Literature_Review

Literature Review of infrared thermometers ABC DeviceByXXXXXXXXXXX ManagerIssued Date: Oct. 10, 2006Table of ContentSECTION I. LITERATURE REVIEW PLAN ------------------------------------------------4 Introduction ------------------------------------------------------------------------------------------ 4 Purpose of Literature Review -------------------------------------------------------------------- 4 Selection criteria for documents ----------------------------------------------------------------- 4 Assessment of documents -------------------------------------------------------------------------- 4 Critical evaluation of the literature-------------------------------------------------------------- 5 SECTION II. LITERATURE REVIEW ---------------------------------------------------------6 Abstract of Literature Review -------------------------------------------------------------------- 6 Basic Temperature Measurement Knowledge ------------------------------------------------ 6 Basic design theory of noncontact forehead temperature ---------------------------------- 7 Infrared thermometer technology --------------------------------------------------------------- 7 ABC device design files ----------------------------------------------------------------------------- 7 Literature introduction ---------------------------------------------------------------------------- 7 Clinic review result ---------------------------------------------------------------------------------- 9 Conclusions ------------------------------------------------------------------------------------------- 9 Reference -------------------------------------------------------------------------------------------- 10ForewordThis literature review is prepared according to ISO 14155-1, Clinical investigation of medical devices for human subjects, Part 1: General requirements.Author QualificationThis literature review is written by ABC, who is************************************Device descriptionPlease refer to the Use Manual.Risk ManagementPlease refer to the risk management report.This confidential document is the property of ABC Company. No published and unpublished information contained here in may be disclosed without prior written approval from ABC Company.SECTION I. Literature Review PlanIntroductionPrior to performing the literature review, a plan has been established for the identification, selection, collation and review of all available studies/data.Purpose of Literature ReviewTo review the validity and precision of infrared thermometer use in human body and forehead temperature measurement.Selection criteria for documentsThe criteria for selecting or excluding data are defined as following:1.Clinic data should be taken from recognized scientific publications or2.scientific official website.The literature review should state the sources of literature and data, and the extent of the searches of databases or other compilations of information.Assessment of documentsThis literature review should clearly assess the quality of the documents and the extent to which the literature relates to the specific characteristics and features of the device under consideration, taking into account the intended use of the device.The following shall be considered:a)similarity of the device in the selected documents to the device underconsideration based on technology, critical performance, design and principles ofoperation, so that the applicability of the literature can be assessed;b)the patient or study populations in the documents and the medical purpose,indications for use and severity and type of disease or condition compared tothose intended for the device under assessment;c)conditions of use of the device in the documents and the intended use of thedevice in question.The literature review should make an assessment of the significance and weight of studies of different designs and between published and unpublished data. If unpublished data are being included in the assessment, the literature review will need to distinguish between the significance that is attached to these.Factors include1)whether the author’s conclusions are substantiated by the available data,2)whether the literature reflects the current medical practice and state of the arttechnologies,3)whether references are taken from recognized scientific publications and whether ornot they have been reported in peer reviewed journals,4)the extent to which the published literature is the outcome of a study/studies thathave followed scientific principles.Ideally, evidence should be generated from a controlled clinical investigation, properly designed cohort- or case-controlled investigation, well-documented case histories conducted by appropriate experts, or reports of significant experience with the marketed device.Critical evaluation of the