Medical device importance

Orga.nic Colora.nts. The importance of coal-tar colorants cannot be overemphasized. The cosmetic industry, in cooperation with the FDA, has spent a great deal of time and money in efforts to estabUsh the safety of these dyes (see Colorants for food, drugs, cosmetics, and medical devices). Contamination, especially by heavy metals, and other impurities arising from the synthesis of permitted dyes are stricdy controlled. Despite this effort, the number of usable organic dyes and of pigments derived from them has been drastically curtailed by regulatory action. 

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

Plastics continue to make inroads regarding medical applications. Certain plastics have been found to exist in the environment of living tissues. In addition to being of direct aid in medicine, they are also important in medical devices and packaging medical items. 

Quality system regulation The past good manufacturing practice (GMP) and process validation (PV) was renamed to quality system regulation (QSR). It is important for the medical device industry (that uses an extensive amount of plastics) and also in other product industries where they want to follow strict processing procedures. It sets up an important procedure for many plastic fabricators to consider that targets to ensure meeting zero defects. 

Parts 800 to 1299. Medical devices and radiological health. Regulations under the Federal Import Milk Act, the Federal Tea Importation Act, the Federal Caustic Poison Act, and for control of communicable diseases and interstate conveyance sanitation. 

Medical device manufacturers, importers and user facilities are obliged to report adverse incidents as summarised in Table 12.4. The criteria for what constitutes a... 

For any intervention intended to impact favorably upon human health, it is important to evaluate its safety and efficacy in order to demonstrate that it does not cause harm and it does provide the expected benefit. The gold standard method for evaluating any intervention, whether it be a botanical product, dietary supplement, drug, medical device or medical procedure, is the randomized, clinical trial (RCT). A clinical trial is a type of experiment conducted in human subjects where the effects of at least two interventions are compared. Often, the clinical trial takes the form of an active treatment compared to an inactive control or placebo. 

Where there is a dosing device provided with the product, the dose reproducibility and accuracy should be demonstrated. Examples include dropper devices, dose-measuring devices, and pen injectors. The instructions for use should also be discussed for such devices and may be particularly important for devices such as two-chamber cartridges and the like containing suspension products. It might be necessary to discuss how dosing devices meet the relevant Essential Requirements of the Medical Device Directives with reference to appropriate and relevant harmonized and other European (EN) and International Standards Organization (ISO) standards. 

The shares for categories 7 and 9 were given with less thanl% and adjusted to 0.5%. Category 8 (medical devices) has been left out by the authors of the WEEEman maybe because of its minor importance. 

E. Medical Device Reporting. The manufacturers, distributors, importers, and users of all devices, including those regulated by CDER, shall report to CDRH under Section 519 of the Act as required. The Center for Devices and Radiological Health will provide monthly reports and special reports as needed to CDER for investigation and follow-up of those medical devices regulated by CDER. 

For example, Asuri and his co-workers (Asuri et al., 2007) reported that the proteases attached to the surface of SWCNTs can create self-cleaning surfaces that resist protein adsorption. This kind of SWCNT-enzyme composite exhibited 30 times higher overall catalytic activity than control composites where the proteases were conjugated to a non-nanoscale graphite support. Importantly, the enzymes preserved more than 90% of their initial activity over 30% days in the liquid buffer, with only negligible amounts of enzymes leaching out. The result demonstrates that the nanocomposites of SWCNTs and polymers can act as hosts for enzymes and can prevent protein contamination on the surface of medical devices. We consider that SWCNTs may have the function as biocatalyst to improve the enzyme activity attached to the surface of CNTs. Our previous work also indirectly hints that CNTs could improve the bioactivity of enzymes such as Taq enzyme Cui et al. (2004). However, there are also adverse reports. CNTs can... 

Excimer lasers are of great importance for UV and vacuum UV (VUV) spectroscopy and photochemistry. They are also found in a wide range of applications. For example, they are used in micromachine medical devices, including refractive surgery, in photo-lithography for the microelectronics industry, for material processing, as optical pump sources for other type of lasers (dyes), and so on. More details about excimer lasers can be found in Rodhes (1979). 

Other DEHP substitutes currently in use, important in terms of produced volumes, are also terephthalates, e.g., di(2-ethyUiexyl) terephthalate (DEHT). DEHT is produced in volumes up to 50,000 tones [116], and the main applications are coatings, vinyl floorings, electric connectors, vinyl water stops, coating for clothes, bottle caps, toys, and medical devices [117]. 

To be successful in the pharmaceutical market it is vital that data on how your product is progressing and what the competition is doing is constantly updated and evaluated. It is also important to keep track of what might be occurring in alternative fields, which may have an impact on the market. A new surgical technique or new medical device may be introduced that completely alters the way a disease is managed. 

The basic structure, concepts and terminology of the three Directives on AlMDs, MDs and 1 VDs are identical the differences that exist among them arise out of the different nature of these products. The following discussion will therefore focus on the medical devices directive (MDD), since this is the central Directive and covers most products. Short sections follow on AlMDs and IVDs. Detailed analysis of the relevant provisions would fill a large book what is intended here is to highlight the important aspects which should be considered. 

Medical devices may be assisted in their function by pharmacological, immunological or metabolic means, but as soon as these means are not any more ancillary with respect to the principal purpose of a product, the product becomes a medicinal product. The claims made for a product, in accordance with its method of action may, in this context, represent an important factor for its classification as MD or medicinal product. Examples of MDs incorporating a medicinal substance with ancillary action include catheters coated with heparin or an antibiotic, bone cements containing antibiotic and blood bags containing anticoagulant. ... 

Responsibility for regulatory review has been passed to an Incorporated Administrative Agency, the Pharmaceutical and Medical Devices Agency (PMDA). PMDA also intensively checks applications for GCP compliance and reliability compliance. Another important role of PMDA includes an advice to sponsors on clinical trials and on which result can be submitted at the time of a new drug application. 

Tamponade media are classic medical devices. The general requirement for an approval of such a product is the conformation of the non-toxicity as an important part of the biocompatibility. There are detailed guidelines available which determine the tests necessary, dependent on the intended use of the product. 

Software validation is not separately defined in the quality system regulation. The FDA considers software validation to be the confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled [14]. Software validations have special concerns on software installation, implementation, and utilization. A software validation consists in several tests, inspections, and verifications performed to assure the adequate installation and use of software and that the tasks performed meet all the specifications defined. Software validations must be performed under the environmental conditions to which software will be submitted. This is particularly important in medical devices that are used under special conditions, such as close to or inside the human body. 

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