Medical Device Manufacturers Association

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... 

When patients undergo surgery, they expect good results. When bad results occur, they may sue the physician, the hospital, and the medical device manufacturer. Modern surgery involves medical devices such as electrosurgery, anesthesia machines, and lai e imaging devices. Problems associated with such devices have resulted in serious burns, loss of limbs, and death. Because the bioengineer maybe an expert on one of these medical devices, he or she may become an expert witness in one of these cases and offer an expert opinion on the cause of the problem. 

CDRH receives many inquiries from healthcare organizations, medical device manufacturers, clinicians, and the public seeking information about experiences with and prevention of electromagnetic interference (EMI) with medical devices. The following information is intended to help minimize the risks associated with medical device EMI and promote EMC in healthcare facilities. Some recommendations for healthcare facilities to follow include the following ... 

In addition to this, any patch upgrades to tools associated with the medical IT network will need careful planning and scheduling, following consultation with the medical device manufacturer. The following section contains some useful suggestions from the FDA in respect of maintenance planning for medical IT networks. 

In total, 19 interviews were conducted, involving 4 industry associations Innovative Pharmaceutical Industry Association (IPASA), National Association of Pharmaceutical Manufacturers (NAPM), South African Chambers of Commerce (SACCI) and South African Medical Device Industry Association (SAMED). 

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. 

Pharmaceutical Manufacturers Association. Guidelines for the Assessment of Drug and Medical Device Safety in Animals. Washington Pharmaceutical Manufacturers Association, 1977. 

In Japan, prior to 1979 no formal regulatory guidance was available to western pharmaceutical companies and a marketing authorization of new drug products could not be obtained by non-Japanese manufacturers. The PMDA as we know it today was established in 2004 from the earlier Pharmaceutical and Medical Devices Evaluation Centre (PMDEC), the Organisation for Pharmaceutical Safety and Research (OPSR), and the Japanese Association for the Advancement of Medical Equipment (JAAME). 

Health Industry Manufacturers Association. Medical Device Sterilization Monographs, Sterilization Cycle Development, report no. 78-4.2 (1978). 

Even for the manufacture of medical devices or diagnostic agents, there are still other equally challenging changeover situations. The point to be made here is that the changeover situations have different inherent risks associated with them and we need to study them, be aware of them, and build them into our master plan or strategy for cleaning. 

The hazards posed to a medical device associated with its manufacture should also be included. Complex arrangements may require multiple phases of hazard analysis. 

AdvaMed. 1200 G Street NW, Suite 400, Washington, DC 20005-3814, U.S.A. Phone +1 202-783-8700, Fax +1 202-783-8750. E-mail info AdvaMed.org. URL http //www.advamed.org. The largest medical technology association in the world, representing more than 1200 manufacturers of medical devices and... 

ISO 62366 2007 Medical devices - Application of usability engineering to medical devices [12] is a design and development standard which is harmonised with medical device compliance requirements in many territories. It is closely aligned to risk management standard ISO 14971 2012, essentially ISO 62366 explores in greater depth those hazards which arise from a product s usabifity characteristics. Whilst intended as a standard to support the manufacture of medical devices it contains a useful framework that could be utilised by manufacturers of general HIT products where the user interface is associated with a number of important safety related hazards. 

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