Medical device safety

Emphasis on engineering controls is based on ways to better protect workers from contaminated needles or other sharp objects. Many safety medical devices are already available and effective in controlling these hazards, and wider use of such devices would reduce thousands of injuries each year. OSHA issued a final regulation (29 CFR 1910.1030) on occupational exposure to bloodbome pathogens in 1991, to protect nearly six million workers in healthcare and related occupations at risk of exposure to bloodborne diseases. Occupational exposure to blood and other potentially infectious materials that may contain bloodbome pathogens, or microorganisms that can cause bloodborne diseases, is of concern to those workers who are at risk for exposure. 

Certain types of equipment are specifically excluded from the scope of the directive. It is self-evident that equipment which is already regulated at Union level with respect to the pressure risk by other directives had to be excluded. That is the case with simple pressure vessels, transportable pressure equipment, aerosols and motor vehicles. Other equipment, such as carbonated drink containers or radiators and piping for hot water systems are excluded from the scope because of the limited risk involved. Also excluded are products which are subject to a minor pressure risk which are covered by the directives on machinery, lifts, low voltage, medical devices, gas appliances and on explosive atmospheres. A further and last group of exclusions refers to equipment which presents a significant pressure risk, but for which neither the free circulation aspect nor the safety aspect necessitated their inclusion. 

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marketed product constitutes an actual or potential threat to the safety and welfare of the pubhc, that product must be withdrawn from the marketplace, ie, recalled.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. 

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. 

AH medical devices marketed before May 28, 1976, are distinguished from devices developed after this date, ie, pre-1976 devices were grandfathered. Pre-1976 devices, and those devices similar to them are placed into one of three categories based on the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. 

Orga.nic Colora.nts. The importance of coal-tar colorants cannot be overemphasized. The cosmetic industry, in cooperation with the FDA, has spent a great deal of time and money in efforts to estabUsh the safety of these dyes (see Colorants for food, drugs, cosmetics, and medical devices). Contamination, especially by heavy metals, and other impurities arising from the synthesis of permitted dyes are stricdy controlled. Despite this effort, the number of usable organic dyes and of pigments derived from them has been drastically curtailed by regulatory action. 

The needle stick log will help both employees and employers track all needle sticks to help identify problem areas. The log must be maintained to protect the confidentiality of the injured employee. In addition, employers must have a written Exposure Control Plan that is updated annually. During the annual review, inquiries must be made about new or prospective safer options. If new safer devices are available, they should be adopted for use in the agency. The new guidelines will help reduce needle stick injuries among health care workers and others who handle medical sharps. Safety engineered devices such as self-sheathing needles and needleless systems can be used. 

Medical Device Amendments passed to ensure safety and effectiveness of medical devices, including diagnostic products. 

General medical devices are the responsibility of the Center for Devices and Radiological Health (CDRH). The CDRH is also responsible for assessing the safety of non-medical radiation-emitting products such as televisions, microwaves and mobile telephones. 

The CE Mark is not specific to medical devices, but is used generally to indicate to European consumers that a product conforms to applicable European performance and safety requirements. It can be found on electrical equipment, children s toys and safety equipment, among other products. 

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. 

Studies to investigate the safety and effectiveness of In Vitro Diagnostic (IVD) medical devices under intended use conditions are conducted as performance evaluations. They are considered to present less risk than clinical investigations since, by their nature, studies involving IVDs cannot have any direct impact on the health and safety of trial subjects. 

The Competent Authority to which the incident was originally reported usually takes on the role of monitoring and evaluating how the incident is dealt with. When all actions are complete, including any necessary Field Safety Correction Actions, the manufacturer must submit a final report to the Competent Authority. Under a safeguard clause. Competent Authorities may take unilateral action to remove a device from their market, if they believe that it poses an unacceptable health risk, but the Commission must be informed of such actions. In less-urgent situations, concerns may be referred to the Committee for Medical Devices for consideration. 

