Proactive Role of Clinical Engineering in the Adoption of ISO/IEC 80001-1 within Healthcare Delivery Organization.

The integration of medical device systems and general hospital information technology (IT) infrastructure creates a medical device-IT network that requires patient-oriented cybersecurity risk management to ensure patient safety. This study discusses the roles of clinical engineering in taking initiatives in the implementation of the ISO/IEC 80001-1 risk management framework in a hospital environment. Further, we present lessons learned and clinical engineering opportunities in managing medical device cybersecurity, which include development of an integrated systems test lab.Clinical Relevance- This paper highlights Clinical Engineering's leadership role in implementing an effective risk management system for integrated medical device systems to reduce cybersecurity risks to enhance patient care and safety.

Photoacoustic correlation signal-to-noise ratio enhancement by coherent averaging and optical waveform optimization.

Photoacoustic (PA) imaging of biological tissues using laser diodes instead of conventional Q-switched pulsed systems provides an attractive alternative for biomedical applications. However, the relatively low energy of laser diodes operating in the pulsed regime, results in generation of very weak acoustic waves, and low signal-to-noise ratio (SNR) of the detected signals. This problem can be addressed if optical excitation is modulated using custom waveforms and correlation processing is employed to increase SNR through signal compression. This work investigates the effect of the parameters of the modulation waveform on the resulting correlation signal and offers a practical means for optimizing PA signal detection. The advantage of coherent signal averaging is demonstrated using theoretical analysis and a numerical model of PA generation. It was shown that an additional 5-10 dB of SNR can be gained through waveform engineering by adjusting the parameters and profile of optical modulation waveforms.

Silica-coated super paramagnetic iron oxide nanoparticles (SPION) as biocompatible contrast agent in biomedical photoacoustics.

In this study, we report for the first time the use of silica-coated superparamagnetic iron oxide nanoparticles (SPION) as contrast agents in biomedical photoacoustic imaging. Using frequency-domain photoacoustic correlation (the photoacoustic radar), we investigated the effects of nanoparticle size, concentration and biological media (e.g. serum, sheep blood) on the photoacoustic response in turbid media. Maximum detection depth and the minimum measurable SPION concentration were determined experimentally. The nanoparticle-induced optical contrast ex vivo in dense muscular tissues (avian pectus and murine quadricept) was evaluated and the strong potential of silica-coated SPION as a possible photoacoustic contrast agents was demonstrated.

Frequency-domain photoacoustic phased array probe for biomedical imaging applications.

We report the development of a frequency-domain biomedical photoacoustic imaging system that utilizes a continuous-wave laser source with a custom intensity modulation pattern, ultrasonic phased array for signal detection, and processing coupled with a beam-forming algorithm for reconstruction of photoacoustic correlation images. Sensitivity to optical contrast was demonstrated using tissue-mimicking phantoms and in-vivo tissue samples.