Medical Devices : Evidence and Research

BACKGROUND: Medical equipment are vital items to deliver quality services in health facilities and the role of medical equipment is a well-founded reality. It is mainly used in many diverse settings in hospitals to diagnose, treat illnesses; support disabled and intervened acute and chronic cases. Effective maintenance and proper management are major utilization issues to provide quality services while saving scarce resources. However, managing medical equipment, especially, the utilization phase of medical equipment, was not well studied in this general hospital...

[This retracts the article DOI: 10.2147/MDER.S25800.].

We used a safety-valve (Trans-Urethral Catheterisation Safety Valve, Class Medical, Limerick, Ireland) to prevent urethral trauma due to inflation of the anchoring balloon in the urethra during catheterisation of male spinal cord injury patients in a spinal unit. The safety-valve is attached to the balloon channel of a Foley catheter. If the balloon is inflated when it is in the urethra, the pressure valve is activated. Any fluid pushed into the balloon channel leaks out and balloon inflation stops, indicating that the balloon is not inside the bladder...

BACKGROUND: The significance of effectively using medical equipment has received widespread public attention. Due to its complex effects on healthcare costs and quality, the relationship between hospital features and medical equipment consumption has drawn increased attention. Therefore, the study aimed to evaluate the efficiency of medical equipment utilization and its associated factors. METHODS: The study was conducted at public referral hospitals in East Wollega, Oromia Regional National State, Ethiopia, in 2021...

PURPOSE: The global rise in frequency of cesarean delivery raises the concern to minimize the post-operative complications, in order to improve the maternal and neonatal health. Closure of subcutaneous tissue following cesarean section closes dead space, hence reduces the wound complications. No previous study has compared the clinical equivalence of polyglycolic acid suture with polyglactin 910 suture for subcutaneous tissue closure following cesarean section. Therefore, this study compared the incidence of subcutaneous abdominal wound disruptions within the first 6 weeks of subcutaneous tissue closure with either of the sutures...

BACKGROUND: Intracranial pressure (ICP) monitoring requires placing a hole in the skull through which an invasive pressure monitor is inserted into the brain. This approach has risks for the patient and is expensive. We have developed a non-invasive brain pulse monitor that uses red light to detect a photoplethysmographic (PPG) signal arising from the blood vessels on the brain's cortical surface. The brain PPG and the invasive ICP waveform share morphological features which may allow measurement of the intracranial pressure...

PURPOSE: This paper focuses on developing and testing three versions of interactive bike (iBikE) interfaces for remote monitoring and control of cycling exercise sessions to promote upper and lower limb rehabilitation. METHODS: Two versions of the system, which consisted of a portable bike and a tablet PC, were designed to communicate through either Bluetooth low energy (BLE) or Wi-Fi interfaces for real-time monitoring of exercise progress by both the users and their clinical team...

PURPOSE: Linear surgical staplers reduce rates of surgical adverse events (bleeding, leaks, infections) compared to manual sutures thereby reducing patient risks, surgeon workflow disruption, and healthcare costs. However, further improvements are needed. Ethicon Gripping Surface Technology (GST) reloads, tested and approved by regulatory authorities in combination with powered staplers, may reduce surgical risks through improved tissue grip. While manual staplers are used in some regions due to affordability, clinical data on GST reloads used with manual staplers are unavailable...

PURPOSE: This study describes the incremental healthcare costs associated with retreatment among adults undergoing ureteroscopy (URS) or percutaneous nephrolithotomy (PCNL) for upper urinary tract stones (UUTS). PATIENTS AND METHODS: The IBM® MarketScan® Commercial Database was used to identify adults aged 18-64 years with UUTS treated with URS or PCNL between January 2010 and December 2019. Patients had 12 months of continuous insurance coverage before (baseline) and after (follow-up) the first (index) procedure...

No abstract text is available yet for this article.

No abstract text is available yet for this article.

