1、ANSI/AAMI NS28:1988/(R)2015Intracranial pressure monitoring devicesAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or recommended practice are clearly understood. The obj
2、ectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of current technologies to patient care, and (2) the encouragement of new tec
3、hnologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to these objectives and provided that arbitrary and restrictive uses are avoided. A voluntary standard for a
4、medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device for clinical use, and the measurement techniques that can be used to determine whether the device con
5、forms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the device, including performance characteristics, instructions for use, warnings and precautions, and other d
6、ata considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods to facilitate uniformity in reporting; reaching consensus on these test
7、s can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the reasons for establishing the criteria must be documented in the rationale. A
8、 recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices that will help ensure that a device is used safely and effectively and that its perform
9、ance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of reference for device evaluation. Similarly, even though a recommended practice is usually oriented towards healthcare
10、professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria, provide guidelines to industrial personnel on such subjects as sterilization process
11、ing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial practices. In determining whether an AAMI standard or recommended practice is rel
12、evant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities). The application of a standard or recom
13、mended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care professionals and industrial representatives, whose work has been reviewed nationally (and
14、 sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard or recommended practice is limited, however, in the sense that it responds generally
15、 to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace responsible decision-making. Despite periodic review and revision (at least once every f
16、ive years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed and the specific rationale for each of its provisions. This review will reveal wheth
17、er the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to current procedures and practices. While observed or potential risks with existing equipment
18、typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of information will serve to identify a particular product as “unsafe“. A voluntary standard can be used as on
19、e resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should be analyzed in the context of the specific needs and resources of the individual insti
20、tution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or recommended practice is truly useful only when it is used in conjunction with other sources of information
21、 and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be made in writing, to the AAMI Vice President, Standards Policy and Programs. An
22、 official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation of the Association only upon exhaustion of any appeals and upon publication of notice
23、 of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended practice which has not been developed and communicated in accordance wi
24、th this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. Association for the Advancementof Medical Instrumentation4301 N Fairfax Drive, Suite 301Arlington, VA 22203-1633 2000 b y the Association for the Advancement of Medical Instrumentatio
25、nAll Rights ReservedCopyright and PermissionsPublication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of these documents without the prior written permission of the Association for the Advancement of Medical Instrumentation or the copyright h
26、older (if not AAMI) is prohibited by law. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of these documents (whether internally or externally) without the prior written permission of the copyright holder. Violators risk legal action, including civil and cr
27、iminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of these documents, contact AAMI, 14301 N Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067.Violators of this copyright policy should be reported to
28、 AAMIs legal counsel:McKenna remote transducers; internal pneumatic devices; and displaymodules(3) Implantable electrical transducers with percutaneous leads (strain gauges), such as implantable,diaphragm-mounted, strain-gauge transducers and implantable, passive-resistance, circuit transducers(vari
29、able inductance and capacitance)(4) Fully implantable devices, such as variable oscillators, passive-absorption devices, and interrogators,receivers, display modules, power sources, and pressure-balancing devices for the transducers in (3)1.3 ExclusionsThis standard does not cover components that ma
30、y be used with the ICP monitoring device to expand itstherapeutic or diagnostic applications (for example, drainage bags for cerebrospinal fluid collection orcomputer additions for trend analysis). Nei ther does this standard cover tonometric devices limited toexternal scalp-fontanel applications. I
31、f such additions to the ICP monitoring device are supplied by themanufacturer, the manufacturer must demonstrate that they do not compromise complianc e with thisstandard. Specifically, the manufacturer must address the possibility of physiologic alterations in the patientthat might compromise the a
