Update regarding opportunities for orthopaedic surgeons to contribute to postmarket surveillance of potential safety issues for orthopaedic medical devices marketed in the United States.

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health [1]. Through consideration of benefit-risk principles for the evaluation of medical devices, CDRH decisions seek an appropriate balance between protection of the US public and encouragement of innovation directed toward improvement in health outcomes [2], [3]. Within the regulatory framework established for medical devices by the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act, CDRH evaluates the safety and effectiveness of medical devices according to a risk-based paradigm. Risk is assessed as the potential for a device to present harm to the patient, including circumstances in which the device could malfunction or be used improperly under anticipated conditions of use.

Medical device product evaluation presents unique challenges compared to drugs and biologics. These challenges relate to the great diversity and complexity of medical devices, the rapid pace of technological innovation, and iterative nature of medical product device development [4]. Following approval or clearance of a medical device for the US market, residual uncertainty regarding the benefits and risks of a specific medical device often exists. Although nonclinical and clinical testing is used to help evaluate the safety of devices, premarket clinical studies are typically performed in small samples of the target population, and device-related problems may only be recognized after a device is used by a larger number of physicians across the spectrum of patients likely to receive the device in clinical practice [5]. Due to their role as primary users of orthopaedic medical devices in the course of providing care to patients, orthopaedic surgeons are uniquely positioned to play an important public health role in the identification and reporting of adverse events that result from the use of medical devices [6], [7].

Orthopaedic surgeons can identify adverse events associated with medical devices in the course of clinical care, and they are able to make an important contribution to the public health by working with healthcare facilities and manufacturers to help ensure healthcare facilities and manufacturers obtain the necessary information to meet their mandatory reporting requirements. The medical device reporting (MDR) regulations (21 CFR Part 803) contain specific mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to Food and Drug Administration (FDA), such as deaths, serious injuries or illnesses, and device malfunctions or failures [8].

Orthopaedic surgeons are encouraged to submit voluntary reports of suspected device-related adverse events to MedWatch, the FDA's Safety Information and Adverse Reporting Program. The FDA defines an adverse event as any undesirable experience associated with the use of a medical product in a patient. An adverse event is deemed serious and reportable if it results in any of the following problems: death, life-threatening circumstances, hospitalization (initial or prolonged), disability or permanent damage, necessity for additional medical or surgical intervention (to preclude permanent impairment or damage to the patient), or exposure to the product prior to conception or during pregnancy may have led to a congenital anomaly or birth defect [9]. The FDA encourages physicians to report product quality problems such as defective devices; inaccurate or unreadable product labeling; packaging or product mix-up; any adverse reaction or side effect not addressed in the product labeling; failure to meet specifications in product labeling; or any important chemical, physical, or other deterioration or change in the device. Physicians are encouraged to report when there is suspicion that the device may be related to a serious adverse effect, and are not expected to establish a causal connection or to wait until evidence seems compelling [10]. In addition to notifying FDA, physicians may notify the device manufacturer regarding suspected device-related adverse events and inquire whether similar adverse events related to the specific device have been reported.

There are several ways an orthopaedic surgeon may report to MedWatch [11]. Voluntary reports to FDA by orthopaedic surgeons may be submitted through an online form, fax, or pre-paid mailer using the MedWatch FDA Form 3500 (ie, voluntary adverse event form for health professional; www.fda.gov/medwatch/report.htm); through use of the MedWatcher mobile app; or by telephone (Table 1). Completion of information in Section B (Part 5: Describe Event, Problem or Product Use Error) and Section E (Suspect Medical Device) is especially important. When completing Section E, it is important to provide all available device-specific information such as brand name, manufacturer, model number, serial number, lot number, unique device identifier number, and date of implantation/explantation. If the adverse event report involves more than one suspect medical device, the reporter is requested to prepare a complete copy of FDA Form 3500 that identifies one device and attaches an additional copy of FDA Form 3500, with only Section E filled in, for each additional device. Other actions for orthopaedic surgeons to consider when device-related adverse events are suspected include notification of the physician's healthcare facility and any relevant committees, and conducting a search of the FDA Manufacturer and User Device Experience (MAUDE) database. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters such as healthcare professionals, patients, and consumers [12]. The results of MAUDE searches may provide orthopaedic surgeons with a larger scope of potential adverse events related to real-world use.

Table 1

Summary: to submit voluntary report to MedWatch—how, where, and who to contact.

Online Voluntary Reporting Form (FDA Form 3500) www.fda.gov/medwatch/report.htm

Instructions for Completing FDA Form 3500 https://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ucm149236.htm

FDA Form 3500 with pre-paid mailer https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf

MedWatcher Mobile App https://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ucm385880.htm

Voluntary report by phone1-800-FDA-1088; 1-800-332-1088

Voluntary report by faxFax Form FDA 3500 to 1-800-FDA-0178; 1-800-332-0178

Questions about reporting for Medical DevicesCenter for Devices and Radiological Health (CDRH),Division of Industry and Consumer Education (DICE)E-mail: DICE@fda.hhs.gov800-638-2041

Voluntary reporting of adverse events by orthopaedic surgeons provides valuable information regarding potential safety issues for medical devices marketed in the United States. These reports are evaluated by FDA to formulate a qualitative profile of adverse events for a specific device or device type. Adverse event data are analyzed to detect safety signals including unexpected adverse events associated with a specific device or device type. These reports may also assist in defining the most appropriate populations for use of specific medical devices. Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential for submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. FDA recognizes the limitations inherent in the use of MDR data, and considers additional postmarket surveillance data sources including an enhanced surveillance network of approximately 300 hospitals (Medical Product Safety Network; MedSun), studies ordered by the FDA for selected devices (Post-Approval Studies and Postmarket Surveillance Studies), FDA research using other data sources (FDA Discretionary Studies), and additional tools such as Device Tracking. Orthopaedic surgeons who work at hospitals that participate in FDA's MedSun program can help their hospital submit both mandatory and voluntary reports through MedSun by sharing information about device-related adverse events, product problems, and usability issues with their hospital's risk management department, either directly or through the hospital's internal incident reporting system.

In 2012, the FDA initiated plans for the development of a National Evaluation System for Health Technology to more efficiently generate better evidence for medical device evaluation and regulatory decision making [13]. A national evaluation system would enable the generation of evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence, and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices. This system is designed to create strategic alliances among data sources including registries, electronic health records, and payer claims, and will incorporate unique device identifiers over time. Orthopaedic surgeons are encouraged to remain informed regarding these developments and participate in related projects so we can collectively build a future medical device postmarket surveillance system that will achieve all our goals.