Manufacture / manufacturer medical devices

In the USA, the National Toxicology Program has declared dioxin a known human carcinogen - but injection moulder Brevet Inc. (who manufactures medical devices from PVC) plans to challenge the action in court. Brief details are given here. 

MED has a long history in the healthcare industry that dates back to 1877 when Erwin Mortiz Reiniger started manufacturing medical devices at the company s headquarters in Erlangen, Germany. After the discovery of the X-ray, the company successfully developed the first tube and equipment, and trend-setting innovations continued to drive the growth of the company (Table 2.1) (Mills Kurz, 2003). 

Software Validation Authorities are demanding rules in order to outline the software validation principles used in medical device software or the validation of software used to design, develop, or manufacture medical devices. 

Self-regulation is usually only effective when it concerns a product that is relatively simple to describe and to provide, with widely accepted standards regarding its safety performance (e.g., aviation), or when it concerns a product that is not allowed onto the market unless it has successfully passed various process stages by responding adequately to laws of certainty and predictability and technically engineered solutions (Freed et al, 2001). Medical device manufacturing, medical device application, and patient safety are not such simple issues. Past... 

Based on the obtained data, it is possible to state that no investigated materials are cytotoxic, and they can be used to manufacture medical devices. Furthermore, the absence of cytotoxicity allows to consider the BSTPE as a basis for the devices working in the body s internal environment. 

This simple business model became untenable, as the expensive-to-treat diseases drove many households bankrupt. Fortunately, the fact that such diseases afflicted only a small portion of the population enabled incorporation of risk sharing in the business model through 3rd party insurance companies. Today, the major stakeholders in the healthcare system include providers (hospitals, labs, and clinics), insurance companies with a diverse set of health plans, drug suppliers (retailers and manufacturers), medical device manufacturers, payers (employers and the government), research institutions, and patients as shown in Fig. 10.1. 

Colorants. According to U.S. regulations, colorants are divided into two classes certified and exempt (see Colorants for foods, drugs, COSMETICS, AND MEDICAL DEVICES). Batch samples of certified colors must be sent to the FDA for analysis and confirmation that the colorants comply with estabhshed specifications. Color manufacturers pay a small fee for each batch of color that is analy2ed. The number of certified colors available to food technologists has declined. Several of the historical colorants were found to have carcinogenic effects. Table 1 shows the certified colors that are permissible for food use in the United States as of 1993. 

Polymers and Coatings Advances ia polymer chemistry have resulted ia many successful medical devices, including diagnostic assays (26). Polymers (qv), which can be manufactured ia a wide range of compositions, ate used to enhance speed, sensitivity, and versatiUty of both biosensors and dry chemistry systems to measure vital analytes. Their properties can be regulated by composition variations and modifications. Furthermore, polymers can be configured iato simple to complex shapes. 

The pharmacist or physician can report any problems experienced with dmg products and medical devices. In cases where the PDA and/or manufacturer finds that a marketed product constitutes an actual or potential threat to the safety and welfare of the pubhc, that product must be withdrawn from the marketplace, ie, recalled. Several classes of recalls exist, depending on the relative danger that the product exhibits. C/ass I dmgs pose a serious health threat and may require withdrawal at the consumer level C/ass II dmgs pose a possible or potential health problem that usually means withdrawal at the pharmacy or wholesaler levels and C/ass III dmgs may present a remote hazard to health and safety. 

Various medical devices based on Terathane have been approved by the U.S. FDA, including those used within the body. Formulators are cautioned, however, that FDA approval is not given genericaHy for these devices it must be appHed for separately by each manufacturer for each device. Additional data on safety of PTMEG may be found in the material safety and data sheets provided by the manufacturers. 

AH implantable medical devices ate complex in design, materials, and implementation procedures. The biocompatibiUty, biodurabiUty, and efficacy of medical devices are the subject of extensive research by biomaterials scientists, device manufacturers, and health care professionals. 

Two statutory provisions of Tide 21 govern the introduction of new medical devices into the marketplace. Section 515 estabHshes a premarket approval appHcation (PMA) containing data and information demonstrating the safety and effectiveness of a device. Section 510(k) estabHshes a premarket notification process. Under this process, a manufacturer is required to file with the EDA, 90 days before a new device is to be marketed, a premarket notification demonstrating that the device in question is substantially equivalent to a device that was on the market before enactment of the 1976 Amendment and therefore marketable without formal EDA approval. 

Color Additives. The FDA has created a unique classification and strict limitations on color additives (see also CoLORANTS FOR FOOD, DRUGS, COSMETICS, AND MEDICAL DEVICES). Certified color additives are synthetic organic dyes that ate described in an approved color additive petition. Each manufactured lot of a certified dye must be analyzed and certified by the EDA prior to usage. Color lakes are pigments (qv) that consist of an insoluble metallic salt of a certified color additive deposited on an inert substrate. Lakes are subject to the color additive regulations of the EDA and must be certified by EDA prior to use. Noncertifted color additives requite an approved color additive petition, but individual batches need not be EDA certified prior to use. 

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. 

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. 

As a general rule, clinical data are required as evidence to support conformity with the requirements of the Active Implantable Medical Devices (AIMD) and the Medical Device (MD) directives with regards to safety and effectiveness under the normal conditions of use, evaluation of undesirable side effects, and the acceptability of the benefit/risk ratio. Risk analysis should be used to establish key objectives that need to be addressed by clinical data, or alternatively to justify why clinical data are not required (mainly for Class I devices). The risk analysis process should help the manufacturer to identify known (or reasonably foreseeable) hazards associated with the use of the device, and decide how best to investigate and estimate the risks associated with each hazard. The clinical data should then be used to establish the safety and effectiveness of the device under the intended use conditions, and to demonstrate that any of the residual risks are acceptable, when weighed against the benefits derived from use of the device. 

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