Expert review of medical devices
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Expert Rev Med Devices · Apr 2017
Review Comparative StudyA comparison study of Taiwan regulation and GHTF regulatory model on in vitro diagnostic medical devices.
In Taiwan, In Vitro Diagnostic Medical Device (IVD) is regulated as medical device since 1987, and the implementation of IVD registration was fully completed in 2005. The management system of IVD medical device is highly similar with a guidance 'The GHTF Regulatory Model' developed by Global Harmonization Task Force (GHTF) in 2011 for use of regulation development on medical devices. Area covered: In this study, the Regulatory Model developed by GHTF was compared with Taiwanese IVD management system and it has shown that these two regulatory frameworks are highly similar. Expert commentary: The experience of IVD management in Taiwan can serve a strong evidence to prove the feasibility and effectiveness of GHTF Regulatory Model.
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Expert Rev Med Devices · Feb 2017
ReviewOxygen therapy devices and portable ventilators for improved physical activity in daily life in patients with chronic respiratory disease.
Patients with hypoxemia and chronic respiratory failure may need to use oxygen therapy to correct hypoxemia and to use ventilatory support to augment alveolar ventilation, reverse abnormalities in blood gases (in particular hypercapnia) and reduce the work of breathing. Areas covered: This narrative review provides an overview on the use of oxygen therapy devices or portable ventilators for improved physical activity in daily life (PADL) as well as discusses the issue of lower mobility in daily life among stable patients with chronic respiratory disease who present indication for long-term oxygen therapy (LTOT) or home-based noninvasive ventilation (NIV). A literature review of these concepts was performed by using all related search terms. ⋯ However, the day-by-day dependence of a device may reduce mobility and partially impair patients' PADL. Nocturnal NIV implementation in hypercapnic patients seems promising to improve PADL. The magnitude of their equipment-related physical inactivity is underexplored up to this moment and more long-term randomized clinical trials and meta-analysis examining the effects of ambulatory oxygen and NIV on PADL are required.
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Expert Rev Med Devices · Jan 2017
ReviewEvaluation of the axonics modulation technologies sacral neuromodulation system for the treatment of urinary and fecal dysfunction.
Sacral neuromodulation (SNM) remains one of the few effective treatments for refractory bladder and bowel dysfunction. However, SNM is associated with frequent need for surgical intervention, in many cases because of a failed battery. A rechargeable SNM system, with a manufacturer-reported battery life of 15 years or more, has entered post-market clinical testing in Europe but has not yet been approved for clinical testing in the United States. ⋯ However surgical revision not related to battery changes is not uncommon. Therefore, while a rechargeable system would be expected to reduce costs, it will not eliminate the ongoing maintenance associated with neuromodulation. No matter the apparent benefits, all new technologies require extensive post-market monitoring to ensure safety and efficacy.
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Expert Rev Med Devices · Sep 2016
ReviewCerebral perfusion monitoring in acute care surgery: current and perspective use.
The technology near infrared spectroscopy (NIRS) has been utilized extensively in several clinical settings and one of which is in cerebral oximetry. This review will provide information on the technology, clinical applications and algorithm to follow when desaturation occurs. ⋯ The review will cover the technology of near infrared spectroscopy, cerebral oximetry and the utilization of cerebral oximetry in each clinical setting. Expert commentary: Cerebral oximetry provides a noninvasive measure of cerebral oxygenation, which when persistently declining, can serve as a warning sign of hemodynamic or metabolic compromise intraoperatively or a predictor of postoperative cognitive dysfunction. Although useful, the cerebral oximetry readings must be interpreted in the context of other clinical information. When cerebral desaturation is confirmed, an algorithm should be followed in an attempt to increase oxygen delivery to the brain and/or decrease cerebral metabolic rate of oxygen.
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Expert Rev Med Devices · Sep 2016
ReviewMobile health in cardiology: a review of currently available medical apps and equipment for remote monitoring.
Recent developments in implantable cardioverter-defibrillators (ICDs) and smartphone technology have increased the possibilities for remote monitoring. It is the purpose of this review to give an overview of these new possibilities. ⋯ Remote monitoring in ICD allows for early detection of lead fractures and remote follow-up of patients. Possible limitations are the lack of standardization and the possible unsafety of the data stored on the ICD. Secondly, remote monitoring of health parameters using smartphone compatible wearables and smartphone medical apps is addressed. Possible limitations include the fact that the majority of smartphone apps are unregulated by the regulatory authorities and privacy issues such as selling of app-generated data to third parties. Lastly, clinical studies with smartphone apps are discussed. Expert commentary: New technologies in ICDs and smartphones have the potential to be used for remote monitoring. However, unreliability of smartphone technology, inadequate legislation and lack of reimbursement impede implementation.