La greffe de cornée est-elle une option de traitement ?
Oui, la greffe de cornée peut être nécessaire en cas de défaillance sévère.
Greffe de cornéeDéfaillance cornéenne
#3
Les gouttes oculaires peuvent-elles aider ?
Oui, des gouttes oculaires peuvent réduire l'inflammation et améliorer le confort.
Gouttes oculairesInflammation
#4
Y a-t-il des traitements non chirurgicaux disponibles ?
Oui, des traitements médicaux et des thérapies de soutien sont disponibles.
Thérapies médicalesSoutien thérapeutique
#5
Les traitements varient-ils selon la gravité de la condition ?
Oui, les traitements sont adaptés en fonction de la gravité et des symptômes.
Gravité de la conditionAdaptation des traitements
Complications
5
#1
Quelles complications peuvent survenir avec des problèmes de Descemet ?
Les complications incluent l'œdème cornéen, la perte de vision et l'infection.
Œdème cornéenPerte de vision
#2
L'infection est-elle une complication possible ?
Oui, une infection peut survenir, surtout après une chirurgie ou un traumatisme.
Infection oculaireChirurgie cornéenne
#3
Les cicatrices cornéennes peuvent-elles résulter de problèmes de Descemet ?
Oui, des cicatrices peuvent se former, affectant la clarté de la vision.
Cicatrices cornéennesClarté de la vision
#4
Peut-on développer un glaucome à cause de problèmes de Descemet ?
Oui, des problèmes de Descemet peuvent augmenter le risque de glaucome.
GlaucomeRisque accru
#5
Les complications peuvent-elles nécessiter une intervention chirurgicale ?
Oui, certaines complications graves peuvent nécessiter une intervention chirurgicale.
Intervention chirurgicaleComplications graves
Facteurs de risque
5
#1
Quels sont les facteurs de risque pour les problèmes de Descemet ?
Les antécédents familiaux, les traumatismes oculaires et certaines maladies augmentent le risque.
Antécédents familiauxTraumatismes oculaires
#2
L'âge est-il un facteur de risque ?
Oui, le vieillissement peut augmenter le risque de défaillance de la membrane de Descemet.
VieillissementRisque accru
#3
Les maladies systémiques influencent-elles la santé de Descemet ?
Oui, des maladies comme le diabète peuvent affecter la santé cornéenne.
DiabèteSanté cornéenne
#4
Le port de lentilles de contact est-il un facteur de risque ?
Oui, un usage inapproprié des lentilles peut augmenter le risque d'infections.
Lentilles de contactInfections oculaires
#5
Les allergies peuvent-elles être un facteur de risque ?
Oui, les allergies oculaires peuvent contribuer à l'inflammation et aux problèmes de Descemet.
Allergies oculairesInflammation
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"position": 11,
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"@type": "Question",
"name": "Les examens réguliers des yeux sont-ils importants ?",
"position": 12,
"acceptedAnswer": {
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}
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"name": "Les maladies systémiques influencent-elles la santé de Descemet ?",
"position": 28,
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"@type": "Answer",
"text": "Oui, des maladies comme le diabète peuvent affecter la santé cornéenne."
}
},
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"position": 29,
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"@type": "Answer",
"text": "Oui, un usage inapproprié des lentilles peut augmenter le risque d'infections."
}
},
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"name": "Les allergies peuvent-elles être un facteur de risque ?",
"position": 30,
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Department of Ophthalmology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. Electronic address: namrata.sharma@gmail.com.
Orthopaedic devices comprise nearly 20% of devices on the market and 12% to 20% of these devices undergo a recall within 10 years. More than 95% of these devices are approved without supporting clinic...
The FDA 510(k) database was queried for orthopaedic devices approved between January 01, 2008 and December 31, 2018 and subsequently codified to hip and knee arthroplasty devices using product codes. ...
In total, 94 (19.4%) hip and 85 (20.3%) knee devices were recalled. The hazard of recall by 10 years for hip and knee arthroplasty devices was approximately 24%, with no statistical differences betwee...
The risk of recall for arthroplasty devices is more than that previously understood. Improved postmarket surveillance strategies along with increased physician participation in detecting and reporting...
Computer-assisted arthroplasty supports the surgeons in planning, simulating, and performing the replacement procedure, using robotic or navigation technologies. However, the safety of the technology ...
The Medical Device Recalls database was investigated about software-related recalls in computer-assisted hip and knee arthroplasty surgery, between 2017 and 2022. The incidence of the software-related...
Eighteen recall numbers could be identified (1.6%), corresponding to 11 recall events. A total of 4634 units were involved. The FDA determined root causes were: software design (66.6%), design change ...
Software-related recalls in computer-assisted hip and knee arthroplasty were quite uncommon among all the recalls, deemed non-life threatening and usually due to software design errors. The main actio...
Medical devices are used in almost all orthopedic surgical subspecialties, and the frequency of adverse events is increasing, which should not be ignored. To provide suggestions on how to avoid implan...
