An in-depth understanding of the different types of recalls as well as each stakeholder’s responsibilities is critical
Orthopaedic surgeons are in a unique position to discover possible issues with orthopaedic devices. Accordingly, the surgeon’s role in ensuring the quality of those devices cannot be overstated. This responsibility requires surgeons to report device failures to the U.S. Food and Drug Administration (FDA) and to understand the hospital’s role in reporting as well.

Recent innovations in arthroplasty have resulted in many positive advances for patients. However, there has been an associated increase in device recalls. After the initial FDA approval, post-market mechanisms are designed to detect and report issues with arthroplasty implants. When issues are recognized, a voluntary or involuntary device recall may be issued.

To promote patient safety, the surgeon must appreciate the steps necessary during a recall. This article discusses both the FDA clearance process for orthopaedic devices and ethical and legal issues regarding the recall of problematic devices. It also highlights the key responsibilities of orthopaedic surgeons.

Initial clearance processes
Manufacturers may use one of two general pathways to obtain FDA clearance prior to introducing a product to the U.S. market—the 510(k) Premarket Notification process or the Premarket Approval Process.

Premarket Approval Process (PMA)—Of the two pathways, the PMA process is the more stringent. As part of the PMA process, the manufacturer must present adequate scientific evidence to assure regulators that the device is safe and effective for its intended use(s) prior to the device’s approval. The PMA pathway is generally required for class III medical devices, which the FDA defines as “devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.” Because the PMA process is more rigorous, it can create large economic obstacles that may prevent manufacturers from bringing device innovations to market.

510(k) Premarket Notification Process—In contrast, the 510(k) Premarket Notification process has lower regulatory hurdles to bring a device to market. This process is available to a new device that is “substantially equivalent” to an existing (predicate) device or to a standard recognized by the FDA and has the same intended purpose(s) as the existing device. This process is generally reserved for class I and II devices, which are deemed not to pose the same risk as class III devices. The 510(k) pathway generally does not require manufacturers to present clinical data demonstrating device safety and efficacy.
For incremental changes on predicate devices, the 510(k) pathway is an important vehicle that allows innovation without excessive regulation. Many orthopaedic devices go through the 510(k) process. One study found that, from 1992 through 2012, of 8,991 new orthopaedic devices reviewed, 8,345 (93 percent) went through the 510(k) process; just 646 (7 percent) were cleared through the more
rigorous PMA process.

Although innovation has brought many positive advances for patients, metal-on-metal bearing designs and dual modular taper stems are examples of problematic implants.

The less rigorous standards of the 510(k) process are meant to streamline the process of bringing to market a device that is substantially equivalent to a predicate device, and thus should have similar in vivo performance. However, 510(k) approved devices have not always performed similarly to their predicate. From 1992 through 2012, 20,093 device recalls were initiated by manufacturers across all medical specialties; devices approved through the 510(k) process were 11.5 times more likely to be subject to recall than PMA-approved devices.

Reporting device failures
Problems with devices are difficult to detect, and a large proportion are believed to go unreported. The FDA uses a number of tools to monitor the safety of devices after they have been introduced; medical device reporting is the primary tool.

The FDA created the MedWatch program as a gateway for reporting adverse events (www.fda.gov/medwatch/report ). MedWatch can be used to report both adverse events resulting from a specific device and product quality issues.

When medical personnel (including physicians) become aware of a reportable event, the physician’s facility (the hospital or surgery center) is considered aware of the event. Under FDA law, manufacturers, device importers, and device user facilities (including hospitals and ambulatory surgical facilities) are required to submit reports of adverse events, including death or serious injury, to the FDA. Many manufacturers require that sales representatives be present during surgeries to report all revision cases, but compliance with these rules is unknown.

From the MedWatch website, individual healthcare professionals can use Form 3500 to report adverse events, and patients can use Form 3500a. Although the facility is required to report, individual healthcare professionals and patients are encouraged—but not required—to submit reports. Physicians who complete these reports should remember to respect HIPAA privacy rules and preserve patient confidentiality.

After an adverse event with a device occurs, providing the documentation to MedWatch may seem like a thankless job with little perceived benefit. However, when combined with multiple reports from different institutions, this important initial step generates the necessary momentum and documents a history of problems that may initiate a product recall.

Removing devices from the market
Several mechanisms—both independent of and dependent on the FDA—can be used to remove a problematic device from the market. Such mechanisms include stock recovery, market withdrawal, and voluntary or involuntary recall.

The simplest mechanism of removal is a stock recovery. In this situation, if the device is taken off the market before any components have been sold, a stock recovery may enable the manufacturer to recover all devices before any are used in patients.

