Medical devices incorporation

EC Amends Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma... 

Fig. 8.12 A functional nanoscale medical device incorporating targeting protein sequences (red), a flagella-type propulsion mechanism (green and purple) and drug delivery vehicle (gold)...

Thus, the EU, in particular, develops a series of interpretative guidelines [28] to help manufacturers in the correct implementation of the requirements of Directive 93/42/EEC in particular, the context of MD applies to guideline MEDDEV 2.1/3 MEDICAL DEVICES Guidance document—Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative. ... 

MEDDEV 2.1/3 MEDICAL DEVICES Guidance document - borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative. 

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. 

M.C. Frost, M.M. Reynolds, and M.E. Meyerhoff, Polymers incorporating nitric oxide releasing/gener-ating substances for improved biocompatibility of blood-contacting medical devices. Biomaterials 26, 1685-1693 (2005). 

Antibodies are powerful tools in pharmaceutical development, and as den-drimers are incorporated into various drugs and medical devices, antibodies such as described should be useful to study dendrimer biodistribution and pharmacokinetic properties. We have not attempted to detect PAMAM de-ndrimers in biological fluids (blood, urine, sputum, etc.), but expect that it would work. Additionally, the antibodies might be used in immunohistochemistry to study the tissue and cellular distribution of dendrimer therapeutics. 

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. ... 

Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product and which is liable to act upon the body with action ancillary to that of the device (e.g. a heparin-coated catheter), the product is classed as a medical device. However, the medicinal product is to be assessed in accordance with the requirements of Directive 75/318/EEC (replaced by 2001/83/EC and updated by 2003/63/EC). A notified body undertaking conformity assessment on a medical device which incorporates a medicinal substance having ancillary action has a responsibility to consult a national medicines agency about the medicinal substance, to verify its safety, quality and usefulness by analogy with the appropriate methods specified in Directive 75/318/EEC. 

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. 

Weinger M.B. et al. Incorporating human factors into the design of medical devices [letter]. JAMA 1998 280 1484. 

Early on in the design phase it is important to identify and imderstand the impact of faults on the medical device so that controls can be incorporated as necessary. Fault Tree Analysis is often used... 

FDA Enforcement Report Index. 1990-. Weekly. URL http // www.fda.gov/opacom/Enforce.html. This database provides access to drug and medical device recalls and product seizures in the United States. A search form incorporated into the opening page enables keyword searches of the entire collection. Simple queries involving only one factor, such as a company or brand name, quickly locate pertinent recall notices, each of which identifies specific product batches, quantities withdrawn from commerce, and their previous geographic distribution. Each entry also describes the reason for recall (contamination,... 

These include acidic chelating components reactively bound to a hydiophiUc PU prepolymer together with noble metal combinations or antibacterials. The combinations can be incorporated as additives during plastic moulding of medical devices. The compositions are useful for making mological applieations. 

The present invention provides for medical devices which are antiinfective as a resirlt of antinfective agents impregnated onto their surfaces and/or antinfective activity incorporated into their access sites. It is based, at least in part, on the discovery that certain combinations of antimicrobial agents and solvents change the surface characteristics of polymeric medical devices, thereby facilitating the retention of antimicrobial agents. It is further based on the discovery that the incorporation of antinfective polymeric inserts into the access sites of a medical device provides improved antinfective activity. 

K. (2006) Incorporation of growth factors into medical devices via biomimetic coatings. Philos. Trans. R. Soc. London, Ser. A, 346 (1838), 233-248. 

Today, substantial cross-cutting between the medical and physical, chemical, and biological defense research communities already exists. For example, genetics research has long been incorporated into detection schemes in industrial pharmaceutical and medical device development. In some applied research and advanced development, however, islands of specialization remain isolated, for example, animal testing to satisfy regulatory requirements. 

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