Professional Documents
Culture Documents
CHAPTER OUTLINE
What Is a Standard?
OVERVIEW
OVERVIEW
It was once possible to practice safe and modern
anesthesia without any knowledge of the regulatory and
voluntary standards governing anesthesia equipment
and practice. This has changed, however, and individual
practitioners are now subject to federal and state regulations regarding the use of these devices and are strongly
influenced by international standards and agreements.
The arena of medical device standards and regulations is
complex and arcane, and there is much overlap of
authority. This chapter reviews the history, present status, interested parties, relevant standards, standards
processes, and pending developments that will affect the
clinician in the future. The reader should be left with a
good understanding of both the processes and the interested parties in the constantly evolving international
setting of standards and regulations.
Overview
Stages in the Development of International
Standards
Organization of Standards Development
Organizations
U.S. Standards Development Organizations
of Interest
American National Standards Institute (ANSI)
ASTM International
Association for the Advancement of Medical
Instrumentation (AAMI)
National Fire Protection Association (NFPA)
Institute of Electrical and Electronics
Engineers (IEEE)
Medical Device Standards
The General Standard (60601-1)
Standards of Particular Interest
Other Standards and Changes
Interoperability
Small-Bore Connectors
Alarm Systems
What Is a Standard?
A standard is a document, established by consensus and
approved by a recognized body, that provides for common and repeated use, rules, guidelines, or characteristics
for activities or their results, aimed at the achievement of
the optimum degree of order in a given context.1 Standards should be based on the consolidated results of science, technology, and experience, and they should be
aimed at the promotion of optimum community benefits.
In reality, a standard is an agreed restriction for a common good and a shared benefit.1
694
Labeling requirements
Premarket Notification 510(k), unless exempt, or
Premarket Approval (PMA)
Medical device listing
Medical Device Reporting (MDR)
Definition of Terms
Establishment Registration. A manufacturer must file
its name and all places of business with the FDA. Any
additional place of business must be registered immediately. Registration is performed electronically.
Quality System Regulation. The QS regulation requires
the manufacturer to have a written quality system that is
subject to periodic audit by the FDA. The QS regulation
requires every medical device to be designed, manufactured, packed, stored, and installed in conformity with
current Good Manufacturing Practices (GMP). The QS
regulation requires use of design validation, investigation
of complaints, and a corrective and preventive action plan
to identify root causes of product nonconformance with
standards and specifications and to implement effective
actions to prevent recurrence.
Labeling Requirements. Medical devices must be
labeled either on the medical device or on its immediate
container. The label must identify the company name,
trade name, or trade symbol of the manufacturer as well
as the name and place of business of the manufacturer,
packager, or distributor and the identity of and quantity
of the contents of the package. In addition, the labeling of
a medical device must provide adequate directions for use
and adequate warnings against unsafe use for a layperson,
unless the medical device is a prescription medical device,
in which case the labeling may be written for health care
professionals. The labeling of a prescription medical
device may be made available electronically.
Premarket Notification 510(k). The 510(k) process is
designed to ensure, through a quality review process,
that marketed medical devices, subject to general and
applicable special controls, provide a reasonable assurance of safety and effectiveness. It is also designed to
foster innovation. This is achieved by comparing the
(new) device to an existing (predicate) moderate-risk
medical device and demonstrating that the new medical
device is substantially equivalent to the predicate. The
510(k) process applies to moderate-risk medical devices
(typically class II; Table 34-1).
Premarket Approval. The premarket approval (PMA)
process is designed to ensure that a specific marketed
medical device provides a reasonable assurance of safety
and effectiveness through a scientific review process of
safety and effectiveness data (clinical trials). The PMA
process applies to novel medical devices or new high-risk
medical devices (typically class III; see Table 34-1).
Medical Device Listings. A manufacturer must file a list
identifying each medical device made or processed for
commercial distribution in the United States and its
695
TABLE 34-1 Comparison of FDA 510(k) Premarket Notification and Premarket Approval
Factor
Premarket Approval
Classes of devices
Number annually
Documentation (length)
Regulatory requirement
Evidence
Clinical studies provided?
