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Baska mask versus endotracheal tube in laparoscopic cholecystectomy surgery: a prospective randomized trial

Ng CC, Sybil Shah MHB, Chaw SH, Mansor MB, Tan WK, Koong JK, et al.

Expert Rev Med Devices, 2021 Feb;18(2):203-210.
PMID: 33322949 DOI: 10.1080/17434440.2021.1865796

Background: Supraglottic airway devices have increasingly been used as the airway technique of choice in laparoscopic surgeries. This study compared the efficacy and safety of the Baska Mask with endotracheal tube (ETT) in patients undergoing elective laparoscopic cholecystectomy.Research design and methods: This single-center, prospective, randomized controlled trial recruited 60 patients aged 18-75 years with American Society of Anesthesiologists' classifications I to III. The time taken to achieve effective airway, number of attempts, ease of insertion, ventilation parameters, hemodynamics data, and pharyngolaryngeal complications were recorded.Results: The time taken to achieve effective airway was shorter for the Baska group (26.6 ± 4.7 vs. 47.2 ± 11.8 s; p
Randomized comparison of the Baska FESS mask and the LMA Supreme in different head and neck positions

Foo LL, Shariffuddin II, Chaw SH, Lee PK, Lee CE, Chen YS, et al.

Expert Rev Med Devices, 2018 Aug;15(8):597-603.
PMID: 30095289 DOI: 10.1080/17434440.2018.1506329

BACKGROUND: The Baska functional endoscopic sinus surgery (FESS) mask is a new supraglottic airway designed for head and neck procedures. This prospective, randomized controlled trial compared the oropharyngeal leak pressure (OLP) of the Baska FESS mask with the laryngeal mask airway (LMA) Supreme in different head and neck positions.
METHODS: One hundred patients undergoing elective surgery were recruited. OLP was compared in supine position, 45° lateral rotation, 45° neck extension, and 30° neck flexion. Glottic view, insertion time, ease of insertion, number of attempts, ease and time of insertion of gastric tube, and complications were also compared.
RESULTS: The OLP of the Baska FESS was higher than the LMA Supreme in all head and neck positions studied (p
Partial vs full glottic view with CMACTM D blade intubation of airway with simulated cervical spine injury: a randomized controlled trial

Cheong CC, Ong SY, Lim SM, Wan A WZ, Mansor M, Chaw SH

Expert Rev Med Devices, 2023 Feb;20(2):151-160.
PMID: 36715659 DOI: 10.1080/17434440.2023.2174850

PURPOSE: A previous study reported a shorter time to tracheal intubation by reducing percentage of glottic opening (POGO) view to <50% when intubating a normal adult airway using the GlidescopeTM blade. We evaluate the efficacy of reducing POGO to <50% when intubating patients with rigid cervical immobilization using CMACTM D blade.
METHODS: One hundred and four adult patients were randomized to group POGO 100% or POGO <50% . Laryngoscopy was performed by advancing tip of the D blade at vallecula. POGO 100% was achieved by exerting upward force to displace epiglottis until glottic opening from the anterior commissure to inter arytenoid notch. POGO < 50% was acquired by withdrawing the D blade tip dorsally from vallecula. The primary outcome was time to intubation.
RESULTS: The median time (IQR) to successful intubation was 29 (25-35) seconds for group POGO < 50% and 34 (28-40) seconds for group with POGO 100% (difference in medians, 5 seconds; 95% confidence interval, 2 to 8, p = 0.003). Complications were minor.
CONCLUSION: Using the CMACTM D blade with a reduced POGO in patients with cervical spine immobilization resulted in faster tracheal intubation.
TRIAL REGISTRATION: The trial is registered at ClinicalTrial.gov (CT.gov identifier: NCT04833166).
Towards an evaluation framework for medical device-integrated electronic medical record

Alhammad A, Yusof MM, Jambari DI

Expert Rev Med Devices, 2024 Mar;21(3):217-229.
PMID: 38318674 DOI: 10.1080/17434440.2024.2315024

INTRODUCTION: Medical device (MD)-integrated (I) electronic medical record (EMR) (MDI-EMR) poses cyber threats that undermine patient safety, and thus, they require effective control mechanisms. We reviewed the related literature, including existing EMR and MD risk assessment approaches, to identify MDI-EMR comprehensive evaluation dimensions and measures.
AREAS COVERED: We searched multiple databases, including PubMed, Web of Knowledge, Scopus, ACM, Embase, IEEE and Ingenta. We explored various evaluation aspects of MD and EMR to gain a better understanding of their complex integration. We reviewed numerous risk management and assessment frameworks related to MD and EMR security aspects and mitigation controls and then identified their common evaluation aspects. Our review indicated that previous evaluation frameworks assessed MD and EMR independently. To address this gap, we proposed an evaluation framework based on the sociotechnical dimensions of health information systems and risk assessment approaches for MDs to evaluate MDI-EMR integratively.
EXPERT OPINION: The emergence of MDI-EMR cyber threats requires appropriate evaluation tools to ensure the safe development and application of MDI-EMR. Consequently, our proposed framework will continue to evolve through subsequent validations and refinements. This process aims to establish its applicability in informing stakeholders of the safety level and assessing its effectiveness in mitigating risks for future improvements.
Regulatory landscape, risks, and solutions for refurbished medical devices: a comparative analysis in the US, EU, Malaysia, and Ghana

Pinheiro AM, Chettri B, Mehra A, Deepti I, Ravi R

Expert Rev Med Devices, 2024 Aug 09.
PMID: 39119692 DOI: 10.1080/17434440.2024.2390581

INTRODUCTION: Refurbished medical devices are previously owned equipment that undergo a process of restoration to ensure they meet quality standards and function effectively. The utilization of refurbished medical devices, coupled with the integration of software, poses intricate challenges in terms of regulatory compliance, risk management, and patient safety.
AREAS COVERED: This article explores the regulatory frameworks governing refurbished medical devices in the United States (US), the European Union (EU), Malaysia, and Ghana. Included information from a range of primary and secondary sources. Additionally, it aims to identify and analyze the risks associated with refurbished medical devices, with a specific focus on the implications of software integration, and recommend practical solutions for mitigating these risks.
EXPERT OPINION: The landscape of refurbished medical devices presents challenges in terms of regulatory compliance, risk management, and patient safety. Addressing these challenges requires careful consideration and strategies to ensure that refurbished devices meet stringent quality standards. By focusing on these areas, policymakers and healthcare professionals can enhance the safe utilization of refurbished medical devices, thereby improving access to quality healthcare, particularly in underserved regions.