Quantification by Mass Of Residual Debris in Reusable Medical Devices

Haugen, Shanil P.; Duraiswamy, Nandini; Hitchins, Victoria M.

doi:10.2345/0899-8205-12.1.61

Cited by 6 publications

(12 citation statements)

References 20 publications

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“…The same recipe is also used in the ASTM D7225‐13 standard for testing blood cleaning efficiency of detergents and washer‐disinfectors. In addition, several published studies have used this test soil in their research studies .…”

Section: Methodsmentioning

confidence: 99%

“…Preventing cross‐infection between patients is essential for reusable devices; therefore, the reprocessing protocol must ensure sufficient decontamination of the devices before reuse. For medical devices that are labeled as “reusable”, the US Food and Drug Administration (FDA) requires device manufacturers to provide adequate instructions for reprocessing in their instructions for use . The reprocessing instructions are reviewed by the FDA as a part of the device approval or clearance processes.…”

Section: Introductionmentioning

confidence: 99%

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A test method to assess the contribution of fluid shear stress to the cleaning of reusable device surfaces

et al. 2018

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Adequate cleaning of reusable medical devices is critical for preventing cross-infection among patients. For reusable medical devices, cleaning using mechanical brushes and detergent may not be sufficient to completely remove the infectious contaminants from the surfaces. This study evaluates the role of fluid flow-induced shear stress in the detachment and removal of contaminants from device surfaces. A stainless-steel test coupon, acting as a surrogate for a device surface, was coated with artificial clot of varying mass. The test coupon was exposed to fluid shear stress both with and without an enzymatic detergent. The relationship between clot removal quantity and the applied shear stress was obtained for multiple clot masses. Our results showed that fluid shear increased the effectiveness of the cleaning process. In the absence of flow, soaking the clot surface in the enzymatic detergent removed 67%, 77%, and 95% of the clot for 16 mg, 6.8 mg, and 1 mg initial masses, respectively. In the presence of fluid shear (0.3 Pa for 5 min), approximately 85%, 97%, and 99% of the clot was removed from the surface. The clot mass removed followed a linear relationship (R = 0.98) versus the applied fluid shear stress. This study showed that different cleaning processes such as fluid shear and detergent action contribute to the soil removal process. This method could be used to evaluate cleaning protocols for minimizing contaminant residue after the reprocessing of medical devices.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A test method to assess the contribution of fluid shear stress to the cleaning of reusable device surfaces

et al. 2018

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“…Para simular o uso assistencial, cada amostra foi submetida à contaminação desafio interna e externamente com Soil Test™ e suspensão de Geobacillus stearothermophilus, na concentração de 10 6 UFC/mL, contendo formas esporuladas. Após a contaminação com a solução, as amostras foram contaminadas interna e externamente com farinha de osso bovino (~3,5 g), simulando os resíduos ósseos ao final de um procedimento cirúrgico 4 . O contato com os contaminantes foi mantido por 3 horas, tempo estimado de um procedimento cirúrgico.…”

Section: Fase 1: Avaliação Da Limpeza E Da Esterilidadeunclassified

Avaliação da segurança do processamento de fresas intramedulares flexíveis Para cirurgia ortopédica

et al. 2017

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Objetivos: Avaliar a eficácia de um procedimento operacional padrão para limpeza de fresas intramedulares flexíveis, bem como o alcance da esterilidade, e evidenciara citotoxicidade da sujidade residual de uma fresa flexível utilizada na prática assistencial. Métodos: Fresas intramedulares flexíveis foram pesadas antes do processamento,após contaminação desafio e depois da limpeza. Elas foram contaminadas com Soil Test™, suspensão de Geobacillus stearothermophilus, na concentração de106 UFC/mL, e farinha de osso bovino. Após processamento, as amostras foram incubadas em meio de cultura por 21 dias. A sujidade residual de uma fresa utilizadana prática foi submetida ao teste de citotoxicidade in vitro. Resultados: As amostras, embora esterilizadas, apontaram acúmulo de sujidade e o processamento foi ineficaz.A sujidade residual apresentou efeito citotóxico. Conclusão: Recomenda-se que o design flexível das fresas seja descontinuado pela insegurança no processamento.

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“…10 • In another groundbreaking development in 2002, physicians at Massachusetts General Hospital used voice and video connections to help a doctor in Antarctica perform knee surgery on a meteorologist injured at the South Pole. 11 • In 2009, a real-time electrocardiogram with GPS coordinates was transmitted via satellite phone from Mount Everest to determine a climber's physiological capability for continued ascent. 10 Healthcare providers will need to make sure patients and caregivers can use any equipment they'll need for telemedicine services at home, which can be a chaotic environment.…”

Section: Highpoints In the History Of Telemedicinementioning

confidence: 99%

“…2,6 Water-soluble debris in a device can become insoluble and adhere to device surfaces as a result of the heat and chemicals used in sterilization if not thoroughly cleaned prior to sterilization. 10 Haugen et al 11 developed a method to determine total mass of loose insoluble orthopedic debris in models of increasing complexity ranging from a straight lumen to a replica of an arthroscopic shaver handle. This work modeled the capture of loose debris one might find inside used orthopedic devices.…”

Section: In Addition To Cleaning and Following Directions For Reprocementioning

confidence: 99%

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2015

Biomedical Instrumentation & Technology

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> Breakthrough Measurements • Masimo SET ® Measure-through Motion and Low Perfusion™ pulse oximetry • rainbow Acoustic Monitoring™ with Acoustic Respiration Rate (RRa ®) > Small, lightweight, and wearable for untethered monitoring and ambulation > Integration with Patient SafetyNet* for surveillance monitoring www.masimo.com Each Radius-7 comes with two rechargeable, "hot-swappable" modules with short-range communication to Root.

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Quantification by Mass Of Residual Debris in Reusable Medical Devices

Cited by 6 publications

References 20 publications

A test method to assess the contribution of fluid shear stress to the cleaning of reusable device surfaces

A test method to assess the contribution of fluid shear stress to the cleaning of reusable device surfaces

Avaliação da segurança do processamento de fresas intramedulares flexíveis Para cirurgia ortopédica

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