Patient sustained a burn during iontophoresis therapy

Summary

The patient was a 35-year-old male with a significant medical history including obesity (BMI of 42), diabetes, chronic left ankle pain since childhood, and multiple ankle stabilization surgeries. He reported experiencing numerous falls over the past several years, each resulting in re-injury to the left ankle. Prior to beginning physical therapy, an MRI ordered by the patient’s orthopedic surgeon revealed Achilles tendonitis and chronic plantar fasciitis of the left ankle. The surgeon determined that surgical intervention was not warranted and referred the patient to physical therapy, recommending iontophoresis with transdermal delivery of anti-inflammatory medication for pain management.

The patient presented to the insured’s physical therapy clinic and underwent three iontophoresis treatments. Each session involved the application of a medicated anti-inflammatory solution to the left ankle, followed by the placement of two electrodes. Treatments lasted approximately twenty minutes. The patient reported no issues during the first two sessions. However, during the third session, he noted that the electrical current felt “stronger than usual.” He attempted to alert the PT, but the therapist was on the phone and did not respond until the session had concluded. When the PT returned to remove the electrodes, the patient reported that he had been experiencing a “stinging” sensation at the electrode site and asked if the current had been increased. The PT acknowledged that the current had been adjusted but stated it remained within a “clinically acceptable range”. The PT evaluated the patient’s ankle, found no abnormalities and subsequently discharged the patient home.

Shortly after the patient returned home, he began to experience moderate pain at the site where the electrode had been placed and noticed a blister and what appeared to be a burn. He immediately contacted the PT, expressing concern that he had not been informed of the risk of burns associated with iontophoresis. He stated that he would have declined the treatment had he been aware of this risk. The PT advised the patient to seek evaluation from his primary care physician (PCP). Following the call, the PT made a late entry in the healthcare information record, documenting that the patient reported a burn on the lateral aspect of the left ankle at the electrode site and indicated he would not be returning for further therapy. The patient did not return to the clinic, and no further communication occurred.

The following day, the patient began experiencing severe pain and was evaluated by his PCP who diagnosed a third degree burn at the anterior lateral aspect of the left ankle corresponding to the site of the iontophoresis pad placement. Over the following months, the patient complained of constant pain and hypersensitivity consistent with burn-related nerve involvement. The PCP initially referred the patient to a vascular surgeon, who ruled out peripheral artery disease and venous insufficiency. Following this evaluation, the patient was referred to a wound clinic, where he underwent several months of treatment with minimal improvement. Subsequently, the patient was referred to a pain specialist who diagnosed his symptoms as neuropathic pain resulting from the burn injury. The patient underwent several nerve block treatments and participated in aqua physical therapy with no relief. Approximately one year following the initial injury, the patient was diagnosed with Complex Regional Pain Syndrome (CRPS). A permanent spinal cord stimulator was implanted which resulted in significant improvement of the patient’s symptomatology.

Risk Management Comments

Approximately one year following the implantation of the spinal cord stimulator, the patient (plaintiff) filed a lawsuit asserting that the PT incorrectly performed the ionotophoresis treatment and that he failed to monitor him during the treatment. Liability was not contested in this matter, as it was clearly established that the patient sustained a burn during the iontophoresis treatment. The PT admitted that he had not monitored patient appropriately during the third session due to being distracted by a phone call. The defense also faced significant challenges due to incomplete documentation of key treatment details—such as electrode placement, current intensity, and session duration—as well as the absence of a documented informed consent. The defense team’s investigation did confirm that the iontophoresis equipment’s preventative maintenance (PM) records were up to date, and the equipment was found to be in proper working order.

With respect to causation, the plaintiff’s expert, while acknowledging the patient’s pre-existing ankle injuries, opined that the onset of neuropathic pain was attributable solely to the burn injury. This conclusion was based on the absence of hypersensitivity and numbness symptoms prior to the incident. The issue of causation was disputed by the defense team. The PT argued that the burn did not directly cause the neuropathic pain but may have exacerbated the patient’s pre-existing pain levels. However, the defense experts ultimately failed to provide sufficient evidence to support their position and conceded that the burn injury was more than likely the primary precipitating factor in the development of the plaintiff’s neuropathic pain. Notably, the defense experts indicated that the plaintiff’s post-incident physical exam findings--including temperature differential between the ankles, swelling and erythema—were consistent with a diagnosis of neuropathic injury and Complex Regional Pain Syndrome (CRPS). The defense expert concurred with the plaintiff’s expert that there was limited documentation of such symptoms prior to the burn incident.

Resolution:

Burn injuries identified during or immediately after physical therapy are inherently challenging to defend. In this case, the situation was further complicated by the physical therapist’s failure to adequately monitor the patient during treatment. Additionally, there was no documentation detailing the specifics of the procedure, nor was informed consent obtained. Given these factors—combined with the absence of expert support for disputing causation—the defense team determined that the likelihood of mitigating damages was low. As a result, the case was resolved through mediation.

The total incurred for this case, including the expenses associated with defending the claim, was more than $650,000.

Risk Management Recommendations for Physical Therapists:

• Remain vigilant in preventing burns associated with commonly used therapeutic modalities, including hot packs, cold/ice packs and electrical stimulation treatments, among others.
• Conduct informed consent discussions with patients and document the discussion in the healthcare information record, including questions asked and answered.
• Apply evidence-based strategies to prevent burns during electrical stimulation treatments including but not limited to the following practices:
  • Conduct routine inspections of electrode pads and avoid reusing them beyond the manufacturer’s recommended lifespan. Pads that are worn or have lost adhesion can lead to uneven current distribution, increasing the risk of burns in areas where the pad remains in contact with the skin.
  • Prepare the skin in accordance with manufacturer guidelines and evaluate the skin’s condition at the intended electrode site. Avoid placing electrodes on irritated or compromised skin.
  • Increase the current gradually and maintain continuous observation of the patient throughout the session to promptly identify any signs of discomfort or adverse reactions.
  • Ensure that the selected treatment is clinically appropriate and that there are no contraindications for use, such as pregnancy, the presence of metal implantable devices or impaired skin integrity, among others.
• Monitor patients closely giving special attention to the elderly, pediatric, or other patients with specific clinical needs or conditions.
• Perform a comprehensive assessment in order to recognize underlying medical conditions, co-morbidities or any additional risk factors that may affect patients’ ability to participate in the PT treatment plan, including but not limited to orthopedic conditions/surgery, diabetes, sensory loss, vision and hearing loss, neurological impairments, dementia, age-related risks, cardiopulmonary disease and side effects of medications.
• Document all pertinent patient information in the healthcare information record in an objective, concise manner. Maintaining consistent, comprehensive, and timely documentation of services provided is one of the physical therapist’s primary professional responsibilities, as noted in Principle 7E of the American Physical Therapy Association Code of Ethics for the Physical Therapist. Consider the following recommendations, among others, when documenting physical therapy notes:
  • Document patient assessments, equipment settings and operator of equipment, observations, communications, treatments, patient education.
  • Prior to initiating treatment, evaluate and document the patient’s skin integrity, neurological status, sensory status, as well as their ability to perceive pain and communicate with staff. 
  • Include the results of objective tests and any evaluation of the patient’s sensory, and cognitive status, if applicable.
  • Document reexaminations and revisions to goals/treatment plans, including data from repeated or new examination elements, to provide useful context for evaluating progress and modifying treatment plans.
  • Refrain from altering the healthcare information record and enter late entries only when pertinent to patient care.
• Seek opportunities for continuing education regarding handling patient injuries and notify the patient’s medical provider of any untoward reactions to treatment.
• Ensure that clinical and operational practices comply with state and federal standards and those endorsed by physical therapy professional associations, such as the American Physical Therapy Association (APTA) Standards of Practice, including but not limited to, the following:
  • The physical therapy service has a written and implemented plan for continuous improvement of quality of care and performance of services.
  • The physical therapy service has written policies and procedures that align with the APTA Standards of Practice that are implemented, reviewed regularly and revised as necessary, and reflect the operation, mission, purposes, goals, objectives, and scope of the Standards of Practice for Physical Therapy.
  • The physical therapist communicates, coordinates, and documents all aspects of patient care, including the results of the initial examination and evaluation, diagnosis, prognosis, plan of care, intervention, responses to intervention, changes in patient status relative to the intervention, reexamination, and episode of care summary.

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