to improving both patient safety and clinical outcomes. The Dr. Clean PVA products are an innovative solution to the traditional woven products currently used in hospitals for open surgical and catheter‐based procedures. These woven products may leave behind particulate debris, determined to be an underappreciated complication associated with these procedures. Bentec Medical’s Dr. Clean PVA products are lint and fiber‐free which may prove to be effective in eliminating unintentional foreign body debris and foreign body emboli. The Dr. Clean products are designed to be a safer alternative for all invasive and minimally invasive surgical procedures.
THERE HAS NEVER BEEN AN ALTERNATIVE
Foreign body embolization and foreign body granuloma have been described as early as 1949 by The American Journal of Pathology where Glahn states that the introduction of cotton fibers through a vein produced foreign body granulomata. A granuloma forms when the immune system attempts to wall off substances it perceives as foreign but is unable to eliminate. Such substances include infectious organisms such as bacteria and fungi as well as other materials, including sterile cotton gauze fibers. An article from the Annals of Surgery, published in 1967, demonstrated that fragments of gauze, introduced at operation, may induce granulomata and deposition of fibrous tissue. Sturdy, et al concluded that foreign body granulomas as a sequellae of surgical operations are of clinical importance. In addition, a review of clinical cases of foreign body granulomata indicated that gauze may be an important etiological factor. More Recently, Shannon, in an article from the American Journal of Neuroradiology 2006, concluded that inadvertent foreign body embolization is common in modern cerebral angiography and are probably underappreciated clinically. His article reports a comprehensive 5‐year retrospective study of all postmortem cases of post‐angiographic neurologic complications at Toronto Western Hospital. This required a review of 841 autopsy reports with diagnosis of intracranial hemorrhage, aneurysm, vascular malformation, or multiple infarctions. Of the 60 arteriovenous malformations that were identified, he found particulate embolization, which was usually cotton fiber, to be present in as many as 25% of the malformations studied. All angiographic and cardiovascular procedures are susceptible to these complications. Truscott, with Kimberly‐Clark Health Care in Roswell, Georgia, maintains that complications of interventional cardiac catheterization may be caused or exacerbated by foreign debris deposited on the inside or outside surfaces of the catheter and subsequently co‐inserted into the bloodstream. Because of the direct vascular insertion and extensive surface area exposed, minimally invasive procedures performed through the vascular system actually place the patient at greater risk of particulaterelated complications. Examiners have found that particulates or “linting” may inadvertently occur during procedural preparation and the actual surgery. The Society of Toxicology and Pathology published a study in May of 2008 where foreign‐body granulomas within the intramyocardial arteries were detected in 3 of the 5 test subjects in a routine transcoronary safety assessment test. The foreign bodies were strongly birefringent by polarized light microscopy. By their morphological features, they were identified as cotton fibers. The study concluded that “this observation emphasizes that foreign‐body embolization can occur during invasive vascular interventions, which may lead to foreign‐body reaction and misinterpretation of drug safety results.