In 1992, the FDA issued a moratorium on silicone-gel-filled implants, and restricted their use to reconstmction and clinical smdies. In 2000, they approved saline-filled implants. In 2003, the General and Plastic Surgery Devices (GPSD) Advisory Panel recommended reapproval of gel-filled implants, but the FDA decided to wait for more clinical evidence of safety. In late 2005, the Panel recommended conditional approval of Mentor s and Inamed s gel implants. In October 2006, Health Canada approved the use of sUicone-gel-filled implants, with a warning that no medical device is 100% safe. ... 

There is much concern for the safety of personnel handling articles contaminated with pathogenic viruses such as hepatitis B virus (HB V) and human immunodeficiency vims (HIV) which causes acquired immune deficiency syndrome (AIDS). Some agents have been recommended for disinfection of HBV and HIV depending on the circumstances and level of contamination these are hsted in Table 10.4. Disinfectants must be able to treat rapidly and reliably accidental spills of blood, body fluids or secretions from HIV infected patients. Such spills may contain levels of HIV as high as lO" infectious units/ml. Recent evidence Irom the Medical Devices Agency evaluation of disinfectants against HIV indicated that few chemicals could destroy the vims in a... 

For any intervention intended to impact favorably upon human health, it is important to evaluate its safety and efficacy in order to demonstrate that it does not cause harm and it does provide the expected benefit. The gold standard method for evaluating any intervention, whether it be a botanical product, dietary supplement, drug, medical device or medical procedure, is the randomized, clinical trial (RCT). A clinical trial is a type of experiment conducted in human subjects where the effects of at least two interventions are compared. Often, the clinical trial takes the form of an active treatment compared to an inactive control or placebo. 

The FDA of the U.S. Department of Health and Human Services (DHHS) administers the regulatory controls for the Food, Drug, and Cosmetic Act of 1906 and the 1976 and 1990 amendments, which provide approval for commercial distribution of safe and effective medical devices. The 1976 amendments directed the FDA to regulate medical devices under control levels that are necessary to ensure safety and effectiveness. In order to achieve this task, the Medical Device Law under the amendments required the FDA to issue regulations placing all medical devices on the market at that time into one of three regulatory classes ... 

Polycarbonate can be readily injection molded. Polycarbonates typically require only a short injection molding cycle time, because the polymer flows into the mold easily and solidifies rapidly. We injection mold polycarbonate to produce a wide variety of commercial goods, including compact disks, jewel cases, aircraft windows, kitchen utensils, and clear refrigerators drawers. Polycarbonates are also found in a wide range of disposable medical devices, such as the flow locks on intravenous tubes and the hard, disposable components of dialysis machines. Impact resistant polycarbonate is used to manufacture sports and other safety helmets. Glass fiber reinforced polycarbonate is used in the housings for power tools. 

Clinical trials serve to assess the safety and efficacy of any potential new therapeutic intervention in its intended target species. In our context, an intervention represents the use of a new biopharmaceutical. Examples of other interventions could be, for example, a new surgical procedure or a novel medical device. Veterinary clinical trials are based upon the same principles, but this discussion is restricted to investigations in humans. Clinical trials are also prospective rather than retrospective in nature, i.e. participants receiving the intervention are followed forward with time. 

Medical grade plastics are discussed with reference to biocompatibility and the tests that the end-product manufacturer should perform in order to ensure the safety of the material. Regulatory requirements are described, and tabulated data is presented on mostly European suppliers of medical grade plastics. The data shows that most companies rely onUSP Class VI certificates to demonstrate the suitability of their materials for the medical industry. However, it is argued that most manufacturers of medical devices would benefit more from tests carried out according to ISO 10993. 6 refs. 

Passage of the Food, Drug and Cosmetic Act. Superseded the law of 1906. Required evidence of safety, e.g., studies in animals. Included coverage of cosmetics and medical devices. Specifically excluded biologies. 

Medical Device Amendment to the FDCA requiring for devices that not only effectiveness be proven, but also safety. 

There are a number of special concerns about the safety of materials that are routinely injected (parenterally administered) into the body. By definition, these concerns are all associated with materials that are the products of the pharmaceutical and (in some minor cases) medical device industries. Such parenteral routes include three major ones IV (intravenous), IM (intramuscular), and SC (subcutaneous) and a number of minor routes (such as intra-arterial) that are not considered here. 

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