患者安全目标:加强医学装备安全与警报管理

阐述医疗器械使用安全与警报管理的意义和内涵,分析医疗器械使用安全与警报的风险点,探讨建立医疗器械使用安全与警报风险防范体系的方案,列举了医疗器械使用安全与警报管理的实践案例。     

The Lillehei Heart Institute: Building on the Shoulders of Giants

Scientific revolutions require a series of paradigm shifts that are promoted by a series of discoveries. These discoveries, paradigm shifts, and scientific revolutions are dependent on timing, environment, and innovative pioneers. More than 50 years ago, a series of discoveries led to such a paradigm shift at the University of Minnesota which in turn revolutionized the field of cardiovascular medicine forever. Today, this spirit of innovation and discovery is alive and thriving at the Lillehei Heart Institute at the University of Minnesota.     

A new design approach of user-centered design on a personal assistive bathing device for hemiplegia

Purpose. To move closer to the goal of independent living for stroke patients with hemiplegia, this study is to design an assistive bathing device approached from a User-Centred Design (UCD).

Method. Based on User-Centred Design methodology, a design process is adopted for this study. Observation and evaluation results from a Usability Context Analysis (UCA) are employed to improve the strengths, weaknesses, opportunities and threats (SWOT) and the matrix for matching the environmental threats and opportunities with company's weaknesses and especially it's strengths (TOWS), resulting in two assistive device (AD) design methods named AD-SWOT and AD-TOWS. Therefore, a new assistive device design process (AD-Design process) is proposed. A case study of stroke patients is conducted to practically apply the AD-Design process to the design of assistive bathing devices for stroke patients.

Results. By using the AD-Design process, three design concept orientations (AD-SO, AD-ST, AD-WO) were found for design concept generating from AD-TOWS. Four concepts for AD were decided and designed by the viewpoint of UCD. Finally, three ADs for bathing were tested by user-based assessment. And results showed the devices can help individuals clean case's body parts, such as case's backs and armpits that they were previously unable to clean independently.

Conclusions. AD-design process could help a product designer to generate suitable design approaching from UCD. In this study, three ADs (Back Cleaning Board, Feet Cleaning and Single-Sided Elastic Bathing Belt) were designed for a stroke patient's individual bathing.     

Tunneling a Pulmonary Artery Graft: A Simplified Way to Insert and Remove a Temporary Right Ventricular Assist Device

Right ventricular failure can occur early or late after left ventricular assist device implantation. Support with a right ventricular assist device is needed in patients whose right ventricular failure does not respond to conservative management. The use of a temporary right ventricular assist device can enable the recovery of right ventricular function and avoid the use of a more permanent biventricular assist device, which is associated with complications and higher costs. We present our technique of instituting temporary right ventricular assist device support in patients who have undergone left ventricular assist device implantation.     

Inappropriate shock for myopotential over-sensing in a patient with subcutaneous ICD

Inappropriate ICD shocks are common adverse events; they are mainly due to supraventricular arrhythmias and secondly are related to noise, undersensing, oversensing, device malfunctions. We present a case of inappropriate device therapy due to myopotential oversensing in a patient with a subcutaneous ICD (s-ICD). A 58 years old male with an s-ICD during the device interrogation showed a previous episode of suspected sustained ventricular tachycardia at 210 bpm, which was effectively treated with ICD shock. The patient experienced the electrical shock while holding a big gas-cylinder in his arms. The EGM analysis revealed many irregular ventricular signals of low amplitude lasting for 24 s and interrupted by the shock. The device showed no malfunctions. This is the first case report of inappropriate S-ICD shock related to myopotential over-sensing. By recording intracardiac EGM, we demonstrated that the noise was created by the activity of the pectorals muscles.     

Staphylococcus bacteremia without evidence of cardiac implantable electronic device infection

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