From good to better

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Objectives To determine the frequency and type of adverse events (AEs) associated with dental devices reported to Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Methods We downloaded and thoroughly reviewed the dental device-related AEs reported to MAUDE from January 01, 1996 – December 31, 2011. Results MAUDE received a total of 1,978,056 reports between January 01, 1996 and December 31, 2011. Among these reports, 28,046 (1.4 percent) AEs reports were associated with dental devices. Within the dental AE reports that had event type information, 17,261 reported injuries, 7,777 reported device malfunctions, and 66 reported deaths. Among the 66 entries classified as death reports, 52 actually reported a death in the description; the remaining were either misclassified or lacked sufficient information in the report to determine whether a death had occurred. 53.5 percent of the dental device associated AEs pertained to endosseous implants. Conclusion There is a plethora of devices used in dental care, and to achieve Element 1 of AHRQ’s Patient Safety Initiative, we must be able to monitor the safety of dental devices. While MAUDE is essentially the single source of this valuable information, our investigations led us to conclude that it currently has major limitations that prevent it from being the broad-based patient safety sentinel the profession requires. Practical Implications As potential contributors to MAUDE, dental care teams play a key role in improving the profession’s access to information about the safety of dental devices.

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confidence: 99%

Section: Introductionmentioning

confidence: 99%

The dangers of dental devices as reported in the Food and Drug Administration Manufacturer and User Facility Device Experience Database

Hebballi

Ramoni

Kalenderian

et al. 2015

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“…18 While these safety systems are siloed, they are steps in the right direction and dentistry will benefit from adapting some of these systems 21,22 as the profession moves towards developing a comprehensive patient safety initiative. 23 …”

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confidence: 99%

“…With the exception of a few pioneer efforts, 12,21,23,24 the dental profession has essentially watched from the sidelines, as medicine moved towards developing patient safety initiatives. The time has now come for dentistry to commit to patient safety by systematically addressing adverse events and errors in dentistry.…”

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confidence: 99%

Lessons learned from dental patient safety case reports

Obadan

Ramoni²,

Kalenderian

2015

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Background Errors are commonplace in dentistry, it is therefore our imperative as dental professionals to intercept them before they lead to an adverse event, and/or mitigate their effects when an adverse event occurs. This requires a systematic approach at both the profession-level, encapsulated in the Agency for Healthcare Research and Quality’s Patient Safety Initiative structure, as well as at the practice-level, where Crew Resource Management is a tested paradigm. Supporting patient safety at both the dental practice and profession levels relies on understanding the types and causes of errors, an area in which little is known. Methods A retrospective review of dental adverse events reported in the literature was performed. Electronic bibliographic databases were searched and data were extracted on background characteristics, incident description, case characteristics, clinic setting where adverse event originated, phase of patient care that adverse event was detected, proximal cause, type of patient harm, degree of harm and recovery actions. Results 182 publications (containing 270 cases) were identified through our search. Delayed and unnecessary treatment/disease progression after misdiagnosis was the largest type of harm reported. 24.4% of reviewed cases were reported to have experienced permanent harm. One of every ten case reports reviewed (11.1%) reported that the adverse event resulted in the death of the affected patient. Conclusions Published case reports provide a window into understanding the nature and extent of dental adverse events, but for as much as the findings revealed about adverse events, they also identified the need for more broad-based contributions to our collective body of knowledge about adverse events in the dental office and their causes. Practical Implications Siloed and incomplete contributions to our understanding of adverse events in the dental office are threats to dental patients’ safety.

“…10 However, the dental patient safety literature has mainly focused on managing risk, 11 exploring different approaches to improving specific surgical procedures, 12 or selection of dental products/materials. 13 In our previous work 14–16 we have proposed the adoption of The Agency for Healthcare Research and Quality Patient Safety Initiative which incorporates four major elements to address patient safety: (1) Identifying threats to patient safety; (2) Identifying and evaluating effective patient safety practices; (3) Educate, disseminate, implement, and raise awareness; and (4) Monitor threats to patient safety to ensure that a positive safety culture is maintained and a safe environment continues. In order to benchmark the safety culture in dentistry, we previously adapted the extensively validated Medical Office Survey on Patient Safety Culture 17, 18 and surveyed providers at 3 academic dental institutions.…”

Section: Introductionmentioning

confidence: 94%

How dental team members describe adverse events

Maramaldi¹,

Walji²,

White³

et al. 2016

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Background There is increased recognition that patients suffer adverse events (AEs) or harm caused by treatments in dentistry, and little is known about how dental providers describe these events. Understanding how providers view AEs is essential to building a safer environment in dental practice. Methods Dental providers and domain experts were interviewed through focus groups and in-depth interviews and asked to identify the types of AEs that may occur in dental settings. Results The first order listing of the interview and focus group findings yielded 1,514 items that included both causes and AEs. 632 causes were coded into one of the eight categories of the Eindhoven classification. 882 AEs were coded into 12 categories of a newly developed dental AE classification. Inter-rater reliability was moderate among coders. The list was reanalyzed and duplicate items were removed leaving a total of 747 unique AEs and 540 causes. The most frequently identified AE types were “Aspiration/ingestion” at 14% (n=142), “Wrong-site, wrong-procedure, wrong-patient errors” at 13%, “Hard tissue damage” at 13%, and “Soft tissue damage” at 12%. Conclusions Dental providers identified a large and diverse list of AEs. These events ranged from “death due to cardiac arrest” to “jaw fatigue from lengthy procedures”. Practical Implications Identifying threats to patient safety is a key element of improving dental patient safety. An inventory of dental AEs underpins efforts to track, prevent, and mitigate these events.