The Doctor’s Advocate | Fourth Quarter 2013
An Ounce of Prevention
Dr. Jerrald Goldman and Victoria Rollins explore the patient safety issues and risk factors involving device recalls.
—Robin Diamond, JD, RN; AHA Fellow–Patient Safety Leadership; Chief Patient Safety Officer, Department of Patient Safety
Device manufacturers often contact physicians with issues regarding implantable devices. Contact can range from an alert of issues with the device to a U.S. Food and Drug Administration (FDA) Class I recall.
Implantable devices may be recalled for a variety of reasons: product efficacy, defects, sterility issues, risk to public health, or a violation of FDA regulations. Most recalls are carried out voluntarily by the manufacturer; however, the FDA can request a recall if the manufacturer does not take action on its own.
The FDA classifies recalls into three categories:
- Class I recalls are the most serious. They involve a health hazard with a reasonable probability that the use of the product will cause serious adverse health consequences or death.
- Class II recalls present a remote possibility of adverse health consequences from the use of the product.
- Class III recalls involve a situation where the use of the product is not likely to cause adverse health issues.
Consider the following case study:
The claim involved a 58-year-old female with a history of valgus knee arthritis. She had a total knee replacement. Five years after the replacement, the patient returned to the orthopedist complaining that her knee felt “loose” and was making a popping sound. After examination, the orthopedist recommended an arthroscopy to inspect and correct the instability. During the arthroscopy, the orthopedist replaced the plastic post with a slightly thicker post but noted that, although there was some medial wear in the device, the replaced post had not failed.
A year later, the patient called the orthopedist after a fall. She was directed to the emergency department, where she was evaluated by another orthopedist. The patient claimed that the first orthopedist had used a defective knee component and had concealed the information.
The first orthopedist refuted the allegation, stating that she had never received notice the knee component was defective and that she had used the device with a number of patients without problems or complaints. After the patient filed a lawsuit, the orthopedist learned from the manufacturer’s representative that one of the posts in the hardware had been found to be defective. Although the manufacturer had identified the post defect, it was not enough to warrant an FDA recall during this time period. In this case, the FDA did not consider that the device met the requirements for a class recall. However, had the physician known of the defect, disclosure to the patient should have occurred—an action that might have prevented the malpractice allegation.
If you receive a patient complaint about a device or are concerned that an incident might lead to a claim, it is essential that you notify your Regional Claims Office. Your claims specialist will take action immediately to protect you and advise you of the next steps. Find details on reporting an incident or a claim at www.thedoctors.com/claims. If you receive a class recall notification, it is imperative that you disclose it to your patient.
The FDA has mandated that manufacturers must include a unique device identifier (UDI) on all devices, starting with implantable devices. Implementation of the UDI system is expected to begin in 2014. UDIs can be captured in the EHR and used for device-tracking over time. The use of UDIs may allow for more accurate adverse event reporting, reviewing, and analyzing so that problem devices can be identified and corrected more quickly. UDIs may also reduce medical errors by enabling healthcare professionals and others to identify a device and obtain important information concerning its characteristics more rapidly and precisely. It will also provide a standardized identifier to allow manufacturers, distributors, and healthcare facilities to more effectively manage medical device recalls.1
Patient Safety Recommendations
- Involve the patient in an informed consent discussion that encompasses the possible complications and side effects of device implantation so he or she can understand the benefits, risks, and alternatives.
- Dictate in the postoperative report the type of implanted device and its serial number or UDI, and copy the post-op report to the office record. Note the UDI number on the patient’s card in the office record on the first post-op visit.
- Assign a specific individual in the practice the responsibility of receiving, assessing, and acting on device recall information.
- Review and understand the recall information provided by the manufacturer before determining the next steps for the practice and affected patients.
- Have a process in place for notifying patients of medical device recalls. Follow FDA and manufacturer recommendations regarding actions to take, even if the action is monitoring only.
- Obtain manufacturer guidance; complete a clinical assessment; and discuss treatment options, risks, benefits, and alternatives with the patient.
- Document the date the notice was received, the source of the notice, the device or product name and model number, the names of patients in the practice who were notified, and actions taken. Monitor patient compliance with and response to the notification.
- Subscribe to the FDA recall web service, and assign a staff member to review the website at specific intervals: www.fda.gov/safety/recalls.
- Follow the established process for properly handling explanted devices.
- If the device is removed in a hospital setting, the hospital retains responsibility and will ordinarily store it and maintain custody or control. Direct patient requests for the device to the hospital risk manager.
- For Class I recalls, work with the surgical facility where the device was implanted to verify which patients have the device. Notify the patients immediately, and determine the appropriate course of action.
- For Class II or III recalls, it is appropriate to inform patients of their options. Contact your patient safety risk manager at (800) 421-2368, extension 1243, or email@example.com for a sample letter.
Not all devices recalled are defective, and patients may not incur health problems. Not all recalls require revision or explantation. Monitoring the device may be the recommended option. The patient’s safety must be the highest priority, and care should be taken to confirm device failure if revision surgery or explantation is being contemplated.
After reading the recall information, determine whether the patient must be seen and assessed and how quickly action must be taken. Depending on the category of the recall, the physician practice can be responsible for taking appropriate corrective action. The time frame for acting should be determined by the manufacturer’s recommendations and the classification of the recall.