32、ccuracy or reliability of the ICP monitor (for example, ventricular collapsemight occur with use of fluid-coupled ventricular monitors during simultaneous CSF drainage and ICP 2000 Association for the Advancement of Medical Instrumentationmonitoring).2.Applicable Documents.To the extent specified by
33、 this standard, compliance with the following documents is required.2.1 American Society for Testing and Materials. Standard classification for silicone elastomers used in medicalapplications (ASTM F604-78). Philadelphia, PA: ASTM: 1978.2.2 American Society for Testing and Materials. Standard practi
34、ce for assessment of compatibility of nonporouspolymeric materials for surgical implants with regard to effect of materials on tissue (ASTM F469-78).Philadelphia, PA: ASTM: 1978.2.3 American Society for Testing and Materials. Standard practice for evaluating and specifying implantableshunt assemblie
35、s for neurosurgical application (ASTM F647-79). Philadelphia, PA: ASTM; 1979.2.4 American Society for Testing and Materials. Standard specification for cast cobalt-chromium-molybdenumalloy for surgical implant applications (ASTM F75-76). Philadelphia, PA: ASTM; 1976.2.5 American Society for Testing
36、and Materials. Standard specification for stainless steel bar and wire forsurgical implants (ASTM F55-82). Philadelphia, PA: ASTM; 1982.2.6 American Society for Testing and Materials. Standard specification for stainless steel bar and wire forsurgical implants (special quality) (ASTM F138-82). Phila
37、delphia, PA: ASTM; 1982.2.7 American Society for Testing and Materials. Standard specification for unalloyed titanium for surgicalimplant applications (ASTM F67-77). Philadelphia, PA: ASTM; 1977.2.8 American Society for Testing and Materials. Standard specification for wrought cobalt-chromium-tungst
38、ennickel alloy for surgical implant applications (ASTM F90-82). Philadelphia, PA: ASTM; 1982.2.9 American Society for Testing and Materials. Standard test methods for radiopacity of plastics for medicaluse (ASTM F640-79). Philadelphia, PA: ASTM; 1979.2.10 Association for the Advancement of Medical I
39、nstrumentation. Safe current limits for electromedicalapparatus (ANSI/AAMI ES1-1985). Arlington, VA: AAMI; 1985.2.11 Rosenbluth, S.A.; Weddington, G.R.; Guess, W.L.; Autian, J. Tissue culture method for screening toxicityof plastic materials to be used in medical practice. J. Pharm. Sci. 54: 156-159
40、: 1965.2.12 United States Pharmacopeia (Vol. 21). Easton, PA: Mack Publishing Company; 1985.3.Requirements3.1 Labeling RequirementsThe requirements of this section, in addition to the requirements of federal regulations applicable to allmedical devices, shall apply to ICP devices.3.1.1 Device and Pa
41、ckage Labeling3.1.1.1 Device Identification. Identifying information shall be clearly marked on each ICP device, or, if thedevice is too small or it is otherwise inappropriate to label directly on the device, on the immediate devicepackage. This information shall consist of the following:(1) The man
42、ufacturers name, symbol, trademark, or other clear means of identification(2) The manufacturers address(3) The devices name, catalog or model number, or other clear means of identification 2000 Association for the Advancement of Medical Instrumentation(4) The devices lot number, serial number, or bo
43、th3.1.1.2 Storage Conditions. Labeling on the device or its package shall describe recommended storageconditions or refer the user to the package insert for information on storage conditions.3.1.1.3 Sterility Designation. Whether or not the device is supplied sterile shall be indicated on the device
44、, itspackage, or both.3.1.1.4 Directionality Marking. Any ICP device or component that must be inserted or joined in a specificmanner for proper placement or function shall be labeled or marked with arrows, insertion characters, orother indicators, or shall be accompanied by clear directions in the
45、package insert.3.1.1.5 Calibration. Calibration requirements to ensure the proper function of the ICP device shall appear onthe device, in the package insert, or in other provided labeling.3.1.1.6 Controls and Indicators. The functions of all controls and indicators shall be clearly labeled on thede
46、vice and explained in the package insert or other provided labeling.3.1.2 Physician Information. A package insert or an instruction or operators manual containing technical andperformance information, adequate instructions for proper use of the device, and appropriate warnings andprecautions shall b
47、e provided with each ICP device. At a minimum, the following information shall beincluded.3.1.2.1 Device Characteristics(1) The maximum frequency response of the ICP system, including the ICP readout display, at peakpressures of 10, 20, and 50 tort (mmHg).(2) The slew rates (the systems fastest outp
48、ut during a unit of time) from zero to peak and peak to zerofor peak pressures of 10, 20, and 50 torr.(3) The time constants for full-scale deflection of the system, with both increasing and decreasingpressure.(4) The pressure range over which the ICP system will accurately perform, specified in tor
49、r, centimetersof water, or both, and the accuracy of the ICP system, specified in both absolute values and inpercentage error, over the minimum range of 3.2.1 and (if applicable) over the extended pressurerange claimed by the manufacturer. The expected time period during which the device will maintainthe specified accuracy shall also be disclosed (see also 3.2.2).(5) The pressure range of the display module, specified in torr, centimeters of water, or both, and theaccuracy of the display module over the specified pressure range.(6) The size of the intracranial portion of the ICP
