251 FDA 510 K medical clearance for vaginal lubricants: issues and answers

2018 ◽  
Vol 15 (7) ◽  
pp. S222-S223
Author(s):  
M. Krychman
2018 ◽  
Vol 36 (4) ◽  
pp. 265-271 ◽  
Author(s):  
Holly Hackman ◽  
Jonathan Howland ◽  
Alyssa Taylor ◽  
Linda Brown ◽  
Mary Ann Gapinski ◽  
...  

Appropriate management by schools of all students with a concussion, regardless of the cause, has not received the same attention as sports-related concussions. Focus groups conducted with Massachusetts School Nurses in 2015 found that some had applied protocols required in the state’s sports concussion regulations to all students with concussion, not just student athletes. We surveyed high school nurses in Massachusetts to examine (1) the extent of this practice and (2) the extent to which protocols for all students with concussion are included in school policies. Of 168 (74%) responding, 94% applied the return-to-learn and play, and medical clearance requirements to all students with concussion, regardless of how or where the concussion occurred and 77% reported their school’s policy required these protocols for all students with concussion. A significant association (odds ratio: 13.3, 95% confidence interval [2.4, 72.8], p <.01) existed between the two measures. These findings have important clinical and academic implications.


2017 ◽  
pp. 105-114
Author(s):  
Libet Lev ◽  
Balan Yener ◽  
Thomas Seth
Keyword(s):  

2021 ◽  
Vol 84 (1) ◽  
pp. 51-57
Author(s):  
Jamie Rodríguez-León ◽  
Lorena Lucía Ortiz-Pinillos ◽  
Lizardo Cruzado
Keyword(s):  

Los trastornos de ansiedad tienen gran importancia en la psiquiatría de urgencias, tanto por la frecuencia con la que se presentan, como por la relevancia de las enfermedades somáticas que pueden subyacer a un cuadro ansioso. Resulta imperativo determinar desde el abordaje diagnóstico inicial si los signos y síntomas de la ansiedad constituyen una plena respuesta a situaciones de estrés, son manifestaciones de una patología somática subyacente, o se pueden explicar como síntomas de un trastorno psiquiátrico primario específico. En el momento actual, la pandemia de COVID-19 –en la que el Perú ha llegado a tener la mayor tasa de mortalidad mundial-- desborda los servicios de salud con abigarrados cuadros en los que se combinan tanto los síntomas de la infección viral por sí misma, como los de reacciones ansiosas y respuestas al estrés. A propósito de un caso ilustrativo, en el que el proceso de tamizaje médico fue deficitario y se etiquetó al paciente como un caso primario de “ansiedad”, con un desenlace lamentablemente ominoso, se revisa brevemente la literatura acerca del proceso de medical clearance  (o descarte de condiciones  médicas) y se reafirma concluyentemente la importancia de una consideración diagnóstica inicial abarcadora, no sesgada, y basada en criterios clínicos sólidamente elaborados y sustentados. Es evidente, por otro lado, que el psiquiatra requiere estar permanentemente actualizado sobre las formas de presentación psicopatológica asociadas a la sintomatología de COVID-19.


Author(s):  
Walid Alam

Background: Despite the evidence and guidelines recommending otherwise, routine testing remains pervasive in the management of patients presenting to the Emergency Department (ED) for behavioral complaints, under the guise of medical clearance (MC). The aim of this review is to highlight the evidence available concerning routine laboratory testing in psychiatry patients presenting to the ED, underline available guidelines, list possible reasons for over-testing, and propose a possible approach based on all the evidence and recommendations. Methods: Electronic database searches were carried out in Medline/PubMed and Google Scholar with the period set from January 1, 1990 to March 1, 2021. The search process was focused on studies where MC was evaluated in the management of patients presenting for psychiatric complaints to the ED. The references listed in each identified article were also screened and manually searched. Results: 14 relevant studies were found with the majority evaluating the impact of routine laboratory testing on the management and disposition of adults in the ED presenting for an acute psychiatric condition. Two studies investigated the use of a screening tool to rule out the presence of acute medical illness. Conclusion: While ED physicians are faced with many challenges such as litigation and fear of diagnostic uncertainty, few solutions have been proposed. A suggested approach relies on history taking, physical examination, and assessment of mentation to evaluate for the presence of an organic etiology requiring further testing. Adequate communication between the ED physician and psychiatrist, along with shared decision-making are also key to optimizing care.


2012 ◽  
Vol 10 (6) ◽  
pp. 26-30
Author(s):  
Morris Gordon
Keyword(s):  

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