The Dangers of Dental Devices As Reported in the Food and Drug Administration Manufacturer and User Facility Device Experience Database
Total Page：16
File Type：pdf, Size：1020Kb
ORIGINAL CONTRIBUTIONS The dangers of dental devices as reported in the Food and Drug Administration Manufacturer and User Facility Device Experience Database Nutan B. Hebballi, BDS, MPH; Rachel Ramoni, DMD, ScD; ABSTRACT Elsbeth Kalenderian, DDS, MPH, PhD; Veronique F. Delattre, DDS; Background. The authors conducted a study to deter- Denice C. L. Stewart, DDS, MHSA; Karla Kent, PhD; mine the frequency and type of adverse events (AEs) Joel M. White, DDS, MS; Ram Vaderhobli, DDS, MS; associated with dental devices reported to the Food and Muhammad F. Walji, PhD Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. Methods. The authors downloaded and reviewed the roviding dental care to patients demands the dental device–related AEs reported to MAUDE from use of a dizzying range of devices: endodontic January 1, 1996, through December 31, 2011. files, endosseous implants, orthodontic brackets, Results. MAUDE received a total of 1,978,056 reports P handpieces, and fluoride varnish, just to name a between January 1, 1996, and December 31, 2011. Among few. These items are essential to the practice of dentistry these reports, 28,046 (1.4%) AE reports were associated but are accompanied by the risk for adverse events (AEs), with dental devices. Within the dental AE reports that had which the Food and Drug Administration (FDA) defines event type information, 17,261 reported injuries, 7,777 as “any undesirable experience associated with the use of reported device malfunctions, and 66 reported deaths. a medical product in a patient.”1 To uphold our pro- Among the 66 entries classified as death reports, 52 re- fession’s responsibility to provide the safest possible care ported a death in the description; the remaining were either to our patients, we must be vigilant and continually misclassified or lacked sufficient information in the report monitor the safety of dental devices and products, which to determine whether a death had occurred. Of the dental by their very nature, expose our patients to risk. As we device–associated AEs, 53.5% pertained to endosseous described in our previous article,2 the Agency for implants. Healthcare Research and Quality (AHRQ) of the US Conclusions. A plethora of devices are used in dental Department of Health and Human Services has proposed care. To achieve Element 1 of Agency for Healthcare a 4-element patient safety initiative to minimize patient Research and Quality’s Patient Safety Initiative, clinicians safety hazards. This model provides a useful framework and researchers must be able to monitor the safety of dental for dentistry to “identify, understand, and reduce the risk devices. Although MAUDE was identified by the authors as of harm associated with medical errors and health care essentially the sole source of this valuable information on system–related problems.”3 By continually updating the adverse events, their investigations led them to conclude risks associated with dental devices, we as a profession that MAUDE had substantial limitations that prevent it reaffirm our commitment to Element 1 of the Patient from being the broad-based patient safety sentinel the Safety Initiative,3 Identifying Threats to Patient Safety. profession requires. The FDA, which regulates all medical devices and Practical Implications. As potential contributors to products in the United States, has a postmarket sur- MAUDE, dental care teams play a key role in improving the veillance system to keep track of device problems after it profession’s access to information about the safety of dental has been brought to market. Here, it is useful to un- devices. derstand the definition of a device as compared with a Key Words. Dental equipment; dental public health; drug: devices achieve their intended effect without a dental records; informatics; quality of care; safety chemical interaction with, or metabolism by, the body.4 management. JADA 2015:146(2):102-110 http://dx.doi.org/10.1016/j.adaj.2014.11.015 Copyright ª 2015 American Dental Association. All rights reserved. 