Review period (goal/typical)
Source of required
information
Outside review?
User fees
*2011 actual.
An analysis of FDA 510(k) data from 2006 to 2010, Emergo Group (January 9, 2012).
Three-year average, fiscal years 2006 to 2008.
2012 actual.
CFR, Code of Federal Regulations; FDA, Food and Drug Administration; PMA, Premarket Approval.
696
1976
Medical Device
Amendments
1990
Safe Medical
Devices Act
1993
MedWatch
launched
1976
2010
FIGURE 34-1 n Timeline of Food and Drug Administrationrelated medical device legislation since 1976.
697
698
Office of the Commissioner to oversee review of products that fall into multiple jurisdictions within the FDA.
An excellent review of the regulatory history of the FDA
may be found in Section 2 of the recent Institute of Medicine (IOM) report.7 In late 2012, the MDUFMA was
reauthorized for an additional 5 years. This reauthorization includes numerous incremental improvements to the
device approval process.
Organization of the Food and Drug
Administration
The FDA is an agency within the DHHS. It consists of
the following centers and offices:
Office of the Commissioner
National Center for Toxicological Research
Office of Operations
Center for Veterinary Medicine
Office of Medical Products and Tobacco
Center for Devices and Radiological Health (CDRH)
Center for Biologics Evaluation and Research
(CBER)
Center for Drug Evaluation and Research (CDER)
Center for Food Safety and Applied Nutrition
Center for Tobacco Products
Office of Regulatory Affairs
The parts of the FDA of most interest to anesthesiologists include the CDRH (devices), CDER (drugs), and
CBER (biologics/vaccines, gene therapies). The discussion will focus on the CDRH and its activities.
Center for Devices and Radiological Health. In 1982,
the FDA established the CDRH, which was formed from
elements of the old Bureau of Medical Devices and the
Bureau of Radiological Health. The CDRH has evolved
over the past 30 years and now has seven divisions, or
offices, that report to the Directors Office: 1) Compliance, 2) Management Operations, 3) in Vitro Diagnostic
Device Evaluation and Safety; 4) Surveillance and Biometrics, 5) Communication, Education, and Radiation
Programs, 6) Science and Engineering Laboratories, and
7) Device Evaluation.
The Office of Device Evaluation (ODE) is responsible
for the program areas through which medical devices are
evaluated or cleared for clinical trials and marketing. These
programs include PMA, product development protocol,
humanitarian device exemption, investigational device
exemption, and premarket notification programs. The
ODE is presently divided into five scientific divisions:
1. Anesthesiology, General Hospital, Infection Control, and Dental Devices
2. Cardiovascular Devices
3. Reproductive, Gastro-Renal, and Urological Devices
4. Ophthalmic, Neurological, and ENT Devices
5. Surgical, Orthopedic, and Restorative Devices
Each division is further subdivided. The Anesthesiology, General Hospital, Infection Control, and Dental
Devices division is divided into four branches, each with
a separate branch chief.
Medical Devices Advisory Committee. The 1976
amendments also established the Medical Devices Advisory
Classification of Devices
Different parts of the world use different classification
approaches as illustrated in Table 34-2.
Europe
Europes classification system of medical devices is
defined in EU directives on medical devices.8 These topdown classification rules are based on criteria such as the
duration of contact with the patient (less than 60 minutes,
not more than 30 days, and more than 30 days), the
degree of invasiveness, and the part of the body affected
by the use of the device.
United States
In the United States, the FDA was required to classify all
medical devices into one of three categories per the 1976
amendments, based on the intended use of the device.
Intended use refers to objective intent of the persons legally
responsible for the labeling of a medical device. The FDA
expects the intended use to address:
The intended medical indication
The intended patient population
The intended part of the body or type of tissue
applied to or interacted with
The intended user
The conditions of use
The operating principle
699
TABLE 34-2 S
ummary of Classification Systems and Approval and Clearance Processes of Medical
Devices in Selected Countries and Regions
Country
Primary Agency
Canada
Health Canada
(www.hc-sc.gc.ca)
China
European
Union
Japan
United States
Premarket
Placing on Market*
Establishment
license
Device license
Product registration
certificate
Licensing of
manufacturers
and distributors
Compliance label
(CE marking)
Responsible person
registration
PMDA Notification
Third-party
certification
MHLW approval
Establishment
registration
Classification and
finding of substantial equivalence
(510[k]) or PMA
*Premarket (product control/tools for acknowledging product cleared for the market); placing on market (medical device/establishment
control).
EC, European Commission; EEC, European Economic Community; PMA, premarket approval; PMDA, premarket drug approval.
700
701
702
Organizations
Committee of Interest
Committee Focus/Comment
ASTM
AAMI
ANSI
IEEE
NEMA
NCCLS
CGA
BSI, DIN, JISC, SAC, ABNT
CEN (EU)
CENELEC (EU)
ISO
F29
U.S. TAG for IEC/SC 62D
Anesthesia
Safety
EMB/11073
MITA
Communications
IEC
SC 62A, 62D
Anesthesia
ISO TC 121 mirror
IEC TC 62 mirror
Anesthesia; quality systems
and risk management
Electrical aspects
AAMI, Association for the Advancement of Medical Instrumentation; ABNT, Associao Brasileira de Normas Tcnicas (Brazilian Association of
Technical Standards); ANSI, American National Standards Institute; ASTM, American Society for Testing and Materials; BSI, British Standards
Institute; CEN, Comit Europen de Normalisation (European Committee for Standardization); CENELEC, Comit Europen de Normalisation
lectrotechnique (European Committee for Electrotechnical Standardization); CGA, Compressed Gas Association; DIN, Deutsches Institut fr
Normung (German Standards Institute); IEC, International Electrotechnical Commission; IEEE; Institute of Electrical and Electronic Engineers;
ISO, International Organization for Standardization; JISC, Japanese Industrial Standards Committee; MITA, Medical Imaging and Technology
Alliance; NCCLS, National Clinical and Laboratory Standards Institute; NEMA, National Electrical Manufacturers Association; SAC, Standardization Administration of China; SC, Scientific Committee; TAG, Technical Advisory Group; TC, Technical Committee.
TABLE 34-4 Selected Recognized, Harmonized, and Particular Standards in Relation to Technology
FDA
MDD
Latest International
Particular Standard
(ISO, IEC, ASTM)
Product
Code(s)*
Harmonized
Standard
Related Clinical
Guidelines
Anesthesia
workstation
BSZ
IEC 60601-2-13
Ed 3.1: 2009
EN 60601-2-13: 2006
Anesthetic
agents
monitor
Carbon dioxide
monitor
CCK
Pulse oximetry
DQA
Oxygen
monitor
CCL
Machine checklist,
obsolescence, gas
disposal (ASA,
FDA, institutional,
government)
Regulatory bodies
with respect to
gases
AARC (CPG, 2011)
Numerous
anesthesia
guidelines for
different settings
(e.g., ASA)
CLSI (POCT11-A2)
AARC (CPG-1992)
ASA
AARC (various CPGs)
Equipment
*Per http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm.
As of March 1, 2012, per http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
As of March 1, 2012, per http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices.
AARC, American Association for Respiratory Care; ASA, American Society of Anesthesiologists; CLSI, Clinical Laboratory and Standards Institute;
CPG, clinical practice guideline; EN, European Committee standard designator; FDA, Food and Drug Administration; IEC, International Electrotechnical Commission; ISO, International Organization for Standardization; MDD, Medical Device Directive; POCT, point-of-care testing.
can be cavalier or ignorant with regard to legal requirements. In the interest of fairness and to prevent legal ramifications, all interested parties are allowed to participate in
the process of creating standards in accordance with the
individual organizations bylaws.
