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The Committee on Equipment and Facilities identifies and monitors
standards-writing activities in regard to equipment and facilities
of concern to the ASA membership. Some committee members serve
as ASA liaisons to the major standards-writing organizations,
in particular, the American Society for Testing and Materials
(ASTM) and the National Fire Protection Association (NFPA). Activities
at the International Standards Organization (ISO) and the European
Committee for Standardization (Comité Européan de
Normalization [CEN] and CEN's Healthcare Forum [CheF]) are monitored
via United States Technical Advisory Groups (US TAG) to ISO Technical
Committees (TC).
ASTM is a not-for-profit organization that "provides a forum
for producers, users, ultimate consumers and those having a general
interest (representatives of government and academia) to meet
on common ground and write standards for materials, products,
systems and services." The ASTM Committee on Anesthetic and
Respiratory Equipment is designated F-29. One of the better-known
ASTM voluntary consensus standards is F1161.88, titled Standard
Specification for Minimum Performance and Safety Requirements
for Components and Systems of Anesthesia Gas Machines. It describes
"the requirements to be used in the design of gas machines
for human use in order to enhance the safety of the patient and
operator." Approved in 1988 and reapproved in 1994, it defined
many of the safety features that we have come to expect from our
modern anesthesia machines. In 2000, F1161.88 was superseded by
ASTM F1850.00, Standard Specification for Particular Requirements
for Anesthesia Workstations and Their Components, which defines
minimum safety requirements for an anesthesia workstation. The
latter is defined as a system for administration of anesthesia
to patients, comprising anesthesia gas supply device, anesthesia
ventilator, monitoring devices and protection devices.
Although ASTM standards such as F1850 are a consensus of producers,
users and other interested parties in the United States, it is
not a requirement that all new devices conform to such standards.
However, an informed consumer would likely prefer to purchase
new equipment that did meet or exceed the specifications of the
most recent standard.
Recognizing that the anesthesia equipment market is becoming
global (and less national), ASTM began in 2001 to reorganize and
sought to adopt international standards (ISO) with a one-page
cover sheet of American deviations from ISO. Similarly, the ASTM
F-29 Committee will be able to submit their standards to ISO for
"fast-track" adoption. This should eliminate duplication
of effort in writing a standard, although ASTM F-29 retains the
option of publishing an American standard in the event that the
ISO standard is unacceptable.
In 2001, the European organization CEN/CHeF issued a report on
Luer connectors. There had been several incident reports of cross-connects
of different systems that used such connectors; mainly enteral
feeding being given intravenously and gas being pumped intravenously.
The CEN/CHeF report stated that Luer connectors should be used
only for intravenous systems. While work on the potential hazards
of Luer misconnections is ongoing, the most likely change expected
at this time will be that of changing the exhaust port of the
respiratory gas monitor to a sleeved male Luer connector and some
labeling requirements.
ASTM Committee F-29 on Anesthetic and Respiratory Equipment proposes
to bolster patient safety by establishing standard requirements
for devices that open airways in supraglottic areas of the throat
during surgery. The Food and Drug Administration (FDA) Manufacturer
and User Facility Device Experience Database (CDRH MAUDE) includes
more than 500 reports of adverse events involving supraglottic
airway-like medical devices. Examples of supraglottic devices
are laryngeal-mask airways, cuffed-oropharyngeal airways, pharyngeal
airways, laryngeal airways and seals, and glottic/laryngeal airways
and seals not regulated by other tracheal or tracheostomy tubes,
oral/nasal airway, laryngoscope or anesthesia-mask standards.
The F-29 committee has invited producers and users of these devices,
members of US TAG to ISO TC 121 and others to develop a "Standard
for Supraglottic Airways." The standard will provide essential
requirements for the safe use of devices that open, secure and
seal the supraglottic area (above the larynx) typically during
anesthetic administration, providing unobstructed airways in patients
who are breathing spontaneously or whose lungs are being ventilated.
A committee task group will draft the standard as an informational
review of current literature and best practices, describing general
essential requirements with a suggested risk assessment and specific
design attributes when required in the risk assessment.
Other equipment on which standards work by ASTM is ongoing includes
nitric oxide delivery devices, respiratory gas monitors, sleep
apnea devices, blood/fluid warmers, pulse oximeters and operating
room fire safety equipment.
NFPA publishes criteria to minimize the hazards of fire, explosion
and electricity in health care facilities. In this past year,
NFPA has issued updated 2002 editions of both NFPA 99 – Standard
for Health Care Facilities and NFPA 70 – National Electrical
Code.® NFPA 115 – Recommended Practice on Laser Fire Prevention,
published in 1999 is currently being revised with the intention
of publishing a new standard in 2003.
The ASA Committee on Equipment and Facilities has undertaken
to review and possibly revise the 1988 ASA statement "Policy
for Assessing Obsolescence" in relation to anesthesia gas
delivery systems (machines). In this litigious yet cost-sensitive
era, there is concern as to the appropriateness or advisability
of the use of older anesthesia machines and ventilators that may
not meet even the ASTM F1161.88 standard. Some believe that the
use of such "older" machines, perhaps in office-based
anesthesia practice, may be dangerous. With the recent introduction
of the electronic anesthesia workstation, the Committee on Equipment
and Facilities also is revisiting the generic Anesthesia Apparatus
Checkout Recommendations, published by the FDA in 1993.
The Committee on Equipment and Facilities serves a very important
function in determining optimum anesthesia equipment and facilities
as our specialty continues to evolve. A panel on anesthesia equipment
issues is scheduled to be held on Monday, October 14, 2002, from
9-11:30 a.m. at the ASA Annual Meeting in Orlando, Florida.
In October 2002, Daniel E. Supkis, Jr., M.D., will become chair
of this committee. He is ideally qualified for this position,
having a longstanding interest in standards and equipment and
serving as secretary of ASTM Committee F-29. I would encourage
anyone with an interest in anesthesia equipment or facilities
to become involved with the Committee on Equipment and Facilities
and the standards organizations described above. Information on
membership in ASTM can be obtained by visiting its Web site at
. The F-29 committee homepage address is: < http://www.astm.org/COMMIT/COMMITTEE/F29.htm
>.
Input from practicing anesthesiologists is essential to future
success.
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James B. Eisenkraft,
M.D., is Attending Anesthesiologist, Mount Sinai Medical Center,
New York, New York. |
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