[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
