User, medical devices

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. 

The range of devices regulated under the general medical device directive, 93/42/EEC, can vary from the simple devices that pose little or no risk to patient or user health to those that are life-critical. It is neither economically feasible, nor justifiable in practice. 

The FDA are allowed 90 days to review a Traditional or Abbreviated 510(k) notification, and just 30 days for a Special 510(k). With the introduction of the Medical Device User Fee and Modernization Act of2002, provision was made for the participation of third-party organisations in the review process. This represents a partial adoption of the concept of Notified Bodies, which prevails in Europe. The FDA have accredited a number of commercial organisations to conduct primary 510(k) reviews of670 types of device. The FDA must then give a final determination within 30 days of receipt of the recommendation of a third-party reviewer. Because they are commercial, third-party reviewers will seek to offer faster review times in return for their review fee. If using a third-party reviewer, the FDA user fee does not apply. The outcome of a successful 510(k) notification is a letter from the FDA clearing the device for commercial sale. 

A copy of a completed Medical Device User Fee Coversheet, which permits checking that the review fees have been paid... 

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... 

Safe Medical Device Amendments, requiring more extensive testing of devices. 1992 Prescription Drug User Fee Act. Established the payment of fees for the filing of applications (e.g., IND, NDA, PLA, etc.)... 

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. 

BASF is thus currently endeavouring to establish the substance DINCH as a new registered substitute (entirely tested plasticiser without any hazardous properties) for DEHP in high-price market segments (e.g. medical devices). Soft PVC users substitute on the material level, if they can achieve further process-related and/or quahty-related optimisations in the course of technological development (e.g. underbody hard shells) Environment and health-compatible substance properties are additional qualities in business-to-business (B2B) markets. They are of relevance almost only for manufacturers, who market their products on demand-dominated, saturated markets with differentiated quality production — Hypothesis 8). 

Medical devices were first made subject to FDA regulation under the FD C Act of 1938. At that time, the statute included no requirement for premarket testing or approval. Congress enacted the Medical Device Amendments of 19766 to require pre-market notification for all medical devices, and pre-market approval for some old and new devices for which there is no adequate assurance of safety and effectiveness. The 1976 Amendments established a broad new array of statutory requirements and enforcement provisions. This new regulatory approach was supplemented by the Safe Medical Devices Act of 1990 3 and further refined by the Medical Device Amendments of 1992,61 Food and Drug Administration Modernization Act of 1997,6 jj g Medical Devise User Fee and Modernization Act... 

Food and Drug Administration, Department of Health and Human Services Final Rule, Natural rubber-containing medical devices user labeling. Fed Reg 62 51021, 1997... 

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. 

This legislation amended the Federal Food, Drug, and Cosmetic Act to improve the regulation of prescription drugs (as well as medical devices and food). The law notes that the PDUFA of 1992 successfully reduced review times and reauthorized the user fees to expedite the review process. Other provisions aimed to give some patients access to experimental drugs. Beyond that, the law made several other changes. 

Category 3 Medical devices that are controlled with each component (part) for assembly in the manufacturing process, and constituted (assembled) and maintained at the user site. Of course, the function of the medical device after assembly must be tested before release. 

The medical devices for category 3 in Table 1 are constituted (assembled) at the user site. Method verification for constitution should be one of the key factors, as well as qualification and validation in the manufacture of components (parts). Nuclear magnetic resonance spectroscopy (NMR) is included in this category. 

Validation in quality systems includes establishment of procedures on how to qualify the equipment and machinery, how to verify the design of products, how to verify the process designed, how to verify the achievement of production procedures, how to validate the process developed, and how to validate the methods for measurement and assay. Validation also requires verification of specifications or acceptance criteria of in-process parameters relating to both raw materials and intermediate (in-process product) and finished products, and verification of acceptance criteria for in-process parameters relating to operating conditions of machinery and equipment. Further, when the medical device is assembled at the user s site, validation includes establishing procedures of how to verify assembly. 

The most commonly used samplers in the pharmaceutical and medical device industry are impaction and centrifugal samplers. The selection, appropriateness, and adequacy of using any particular sampler is the responsibility of the user. 

Computer systems validation personnel must also deal with design errors. A program that perfectly meets a lousy specification is a lousy program. Specifically for medical devices, books on software reliability tend to set aside the user interface issue, and treat it as the sole province of the human factor analyst. The reliability of a system is determined by how all its various parts, including the people who use it, work together. 

PMDA also consolidates all information regarding the quality, efficacy, and safety of pharmaceuticals and medical devices from manufacturers, medical institutions, and other sources. This information is scientifically reviewed and considered in the implementation of appropriate safety measures in collaboration with Ministry of Health, Labour and Welfare. Essential information is broadly disseminated to medical experts, manufacturers, and users of pharmaceuticals, medical devices, and others. 

In contrast to chemicals, biomaterial and medical device testing constitutes an extremely diverse, heterogeneous category of evaluation. Because the use of these products normally entails direct or indirect contact with patients, there is an obligation for manufacturers to establish the product s safety before marketing. Medical device safety evaluation assesses the risk of adverse effects due to normal use and misuse. Since adverse effects could result from exposure to the materials from which a device is made, preclinical assessment is needed to minimize the potential hazard to the user, namely, the patient. 

End users of adhesives and medical devices expect the device to withstand the rigors of sterilization, exposure to fluids, and occasional abuse. Because of the criticality of the product, the medical device manufacturer is generally more motivated than most to pay attention to adhesive selection criteria and the requirements of good bonding practice. 

In this case there is no sense of measuring a characteristic. With this data we use a system of classifications, with no natural ordering. For example, one of the factors that might influence the effectiveness of treatment could be the specific manufacturer of a medical device. Therefore, all patients would be classified as users of Smith , Jones or Williams equipment. There is no natural sequence to these they are just three different makes. 

Ensure that drugs and medical devices are safe and effective, food is safe and wholesome, cosmetics are harmless, and that electronic products do not expose users to dangerous amounts of radiation. 

Requirements should be developed for the medical device and automated equipment used to support its manufacture. The requirements should clearly state the intended use of software. Areas of special importance include allocation of system fimctions to hardware/software, operating conditions, user characteristics, and potential hazards. ... 

It is not uncommon for a company to design a medical device prototype and then have it built by a company specializing in electronic manufacture. Where this happens, as in our case, a number of suitable companies should be considered for the project, and those shortlisted should be audited for capability. Selection would depend on the quality system in place, previous experience in medical device manufacture, control of subcontractors, level of testing supplied, and the amoimt of in-house technical support available. It is advisable to ensure that a legal agreement, Quality Plan, and User Requirements Specification (URS) are employed to secure production standards for the device. 

CFR part 801 natural rubber-containing medical devices, user labeling. Fed. Reg. 1997, 62 (189), 51021-51030. 

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