literatureThe literature review should contain a critical evaluation of the literature.After documents are obtained and assessed, the selection criteria that are applied and the exclusion of any documents from this critical evaluation must be justified. A review is then completed as it relates to the device in question and its intended use, and a structured report of the review should be written, consisting ofa) a short description of the medical device including its intended functions, the typeof device, technology and features and a description of the intended method of use,b)an analysis of all the selected literature and data, both favourable and unfavourable,c) a critical evaluation of the hazards, associated risks and appropriate safety measuresfor patients, medical staff and third parties,d) a description of the methods of weighting the different papers and the statisticalmethods of analysis employed, taking into account the assessment methods, thetype and duration of study and the heterogeneity of the population included within the study. Particular attention should be given to circumstances where there arerepeated publications on the same group of patients by the same authors, in order to avoid over-weighting multiple publications of the same test subjects,e) a list of publications appropriately cross-referenced in the evaluation,f) a conclusion with a justification, including an assessment of any probable benefit tohealth from the use of the device as intended by the manufacturer, against probable risks of injury or illness from such use, taking account of the “state of the art”. The conclusions should make it clear how the objectives of the literature review havebeen met and identify any gaps in the evidence necessary to cover all relevantaspects of safety and performance. If a clinical investigation is considered necessary, the conclusion should also give details on the relevant objectives and design of such an investigation, based on results of the literature review;g)the signature(s) of the reviewer(s) and date.Section II. Literature ReviewAbstract of Literature ReviewWe reviewed 4 papers issued on the profession medical science journal. The conclusion support that infrared thermometer has been widely use in temperature measurement since 1960’s. The technical is mature and validated by clinical application.Basic Temperature Measurement KnowledgePatients present to Emergency Departments, Urgent Care’s, and primary care offices with various complaints, one of the more common is a febrile condition. Obtaining a patient’s body temperature is a routine part of data collection. It is a well-known fact that accurate measurement provides useful clues about the severity of the illness.Body temperature is not fixed, but is responsive to cyclical changes, such as circadian rhythms and menstrual cycles. Body temperatures increase during the day reaching a maximum point by evening and then lowers to a minimum point in early AM. Remember, these descriptions are for people who live and work normal daytime shifts. Those who work off-hours will have significant differences (DiBenedetto, 1993).To understand temperature assessment (today called "thermometry"), requires an understanding of physics and bio-science. Thermal energy is released by every object animate or inanimate, and is measured by a device that can record it on a readable scale. Thermal energy is transferred by physical objects in four ways: evaporation, convection, conduction, and radiation. Conduction and radiation are measurable by devices such as glass thermometers and infrared thermometers respectively. However, evaporation and convection can affect the outcome measurements of the aforementionedAs discussed earlier there are several sites besides the inaccessible hypothalamus for measuring temperature. The issues of accessibility and accuracy are the critical thinking points of contention. You would not put in a central monitoring device (Swan-Ganz catheter, or urinary bladder sensor catheter) just to measure temperature. Other sites are affected by treatments and environmental factors, for example the mouth and forehead are affected by ambient air and oral medications or topical lotions. The rectum is affected by stool content, and disease states such as hemorrhoids or colitis (Severine & McKenzie, 1998).Basic design theory of noncontact forehead temperatureThe most basic design consists of a lens to focus the infrared (IR) energy on to a detector, which converts the energy to an electrical signal that can be displayed in units of temperature after being compensated for ambient temperature variation. This configuration facilitates temperature measurement from a distance without contact with the object to be measured. As such, the infrared thermometer is useful for measuring temperature under circumstances