Introduction: Whilst risk management has become fundamental in the development of medical devices, enforced by regulations and international standards, there is still no comprehensive model that explains how risk management in medical devices' development should be tackled, especially with regard to the type of risks that should be addressed. Risk management in the medical devices' development field is currently focused on technical risks, comprising product, usability, and development process risks, in alignment with standards' requirements and regulations, without giving enough attention to non-technical risks, which include business and project risks...

Introduction: Simple non-invasive biomarker is urgently needed to detect the largely silent osteopenia in order to prevent osteoporosis-related fracture later in life. The accumulation of advanced glycation end products (AGEs) has been related to reduced bone density and osteoporotic fractures. Whether lens autofluorescence (LAF) based AGEs (LAF-AGEs) measurement could be used to assess the risk of osteopenia is aimed to investigate in this paper. Methods: Through routine health examination, 368 individuals under the age of 50 were enrolled...

Purpose: To compare outcomes of non-donor patients undergoing radical nephrectomy using fixed-height gripping surface (FHGS) vs variable-height Tri-Staple™ (VHTS) reloads for transection of the renal vessels. Patients and Methods: Using the Premier Healthcare Database of US hospital discharge records, we selected non-donor patients undergoing inpatient radical nephrectomy with dates of admission between 1 October 2015, and 31 December 2020 (first=index admission)...

Background: Modern surgical staplers should provide precise placement and transection, especially in tight spaces and on thick tissue. Ideally, a stapler would move to accommodate variations in the tissue and anatomy instead of having to move the tissue around to fit the stapler. This study was undertaken to evaluate the performance characteristics of the new Echelon 3000 Stapler (ECH3). Use of the ECH3 was compared to another marketed stapler, including tests for access, seal strength, staple formation in thick tissue, and end effector stability...

PURPOSE: Non-invasive ventilation (NIV) may reduce intubation rates and be especially beneficial in the care of preterm infants, in addition to other care modalities. Currently, ventilators do not display the pressure at the nares but the pressure in the ventilator tubing system. There are several nasal cannulas available for use to deliver NIV. The purpose of this study was to compare the inspiratory pressure on the ventilator to the measured pressure delivered at the nares using three cannula brands (Manufacturer A, Fisher & Paykel; Manufacturer B, Neotech RAM; and Manufacturer C, Hudson RCI)...

Purpose: To evaluate the rheological properties of the ophthalmic viscoelastic device (OVD) PRO-149, its preclinical safety, and its effectiveness when used during cataract surgery in patients with age-related cataract. Material and Methods: Control (HEC) and test (PRO-149) OVDs were compared through rheological measures, by two preclinical safety studies in rabbits, and under normal-use conditions during cataract removal and lens implantation in a parallel randomized clinical trial...

Introduction: Heart sound signal is an important physiological signal of human body, and the identification and research of heart sound signal is of great significance. Methods: For abnormal heart sound signal recognition, an abnormal heart sound recognition system, combining hidden semi-Markov models (HSMM) with deep neural networks, is proposed. Firstly, HSMM is used to build a heart sound segmentation model to accurately segment the heart sound signal, and then the segmented heart sound signal is subjected to feature extraction...

Background: Cold plasma has many characteristics that allow for effective wound healing. Due to its efficacy, we have applied it in treating patients with severe Covid-19 who have soft tissue skin lesions and diseases including burns, pressure ulcers, shingles, and contact or atopic dermatitis. This study aims to assess the general characteristics of Covid-19 patients with soft tissue lesions and to conduct a fundamental evaluation of the efficacy of cold plasmamed beams in treating soft tissue wounds in patients with severe Covid-19...

Background: Mechanical ventilation (MV) is used to support patients with respiratory impairment. Evidence supports the use of lung-protective ventilation (LPV) during MV to improve outcomes. However, studies have demonstrated poor adherence to LPV guidelines. We hypothesized that an electronic platform adapted to a hand-held tablet receiving real-time ventilatory parameters could increase clinician awareness of key LPV parameters. Furthermore, we speculated that an electronic shift-change tool could improve the quality of clinician handoffs...