Medical Device Reporting System

It is very important to ensure that having a signed paper-based record (e.g., a report) associated with one or more electronic records, the electronic file(s) associated with these records must not be deleted. The Part 11 regulation is very specific regarding this issue. Electronic files in hybrid systems must be maintained electronically. The interpretation of this requirement in the medical devices CGMP regulations (21 CFR 820) is different. Part 820 requires that the results of acceptance activities are recorded, but are not necessarily raw data, and these results must have audit trails. This interpretation is contained in the medical device quality system preamble (pp. 52631 and 52646). 

Federal Register April 10,1998 (Volume 63, Number 69). Mutual Recognition of the FDA and European Community Member State Conformity Assessment Procedures Pharmaceutical GMP Inspection Reports, Medical Device Quality System Evaluation Reports, and Certain Medical Device Premarket Evaluation Reports. 

Medical Device Monitoring System. Another similar system reports to the MHLW the problems encountered with medical devices. 

The Silver Sheet. Chevy Chase, MD FDC Reports. Monthly. ISSN 1093-28IX. Available electronically. Provides information on the FDA s interpretation and application of the FDA s Medical Device Quality System Final Rule. Focuses on quality control, manufacturing compliance and design issues affecting the medical device and diagnostics industries. 

The number of medical device reports has risen over the past decade, as technology has become more complex and sophisticated, patients and professionals have been encouraged to report problems, and the number of devices in use has dramatically increased. Increased reporting reflects a high level of awareness and therefore the effectiveness of the safety monitoring system. It does not mean that manu cturing standards have fallen or that devices have become less safe, overall... 

Postmarketing controls include estabUshment registration, device listing, quality system compliance inspection, and medical device reporting (MDR). 

The submission of an application conveys an acceptance of certain responsibilities, including the accuracy and the quality of the data as well as the required subsequent reporting and technical commitments for the product and its intended use. To assure the accuracy and quality of the data and information provided in applications, the Act gives the FDA broad authority to inspect pharmaceutical and medical device establishments, including manufacturers and other research testing facilities from which data are derived. Applicants therefore must have documented systems in place for all processes from which data are derived and included... 

Pseudomonas aeruginosa is an opportunistic pathogen and infects especially immunocompromised patients.266-270 Many clinical isolates of P. aeruginosa are identified not only from the inside of the body but also from the biofilm formed on indwelling catheter or medical devices. Quorum sensing system of P. aeruginosa has been extensively studied and several kinds of systems have been reported.2 1-292... 

The use of dynamic mechanical analysis for the development of polymeric systems as medical devices has been described by several authors. In one report, Silver et al. (82) examined the physical properties and hemocompatibility of polyurethanes containing polyethylene oxide macrogols. Using this technique, a series... 

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