Design Inputs

This device is broken down into two components:

Part A: Sample Collection Area
Part B: Sample 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 1SpecificationJustification
The device must be comfortable for the patient.Shore 30A Hardness SiliconePlastics are a common cause of occupational skin disorders such as irritant or allergic contact dermatitis (ACD).1
[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 662–664
Requirement 2SpecificationJustification
The device must collect a clinically acceptable urine sample.[2.1] Urine sample volume of 2.0 ± 0.5 mL2It is difficult to sample urine from geriatric patients due to urinary incontinence or cognitive impairment.3
[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. “Diagnosis and management of urinary infections in older people.” Clinical medicine (London, England) vol. 11,1 (2011): 80-3.
Requirement 3SpecificationJustification
The device must be able to detect the presence of bioburden associated with UTIs.[3.1] ≥ 2 mg/L of nitrites indicates a UTI.4

[3.2] > 10 Leukocytes/HPF indicates UTI.5		UTIs are caused by the presence of bacteria.6
[4] Man Zhang, et al. Goldberger (2023), Presumptive identification of nitrite by Griess reagent test strips—Case reports of fatal poisoning with sodium nitrite, Journal of Analytical Toxicology, 47(8), 746–749,
[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), 269–284.
Requirement 4SpecificationJustification
The device must communicate the levels of bioburden detected in the urine sample.Range of bacteria detected will be displayed with negative, caution, or positive.To indicate to caretakers whether or not the patient has an infectious level of bacteria present.7
[7] Martina Franz, Walter H. Hörl, 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 2746–2753
Requirement 5SpecificationJustification
The device must be able to provide results in a clinically relevant amount of time.15 minutesClinicians need to be given results in a timely manner to reduce risk of worsening infection.8
[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
Requirement 6SpecificationJustification
The device must meet electrical safety standards IEC 60601.Maximum allowable leakage current must be lower than 500 µA.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
[9] International Electrotechnical Commission. “Medical electrical equipment – Part 1-1: General requirements for basic safety and essential performance.” Standard No. IEC 60601-1-1: 2020. IEC, 2020.
Requirement 7SpecificationJustification
The device must be sanitizable.They must be sanitized with EPA approved disinfectants.10Device will come in contact with the urine sample.11
[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.