{"id":69,"date":"2024-09-19T15:29:22","date_gmt":"2024-09-19T15:29:22","guid":{"rendered":"https:\/\/engprojects.tcnj.edu\/uroease\/?page_id=69"},"modified":"2024-12-06T22:17:25","modified_gmt":"2024-12-06T22:17:25","slug":"design-inputs","status":"publish","type":"page","link":"https:\/\/engprojects.tcnj.edu\/uroease\/design-inputs\/","title":{"rendered":"Design Inputs"},"content":{"rendered":"\n

This device is broken down into two components<\/em>:<\/p>\n\n\n\n

Part A:<\/strong>\u00a0Sample Collection Area
Part B:<\/strong>\u00a0Sample Transport & Urinalysis Testing Apparatus<\/p>\n\n\n\n

<\/div>\n\n\n\n

The design inputs for the device are listed below,
and their respective design solutions can be
accessed here<\/a><\/strong> as well as from the menu above.<\/p>\n\n\n\n

<\/div>\n\n\n\n
Requirement 1<\/th>Specification<\/th>Justification<\/th><\/tr><\/thead>
The device must be comfortable for the patient.<\/td>Shore 30A Hardness Silicone<\/td>Plastics are a common cause of occupational skin disorders such as irritant or allergic contact dermatitis (ACD).1<\/sup><\/td><\/tr><\/tbody><\/table>
[1] J. C. Salles, F. J. Deschamps, Allergic contact dermatitis due to a PVC table cover, Occupational Medicine, Volume 60, Issue 8, December 2010, Pages 662\u2013664<\/figcaption><\/figure>\n\n\n\n
<\/div>\n\n\n\n
Requirement 2<\/th>Specification<\/th>Justification<\/th><\/tr><\/thead>
The device must collect a clinically acceptable urine sample.<\/td>[2.1] Urine sample volume of 2.0 \u00b1 0.5 mL2<\/sup><\/td>It is difficult to sample urine from geriatric patients due to urinary incontinence or cognitive impairment.3<\/sup><\/td><\/tr><\/tbody><\/table>
[2] Mayo S, et al. Clinical laboratory automated urinalysis: comparison among automated microscopy, flow cytometry, two test strips analyzers, and manual microscopic examination of the urine sediments. J Clin Lab Anal. 2008;22(4):262-70.
[3] Woodford, Henry J, and James George. \u201cDiagnosis and management of urinary infections in older people.\u201d Clinical medicine (London, England) vol. 11,1 (2011): 80-3.<\/figcaption><\/figure>\n\n\n\n
<\/div>\n\n\n\n
Requirement 3<\/th>Specification<\/th>Justification<\/th><\/tr><\/thead>
The device must be able to detect the presence of bioburden associated with UTIs.<\/td>[3.1] \u2265 2 mg\/L of nitrites indicates a UTI.4<\/sup>

