scholarly journals Handling of Medical Devices: Reforms and Regulations

Author(s):  
M. Charmila ◽  
M. P. Venkatesh ◽  
G. Ramya Shree

With the evolving technology and changing regulations, the medical device sector is set to grow quickly soon. Even though they are an integral part of patient care they present several unique problems which are not sufficiently addressed by the device manufacturer or the medical community in general. Medical device is widely used by professionals in a clinical setup, by patients, family members at home. As step towards better understanding the rules, regulations, and the required reforms for the safe use of medical devices various measures taken by different regulatory authorities to ensure the minimization of use error are discussed. Human factor engineering and ergonomics are considered while designing a medical device. It is evident that all the stakeholders involved contribute to the safety of the medical device keeping in mind the welfare of the patient but is that enough and what can be done is discussed in this review work.

2021 ◽  
Vol 55 (s3) ◽  
pp. 35-44
Author(s):  
Brian McEvoy ◽  
Stacy Bohl Wiehle ◽  
Ken Gordon ◽  
Gerry Kearns ◽  
Paulo Laranjeira ◽  
...  

Abstract Based on excellent material compatibility and ability for scale, ethylene oxide (EO) sterilization constitutes approximately 50% of single-use medical device sterilization globally. Epidemiological considerations have elevated focus toward optimization of EO processes, whereby only necessary amounts of sterilant are used in routine processing. EO sterilization of medical devices is validated in accordance with AAMI/ANSI/ISO 11135:2014 via a manner in which a sterility assurance level (SAL) of 10−6 is typically achieved, with multiple layers of conservativeness delivered, using “overkill” approaches to validation. Various optimization strategies are being used throughout the medical device industry to deliver the required SAL while utilizing only necessary amounts of sterilant. This article presents relevant experiences and describes challenges and considerations encountered in delivering EO process optimization. Thus far, the results observed by the authors are encouraging in demonstrating how EO processing can be optimized in the delivery of critical single-use medical devices for patient care.


2021 ◽  
Author(s):  
Kaoru Inoue ◽  
Chiyomi Yatsu ◽  
Daryl Patrick Yao ◽  
Chihiro Sasaki ◽  
Kazuyoshi Wada ◽  
...  

Abstract Background: In Japanese society today, many elderly persons with dementia (EPWD) are living at home. This research focused on the family members of EPWD who provide informal care and support. The purpose of this research was (1) to analyse the potential and effectiveness of care provided by the family with the use of the robotic seal PARO, a neurological biofeedback medical device, and (2) to identify and prioritise problems when utilising PARO in the home context. Methods: This study employed a mixed-methods approach involving observational data and interviews. Family members of seven households caring for EPWD were asked to use the seal robot “PARO” as a means to provide care. The family caregivers used PARO at home for more than three times per week, over one to three months. At the initial visit, an individualised purpose of PARO was established. Family members were taught how to operate PARO and how to facilitate PARO use. Research data were collected at initial and subsequent monthly visits, in the form of families’ observational feedback, interviews, and direct assessment of the subjects. Collected data were analysed quantitatively and qualitatively. Results: Five out of the seven elderly persons reacted positively to PARO and achieved their intervention goals. Acceptance of PARO use depended on the positive interaction observed at the initial encounter, which led to continued interest later on. On the other hand, for the subjects where “encouragement was required to trigger interaction” at the initial encounter, their subsequent interest may either increase or decrease. Furthermore, observed activities with PARO use for all families were conversations and physical touch to PARO. Some families facilitated reminiscence and intellectual activities. Conclusions: The study indicated that the effect of PARO application at home is possibly influenced by the participants' initial level of interest towards PARO. It is still crucial to perform careful observation and assessment of the benefit of PARO before adapting the treatment strategy. The families need specific advice from relevant healthcare professionals, such as occupational therapists, to maximise the use of PARO. This implies that effective robotic care at home requires professional support.


Author(s):  
Juliana Shaibun

Quality management system (QMS) is acknowledged as the primary method for any manufacturer, especially medical device manufacturers, in order to sustain the product quality in the competitive advantage in business environment. QMS is an essential requirement for regulatory control in high risk medical devices. Globally, the number of medical device manufacturers certified by ISO 13485 is escalating. Ownership of this certification symbolizes the medical device manufacturer acquired high performance in their QMS. This bibliometric provides a brief review of the quality assurance and how safety plays an important role in medical devices. Bibliometric analysis guided user to summarize the essential part of quality assurance process in medical device. The insights presented in this research assist in building a firm theoretical base and direction for future research.


2019 ◽  
Vol 2019 (3) ◽  
pp. 36-43
Author(s):  
Айсылу Валеева ◽  
Aysylu Valeeva ◽  
Анна Дмитриева ◽  
Anna Dmitrieva ◽  
Денис Шарикадзе ◽  
...  

The article conducts the analysis of the practice in the application of patient registers with implanted medical devices by regulatory authorities of various countries for vigilance of medical devices, as well as review of current patient registers their categories and applicability. In addition, the article review the recommendations of The International Medical Device Regulators Forum (IMDRF) on development, implementation and application methodology of patient registers.


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