Panel recommends reclassification of nonthermal shortwave diathermy devices as class II devices

The Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee today recommended nonthermal shortwave diathermy devices be reclassified as class II devices for indications involving postoperative pain and edema.The panel agreed on the inclusion of the potential risks to the indication of nonthermal shortwave diathermy (SWD), such as cellular or tissue injury, pacemaker and implantable defibrillator interference, tissue necrosis and burns, electric shock, thermal injury from implanted wire leads and metal implants and abnormal cell growth. Additional risks to health related to both on- and off-label use were also discussed in today’s meeting.“I think the core essence here is to discuss among ourselves the safety and effectiveness. Everything else, we can deliberate on that and make some conclusions, but in those two realms, I think the classification will become self-evident,” John D. Kelly IV, MD, panel chair, said.