Checklist for Risk Analysis of Unapproved Devices

By Anne M. Menke, RN, Ph.D., OMIC Risk Manager

Revised 7/2003

DISCLAIMER:  This information is intended solely to provide risk management recommendations. It is not intended to constitute legal advice and should not be relied upon as a source for legal advice. If legal advice is desired or needed, an attorney should be consulted.

This information is not intended to be a modification of the terms and conditions of your OMIC policy of insurance. Please refer to your OMIC policy for these terms and conditions.

The FDA approves and regulates the production, sale, and clinical research of medical devices.  It does not directly regulate the practice of medicine.  Prior to using an unapproved device, use this checklist to perform a risk analysis to determine the patient safety and professional liability risks associated with its use.

• What is the device?
• What is its FDA status?
  • Unapproved but undergoing clinical trials under an IDE (Investigational Device Exemption)
  • Unapproved but not yet undergoing trials
  • Unapproved and unlikely to undergo trials
• Who is manufacturing the device
  • A manufacturer or compounding pharmacy
    • Is the manufacturer or compounding pharmacy reputable and known to you?
    • Does the manufacturer or compounding pharmacy follow industry guidelines for sterility and quality assurance?
      • Keep material documenting the sterility and quality in your file on the device
• Are you distributing or reselling it?
  • If the device is labeled, promoted, or distributed in US, it is regulated by the FDA and subject to pre-marketing and post-marketing regulatory controls to assure safety and effectiveness
  • Distributing or selling greatly increases risk of FDA action
• How are you using it?
  • Research:
    • Gathering new information on multiple patients for publication purposes, or to obtain approval for a new device or a new use of an approved device, is probably research and requires an IDE
    • Part of an IDE (Investigational Device Exemption) to collect safety and effectiveness data required to support the PMA (pre-market approval) application to the FDA
      • Follow federal and state requirements for
        • obtaining approval of an IRB (Institutional Review Board) for the trials and
        • obtaining informed consent of the patient for research on human subject
        • disclosing any financial interests/incentives
  • “Practice of medicine”
    • Not for research AND
    • Use based on firm scientific rationale and sound medical evidence
    • The “practice of medicine” is theoretically unregulated by FDA but some case law exists limiting the use of unapproved devices as part of the practice of medicine
• What role does the device play in the treatment?
  • Does the treatment consist primarily of using this device?  If so, the risk of using it prior to FDA approval is greater
    • Example:  Restylane, used for lip augmentation and facial contouring
  • Does the device play an ancillary or supportive role in the performance of a procedure or treatment?  If so, there is less risk.
    • Example:  use of the dye, trypan blue, to stain the anterior capsule to facilitate visualization during cataract surgery
• What are the patient safety risks and how do you know about them?
  • Has a federal agency or state regulatory agency specifically banned the use of the device because it was determined to be unsafe?
  • Is there sound medical evidence supporting the use of this device?
  • Have peer reviewed articles been published supporting the use of this device?
    • Keep a file containing these articles and presentations
  • Can its use be expected to bring good results without a higher complication rate?
  • If there is an increased risk, do a reasonable number of physicians in your specialty use the device?
  • Is the use of the device in the best interest of this particular patient?
• Is the procedure “therapeutic” or cosmetic?
  • Therapeutic use of an unapproved device is less risky than cosmetic
  • If cosmetic
    • Does the patient have reasonable expectations?
    • Has the patient had problems with other treating physicians in the past?
    • Is he or she set on a certain procedure because of advertisements and recent popularity?
    • What are the patient’s motivations for having this procedure?
    • Does the patient fully understand what this procedure entails and the possible outcomes?
    • Does the patient understand that he or she will have to pay out-of-pocket not only for the procedure but also for any enhancement or follow-up?
• Informed consent discussion
  • Content of the discussion
    • Nature of the device or technique
    • Scientific basis for its use
    • FDA-unapproved status
      • It is always prudent to respect patient’s right to obtain the information needed to make reasoned decisions about his or her own health care
      • If physician reasonably believes that the approval status of the device will be a factor in the patient’s decision, disclose the information
      • Benefits
      • Risks
      • Alternatives
      • Possible drawbacks or criticisms from other practitioners
      • Especially with cosmetic procedures, other options and possibility of obtaining 2^nd opinion
  • If part of research or IDE
    • Must follow federal and state guidelines for informed consent
  • If not part of IDE
    • Consult legal counsel about whether state law requires physician to disclose the device’s unapproved status to the patient as part of informed consent discussion
  • Document the informed consent discussion of the risks, benefits, and alternatives, and include the fact that the patient was informed of the device’s unapproved status
    • If the treatment consists primarily of using the device, consider developing a specific consent form for the device that outlines the risks, benefits, and alternatives, and the FDA status, and give the patient a copy
• Verify coverage with your professional liability insurance carrier
• Consequences of violating the FDCA (Food, Drug and Cosmetic Act)
  • May be evidence of breach of the standard of care and result in determination that medical malpractice has occurred
  • May constitute negligence per se, due to statutory violation
    • Easier to prove if state law is stricter than FDCA and specifically prohibits the use of unapproved devices
  • Prosecution by FDA
    • Unlikely if only practice of medicine, and no distribution or sales

Acute Postoperative Endophthalmitis

Anne M. Menke, RN, PhD, OMIC Risk Manager

Digest, Fall 2003

Several policyholders have called with concerns about protocols they use for endophthalmitis prophylaxis before ocular surgery. They have heard rumors that it is below the standard of care not to use the latest topical fluoroquinolones. Currently, there is no basis for this claim. The fact that prevention and treatment of this rare but devastating complication remains the object of ongoing controversy contributes to the confusion. Two sources of information can help allay concerns and provide direction for sound therapeutic choices: OMIC claims experience and evidence-based studies.

Q  What is the source of infection in postoperative endophthalmitis?

A  In most cases, the causativeorganism is introduced into the eye at the time of surgery. Studies have identified the eyelids and conjunctiva as the primary source, so prophylactic measures are directed there. Other sources of contamination include secondary infection from sites such as the lacrimal system; contaminated eye drops, surgical instruments, intraocular lenses, or irrigation fluids; other agents introduced into the eye; and major breaches in sterile technique.

Q  What standards exist for prophylaxis?

A  There are currently no definitive standards. The latest evidence-based study by Drs. Cuilla, Starr, and Masket (Ophthalmology, January 2002) gave no prophylactic technique the highest clinical rating; however, an intermediate rating was given to preoperative preparation of the eyelids and conjunctiva with a 5% povidone-iodine solution just before surgery. Because of weak and conflicting evidence, all other reported prophylactic interventions received the lowest recommendation; of these, postoperative subconjunctival antibiotics had greater supporting evidence than the rest.

Q  In the absence of standards for prophylaxis, what should I do?

A  Base your treatment protocol on sound medical judgment. Tailor your treatment to the patient by taking into account known risk factors such as diabetes or immunosuppression, as well as the risks and benefits of the proposed treatment. Carefully document discussions with the patient, and provide clear, written instructions for pre- and postoperative care. Stay informed by reading peer-reviewed journals, and keep a risk management file of the articles that form the basis for your infection prevention protocol.

Q  What is the greatest malpractice risk associated with endophthalmitis?

A  Without exception, OMIC claims experience shows that liability arises from a delay in diagnosis or treatment, including a delay in referring the patient to a retina-vitreous specialist.

Q  What can I do to reduce the risk of delay in diagnosis?

A  If the surgery was complicated (e.g., capsular tear), took a long time, or required extensive instrumentation, you should have a higher index of suspicion for the development of endophthalmitis. Give all patients written discharge instructions stating the symptoms that warrant contacting you (blurred vision, red eye, pain, photophobia). Educate your staff members who handle telephone calls about the risk of endophthalmitis and train them to always ask patients who have these complaints if they have had eye surgery or trauma. Instruct them to schedule emergent appointments for such patients. Use the same screening criteria yourself when fielding after-hours calls (call OMIC for sample screening guidelines and contact forms). Err on the side of patient safety when deciding to treat over the phone versus examining the patient. Document your decisionmaking process in the medical record, especially when the patient calls with symptoms of a possible infection. Obtain a thorough intervalhistory, and perform and document a careful examination, noting the presence or absence of the signs of endophthalmitis (the cardinal sign is intraocular inflammation greater than expected for that point in the recovery process). If in doubt, consult with and/or refer patients to retina-vitreous specialists for cultureand management.

Q  Are there other measures I can take to reduce endophthalmitis liability?

A  During the informed consentdiscussion, warn patients about the risk of endophthalmitis and the possibility of vision loss. Emphasize the risk if the patient has diabetes, is immunosuppressed, or is having cataract surgery. Have a prudent follow-up plan, especially in symptomatic patients, and ensure that the patient makes the appointment before leaving your office. Diligently follow up on all patients who miss or cancel appointments, again ensuring that they understand that not receiving appropriate treatment could result in blindness. Carefully instruct patients to call you immediately if vision loss, pain, or other ocular problems develop before their next scheduled visit.

Free Vision Screening Exams

Ophthalmologists and their staff often provide free vision screening examinations at health fairs, schools, senior centers, and local malls. These screenings are enormously beneficial for discovering and preventing eye health problems in the general population. They also generate good public relations for the ophthalmologist who is able to give something back to the community that supports his or her practice. OMIC has not had any claims related to vision screening exams in our 25-year history. We feel that the very low risk of liability can be further minimized by taking a few steps discussed in Free Vision Screening Exams.Recommendations and Sample Form.

Terminating the Physician-Patient Relationship for Financial Reasons

Termination of Care for Financial Reasons  provides guidance on how to evaluate the reasons for non-payment and the steps needed to terminate the relationship if deemed necessary. It also provides sample forms for termination for non-payment, and confirmation that the patient chooses to stop treatment for financial reasons.

 Click on either the name of the document or the “Download” button to access the document.

Terminating the Physician-Patient Relationship

Ophthalmologists frequently have questions about terminating the physician-patient relationship. Using the sample letters and guidelines provided in   this document will help minimize the risk of patient harm and of allegations of patient abandonment. OMIC policyholders may contact our confidential Risk Management Hotline for assistance by emailing us at riskmanagement@omic.com or calling 800-562-6642, option 4.

Following the advice in Terminating the Physician-Patient Relationship can help minimize the risk of patient harm, and reduce the likelihood of allegations of patient abandonment.

Click on the name of the document or the “Recommendations” button to download the document. There are several sample letters at the end.