Manual of Commercial Methods in Clinical Microbiology

• Éditeur: Wiley-Blackwell
• Année: 2016
• ISBN:
  9781119021841
• Édition: 2
• Sujet: Biological Sciences
• Sous-sujet: Microbiology

The Manual of Commercial Methods in Clinical Microbiology 2 nd Edition, International Edition reviews in detail the current state of the art in each of the disciplines of clinical microbiology, and reviews the sensitivities, specificities and predictive values, and subsequently the effectiveness, of commercially available methods – both manual and automated. This text allows the user to easily summarize the available methods in any particular field, or for a specific pathogen – for example, what to use for an Influenza test, a Legionella test, or what instrument to use for identification or for an antibiotic susceptibility test.

The Manual of Commercial Methods in Clinical Microbiology, 2 nd Edition, International Edition presents a wealth of relevant information to clinical pathologists, directors and supervisors of clinical microbiology, infectious disease physicians, point-of-care laboratories, professionals using industrial applications of diagnostic microbiology and other healthcare providers. The content will allow professionals to analyze all commercially available methods to determine which works best in their particular laboratory, hospital, clinic, or setting.

Updated to appeal to an international audience, The Manual of Commercial Methods in Clinical Microbiology, 2 nd Edition, International Edition is an invaluable reference to those in the health science and medical fields.

CHAPTER 1
Role of the US Food and Drug Administration in the Regulation of Clinical Microbiology Devices

Kathleen B. Whitaker, Sally A. Hojvat, and Estelle Russek-Cohen

Food and Drug Administration, White Oak, MD, USA

1.1 Historical overview of in vitro diagnostics

The Medical Device Amendment (MDA) of 1976 [4] was the result of a long history of fraudulent medical devices beginning as early as the 1700s with Dr. Elisha Perkins' patent tractors, which consisted of two rods of brass and iron about three inches long purported to eliminate disease from the body. Despite the surge of fraudulent medical devices throughout the years, no substantial regulation was enacted to ensure the safety and effectiveness of devices. The enactment of the Food Drug and Cosmetics (FD&C) Act of 1938 was the first step towards eventual implementation of device regulation.

1.1.1 Device classification via the MDA of 1976

The subject matter in this section as well as the remainder of the chapter will be confined to a discussion of the regulations that affect the classification of microbiological devices, as well as the various FDA processes which enable the commercial interstate sale and distribution of clinical microbiology in vitro diagnostic devices (IVDs) by the Center for Devices and Radiological Health (CDRH).

The following definition of an in vitro diagnostic device can be found in the FDA regulation 21CFR (Code of Federal Regulations) 809.3

1. In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act.
2. A product class is all those products intended for use for a particular determination or for a related group of determinations or products with common or related characteristics or those intended for common or related uses. A class may be further divided into subclasses when appropriate.

The MDA of 1976 required that all medical devices be divided into three product classes by virtue of the types of controls necessary to assure the safety and effectiveness of the device.

• Class I, general controls, includes devices which appear to pose relatively little risk to human health and for which a series of general controls are believed sufficient to ensure safety and effectiveness. The controls include regulations that: (i) prohibit the sale of adulterated or misbranded devices; (ii) require domestic device manufacturers and initial distributors to register their establishments with the FDA and provide the FDA with a list of all devices being sold before the passage of the law (pre-amendment devices); (iii) grant the FDA authority to ban certain devices; (iv) provide for notification to the FDA of risks and of repair, replacement, or refund (recall); (v) restrict the sale, distribution, or use of certain devices; and (vi) govern good manufacturing practices, records and reports, and inspections. These requirements also apply to Class II and Class III devices.
• Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. Special controls may include special labeling requirements, mandatory performance standards, and post-market surveillance.
• Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. In many cases there is insufficient information to ensure that general controls and performance standards will provide assurance that the devices are safe and effective. New devices are assigned to Class III until they are found to be substantially equivalent to a pre-amendment device (Class I or II) or are reclassified as Class I or II devices through the de novo petition program.

As can be seen from the above descriptions, classification of an IVD is risk based. In addition, device classification is inherently tied to the intended use of a device. For example, when the intended use for a device is as an aid in the assessment of serological status for sexually active adults and expectant mothers the device is classified as Class II as risks may be mitigated with appropriate controls. However, when the intended use for a device is an aid in the assessment of response to therapy in immunocompromised patients, e.g., transplants recipients where there is a substantial increase in risk such as death from cytomegalovirus (CMV) infection, the device classification is Class III.

Microbiology device regulations and their classifications can be found in 21 CFR, Microbiology Regulation, Sections 866.1 through 866.3980. The following are examples of Class I and Class II microbiology devices.

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Sec. 866.3020 Adenovirus serological reagents

(a) Identification.

Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).

(b) Classification.

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

Sec. 866.3390 Neisseria spp. direct serological test reagents

(a) Identification.

Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluores...