Should you let surgeons use devices off label?
Should you let surgeons use devices off label?
Your surgeon says she wants to use a medical device in a different manner than it was approved by the Food and Drug Administration (FDA). She says he has the data to ensure it will be used safely, and the patient already has given informed consent.
What should you do?
"In some circumstances, good evidence may have accumulated that off-label use of a device may be in a specific patient's interest, even though the use of that device for that indication is not approved by the FDA," says Dan Berry, MD, professor of orthopaedics, College of Medicine at Mayo Clinic, chair in the Department of Orthopaedic Surgery at Mayo Clinic, Rochester, MN, and second vice president of the American Academy of Orthopaedic Surgeons. "In other words, sometimes medical knowledge and practice may advance ahead of regulatory approval."
Custom-tailored care
Off-label use clears the way for surgeons to custom-tailor treatment so that they can treat the unique signs and symptoms of each patient, says Patrick J. Hurd, attorney at law with LeClairRyan in Norfolk, VA. "Off-label use of medical devices keeps the focus on healing and not rigidity and conformity, permitting the physician to practice the art and science of medicine," Hurd says.
Sometimes it's not in the best interest of the patient to wait for FDA approval, says Hurd, adding that "if patients had to await FDA approval of every medical device before receiving treatment, their health and well-being would suffer." Some outpatient surgery providers are "guided by very conservative legal advice stating that no off-label use can be permitted," Hurd says. "In my opinion, such policies ignore the realities of the patient mix such entities serve and belittle the professional competence and expertise of the physicians treating such patients."
Off-label use, in and of itself, doesn't imply that the surgery is illegal or clinically improper, says Madelyn S. Quattrone, Esq., senior risk management analyst at ECRI Institute, a Plymouth Meeting, MA-based nonprofit organization that uses applied scientific research to identify approaches to improving patient care.
"Physicians are permitted by law to use medical devices and drugs in an off-label manner," she says. "Congress did not authorize the FDA to regulate the practice of medicine. That is a function of state medical boards."
Guidance issued earlier this year
Still, fear runs rampant among outpatient surgery providers, including fear of lawsuits, Hurd notes.
"Having the off-label use become the recruiting tool for attorneys seeking class-action plaintiffs via commercials and other media advertising," he says. Class-action lawsuits have been filed against manufacturers that involved clinicians and health care facilities as co-defendants, Quattrone says.
She says researchers have claimed "many off-label uses lack supporting scientific and clinical evidence of safety or efficacy, that physicians may rely to their patient's detriment solely on manufacturers' data and information concerning off-label use."
There have been reports of data manipulation, fraud, and conflict of interest, she says. Hurd says, "If [hospitals or ambulatory surgery centers] receive remuneration for promoting certain off-label uses to their medical staff, receive entertainment/money from device/drug companies, etc., then, like physicians, they can be subject to allegations of fraud."
Does the patient understand?
Quattrone says another problem is that many patients undergoing surgery with an off-label device "may erroneously believe that a medical device has been approved by the FDA as safe and effective for use for their condition — a false assumption that may lead patients to overestimate a device's safety."
Still, providers don't have to ban off-label use, sources say. Their fears might be calmed somewhat by FDA guidance issued earlier this year on unapproved new uses of cleared medical devices. These recommendations attempt "to set a science-based standard for disseminating off-label information to physicians," Quattrone says. While the guidance is directed toward drug and medical device manufacturers, "the guidance should be 'must reading' for physicians and staff at every hospital and outpatient surgery center," Hurd says. "It clarifies what information can be exchanged between manufacturers/suppliers and providers and, over time, provides a measure of comfort to those reluctant to permit such off-label use."
Tips for using devices off label Outpatient surgery centers and hospitals should have a policy for the off-label use of medical devices, says Patrick J. Hurd, attorney at law with LeClairRyan, Norfolk, VA. "In my experience, physician input into the policy is key in ensuring its effectiveness," Hurd says. The policy doesn't have to be elaborate, he says. However, it should address informed consent, documentation, basis for use of the device, and tracking and follow-up of postoperative complications, Hurd says. "Some [facilities] require that information on the safety and efficacy of the off-label use be made a part of the patient's record," he says. "Frequent off-label use of the same device by a surgeon or practice may be subject to IRB [institutional review board] or products committee review by some health care entities." Consider involving the clinical engineering departments in developing a policy for off-label use, advises Madelyn S. Quattrone, Esq., senior risk management analyst at ECRI Institute in Plymouth Meeting, MA. Ensure that clinicians are familiar with the indicated uses, contraindications and warnings related to off-label use, she says. Determine if there is an FDA-approved alternative device available, she suggests. Will the device be used safely? Determine whether peer-reviewed literature supports the off-label use, Quattrone says. Also, "weigh the relative risk of harm from the off-label use with anticipated clinical benefit to the particular patient," she says. Be certain that the device has been approved by the Food and Drug Administration (FDA) for on-label use, says Dan Berry, MD, professor of orthopaedics, College of Medicine at Mayo Clinic, chair in the Department of Orthopaedic Surgery at Mayo Clinic, Rochester, MN, and second vice president of the American Academy of Orthopaedic Surgeons. However, you can't rely on the FDA "to have carefully evaluated the safety and efficacy of the device for that specific application," Berry says. "This puts a greater burden on the treating physician to carefully evaluate the available data, in an unbiased manner, to determine the benefits vs. the risks of using that device for the specific patient," he says. Before going off label, the surgeon must be certain that the evidence is solid that the patient will be safe and that off-label use of the device is in the patient's best interest, Berry says. "The responsibility to use the device responsibly lies on the surgeon," he says. However, off-label use is not forbidden, sources emphasize. Hurd says, "The law does not restrict a physician from practicing his/her art." The surgeon can make a decision based on his or her training and experience, he says. "Such use cannot be wanton and reckless; it should be based on a deliberate and studied review of available scientific evidence on the safety and effectiveness of the device for the intended use, including his or her own personal experience with prior similar uses for similar conditions/patients," Hurd says. Is it worth the risk? Carefully consider the risks and benefits, Quattrone says. "It's one thing to use a device off label for a serious condition when there is no FDA-approved device, especially when reliable evidence supports the off label use," she says. "It's another thing to use a device off-label where there is a safe and effective FDA-approved alternative or where the patient's condition is not sufficiently serious to warrant risks of an unproven use or treatment." Ensure that informed consent and documentation is thorough, and ensure the discussion is documented, say sources interviewed by Same-Day Surgery. Hurd says, "In general, my advice is 'document, document, document.'" Surgeons should provide an opportunity for the patient to ask questions to ensure adequate understanding of off-label use, "as well as the risks and benefits of alternatives," he says. "This dialog should be memorialized in the patient record." The surgeons also should document the "rationale and basis for the off-label use," Hurd says. "From the initial H&P to the pre-op work-up to the surgery itself, all the way through post-op assessment and follow-up visits, the patient record should reflect the facts supporting the selection, deployment, and outcome of the off-label use," he says. Resource Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices is available at www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htm. |
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