[Federal Register Volume 59, Number 131 (Monday, July 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16618]


[[Page Unknown]]

[Federal Register: July 11, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 86B-0058]

 

Anesthesia Apparatus Checkout Recommendations, 1993; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Anesthesia Apparatus Checkout 
Recommendations, 1993.'' The document presents a general checkout and 
inspection procedure that should be conducted before administration of 
an anesthesia to ensure that the anesthesia machine, patient breathing 
system, and monitors, which together comprise the anesthesia system, 
are correctly interconnected, adjusted, and functioning as intended. 
The document is a revised version of previously published 
recommendations documents. This action is part of FDA's commitment to 
help ensure the safety and effectiveness of medical devices.

ADDRESSES: Submit written request for single copies of the document 
entitled ``Anesthesia Apparatus Checkout Recommendations, 1993'' to the 
Office of Training and Assistance (HFZ-240), Center for Devices and 
Radiological Health, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857. Requests should be identified with the docket 
number found in brackets in the heading of this document. Send two 
self-addressed adhesive labels to assist that office in processing your 
requests. The documents entitled ``Anesthesia Apparatus Checkout 
Recommendations, 1993,'' and ``Anesthesia Apparatus Checkout 
Recommendations, 1992,'' and received comments and their analyses are 
available for public examination in the Dockets Management Branch (HFA-
305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857, between 9:00 a.m. and 4 p.m. Monday through 
Friday. Single copies of these documents are available upon written 
request from the contact person listed below.

FOR FURTHER INFORMATION CONTACT: Robert Cangelosi, Center for Devices 
and Radiological Health (HFZ-210), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-2436.

SUPPLEMENTARY INFORMATION:

 I. Background

    FDA is committed to carrying out a program to help ensure the 
safety and effectiveness of medical devices. One aspect of this program 
involves regulatory activities under the laws administered by the 
agency concerning the design, manufacture, and distribution of medical 
devices. Patient safety, however, is dependent on more than properly 
functioning devices. Although proper operation, maintenance, and 
periodic inspection of these devices by the user are matters that 
cannot always be addressed effectively through regulatory action under 
the laws administered by the agency, they are essential to minimize 
risks to patients. Consequently, as an important adjunct to its 
regulatory program, FDA has initiated a variety of educational efforts 
to aid medical professionals in the safe use of medical devices. These 
educational endeavors are conducted in cooperation with, and usually 
with the active participation of, the relevant professional 
organizations and other groups within the private sector.
    For example, to reduce unnecessary retakes in radiology and to 
improve image quality, FDA, in cooperation with the American College of 
Radiology and other private sector organizations, developed voluntary 
recommendations for radiology facilities concerning equipment quality 
assurance programs (``A Basic Quality Assurance Program for Small 
Diagnostic Radiology Facilities,'' FDA 83-8218). In cooperation with 
the American College of Radiology and numerous other medical 
professional societies, FDA also fostered the development of guides for 
clinicians on the effective use of selected diagnostic imaging 
procedures (``The Selection of Patients for X-ray Examinations,'' FDA 
80-8104; ``The Selection of Patients for X-ray Examinations: The 
Pelvimetry Examination,'' FDA 81-8174; ``The Selection of Patients for 
X-ray Examinations: Chest X-ray Screening and Examination,'' FDA 83-
8204). As an adjunct to the teaching of medical students and radiology 
residents, FDA funded the development of a basic teaching system in 
radiology, ``The Radiological Health Sciences Learning File,'' which is 
now in use in radiology education and is used in 118 medical schools in 
the United States and in several foreign medical schools as well. These 
examples illustrate FDA's commitment to ensuring that users of medical 
devices are sufficiently educated and motivated to use medical devices 
safely and effectively.

II. Scope of the 1993 Recommendations Document

    The recommendations document that the agency is now making 
available a revised version of the draft document entitled ``Draft 
Anesthesia Apparatus Checkout Recommendations, 1992,'' that was 
announced in the Federal Register of October 6, 1992 (57 FR 46033), and 
that was based on the original document entitled ``Draft Anesthesia 
Apparatus Checkout Recommendations,'' that was announced in the Federal 
Register of February 27, 1987 (52 FR 5583). FDA also intends to make 
this document available to anesthesia clinicians through their 
professional organizations and to anesthesia equipment manufacturers so 
that they may include it in their user education programs.
    The recommendations in ``Anesthesia Apparatus Checkout 
Recommendations, 1993'' should be followed for anesthesia systems that 
conform to current and relevant standards (such as ``Standard 
Specifications for Minimum Performance and Safety Requirements for 
Components and Systems of Anesthesia Gas Machines,'' ASTM F-1161-88) 
and that include an ascending bellows ventilator and at least the 
following monitors: Capnograph, pulse oximeter, oxygen analyzer, 
respiratory volume monitor (spirometer) and breathing system pressure 
monitor with high and low pressure alarms. However, the recommendations 
document offers guidance that users are encouraged to modify to 
accommodate differences in equipment design and variations in local 
clinical practice. Such local modifications should have appropriate 
peer review. The original recommendations document (52 FR 5583) should 
be followed for other anesthesia systems. Users should refer to the 
operators manual for specific procedures and precautions.
    In response to the draft document entitled ``Anesthesia Apparatus 
Checkout Recommendations, 1992'' (57 FR 46033), eight comments were 
received and reviewed by the agency. Some minor refinements were made 
to the checkout recommendations in response to the comments.
    FDA believes that the pre-use inspection procedure provided in the 
checkout recommendations will aid medical professionals in the safe use 
of anesthesia devices. FDA regards the pre-use inspection procedure to 
be a recommendation as defined in Sec. 10.90(c) (21 CFR 10.90(c)). 
Therefore, the checklist is being made available under Sec. 10.90(c) of 
the agency's administrative practices and procedures regulations. That 
regulation provides for FDA to formulate and disseminate 
recommendations about matters that are authorized by, but do not 
involve direct regulatory action under, the laws administered by the 
agency.

    Dated: June 30, 1994.
 Michael R. Taylor,
 Deputy Commissioner for Policy.
[FR Doc. 94-16618 Filed 7-8-94; 8:45 am]
BILLING CODE 4160-01-F