The FDA Food and Drug Administration announced a sweeping plan on March 8, 2019, to review and address the safety of surgical staplers. In a letter sent to health-care providers Friday, the FDA said it will convene an advisory meeting on the safety of the devices and signaled that it might reclassify surgical staplers to put them under tighter control. The agency also said it plans to issue proposed recommendations to companies that make the devices, which are used in countless surgeries. The FDA also acknowledged in its letter that “we are aware that many more device malfunction reports during this time frame” were submitted as “summary reports,” which go to the FDA but are not included in the public database known […]
A recent convening of Alabama BCBS’ Medical Policy Group proposed a positive change to their policy on Minimally Invasive SI Joint Surgery to establish MIS SIJ fusion as medically necessary using an FDA-approved device (not specific to any one device type) when all of the following criteria are met: Pain is at least 5 on a 0 to 10 rating scale that impacts quality of life or limits activities of daily living; AND There is an absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia); AND Patients have undergone and failed a minimum six months of intensive non-operative treatment that must include medication optimization, activity modification, bracing, and active therapeutic exercise targeted at the lumbar spine, pelvis, sacroiliac joint, and […]
The International Society for the Advancement of Spine Surgery released two new statements: one focused on bone graft substitutes and the other examining vertebral augmentation. The bone graft substitute statement outlines historical use and U.S. regulatory pathways for bone grafts, including nonstructural allografts, demineralized bone grafts, cellular-based allografts, synthetic bone grafts, autologous cellular grafts and Class III drug-device combination products. “Bone grafting is an essential part of spinal surgery and ever-evolving science,” concluded the recommendation authors. “With each new advance, one needs to understand the characteristics of material, its mechanism of action, the regulatory pathway by which it came to market and the preclinical and human clinical evidence available on which to base a clinical use decision.” The authors found: Nonstructural cancellous allograft […]
Read the Spring 2019 issue of Vertebral Columns. In this issue: Reevaluating indications for cervical TDA, decreasing hospital stays, MIS options for pelvic fixation, maximizing lordosis, and a review of the literature surrounding PROMIS!