FDA offers shoulder pain pump safety tips to nurses
August 26th, 2010 by Jennifer Walker-Journey
The Food and Drug Administration (FDA) has released safety tips for nurses on elastomeric infusion devices, or pain pumps, used during and up to 72 hours after surgery to deliver a continuous amount of local anesthetic directly into the patient’s intra-articular space, or shoulder joint, for postoperative pain control. The FDA has received approximately 35 reports of chondrolysis in patients who received continuous intra-articular infusions with pain pump devices. This type of chondrolysis, called postarthroscopic glenhumeral chondrolysis (PAGCL), occurs when the shoulder cartilage is worn away, causing bone to rub against bone. It is a severe, life-altering complication that is usually irreversible. Many patients require a total shoulder replacement.
The FDA says it is not known what factor or combination of factors contributed to chondrolysis, but it is believed that the infused local anesthetic or the device materials may have contributed to the condition. Prior to 2000, reports of chondrolysis were low, but reports of PAGCL began to appear more frequently in recent years as surgeons began using newer devices and newer techniques, such as continuous postoperative infusion of anesthetics into the glenohumeral joint in the shoulder.
The FDA informs health care professionals that elastomeric infusion devices are safe when used properly; however, use of pain pumps has not been approved for use in shoulder surgery. The agency now requires pain pump manufacturers to warn health care providers and their patients about the potential for severe joint damage when these devices are used for intra-articular anesthetic administration.
The FDA advises nurses and other health care professionals when treating patients who will or have used elastomeric infusion devices for shoulder surgery to make sure the patient has given informed consent and understands the potential risks and benefits; teach the patient to immediately report signs and symptoms of chondrolysis such as chronic severe joint pain, stiffness, loss of motion, weakness in the shoulder, or popping, grinding or clicking of the shoulder joint; and prepare patients who have signs and symptoms of chondrolysis for additional diagnostic studies, such as X-rays or magnetic resonance imaging, as ordered.
In conclusion, the FDA urges health care professionals to “be vigilant to help patients avoid complications or get further treatment when needed.”