Medical devices manufacture

EC Introduces detailed specifications as regards the requirements laid down in Coundl Directive 93/42/EEC with respect to medical devices manufactured utilizing tissues of animal origin... 

FDA Design Control Guidance for Medical Device Manufacturers www.fda.gov. 

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... 

The ECMRA applies to medical devices manufactured in the EC, Australia and New Zealand. It recognises the competence of designated conformity assessment bodies (CABs) in the EC to undertake conformity assessment of medical devices to Australian regulatory requirements, and the competence of the TGA to undertake assessment of medical devices for compliance with the requirements for certification (CE Marking) for entry onto the EC market. 

Example 1 A medical device manufacturer is concerned about the nonconforming (defective) and the nonconformity (defect) produced in its recently set-up production line. Twenty batches of this medical device were randomly selected from the production line. Each batch contained 100 units. Each unit is inspected and is classified as either conforming or nonconforming. During the inspection, the number of nonconformities (defects) was also counted. The data collected are shown in Table 3. 

FIGURE 7 p Chart for medical device manufacturing example. 

The new medical device regulations were codified in 1996, significantly altering the way in which medical device manufacturers were inspected by the FDA. The quality systems inspection technique (QSIT) was launched as part of the new strategy for inspecting the device industry. This inspection technique allowed FDA to move closer to global harmonization guidelines... 

This focus helped field investigators conduct more effective, efficient, and comprehensive inspections of medical device manufacturers by evaluating key elements of a firm s overall quality system and compliance status. This new and improved inspection approach also led to an unprecedented number of administrative, regulator, and judicial actions against the medical device industry. 

Compliance Program Guidance Manual CPGM—Drugs and Biologies. Chap. 41 CP 7382.830. Inspection of Medical Device Manufacturers. July 1998. 

Medical Many types of medical devices rely on adhesives for assembly. Medical device manufacturing requires that the final product exhibit maximum reliability and performance under many conditions that are not common in other industries. As a result, manufacturers of medical devices require significant testing and verification prior to choosing an adhesive. The standards and regulations in this industry are much different from those of other industries. The nature of the medical device market also dictates that the adhesive be economical and amenable to high-volume manufacturing methods. 

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. 

Though the materials examined are expected to be representative of the materials delivered to medical device manufacturers it is possible that other changes could occur. Thus these results should not be extrapolated to carbon-containing medical devices until the actual carbon components have been surface analyzed. 

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. 

The following is an excellent example of a typical designed experiment performed early in the development process (i.e., long before process validation studies). It is based on an actual study performed at a medical device manufacturing plant. 

Medical Device Manufacturers Association (MDMA). 1900 K Street, N.W. Suite 300, Washington, DC 20006, U.S.A. Phone +1 202-496-7150. E-mail mdmainfo medicaldevices.org. URL http //www.medicaldevices.org. National trade association representing independent manufacturers of medical devices, diagnostic products, and health-care information systems. Its stated mission is to promote public health and improve patient care through the advocacy of innovative, research-driven medical device technology, and to this end is proactive in trying to influence policy that impacts medical... 

Paranoid accusations convince people to buy a product by suggesting that health care providers and legitimate manufacturers are in cahoots with each other promoting only the drug companies and medical-device manufacturers products for financial gain (Kurt-weil, 1999, p. 23). 

Somewhere around the contidence in a standard dose are the practicalities of it being simple and easy to administer by regulatory authorities, and of il being easy to justify by medical device manufacturers who may not be prepared to commit to the levels of microbiological effort required to validate other doses. 

The level of scrutiny given by the FDA to medical devices is less than that given to pharmaceutical products. Inspection is, as always with the FDA, thorough. Most medical device manufacturers, however, are not subject to premarket... 

To have facilities for the control of dust, humidity, insects and rodents. Proviso This provision shall not apply to facilities without such control which is deemed avoidable, based on the type of the medical device manufactured. 

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