The research extracted recalls of osteosynthesis implants and joint replacement implants from January 1, 2011, to June 30, 2021, in the CNMPA, FDA, HC and ATGA websites and collected the information o...
A total of 315 cases of osteosynthesis implants and 286 cases of joint replacement implants were reported in China, the USA, Canada and Australia. The recalls number from 2016 to 2021 was more than th...
To avoid the recalls of such implants, manufacturers should strictly select implant materials and components, develop detailed labels and instructions, severely control the packaging process and estab...
The U.S. Food and Drug Administration (FDA) currently regulates more than 190,000 different medical devices. Like all products, these devices may be subject to manufacturing problems, flawed designs, ...
To support this recommendation, we conducted a rapid review of literature published from 2008-2022 to capture and examine information on risk communication approaches, methods, and best practices for ...
We identified 23 articles to include in our review....
Our review found a lack of research-based studies as well as gaps in understanding about consumer perspectives, comprehension, and communication preferences related to recalls. Despite these limitatio...
Further research is needed to assess consumer attitudes, understanding, and preferences and to reach consensus on best practices for effectively communicating recall information to consumers of medica...
In the landscape of medical device regulation, Class I recalls serve as pivotal indicators of potential risks, necessitating comprehensive analysis to unveil underlying patterns and causal factors. Th...
Observational epidemiological study....
This study's primary objective was to examine the risk of recall for novel spine devices over time. Secondarily, we sought to analyze interbody fusion and vertebral body replacement (VBR) devices (cor...
The recall risk of a novel spine device over time has not been reported. Additionally, FDA regulations were lowered for interbody fusion devices to enter the market in 2007. As well, VBR implants were...
Spine devices cleared between January 1, 2008 and December 31, 2018 were identified from the FDA's 510(k) database. All recall data was collected from the database in January of 2021 to provide a 2-ye...
2,384 spine devices were cleared via 510(k) in the study period. The hazard of recall at 5 years was 5.3% (95% CI: 4.4%-6.2%) and 6.5% (95% CI: 5.4-7.7%) at 10 years. No significant difference in reca...
The risk of recall at 5 and 10 years of a novel spine device is about half the 12% rate reported for orthopedic devices in general. Despite lowered FDA regulations for interbody fusion devices and rec...
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High-risk medical devices approved by the US Food and Drug Administration (FDA) can undergo modifications to their original premarket approval (PMA) via 1 of 5 types of supplements. Only panel track s...
To determine the association between PMA supplements and the risk of any device recall and high-risk (class 1) recall....
In this cohort study, the FDA database was queried for original devices approved via PMA from January 1, 2008, through December 31, 2019. Supplement and recall data were obtained for these devices fro...
Supplements submitted by manufacturers for FDA approval to modify devices....
A mixed-effects Cox proportional hazards regression model with frailty terms was used, modeling device recall as an outcome variable during the observation period. A second model was performed for cla...
A total of 373 original PMA devices with 10 776 associated supplements were included in the analysis. A median 2.5 (IQR, 1.2-5.0) supplements per device were approved annually. Cardiovascular devices ...
The findings of this cohort study suggest that PMA supplements are associated with an approximately 30% increased risk of any recall and class 1 recall. The FDA processes for approving modifications t...
The first two Food and Drug Administration (FDA)-approved stents for treatment of iliofemoral vein obstruction, Boston Scientific's Vici and BD's Venovo venous stent systems, were both recalled in ear...
MAUDE was queried for all adverse event reports for brands "Vici" and "Venovo" from their respective US FDA market approval dates to August 19, 2021. Reported device issues, patient issues, and interv...
A total of 50 unique adverse event reports were compiled for the Vici system and 341 for the Venovo system. The most common device issue reported for the Vici system was migration (48% vs. 0%; P = 0.0...
While 2 venous stent systems were recalled simultaneously, significant differences exist between reported device issues in MAUDE and whether patient injury was involved and well described. Our data su...
Medical device recalls are initiated in response to safety concerns. Class I (highest severity) recalls imply a reasonable likelihood of serious adverse events or death associated with device use. Rec...
To characterize Class I medical device recalls and corresponding recalled devices....
This was a cross-sectional study of Class I recalls posted on the Food and Drug Administration's annual log from January 1, 2018 to June 30, 2022 for moderate-risk and high-risk medical devices. Devic...
There were 189 unique Class I medical device recalls, including 151 (79.9%) for moderate-risk and 34 (18.0%) for high-risk devices. Sixty-five (34.4%) recalls were for cardiovascular devices, 36 (19.0...
High-severity medical device recalls are common and affect millions of device units annually in the US. Recall termination takes a significant amount of time, putting patients at risk for serious safe...
Implementing affective engineering in real-life applications requires the ability to effectively recognize emotions using physiological measurements. Despite being a widely researched topic, there see...