Compliance with voluntary standards is not mandatory, because the parent organization has no legal jurisdiction. Voluntary consensus standards, however, often
have an influence even before they are finalized. Responsible manufacturers find both legal protection and sales
advantages in claiming that their equipment meets various voluntary standards, such as those of AAMI, ANSI,
IEC, ISO or ASTM. New voluntary standards cannot
require that a manufacturer remove from the marketplace
earlier equipment that does not conform to the new standard. Only a municipal, state, or federal authority having
jurisdiction can demand compliance or remove an item
from the market. Often, voluntary consensus standards,
such as those of the National Fire Protection Association
(NFPA), are adopted by local agencies that have the
authority to turn the standards into law. Voluntary equipment standards can also be adopted by a government
agency as part of their procurement or purchasing policies. On occasion, however, a governmental regulation
may be adopted before the voluntary standard has been
finalized.
Proposal stage
Activity in stage
Elapsed time
(months) (default)
Equipment. The stakeholders in TC 121 include equipment manufacturers, clinicians, regulatory agencies, test
houses, and others. Created in 1966, TC 121 has a scope
defined as standardization of anaesthetic and respiratory
equipment and supplies, related devices, and supply systems. It is responsible for 85 standards among its subcommittees (see Table 34-3) and includes 25 participating and
24 observing countries. Also of importance is the IEC,
which has a committee responsible for developing international standards for electrical equipment used in medical
practice (IEC TC 62), whose subcommittee D is responsible for electromedical equipment (e.g., the nonradiology
particular medical electrical device standards of the 60601-2
series).
Given the wide variety of equipment on the market, it
is often not clear which organization should be responsible. So that the expertise of both organizations may be
made available in the development of standards, joint
working groups (JWGs) between ISO and IEC are often
formed. In these cases, either ISO or IEC may take the
lead. For each JWG, one of national standards bodies,
which for ISO is a member body and for IEC is a national
committee, accepts responsibility for administering the
JWG, and that organization holds the secretariat and
appoints one or two individuals to handle the technical
and administrative work. A convenor (chairman) runs the
meetings and works to reach consensus. Frequently a
JWG has a secretary who manages the documents and
works closely with the convenor.
Within each committee, and as part of the standards
development processes, are important roles to play,
both nationally and internationally. Clinician involvement is crucial to the development and revision of medical device standards. Participation can be as an expert
in a working group, a member of a national delegation,
and even as a head of a national delegation. Experts
attend meetings in their own capacity as experts, but
they must be aware of the position of the national body
of the country they represent. Influence may be wielded
2 - Working Draft(s)
(WD)
Building expert
consensus
3 - Committee Draft(s)
(CD)
Consensus building
within Committee
Month
1 2 3 4 5 6 7 8 9 10 11 12
Stage
WD
703
Enquiry stage
4 - Draft International
Standard (DIS)
Commenting and
formal voting on
document within ISO
Approval stage
Publication stage
5 - Final Draft
International Standard
(FDIS)
6
International Standard
13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
CD
DIS
Comments
resolution
FDIS
FIGURE 34-2 n The consensus-building stages of standards. Note: Committee draft, draft International Standard, and final draft International Standard documents are approved only if a two-thirds majority of the participating member bodies of the technical and
scientific committees are in favor, and not more than one quarter of the total number of votes cast are negative.
704
through formal approacheswritten comments, discussions, drafting of resolutions, and votingand by informal means, such as lobbying members of other
delegations and through personal relationships.
types of anesthesia machines. Although this standard contained flaws, it was the best standard that could be developed at the time through voluntary consensus efforts.
However, the standard was deficient in some major areas.
For example, it permitted the use of in-circuit vaporizers
and required neither oxygen analyzers nor a method to
prevent the administration of a hypoxic mixture. It did,
however, serve the anesthesia community well, both manufacturer and user, during the 10 years it functioned as the
ruling anesthesia machine standard. National standards
activity in this area was transferred by committee vote in
1983 from ANSI to ASTM.
