Dental device–associated problems
An analysis of FDA postmarket surveillance data
JANIE FULLER, D.D.S., M.P.H. and
CHRISTINE PARMENTIER, B.S.N., M.P.H.
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ABSTRACT
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Background. The authors provide an analysis of dental device adverse event reports collected through the U.S. Food and Drug Administration’s, or FDA’s, mandatory and voluntary reporting programs between Aug. 1, 1996, and June 30, 1999.
Methods. This study includes an analysis of the total number of dental device adverse events reported during the study period and uses descriptive statistics to depict reporters’ occupations, types of adverse events (deaths, injuries, malfunctions), device categories, device problems and patient problems.
Results. A total of 272,241 device reports were received during the 35-month study period, 28,555 (10.5 percent) of which involved dental devices. Within these reports, two deaths (0.007 percent), 18,406 injuries (64.4 percent) and 9,942 device malfunctions (34.8 percent) were reported. The most commonly reported dental devices were endosseous implants, which represented more than 90 percent of all dental device reports. Most reports (84.1 percent) provided the reporter’s occupation, and the most frequently cited occupation was dentist (76.3 percent), followed by dental assistant (4.2 percent).
Conclusions. Dentists and dental staff members are a vital link in the FDA’s adverse event reporting system and are encouraged to report device problems to the FDA MedWatch program.
Devices are found in every dental office. This study reveals that dental device problems (for example, defects, malfunctions, inadequate use instructions, misuse) result in thousands of injuries each year. Devices1 include most products used in clinical patient diagnosis and treatment that do not fit the definition of a drug. Devices differ from drugs in that their intended purpose is not achieved by chemical action on or in the body, and do not depend on being metabolized. Dental devices include a wide range of products, from implants to floss. For purposes of this article, dental devices are those intended for use specifically in dentistry or otherwise in oral health care. General-use devices, such as surgeons’ gloves and scalpels, are not considered dental devices even though they are used in dentistry.
Dentists are a vital link in the U.S. Food and Drug Administration’s adverse event reporting system.
The U.S. Food and Drug Administration, or FDA (an agency of the U.S. Public Health Service within the Department of Health and Human Services), routinely performs surveillance to monitor for device problems, as well as for problems associated with other FDA-regulated products. Each year, the FDA receives hundreds of thousands of adverse event reports on all regulated products, submitted on a mandatory or voluntary basis. Device reports represent a small proportion of product reports submitted to the FDA. Approximately 15 percent of voluntary reports about FDA-regulated products submitted to the FDA involve devices, and dental device reports make up approximately 10 percent of all device reports (both mandatory and voluntary).
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BACKGROUND
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Public health surveillance.
Public health surveillance is an ongoing process of systematic collection, analysis and interpretation of data.2 Public health surveillance can detect sudden and long-term changes in disease occurrence, trends and patterns. Public health surveillance is used in many settings. For example, health care professionals report new cases of specified communicable diseases to state health departments, which in turn report cases to the Centers for Disease Control and Prevention, or CDC. The National Health and Nutrition Examination Survey, or NHANES, provides data for monitoring nutrition status, physical fitness, immunizations, disease, disability and other health-related topics. Environmental scientists monitor levels of toxic substances in the air, water and soil.
FDA postmarket surveillance.
The FDA enforces the Federal Food, Drug, and Cosmetic Act and other related public health laws. The FDA regulates the manufacture, import, transport, storage and marketing of approximately $1 trillion worth of products annually, which account for 25 cents of every consumer dollar.3 The FDA regulates a variety of products, including some foods, drugs and devices.
Premarket clearance or approval is required for some products, including some devices. But the FDA’s scrutiny of products continues after products go to market. The FDA gathers postmarket surveillance data through reports of adverse events submitted by device manufacturers, health care professionals, consumers and others. The FDA uses postmarket surveillance data to support actions that lead to device improvements and to remove unsafe or ineffective products from the market.
