Injury and Liability Associated with Implantable Devices for Chronic Pain.

BACKGROUND: Due to an increase in implantable device-related anesthesia pain medicine claims, the authors investigated anesthesia liability associated with these devices. METHODS: After institutional review board approval, the authors identified 148 pain medicine device claims from 1990 or later in the Anesthesia Closed Claims Project Database. Device-related damaging events included medication administration events, infections, hematomas, retained catheter fragments, cerebrospinal fluid leaks, cord or cauda equina trauma, device placed at wrong level, stimulator incorrectly programmed, delay in recognition of granuloma formation, and other issues. RESULTS: The most common devices were implantable drug delivery systems (IDDS; 64%) and spinal cord stimulators (29%). Device-related care consisted of surgical device procedures (n = 107) and IDDS maintenance (n = 41). Severity of injury was greater in IDDS maintenance claims (56% death or severe permanent injury) than in surgical device procedures (26%, P < 0.001). Death and brain damage in IDDS maintenance claims resulted from medication administration errors (n = 13; 32%); spinal cord injury resulted from delayed recognition of granuloma formation (n = 9; 22%). The most common damaging events for surgical device procedures were infections, inadequate pain relief, cord trauma, retained catheter fragments, and subcutaneous hygroma. Care was more commonly assessed as less than appropriate (78%) and payments more common (63%) in IDDS maintenance than in surgical device procedure claims (P < 0.001). CONCLUSIONS: Half of IDDS maintenance claims were associated with death or permanent severe injury, most commonly from medication errors or failure to recognize progressive neurologic deterioration. Practitioners implanting or managing devices for chronic pain should exercise caution in these areas to minimize patient harm.

Complications associated with eye blocks and peripheral nerve blocks: an american society of anesthesiologists closed claims analysis.

BACKGROUND AND OBJECTIVES: Concern for block-related injury and liability has dissuaded many anesthesiologists from using regional anesthesia for eye and extremity surgery, despite many studies demonstrating the benefits of regional over general anesthesia. To determine injury patterns and liability associated with eye and peripheral nerve blocks, we re-examined the American Society of Anesthesiologists Closed Claims Database as part of the American Society of Regional Anesthesia and Pain Medicine's Practice Advisory on Neurologic Complications of Regional Anesthesia and Pain Medicine. METHODS: Claims with eye or peripheral nerve blocks performed perioperatively from 1980 through 2000 were analyzed. The liability profile of anesthesiologists who provided both the eye block and sedation for eye surgery was compared with the profile of anesthesiologists who provided sedation only. The injury patterns associated with peripheral nerve blocks and payment factors were analyzed. RESULTS: Anesthesiologists who provided both the eye block and sedation for eye surgery (n = 59) had more injuries associated with block placement (P < .001), a higher proportion of claims with permanent injury (P < .05), and a higher proportion of claims with plaintiff payment (P < .05), compared with anesthesiologists who provided sedation only (n = 38). Peripheral nerve blocks (n = 159) were primarily associated with temporary injuries (56%). Local anesthetic toxicity was associated with 7 of 19 claims with death or brain damage. CONCLUSIONS: Performance of eye blocks by anesthesiologists significantly alters their liability profile, primarily related to permanent eye damage from block needle trauma. Though most peripheral nerve block claims are associated with temporary injuries, local anesthetic toxicity is a major cause of death or brain damage in these claims.