where thermocouples or other probe type sensors cannot be used or do not produce accurate data for a variety of reasons.Infrared thermometer technologyABC device design filesLiterature introductionNoncontact forehead temperature measurement by handheld infrared thermometer was used as a screening tool for fever. However, the accuracy data and normal range of forehead temperature determined by this method were not available. The temperature readings from 3 handheld infrared thermometers were validated against an electronic thermometer. Normal range of forehead temperature was determined by measuring the forehead temperature in 1000 apparently healthy subjects. Significant differences were detected in readings obtained by the 3 different handheld infrared thermometers (analysis of covariance, P < .001) The most accurate one was chosen, and the normal range offorehead temperature in 1000 subjects detected by this method was 31.0[degrees]C to 35.6[degrees]C.In 1999, Yaw Amoateng-Adjepong, Jonathon Del Mundo and Constantine A. Manthous designed a clinic investigation of using infrared thermometer in an ICUs of a 300-bed teaching community hospital with 51 patientsMeasurements: The mean of three temperatures measured with the infrared was compared to temperatures simultaneously measured with the thermistor of right heart catheters and rectal mercury thermometers for the following three groups of observers who had been certified in the use of the infrared thermometers: a single critical care nurse (CCN)/educator (Ed); CCNs, and floor nurses (FNs)/clinical care practitioners (CCPs). Results: Two rounds of measurements were given to 51 patients by 153 observers. Temperatures of the pulmonary artery (PA) measured with the thermistor of right heart catheters (tempPAs) ranged from 96.5 to 102.6[degrees]F, with a mean ([+ or -]SD) of 99.3 + 1.1[degrees]F. The intraobserver variabilities (correlation coefficients) of the tempTTs ranged from 0.90 for those measured by FNs/CCPs, to 0.92 for those measured by CCNs, to 0.98 for those measured by the CCN/Ed. Accuracy, arbitrarily defined as within a deviation of [+ or -] 0.5[degrees]F of the tempPA, was 100% for the rectal mercury thermometer and 98.0% for the infrared TT when used by the CCN/Ed. The accuracy of the infrared TT was 80% when measured by CCNs and 61% when measured by FNs/CCPs. Differences between tempPAs and tempTTs measured by the CCN/Ed ranged from 0 to 0.7[degrees]F, with a mean of 0.2[degrees]F. Similarly, differences between tempPAs and tempTTs measured by CCNs ranged from 0 to 2.4[degrees]F, with a mean difference of 0.3[degrees]F. However, differences between tempPAs and tempTTs measured by FNs/CCPs ranged from 0 to 3.0[degrees]F, with a mean of 0.6[degrees]F (greater differences than those obtained by the CCNs; p [is less than] 0.01). The accuracy of rectal mercury thermometry was 100%. If a temperature [is greater than or equal to] 101.0[degrees]F had been considered as the threshold at which a fever is present, and if the mean of three measurements had been used to designate temperature, workups that were either inappropriately performed or omitted would have resulted from 2% of tempTTs measured by the CCN/Ed, 1% of those measured by CCNs, and 4% of those measured by FNs/CCPs.Clinic review resultThe favorable result is that if used properly, infrared thermometer is very accurate. However, the not good result is that if the infrared thermometer were not use rightly, it will bring both less accurate and less reproducible in clinical practice.ConclusionsOur study shows that an infrared thermometer is a good quick body temperature measurement device with good accurate and reproducible in clinic application and home use. However, the user’s method is very important to assure the accurate of measurement result.Reference1.Bayham, E., Fucile, F., McKenzie, N., & O’Hara, G. (1996). Clinicalconsiderations for use of FirstTempÒ & FirstTemp GeniusÒ Infrared tympanicthermometers. Sherwood Davis & Geck. Sherwood Medical Company: St. Louis,MO.2.Robert C. Knies, RN MSN CEN, Research Applied to Clinical Practice:Temperature Measurement in Acute Care, /Research-Thermometry.htm3.Shinozaki T, Deane R, Perkins FM. Infrared tympanic thermometer: evaluation ofa new clinical thermometer. CritCareMed 1988; 16: 148-50.4.AJIC: American Journal of Infection Control. 33(4): 227-229, May 2005.Ng, Daniel Kwok-keung FHKAM (Paed.); Chan, Chung-hong BSc; Chan, EricYat-tung MRCPCH; Kwok, Ka-li FHKAM (Paed.); Chow, Pok-yu FHKAM(Paed.); Lau, Wing-Fai FHKAM (Paed.); Ho, Jackson Che-Shun FHKAM (Paed.):A brief report on the normal range of forehead temperature as determined bynoncontact, handheld, infrared thermometer.5.Accuracy of an Infrared Tympanic Thermometer, CHEST, April, 1999 by YawAmoateng-Adjepong, Jonathon Del Mundo, Constantine A. Manthous。