The U.S. Food and Drug Administration gathers postmarket surveillance data through reports of adverse events.
The 1976 Medical Device Amendments4 included a requirement, which became effective in 1984, for device manufacturers to report deaths, serious injuries and malfunctions. The FDA requires manufacturers to submit reports when they receive information that suggests that their device malfunctioned or caused or contributed to a death or serious injury. A device malfunction is failure to perform as intended, or failure to meet design specifications when the failure is likely to cause or contribute to serious injury or death. In 1990, the Safe Medical Devices Act5 extended reporting requirements to user facilities. (User facilities include hospitals, ambulatory surgical facilities, nursing homes, and outpatient treatment and diagnostic facilities that are not an employee health or school-based clinic, or the office of a physician, dentist, nurse practitioner, chiropractor or optometrist.)
The FDA receives device reports in two forms: individual and summary reports. Individual reports include voluntary reports submitted by health care providers and consumers through MedWatch, the FDA safety information and adverse event reporting program. Mandatory reports are submitted by manufacturers and user facilities.
Summary reports are abbreviated reports that the FDA allows as an alternative for some selected devices through its Alternative Summary Reporting, or ASR, program. The FDA enters data from all individually submitted reports (voluntary and mandatory) into the Manufacturer and User Facility Device Experience, or MAUDE, database and enters summary data into a separate ASR database.
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METHODS
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To study dental device–associated problems, we analyzed data from both the MAUDE and the ASR databases. The ASR database contains coded information about patient problems and device problems, as well as the results of manufacturers’ evaluations and conclusions about reported events. The MAUDE database contains the same type of information contained in the ASR database, as well as more detailed information, such as a narrative description of the reported event and data regarding the occupations of the reporters. Reports of device-associated deaths must be submitted individually for most devices, with the exception of a few cardiac devices. No dental device–related deaths may be submitted in ASR format.
Our analysis included calculating the total number of dental device reports received during the period evaluated. We used descriptive statistics to depict the occupations that reported, types of events reported (deaths, injuries, malfunctions), patient problems and device problems reported, and devices associated with the reports.
Study period.
The analysis included all reports in the MAUDE database from Aug. 1, 1996, through June 30, 1999 (the most recently available data), and all reports in the ASR database from Jan. 1, 1997 (when relevant ASR reports were first submitted to the FDA) through June 30, 1999. We chose Aug. 1, 1996, because reports received before that date were entered into a different database. Analysis of data from multiple databases can be difficult and cumbersome; therefore, we decided to include only the more recent data rather than expand our analysis to include the older database. We believe a 35-month period—during which more than 28,000 dental device reports were received—is sufficient for analysis.
MedWatch forms.
MedWatch forms 3500 and 3500A ask reporters to enter problem codes from a list provided by the FDA, and to describe the event in narrative format. The figure
illustrates the voluntary reporting form. Reporters sometimes enter codes other than those on the list, write illegibly or provide information that the FDA’s data entry staff cannot interpret. The databases indicate these entries under several categories depending on the item involved. For purposes of this article, missing, illegible, unknown and invalid entries were combined and referred to collectively. Except for the death reports, the analysis excluded the narrative information contained in the reports.
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RESULTS
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Between Aug. 1, 1996, and June 30, 1999, the FDA received 272,241 device reports, 28,555 (10.5 percent) of which involved dental devices. The dental device–associated events included two deaths (0.007 percent), 18,406 injuries (64.4 percent) and 9,942 device malfunctions (34.8 percent). In 130 events (0.46 percent), the reporter described an "other" event in narrative form. Seventy-five reports (0.26 percent) contained invalid data about the event type. The "other" and "invalid data" reports were excluded from further analysis.
The dental device–associated events included two deaths, 18,406 injuries and 9,942 device malfunctions.
Reporter occupations.