102 JADA 146(2) http://jada.ada.org February 2015 ORIGINAL CONTRIBUTIONS Thus, dental floss is a device, whereas lidocaine is a MAUDE reports for identifying threats to dental patient drug. For some devices, such as fluoride varnish, the safety. distinction is subtler. Recalls of dental devices happen By quantifying the frequency and type of dental AEs frequently. The recalls that have occurred in 2013 reported into MAUDE since its inception, we aimed to include an absorbable collagen wound dressing, which update the dental profession’s understanding of device- may have been manufactured with excess pyrogens5; related threats to dental patient safety, thereby endodontic canal preparation instruments with incor- contributing to Element 1 of AHRQ’s Patient Safety rect length markings6; and orthodontic bracket buccal Initiative. In parallel, we evaluated the strengths and tubes with incorrect labeling that might lead to unin- weaknesses of MAUDE as a source of device-related tentional rotation of the molars.7 patient safety information. The importance of this un- The Journal of the American Dental Association dertaking is best understood in context: dentistry does (JADA) articles from 20018 and 20139 reviewed the back- not have the extensive patient safety literature that ground of FDA postmarket device surveillance. What is medicine has accumulated. In fact, it has been noted salient for the work we present here is that the Manu- that there are few studies or reports related to errors or facturer and User Facility Device Experience (MAUDE) AEs that take place in dental practices.2,11 This may be database contains both individual voluntary reports from attributed to a number of causes: harm produced by health care providers and consumers, and individual dental devices may be less severe, follow-up is more mandatory reports from manufacturers and user facilities, difficult in a dispersed ambulatory setting, dentists may dating back to August 1, 1996. Once manufacturers or fear impact on remunerations, and there may be gaps in distributors become aware of device-related AEs like dentistry’s patient safety culture.2,11 deaths, serious injury, or malfunctions, they are obligated to report the AE to the FDA within 30 days. Similarly, METHODS “ user facilities, described as a hospital, an ambulatory One can access the MAUDE data in two ways: through surgical facility, a nursing home, an outpatient treatment an online search available at http://www.accessdata.fda. facility, or an outpatient diagnostic facility which is not a gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM or physician’soffice,” have 10 days to report the AE to the 10 through downloading the data files from the FDA Web FDA. MAUDE contains a narrative description of the site.12 For our study, we included all the reports from reported event, information about the occupations of January 1, 1996, through December 31, 2011. We used the reporters, information about patient problems and ’ MySQL database version 5.0.77 and MySQL Workbench device problems, and the results of manufacturers version 5.2 to analyze the data. The MAUDE data can be evaluations and conclusions about reported events. broadly classified as master event data, patient data, Since its inception, MAUDE has received millions of device data, and free-text data, all collected via the reports, a number of which involve dental devices. The MedWatch forms described previously. Master event 2001 JADA article on the FDA’s postmarket device 8 data includes reporting source and event type details, surveillance presented an analysis of the data collected and text data contains textual information from 1996 1999 from August through June , which included MedWatch. At the time of our search, there were 296 18 406 9 942 13 reports of two deaths, , injuries, and , device distinct dental product codes cataloged by MAUDE, malfunctions. These dental device reports represented which we used to create a dental products lookup table 10 5 . % of all of the device reports during that time frame. to identify the dental products contained within the Endosseous implants represented the most dental device database. 2013 reports at that time. The more recent JADA article To better understand MAUDE reporting trends, we on FDA postmarket surveillance focused primarily on first identified and plotted the medical and dental drug-related reports and did not quantify the device device–associated reports from January 1, 1996, through reports, but at the same time, it reinforced the value of 9 December 31, 2011. We identified the number of continual mining of the device-related AE reports. The mandatory and voluntary reports, as well as the reports device-related AEs uncovered through that work related to death, injuries, and malfunctions, respectively. included detachment or fracture of dental needle com- We also analyzed event locations and the reporters’ ponents; osseointegration failure or loss of endosseous occupations. To determine dental devices that dental implants; and fracture, overheating, or mal- function of dental instruments, for example, high-speed handpieces. ABBREVIATION KEY. AEs: Adverse events. AHRQ: Building upon these previous articles, we determined Agency for Healthcare Research and Quality. DC: District of the frequency and type of dental AEs reported to FDA Columbia. FAERS: FDA Adverse Event Reporting System. by reviewing reports submitted to MAUDE from FDA: Food and Drug Admininstration. JADA: The Journal of January 1, 1996, through