SERVICES

CLEANING VALIDATION

Cleaning validation is an experiment that determines the efficacy of a cleaning procedure on a medical device. Prior to use, all test devices should be worn in with simulated use to properly assess the cleaning procedure as it would perform against actual in-use devices. The device is first soiled with an artificial soil load determined by the Study Sponsor. These soil loads contain biomarkers such as protein and hemoglobin and take the form of blood, mucous, or a combination of substances. Soil is typically added to sites that would be considered ‘worst-case’. These sites are those that will experience more handling during use or sites that are hard to reach such as crevices. Once the test device has been soiled, it is handled to emulate regular use. Once the soil is dry, the cleaning procedure is performed. This procedure varies from test to test depending on what the Study Sponsor provides and can vary greatly. After the test device has undergone cleaning, the extraction process begins. The extraction process involves taking a combination of wet and dry sterile swatches/swabs and wiping down the target sites of the device. As those sites are harvested, the swatches /swabs are placed into a container of recovery fluid so that each site may be evaluated independently. At the request of Study Sponsors, all sites may be pooled into one volume to evaluate the efficacy of the procedure on the entire device. Evaluation of a pooled volume does not provide insight into how well specific areas are being cleaned but can be a cost-efficient way to evaluate a cleaning routine. During experimentation, controls are harvested as well. A positive control is performed by harvesting a soiled test device that has not received the relevant cleaning. The negative control is performed by extracting from a device that has not been soiled but has received cleaning. The recovery fluid samples for each extraction site are then analyzed in a microplate reader. For protein analysis, the Pierce BCA Protein Assay Kit is used. A known standard is made using bovine serum albumin. This standard is used to establish a calibration curve in the data analysis portion of experimentation and to determine the amount of protein remaining at each site after the extraction. The plate is put into the microplate reader and the results are obtained. For hemoglobin analysis, a similar procedure is performed following the instructions for the relevant Sigma-Aldrich Hemoglobin Assay Kit. Once readings have been obtained for both protein and hemoglobin, the results are analyzed in relevant data analysis software. The obtained values are adjusted based on dilution factor, amount of liquid aliquoted from recovery fluid, etc., and the final amount of biomarker observed for each site is determined. These values are compared to the success criteria to determine the efficacy of the cleaning procedure.

DISINFECTION VALIDATION

A disinfection validation is an experiment that determines the efficacy of a disinfection procedure on a medical device. Prior to use, all test devices should be worn in with simulated use to properly assess the disinfection procedure as it would perform against actual in-use devices.
The device is first inoculated with the test microorganism determined by the Study Sponsor. This varies based on the desired disinfection level (Low, Intermediate, or High-level disinfection), largely determined by the kind of contact the device makes with patients. For submission to any regulatory agencies, each test microorganism needs to be evaluated independently, as pooling the test microorganisms can lead to competitive inhibition, resulting in misleading results. Inoculum is applied to sites that would be considered ‘worst-case’. These sites are those that will experience more handling during use or sites that are hard to reach such as crevices. Once the test device has been inoculated, it may be handled to emulate regular use. This can involve twisting dials, pressing on a touchpad, turning a switch on, or any number of actions. The emulation of normal use is to allow inoculum to access areas in a manner typical for the device, allowing for an accurate measure of the efficacy of the disinfection procedure. Once the inoculum is dry, the disinfection procedure is performed. This procedure varies from test to test depending on what the Study Sponsor provides and can vary greatly. After the test device has undergone disinfection, the extraction process begins. The extraction process involves taking a combination of wet and dry sterile swatches/swabs and wiping down the target sites of the device. As those sites are harvested, the swatches/swabs are placed into a container of recovery fluid so that each site may be evaluated independently. At the request of Study Sponsors, this can be altered to pool all sites into one volume to evaluate the efficacy of the procedure against the whole device. Evaluation of a pooled volume does not provide insight into how well specific areas are being disinfected but can be a cost-efficient way to evaluate a disinfection routine. During experimentation, controls are harvested as well. A positive control is performed by harvesting an inoculated test device that has not received the relevant cleaning. The negative control is performed by extracting from a device that has not been inoculated but has received cleaning. The recovery fluid samples for each extraction site are then diluted appropriately and the dilutions plated in duplicate. These dilutions are meant to cover a wide array of dilutions and provide plate counts that can be used to adequately assess the efficacy of the disinfection procedure against the target microorganism. The plates are incubated as appropriate for the microorganism with sterility plates, meant to test the sterility of all media/materials used in testing. After incubation, colony-forming units on the plates are counted and the values are compared to the success criteria stated in the test protocol. All sterility plates are assessed to ensure no systemic contamination was derived from contaminated media.

BIOCOMPATIBILITY

In Vitro and In Vivo safety evaluation studies are conducted on a variety of biomaterials, medical devices and related products to identify the presence of toxins or any other potentially harmful effects. Biocompatibility tests ranges from initial screening of new materials to product release testing and non-clinical or pre-market safety evaluations to meet current global standards. We understand the confidence you require in your biocompatibility testing partner to deliver high-quality, accurate medical device testing results to achieve commercialization goals. Our highly-trained experts perform all tests in-house to evaluate the biocompatibility of your device’s component material / finished product use and regulatory pathway—minimizing cost and time throughout the development continuum. NAMSA’s biocompatibility tests challenge various biological models with test materials or suitable extracts. Specific safety programs follow FDA guidance, ISO 10993 standards and other international guidelines. Primary test categories used to determine biological effect include:

• Acute Systemic Toxicity Testing

• Biodegradation Testing

• Carcinogenicity Testing

• Chronic Toxicity Testing

• Cytotoxicity Testing

• Genotoxicity Testing

• Hemocompatibility Testing

• Implantation Testing

• Intra-cutaneous Irritation Testing

• Reproductive/Developmental Testing

• Sensitization Testing

• Sub chronic Toxicity Testing