ASTM International
Formerly the American Society for Testing and Materials, ASTM International currently handles most of the
activities concerning voluntary standards that affect anesthesia durable equipment. Committee F-29 on Anesthetic and Respiratory Therapy Equipment has 10
subcommittees that focus on safety and performance
standards rather than on design or specific engineering
standards. Design and engineering decisions are best left
to the individual manufacturer. ASTM views standardswriting activities as a method to achieve an orderly
approach to a specific activity or problem. All committee
members are volunteers; the formal ASTM staff provides
only administrative support. ASTM does not fund any
participants, nor does it have its own laboratory facilities;
individual members must have their own funding. At
present, the ASA funds the travel of its liaison to Committee F-29.
Under ASTM bylaws, the members of any committee
should reflect a balance of users, producers, ultimate consumers, technical representatives, insurers, educators,
and those with an interest in the area. The last category
can include members of the FDA or of nonprofit health
care organizations that deal with medical devices directly
or indirectly.
Almost anyone can initiate the creation of a standard
within ASTM. The proponent must first submit a written
request detailing the various companies, individuals, and
organizations participating. The executive staff of ASTM
then decides whether the proposal has merit. If accepted,
the proposal is then referred to a particular committee.
Association for the Advancement of Medical
Instrumentation (AAMI)
AAMI is a nonprofit organization founded in 1967. It is a
unique alliance of more than 6000 members from around
the world united by one mission: to provide global multidisciplinary leadership and programs that enhance the
goals and capabilities of the professions, health care institutions, government, industry, and other organizations
that relate to the delivery, development, management,
use, and other aspects of safe and effective medical instrumentation and related technologies. The AAMI standards
program consists of over 100 technical committees and
working groups that produce Standards, Recommended
Practices, and Technical Information Reports for medical
devices. Standards and Recommended Practices represent
705
706
of a risk management process per ISO 14971, the establishment of acceptable levels of risk, and demonstration
that the residual risks are acceptable (according to the
manufacturers policy for determining acceptable risk).20
The concept of essential performance (EP) or safetyrelated performance was introduced and defined as the
performance of a clinical function, other than that
related to basic safety, where loss or degradation beyond
the limits specified by the manufacturer results in an
unacceptable risk.19 EP is most easily understood by
considering whether its absence or degradation would
result in an unacceptable risk. The process of creating
third editioncompliant versions of all of the related published standards is ongoing, and manufacturers and users
of the standards will have to deal with both the second
and third edition versions of the particular standards until
the transition periods in all countries are completed.
For many specific product types, a standard has been
developed using the general standard as a template with
additions, deletions, and changes made to specific clauses,
thereby creating what is known as a particular standard,
numbered as IEC 60601-2-xx, where xx references the
particular device. Where the particular standard is the
product of an ISO/IEC joint working group, the standard
can be numbered 80601-2-xx, with either an ISO or IEC
prefix, determined by which organization had the lead for
the work. This is shown graphically for a couple of devices
in Figure 34-3.
Collateral standards (Table 34-5) have been created over
the years to add requirements for a subgroup of equipment,
such as for certain safety and performance aspects specific
to environments of use (e.g., home care), or related to a
60601-11
Closed loop
physiologic
controllers
707
80601-2-13
Anesthetic
workstations
60601-8
Alarm systems
60601-2
EMC
60601-1
General
requirements
80601-2-55
Respiratory gas
monitors
FIGURE 34-3 n Organization of International Electrotechnical Commission 60601, its collaterals, and
particular standards. Note that the
particular standard is dominant
and amends the general standard
and its collaterals.
708
Title
Comments*
60601-1-1
60601-1-2: 2007
60601-1-3: 2008
60601-1-4
60601-1-6: 2007
Usability
60601-1-8:2007+A1: 2012
60601-1-9: 2008
Environmentally Conscious
Design
60601-1-10: 2008
60601-1-11: 2010
60601-1-12 Ed 1 (under
development)
Title
Chairman Advisory Group
Breathing Attachments and
Anaesthetic Machines
Airways and Related Equipment
Lung Ventilators and Related
Equipment
Terminology and Semantics
Medical Gas Systems
Suction Devices for Hospital and
Emergency Care Use
709
TABLE 34-7 Selected Published Standards under the Responsibility of ISO TC 121 SC/1 and SC/6
Title
Standard
Anaesthetic and respiratory equipment, Conical connectors. Part 1: Cones and sockets
Anaesthetic and respiratory equipment, Conical connectors. Part 2: Screw-threaded weightbearing connectors
Anaesthetic machines for use with humans
Low-pressure hose assemblies for use with medical gases
ISO 5356-1:2004
ISO 5356-2:2006
ISO 5358:1992
ISO 5359:2008,
Amd 1:2011
ISO 5360:2012
ISO 8835-7:2011
ISO 11195:1995
ISO/TS 18835:2004
ISO 80601-2-13:2011*
ISO 80601-2-55:2011
ISO 11197:2004
ISO 7396-1:2007
ISO 7396-2:2007
ISO 9170-1:2008
ISO 9170-2:2008
ISO 10524-1:2006
ISO 10524-2:2005
ISO 10524-3:2005
ISO 10524-4:2008
ISO 15001:2010
ISO 15002:2008
ISO 10083:2006
ISO 21969:2009
ISO 19054:2005
ISO/WD 16571
From http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=51986&published=on
*Replaces IEC 60601-2-13:2003+A1:2006.
Replaces ISO 21647.
Amd, amendment; TS, technical specification.
710
Terminal
units
(ISO 9170-1)
Pipeline (primary
and secondary)
systems
(ISO 7396-1)
Compressed
gas
Patient monitoring
modules
(various standards)
Vacuum
Integrated suction
(ISO 10079-3)
Terminal
units
(ISO 9170-2)
Anesthesia gas
scavenging
system
(ISO 7396-2)
IEC/ISO 80601-2-13
Includes requirements for the gas devlivery system,
breathing system, gas scavenging system,
vapor delivery system, ventilator,
monitoring equipment,
alarm system, protection devices
FIGURE 34-4 n Selected standardized portions of the anesthesia workstation and its connections. DISS, diameter index safety
system; IEC, International Electrotechnical Commission; ISO, International Organization for Standardization; NIST, National Organization for Standards and Technology. (Courtesy GE Healthcare, Waukesha, WI.)
711
TABLE 34-8 K
ey Differences Between Selected U.S. Anesthesia Machine/Workstations: Standards
from 1979 to the Present
ANSI Z-79.8* (1979)15
Key changes
Cancels or replaces
NA
Selected requirements
Anesthetic gas delivery
system, breathing
system, and ventilator
Anesthesia vapor
delivery system
Patient
monitoring equipment
Scavenging system
Alarm system
Protection module(s)
Other
*Z79.8 developed by Writing Group on Gas Machine Safety and Performance, chaired by Leslie Rendell-Baker, MD.
ISO 80601-2-13 (2011)28 in the international version, which is harmonized with the third edition of IEC 60601-1; note separate requirements for integrated scavenging systems. Clause numbers from each standard are shown.
Parallax error is possible; a rotameter could be read against wrong scale.
When working in the dark, such as in the x-ray room, the anesthesiologist would often use the sense of touch to determine which knob is
the oxgyen control knob.
ANSI, American National Standards Institute; ASA, American Society of Anesthesiologists; ASTM, American Society for Testing and
Materials; BP, blood pressure; ECG, electrocardiogram; FDA, Food and Drug Administration; IEC, International Electrotechnical Commission; ISO, International Organization for Standardization.
712
TABLE 34-9 M
easurement Accuracy of
Respiratory Gas Monitors*
Measurement Accuracy (Volume
Fraction)
Gas
Halogenated
agent
Carbon dioxide
Nitrous oxide
Oxygen
15
0.2
8
8
2.5
0.43
2.0
2.5
There are more than 101,000 devices that fall into one
of 5267 generic device product categories described in 21
C.F.R. Subchapter H, Medical Devices (e.g., an anesthesia machine is described in section 868.5160). The continuum of interoperability based on complexity varies
from physical interoperability, defined as the ability for one
device to connect to or be used with another device and
perform individual functions without alteration of the
individual device, to data/information exchange with
understanding.30 This understanding requires both a
common syntax (messaging standard) and common
semantics (terminology). At present, most medical devices
are not interoperable for reasons that may include:
Lack of incentives or regulatory requirements to
interoperate with other manufacturers devices
Scarcity of accepted medical device interoperability
standards
Slow response of health care sector with respect to
computerization and networking
Liability and regulatory issues33
The potential benefits of medical devices that are
interoperable include improved quality of care and
patient safety, improved clinical decision support, and
closed-loop control of therapies such as medication,
delivery of fluids, and mechanical ventilation.
For example, Arney and colleagues34 demonstrate in a
use case how automatic synchronization of the x-ray
exposure with ventilation eliminates the need to turn off
the ventilator to obtain a radiograph and thereby improves
patient safety by helping to alleviate those circumstances
when an anesthesiologist would turn off the anesthesia
ventilator for a radiograph and forget to turn it back on.
Cortes and colleagues35 propose a design on an interoperable, integrated clinical environment (ICE)compliant
system (see below) for patient-controlled analgesia (PCA)
infusion pumps using integrated decision support and
closed-loop control to detect overmedication using a capnograph and pulse oximeter and to respond to resultant
respiratory depression.
Several consortia working on medical device interoperability include the Medical Device Plug-and-Play
Program (MD PnP; www.mdpnp.org/home.php), the
Continua Health Alliance (www.continuaalliance.org/in
dex.html), and Integrating the Healthcare Enterprise
(IHE; www.ihe.net).
The MD PnP is described as a multidisciplinary,
multi-institutional program committed to simplifying
and standardizing medical device connectivity in support
of improving patient safety and healthcare efficiency.33
Some of their projects include:
Medical Device Clock Errors: A study to address
this issue (e.g., standards) is important given the
general lack of automatic clock setting and time
synchronization in medical devices used in the clinical environment and the potential negative impact
on the electronic medical record (EMR) and analysis of adverse events.
ICE Standard: This set of standards allows comprehensive data acquisition for the EMR and the integration of devices to enable real-time decision
support, safety interlocks, and closed-loop control
through the functions described in a new series of
713
714
7. Medical devices and the publics health: The FDA 510(k) clearance process at 35 years, Committee on the Public Health Effectiveness of the FDA
510(k) Clearance Process. 2011, Institute of Medicine.
8. Council of the European Union: Council Directive 93/42/EEC of
14 June 1993 concerning medical devices (OJ No L 169/1 of
1993-07-12).
9. Class II Special Controls Guidance Document: Apnea Monitors;
Guidance for Industry and FDA. Issued July 17, 2002, Food and
Drug Administration Center for Devices and Radiological
Health.
10. Hedley-Whyte J, Milamed DR: Equipment standards: history, litigation, and advice, Ann Surg 230(1):120127, 1999.
11. Guidance for Industry and FDA Staff: Recognition and Use of
Consensus Standards. Issued on September 17, 2007, Food and
Drug Administration Center for Devices and Radiological Health.
12. CDRH Preliminary Internal Evaluations, Vol I, 510(k) Working
Group -Preliminary Report and Recommendations. August 2010,
Food and Drug Administration Center for Devices and Radiological Health.
13. Henza C, Hutchin G: Reforming the 510(k) process: where we are,
how we got here, and whats to come, MDDI, 2012 Jan 5.
14. ISO/IEC Directives. Part 1: Procedures for the technical work, ed 8,
Geneva, 2011.
15. Minimum Performance and Safety Requirements for Components and
Systems of Continuous-Flow Anesthesia Machines for Human Use,
ANSI Z-79.8, New York, 1979, American National Standards
Institute.
16. NFPA 99: Health Care Facilities Code, 2012 Edition, Quincy, MA,
2012, National Fire Protection Association.
17. Caplan RA, Barker SJ, Connis RT, etal: Practice advisory for the
prevention and management of operating room fires, Anesthesiology
108:786801, 2008.
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