Medical device design reviews

Figure 13.1 Textile science contribution to smart fibrous implantable medical devices designing. Biocompatibility and well-functioning implants in the postoperative stage will be focused on in this review.

The Equivalent of a Development Report for Medical Devices in the Design History File. This comprehensive file would include critical information about the device s design, changes, review, and design controls. For medical devices, the requirements for the device s history have been codified under 21CFR 820.30. 

For medical devices, there is a phenomenon recognized as feature creep , in which the specifications for the design features of a device begin to drift toward a specification limit because inadequate design reviews, output verification and change control. This same sort of variability occurs with... 

Products reviewed range from toys to medical devices to cars to boats to underwater devices to containers to springs to pipes to buildings to aircraft to spacecraft and so on. The reader s product to be designed and/or fabricated can directly or indirectly be related to plastic materials, fabricating processes, and/or product design reviews in the book. 

In concert with the FDA s QSR, the international device community embraced a similar international standard known as ISO 13485 2003. This version of the standard, and the more current version ISO 13485 2012, like the QSR, put the emphasis on design controls. In both systems, the management of the company is held responsible for reviewing products and ensuring they are made according to a sound quality system. Despite international efforts to harmonize these standards and make their implementation as straightforward as possible, medical device manufacturers continue to recall products due to malfunctions and defects. But because of the system known as CAPA (Corrective and Preventative Actions) most medical devices are clean, safe and perform as intended. 

From the view of applied science and science for industry , ideally a new design paradigm specifically for medical applications should be introduced, which would be applicable to biodegradable and bioresorbable polymeric materials. However, number of books and reviews available on the topic is currently extremely limited. This concept will not be discussed any further here as it is out of the scope of this book. This section will not cover any of the scientific and technological details but rather, will focus on explaining the general practices and methodologies which need to be observed in the biopolymer and medical device industries. 

An annual review of the exposure control plan by employers must ensure that their plans reflect consideration and use of commercially available safer medical devices. An emphasis should be placed on the use of effective engineering controls, to include safer medical devices, work practices, administrative controls, and personal protective equipment. Employers should rely on relevant evidence, in addition to Food and Drug Administration (FDA) approval, to ensure the effectiveness of devices designed to prevent exposure to bloodbome pathogens. 

Wang WS, Wang C. Polyurethane for biomedical applications a review of recent developments. Design and Manufacture of Medical Devices, WoodheadPubl Rev Mech 2012 115-51. 

With new plastics and processes always becoming available, the design challenge becomes easier, even when taking today s solid-waste problem into account. Today s plastics and processes, as reviewed throughout this book, allow designers to incorporate and interrelate all the aspects of success. In products such as electronics, medical devices, transportation controls (as for aircraft, cars, and boats), and many others where user-friendly design is required, it has to be obvious to all that plastics play an important role. 

Miller, D. C., T. J. Webster, and K. M. Haberstroh (2004). Technological advances in nanoscale biomaterials the future of synthetic vascular graft design. Expert Review of Medical Devices l(2) 259-268. 

Smart polymers have been used in the design and construction of medical devices, with an emphasis on biosensors, bioactuators and microfluidics-based systems for enhanced diagnostics and therapy, other medical devices for cancer diagnosis and therapy, and for MIS. This section and those following review these applications. Applications of smart polymers for medical... 

Currently, there are still limited, incomplete, and insignificant human studies about the biocompatibility and biodegradability of newly developed chitosan derivatives. There are limited studies published in peer-reviewed journals describing the biocompatibility of chitosan or its derivatives, due to an absence of interest from manufacturers in applications of chitosan or its derivatives in the design of medical devices [104]. 

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