Because the ASR database does not include information about the reporter’s occupation, we included only MAUDE data in our analysis of reporter occupations. Of the 13,804 individually submitted dental device reports, 11,606 (84.1 percent) included the reporter’s occupation (Table 1). Nearly all of the reporters were health care providers or attorneys.
The vast majority of injuries were associated with surgical devices.
Adverse events reported.
We combined all reported dental device adverse events (deaths, injuries, malfunctions) from both MAUDE and ASR databases, and rank-ordered the types of devices according to the total number of reports received (Table 2).
Death reports.
The MAUDE database includes 11 death report entries for the period studied; however, we validated that only two of the 11 deaths were associated with dental devices during our study period. Our validation included a review of all sections of the MAUDE reports, including the narrative event descriptions. In nine of the 11 entries, the reporter indicated "death" on the form; however, the narrative description stated that the patient recovered from the injury. The FDA corrects reporter errors in the database only after the reporter submits a correction to the FDA in writing, and at the time of our analysis, none of these errors had been corrected. Of the two validated deaths, one involved a nursing home resident with a history of dementia and Alzheimer’s disease who aspirated denture adhesive. The other death involved a cerebral edema that developed after a Le Fort III osteotomy procedure in which a bone plate was used.
Injury reports.
The vast majority of injuries (98.97 percent) were associated with surgical devices. The surgical devices included endosseous implants, temporomandibular joint implants, bone plates and bone augmentation materials. Powered devices, primarily hand-pieces and bone saws and drills, were associated with 60 (0.33 percent) of the reported injuries. We associated four other device categories with at least 10 injury reports each: cements, sealants and filling materials (28 reports); dental needles (26 reports); orthodontic devices (includes data for several devices, including brackets, elastics, wires, headgear and orthodontic appliances) (20 reports); dental burs and dental cutting instruments (10 reports); and endodontic files and filling materials (10 reports). The 33 remaining injury-associated devices represented 14 device categories.
Malfunction reports.
Of the 9,942 reports of dental device malfunctions, 9,940 (99.98 percent) referenced a specific device. Most devices (95.86 percent) identified in the malfunction reports were surgical devices, primarily endosseous implants (95.50 percent), with a small number of fixation devices (0.13 percent), bone plates (0.12 percent) and temporomandibular joint implants (0.10 percent). Rubber dam clamps were associated with 173 malfunction reports (1.74 percent). Ninety-one (0.92 percent) of the malfunctions involved a wide range of powered devices, including radiographic units (24 reports), dental units (22 reports), dental handpieces and drills (18 reports), bone saws and drills (12 reports) and ultrasonic scalers (six reports).
Patient problems.
We analyzed data in regard to patient problems from all reported events (deaths, injuries and malfunctions) involving dental devices in both the MAUDE and ASR databases. Among the 28,555 reports analyzed, we found 17,327 patient problem entries (Table 3). Only 8,804 entries (50.81 percent) identified a device-related patient problem. The majority (76.71 percent) of the device-related patient problems identified involved three categories: implant failure (4,565 entries [51.85 percent]), surgical procedures (1,170 entries [13.29 percent]) and infections (1,019 entries [11.57 percent]). Pain or discomfort accounted for 609 (6.92 percent) of the patient problems; trauma or tissue damage, 328 problems (3.73 percent); swelling, 218 problems (2.48 percent); bleeding, 112 problems (1.27 percent); inflammatory conditions, 103 problems (1.17 percent); and neurological problems, 94 (1.07 percent). The remaining 586 entries (6.66 percent) represented a wide range of problems for all major body systems.
The majority of the device-related patient problems identified involved implant failure, surgical procedures and infections.
Device problems.
Our analysis included data about 17,713 device problems from all reported events (deaths, injuries and malfunctions) in both the MAUDE and ASR databases (Table 4). Most entries (78.38 percent) identified relevant device problems. Of the 13,884 problems identified, 12,110 (87.22 percent) were obviously dental implant problems relating to osseointegration. Device integrity problems were identified in 1,297 reports (9.34 percent), with the majority (1,019) being fracture or breakage of a device, device material or component. One hundred eighty-five problems (1.33 percent) involved device malfunction or poor quality, and 122 problems (0.88 percent) involved labeling including instructions for use.
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DISCUSSION
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The majority of dental device event reports received by the FDA between Aug. 1, 1996, and June 30, 1999, were associated with patient injuries and device malfunctions; death rarely was associated with dental devices. Within the reports that identified the reporter’s occupation, dentists represented the majority. A patient problem was identified in most reports, with only about one-fifth reporting no associated patient impact. As might be expected, surgical devices and powered devices were frequently associated with injuries and other patient problems. However, injuries also were associated with devices typically considered to be innocuous (such as cements, saliva ejectors and denture adhesives), pointing out the need to use care when handling all dental devices.
High-risk devices must be shown to be safe and effective in premarket clinical trials
The vast majority of all dental device reports involved endosseous implants; however, we do not conclude that adverse events are more commonly associated with endosseous implants than with other dental devices. The FDA does not have data regarding numbers of the various dental devices used, the overall incidence of adverse events associated with dental devices, or the percentage of all dental device–associated adverse events that are reported to the FDA. However, there is reason to believe that adverse events associated with endosseous implants are better reported than are other dental device adverse events. Endosseous implants are relatively expensive, and dentists may be more likely to return failed implants to the manufacturer for replacement. Manufacturers often submit adverse event reports associated with failed (returned) devices. Endosseous implant problems may require extensive patient treatment to correct and, thus, may be more likely to motivate a dentist to submit a voluntary report.
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WHY THE FDA CONDUCTS POSTMARKET SURVEILLANCE
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The FDA does not routinely perform premarket device testing; instead, it makes decisions based on data submitted by the manufacturer. Health care professionals cannot assume that all devices have been proven to be safe and effective in all postmarket situations before they are marketed. The FDA’s premarket program uses the following risk-based system. Many low-risk devices go to market without FDA review. Of the FDA-reviewed devices, most (>90 percent) must demonstrate only that a device is similar to another legally marketed device. (Legally marketed devices are devices cleared or approved by the FDA, or devices marketed before the May 28, 1976, enactment of the Medical Device Amendments to the Food, Drug, and Cosmetic Act.)
High-risk devices must be shown to be safe and effective in premarket clinical trials. FDA reviews of pre-market studies may include only a relatively small number of cases tested under tightly controlled conditions. These premarket studies provide limited information about potential problems. Infrequently occurring problems may be detected only after clinical use under various conditions with large numbers of cases, such as those seen once a device is marketed.
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WHY SHOULD DENTISTS AND OTHER HEALTH PROVIDERS REPORT?
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Clinicians and other health care professionals are in a unique position to assist with the FDA’s surveillance. Because they are regular users of devices and have specialized training, clinicians and other health care professionals can recognize device problems when they occur. A 1986 Government Accounting Office, or GAO, hospital-based study6 reported that health care professionals detected 82 percent of all device-related events. The GAO study also evaluated how certain device problems were communicated outside the hospital. In that study, 599 (51 percent) of the 1,175 adverse events studied were reported outside the hospital, and less than one percent of the device problems studied were reported to the FDA.
A 1989 follow-up study7 concluded that serious reporting shortcomings still existed. We are unaware of any such studies involving dentistry. Anecdotal information suggests that dental staff members are no more likely to report device problems than are hospital staff members. In addition, anecdotal information suggests that many dentists believe they should not report adverse events to the FDA unless a patient is injured or dies. Our data, which show that more than two-thirds of all reports indicate an associated patient problem, support this anecdotal information.
Information from dentists helps the FDA identify device problems so that it can take regulatory actions to correct them. For example, the FDA received a report about an ultrasonic cleaning device used in a dental office that emitted electrical shocks and resulted in a fire that required fire department assistance. The FDA’s follow-up investigation revealed that the manufacturer was not registered with the FDA, as required by law. (Registration is the process used by device manufacturers to notify the FDA of the firm’s device activity.) The device in this incident was missing a ground wire and was not labeled by Underwriter’s Laboratory, or UL. The firm corrected the problem by redesigning the device to meet UL standards and replaced old-design units with the newly designed units.
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WHAT SHOULD DENTISTS AND OTHER HEALTH CARE PROVIDERS REPORT?
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The FDA encourages health care professionals to report all events that may be device-related. The cause of the adverse event need not be determined before filing a report. Reports of near misses are valuable because these reports allow early intervention to prevent injuries and deaths. Also, use errors may be reported even if they are unrelated to an injury. Repeated use error reports associated with a device may indicate a device design flaw or inadequate labeling or instructions for use. The FDA also is interested in receiving data on device quality issues, such as defective devices, inaccurate or illegible labeling, product contamination and stability problems.
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HOW TO REPORT TO THE FDA
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Reporting is quick and simple, and can be done by telephone, fax or mail or online (see sidebar). The system is designed to handle multiple reports regarding the same event; a health care professional need not worry if the device manufacturer reports the same event. Those who report device problems to the FDA can remain anonymous. However, the FDA encourages reporters to identify themselves so that it can contact them for additional information during its investigations.
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CONCLUSIONS
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Dentists and dental staff members are key players in detecting device problems before injuries occur, because they are in the best position to detect these problems. The FDA encourages dental staff members to take an active role in its device surveillance, and report to MedWatch all device-associated deaths, injuries, malfunctions, defects and near-misses (device malfunctions that may result in injury or death if they recur). Many people may be unaware that the FDA considers device defects to include inadequate and illegible labeling, product contamination, and product stability and packaging problems.
Conscientious reporting by device manufacturers and users provides the FDA with more complete postmarket surveillance data. With complete data, the FDA and manufacturers can better identify device problems, and the FDA can alert clinicians to hazards of device use through safety alerts, advisories and notifications, as well as take needed regulatory actions to require device manufacturers to correct problems.
We hope this article will help increase awareness and improve reporting rates among the dental community. Working together to conduct postmarket surveillance, dental staff members, the FDA and manufacturers can make devices safer and more effective.
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FOOTNOTES
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Dr. Fuller is director, regulatory review officer, Division of Post-market Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 1350 Piccard Drive, Room 300, HFZ-520, Rockville, Md. 20850, e-mail "jyf{at}cdrh.fda.gov". Address reprint requests to Dr. Fuller.
At the time this study was conducted, Ms. Parmentier was a senior regulatory review officer, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, Md. She now is in the San Francisco District, Office of Regulatory Affairs, U.S. Food and Drug Administration.
The opinions or assertions presented in this article are the private views of the authors and are not to be construed as conveying either official endorsement or criticism by the U.S. Department of Health and Human Services, the U.S. Public Health Service or the Food and Drug Administration.
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REFERENCES
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- Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
321(h).
- Guidelines for evaluating surveillance systems. MMWR Morb Mortal Wkly Rep 1988;37(S–5):1–18.
- U.S. Food and Drug Administration about the U.S. Food and Drug Administration. Available at: "www.fda.gov/opacom/hpview.html". Accessed June 11, 2001.
- Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360i.
- Safe Medical Devices Act of 1990, Pub L. No. 101–629, 104, Stat. 4511 (1990).
- Medical devices: Early warning of problems is hampered by severe underreporting. Washington: U.S. Government Printing Office; 1986. GAO publication PEMD-87-1:US.
- Chelinsky E. Medical devices: Underreporting of problems, backlogged systems, and weak statutory support. Washington: U.S. Government Printing Office; 1989. GAO publication T-PEMD-90-3:US.
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TOP
ABSTRACT
BACKGROUND