Once the device is in use, removal options include market withdrawal or recalls. A market withdrawal is considered for products that have been distributed, but whose issues “involve a minor violation that would not be subject to legal action by the FDA or which involves no violation.” A recall, on the other hand, encompasses the removal of a marketed product that, in the view of the FDA, violates the laws that the FDA administers.

In an involuntary recall, the FDA orders a manufacturer to issue a recall. The manufacturer is required to establish a process to notify patients, and, in most cases, an independent fund is created to cover medical expenses.

On initiating an involuntary recall, the FDA conducts a health hazard evaluation for the product. This evaluation includes assessment of whether adverse events have already occurred, the severity of those adverse events or possible adverse events, the likelihood of additional such events, and the identification of particular at risk populations. Following this evaluation, the FDA evaluates the risk to public health associated by placing the device in one of the following three categories, depending on the level of risk the device represents:

• class I—a reasonable probability exists that the use of, or exposure to, the product will cause serious adverse health consequences or death
• class II—use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote
• class III—use of, or exposure to, the product is not likely to cause adverse health consequences

When a voluntary recall is issued, the manufacturer is required to notify the device’s users, not their patients. Typically, manufacturers will send a letter to each surgeon and hospital. In large hospital systems, the patient safety officer will probably receive the letter. In addition, the Emergency Care Research Institute (ECRI) may send notices to hospitals, though not all hospitals receive ECRI notices. The recall communication should include information for accurate identification of the product(s), typically a lot number or serial number. The manufacturer does not directly identify affected patients. In many cases, it remains the physician’s responsibility to correlate the serial and lot numbers to affected patients.

The FDA posts information about recalls in an online Medical Device Recall Database. If the most severe risk is feared, the FDA may issue press releases to broaden the reach of a notification. After a recall is classified, the FDA will post publicly accessible weekly enforcement reports in the recall database. The FDA ultimately terminates the recall after it is successfully completed.

The role of surgeons
Surgeons comprise a critical component of a voluntary recall, but their responsibility in the process is not well-defined. Physicians are not legally required to notify patients, although manufacturers typically suggest that patients need to be appropriately monitored.

A surgeon has an ethical obligation to notify a patient if the surgeon believes the device could put the patient in significant danger. The surgeon may be held liable if an adverse event associated with the recalled device occurs, particularly if patient notification could have prevented the event. Once a surgeon is aware that a patient has a device that has been recalled and may be failing, the time limit to make a legal claim is limited. In most states, it is 2 years, but in some states, it can be as short as 1 year. The risk officer at the surgeon’s institution can be a valuable resource to negotiate this process.

The costs for any medical intervention are typically not covered under a voluntary recall. These bills may go directly to the patient’s insurer. When litigation is involved, payment matters may be resolved through discussions involving the hospital’s and the patient’s legal representatives. In some cases, formal repayment plans may be established.

The role of hospitals
U.S. hospitals that receive federal funding are obligated to comply with the provisions of the Safe Medical Device Act of 1990, which requires them to report to the FDA and/or a device manufacturer any occurrence in which a medical device possibly caused or contributed to a patient death or serious illness or injury. A voluntary reporting mechanism also exists so that hospitals can report any actual or suspected medical device problems to the FDA.

As the initial recipients of medical devices, hospitals are ultimately responsible for documenting the devices that are used in their facilities and the patients who receive them. In the event of an involuntary recall, hospitals must ensure that patients are properly notified with the potential risks and the available options to mitigate those risks.

Manufacturers, hospitals, physicians, and the FDA all share a duty to protect the public. The FDA cannot act upon defects that are not reported.

Patrick Maher, MD, is a resident in the department of orthopaedic surgery at University of Pittsburgh. Kenneth L. Urish, MD, PhD, is associate director at the Magee Bone and Joint Center and assistant professor in the department of orthopaedic surgery at University of Pittsburgh. Chatón T. Turner, Esq., is associate counsel at University of Pittsburgh Medical Center.

References:

1. Day CS, Park DJ, Rozenshteyn, FS, Owusu-Sarpong N, Gonzalez A. Analysis of FDA-Approved Orthopaedic Devices and Their Recalls. J Bone Joint Surg 98(6), 517–24. http://doi.org/10.2106/JBJS.15.00286
2. Health Insurance Portability and Accountability Act (HIPAA) Privacy Rules §164.512
3. U.S. Food & Drug Administration. Recalls, Corrections and Removals http://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/recallscorrectionsandremovals/default.htm
4. Medical device recalls database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm