Certain medical devices, particularly those involved in respiratory care, surgery, and dental procedures, inherently produce aerosols during operation, potentially posing a risk to patient safety and increasing the likelihood of airborne transmission of pathogens. At ARE Labs, we specialize in meticulously determining the concentration and composition of aerosols emitted by these devices, ensuring they meet rigorous regulatory standards and contribute to a safer healthcare environment.
Aerosol Analysis For Medical Devices:
ARE Labs offers comprehensive aerosol analysis for various medical devices. Types of devices which may inadvertently produce aerosols includes but is not limited to:
Mechanical Ventilators: Used to assist or replace spontaneous breathing, ventilators can generate aerosols, especially during procedures like intubation or extubation.
High-Flow Nasal Cannula (HFNC): Used to deliver oxygen at high flow rates, HFNC therapy can generate aerosols, particularly when patients are coughing or sneezing.
CPAP and BiPAP Machines: Continuous Positive Airway Pressure (CPAP) and Bilevel Positive Airway Pressure (BiPAP) machines, commonly used for conditions like sleep apnea, can produce aerosols through the mask, tubing, and exhalation ports.
PCR Devices: These devices may inadvertently produce aerosolization of samples during operation through moving parts or robotic arm operation.
Our approach to testing encompasses a range of analytical techniques designed to provide a complete understanding of aerosol emissions:
Quantitative Aerosol Concentration Measurement: Utilizing advanced instruments, we measure the concentration of aerosols generated by medical devices. This assessment is crucial for understanding the potential exposure risk to healthcare professionals and patients.
Viable Biological Output Testing: We go beyond mere particle counting. Our labs are equipped to determine the viability of biological organisms in aerosol emissions, an essential factor in assessing infection control measures and the potential spread of disease.
Particle Size Distribution Analysis: By analyzing the size distribution of emitted particles, we can predict their behavior and travel distance in a clinical setting. This analysis helps in understanding how effectively aerosols can be captured or filtered. ARE Labs can help ensure your device is not producing aerosols which may pose a risk to patient safety as well as validate cleaning procedures and mitigation features on the device.
The majority of testing involving aerosol production by medical devices will utilize our custom built, HEPA filtered bioaerosol chambers to serve as:
Primary and Secondary Containment: Our HEPA-filtered bioaerosol chambers serve as both primary and secondary containment systems, offering a controlled environment for accurate and safe testing.
Real-Time Monitoring: The use of real-time particle size and concentration monitoring in our chambers provides immediate feedback on aerosol generation and control efficacy, enabling dynamic assessment under various operational conditions.
Efficacy Assessment of Mitigation Techniques:
Mitigation Strategy Evaluation: We evaluate the effectiveness of existing mitigation techniques, such as local exhaust ventilation, air filtration systems, and protective barriers, providing data-driven recommendations for improvement.
Regulatory Compliance Assurance: Our testing ensures that medical devices comply with health and safety regulations, such as those set by the FDA, OSHA, and CDC, safeguarding against non-compliance risks.
Customized Testing Protocols: Recognizing the uniqueness of each medical device and its application, we develop customized testing protocols that align with specific operational contexts and regulatory requirements.