[3.2] > 10 Leukocytes\/HPF indicates UTI.5<\/sup><\/td>		UTIs are caused by the presence of bacteria.6<\/sup><\/td><\/tr><\/tbody><\/table>
[4] Man Zhang, et al. Goldberger (2023), Presumptive identification of nitrite by Griess reagent test strips\u2014Case reports of fatal poisoning with sodium nitrite, Journal of Analytical Toxicology, 47(8), 746\u2013749,
[5] SW;, L. R. (n.d.). Cystitis. National Center for Biotechnology Information. https:\/\/pubmed.ncbi.nlm.nih.gov\/29494042\/
[6] Flores-Mireles, et al. (2015). Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nature reviews. Microbiology, 13(5), 269\u2013284.<\/figcaption><\/figure>\n\n\n\n
<\/div>\n\n\n\n
Requirement 4<\/th>Specification<\/th>Justification<\/th><\/tr><\/thead>
The device must communicate the levels of bioburden detected in the urine sample.<\/td>Range of bacteria detected will be displayed with negative, caution, or positive.<\/td>To indicate to caretakers whether or not the patient has an infectious level of bacteria present.7<\/sup><\/td><\/tr><\/tbody><\/table>
[7] Martina Franz, Walter H. H\u00f6rl, Common errors in diagnosis and management of urinary tract infection. I: Pathophysiology and diagnostic techniques, Nephrology Dialysis Transplantation, Volume 14, Issue 11, November 1999, Pages 2746\u20132753<\/figcaption><\/figure>\n\n\n\n
<\/div>\n\n\n\n
Requirement 5<\/th>Specification<\/th>Justification<\/th><\/tr><\/thead>
The device must be able to provide results in a clinically relevant amount of time.<\/td>15 minutes<\/td>Clinicians need to be given results in a timely manner to reduce risk of worsening infection.8<\/sup><\/td><\/tr><\/tbody><\/table>
[8] Gharbi M, Drysdale J H, Lishman H, Goudie R, Molokhia M, Johnson A P et al. Antibiotic management of urinary tract infection in elderly patients in primary care and its association with bloodstream infections and all cause mortality: population based cohort study BMJ 2019; 364 :l525 doi:10.1136\/bmj.l525<\/figcaption><\/figure>\n\n\n\n
<\/div>\n\n\n\n
Requirement 6<\/th>Specification<\/th>Justification<\/th><\/tr><\/thead>
The device must meet electrical safety standards IEC 60601.<\/td>Maximum allowable leakage current must be lower than 500 \u00b5A.<\/td>Complying with electrical standards protects patients and health care providers from electrical hazards. Meeting standards allows the device to interact with other systems within a clinical setting.9<\/sup><\/td><\/tr><\/tbody><\/table>
[9] International Electrotechnical Commission. \u201cMedical electrical equipment \u2013 Part 1-1: General requirements for basic safety and essential performance.\u201d Standard No. IEC 60601-1-1: 2020. IEC, 2020.<\/figcaption><\/figure>\n\n\n\n
<\/div>\n\n\n\n
Requirement 7<\/th>Specification<\/th>Justification<\/th><\/tr><\/thead>
The device must be sanitizable.<\/td>They must be sanitized with EPA approved disinfectants.10<\/sup><\/td>Device will come in contact with the urine sample.11<\/sup><\/td><\/tr><\/tbody><\/table>
[10] Simulated-use testing of bedpan and urinal washer disinfectors: Evaluation of Clostrium difficile spore survival and cleaning efficacy, American Journal of Infection Control, Volume 36, Issue 1, 2008, Pages 5-11, ISSN 0196-6553
[11] GUIDANCE, D. Draft Guidance for Industry and FDA Staff Processing\/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.  \/Michelle J. Alfa, Nancy Olson, Louise Buelow-Smith.<\/figcaption><\/figure>\n","protected":false},"excerpt":{"rendered":"

This device is broken down into two components: Part A:\u00a0Sample Collection AreaPart B:\u00a0Sample Transport & Urinalysis Testing Apparatus The design inputs for the device are listed below, and their respective design solutions can be accessed here as well as from the menu above. Requirement 1 Specification Justification The device must be comfortable for the patient. […]<\/p>\n","protected":false},"author":613,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ngg_post_thumbnail":0,"footnotes":""},"class_list":["post-69","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/engprojects.tcnj.edu\/uroease\/wp-json\/wp\/v2\/pages\/69","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/engprojects.tcnj.edu\/uroease\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/engprojects.tcnj.edu\/uroease\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/uroease\/wp-json\/wp\/v2\/users\/613"}],"replies":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/uroease\/wp-json\/wp\/v2\/comments?post=69"}],"version-history":[{"count":0,"href":"https:\/\/engprojects.tcnj.edu\/uroease\/wp-json\/wp\/v2\/pages\/69\/revisions"}],"wp:attachment":[{"href":"https:\/\/engprojects.tcnj.edu\/uroease\/wp-json\/wp\/v2\/media?parent=69"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}