Biomedical Engineering Reference
In-Depth Information
17
Laser safety: Risk assessment and quality management
Penny J. Smalley
Laser safety is much more than wearing safety goggles and
posting a sign on the treatment room door. Audit results from
around the country have revealed a number of misconcep-
tions, areas of noncompliance with standards, and potential
unsafe practices, as well as potential medicolegal problems
should an accident or incident occur, and safe practice has to
be defended.
A laser is safe or hazardous depending on how a user handles
it; the user's knowledge and skill defi ne how well and safely a
clinical practice operates. Healthcare lasers are the same, with
the same risks and hazards, regardless of where they are used.
Therefore, standards and guidelines for safety are the same for
all practice settings, including hospitals, clinics, or private
offi ce facilities.
Of all hazards, “complacency” is the most dangerous, and it
is imperative to develop a risk management perspective on
laser safety. Proper safety management requires a fourfold
approach including: knowledge of standards, identifi cation of
hazards and risks, implementation of appropriate control
measures, and consistent program audit and management.
including non-hospital environments, mobile laser units, and
private practices.
Every 5 years, ANSI requires published standards to undergo
a review by a committee of experts, and if necessary, a revision
to ensure that they accurately refl ect the current state of prac-
tice. The Z136.3 has just been revised extensively and is now
available to the medical community. Guidance in this chapter
is based on the newly revised edition of the standard, Z136.3-
2011, and has been available as of January 1, 2012.
An ever-evolving universe of laser safety guidance docu-
ments, laws, regulations, rules, standards, and recommended
practices exists in varying forms from state to state. States
may have regulations that mandate a range of requirements,
from registration of equipment, to verifi cation of staff qual-
ifi cations. Unfortunately, there is no national guidance for
either the content or enforcement of state laws regarding
medical lasers, and so they vary a great deal. It is essential
that all users investigate their own state laws and incor-
porate compliance with those laws into their laser safety
programs.
Because these laws are inconsistent and may change, it is
imperative to access the state's website and locate the agency
that governs the laser use. This may be the Department of
Health, The Bureau of Radiation Safety, The Department of
Nuclear Safety, the Department of Emergency Management,
or other state bureaus. Keywords to use in searching current
and pending legislation may include non-ionizing radiation,
medical laser regulation, or medical laser safety.
Healthcare laser users must understand their responsibilities
relative to the standards, regardless of practice setting. These
responsibilities and requirements are clearly provided in the
ANSI Z136.3. The document contains engineering controls
required by the Food & Drug Administration and the Center
for Devices and Radiological Health, administrative controls,
and procedural controls, and provides guidance for develop-
ment and implementation of hazard-based and operational
policies and procedures.
Material in the standard is either informative (appendices,
narrative text related to clinical application, and references), or
normative (containing the mandatory requirements). The
terms “should” and “shall” are found throughout the norma-
tive part of the standard.
The term “should” means that a material is strongly recom-
mended but not necessarily mandatory if the user has a ratio-
nale for opting for noncompliance. Because it is best practice
compliance is strongly recommended, but remains at the dis-
cretion of the laser safety offi cer (LSO) to implement.
risk management step 1: knowledge
of standards, regulations, and practice
guidelines
Standards are generally nonregulatory, but serve as consensus
documents for best practice. As such, they are often consid-
ered as the usual and customary practice in a given area, and
are the basis for medicolegal decisions in cases of patient or
staff injury, incident, accident, or unanticipated occurrence.
Because standards provide this foundation, laser clinicians
should acknowledge them as the key to individual laser safety
practices.
There are a number of levels of governance in the USA,
ranging from best practice at the professional level to manda-
tory compliance with law.
American National Standards
National safety requirements are based on the American
National Standards Institute (ANSI) Z136.3, Guide to the Safe
Use of Lasers in Healthcare. This document is a benchmark
standard, for safe practice in the USA. Though not regulatory,
and without legal enforcement, this document is evidence
based and is considered best practice, and as such, is the foun-
dation for state laws, Occupational Safety and Health Admin-
istration (OSHA) guidance, the Joint Commission (TJC)
surveys, and professional recommended practices. It applies to
all healthcare laser systems (HCLS), and all practice settings,
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