Biomedical Engineering Reference
In-Depth Information
potential hazards in equipment or work practices, and to lead
to corrective actions. An example might be the discovery that
the CO
2
laser arm is not replaced properly, potentially leading
to damage and misalignment of the optics. If such an item is
noted in the audit report, the resulting action could be to
require every staff member to attend an inservice on handling
the laser arm, and validate skill by performing a return dem-
onstration for the LSO. Another audit result might be that
glasses need to be replaced because they are scratched and have
loose frames.
Audits should also include calibration and output testing,
which can be delegated to biomedical engineering or the com-
pany laser technician. The LSO should keep a copy of audit
reports in the laser program fi les, along with user credentials,
equipment history, staff training validation, service agree-
ments, logs, and other documentation.
Should there be an accident, incident, or occurrence, docu-
mentation of a current audit will help substantiate that the
user maintained both safe systems, and staff compliance, in
accordance with the expectations of standards.
6. Patient Management
7. Maintenance and Repair (Troubleshooting)
8. Audit and Monitoring
9. Documentation and Reporting
Laser vendors and representatives can provide operational
(hands-on) training, but cannot usually provide professional
level education, or non-commercially biased information on the
science and technology outside their own equipment. All profes-
sionals should avail themselves of comprehensive education
before taking operational training, so they will have the knowl-
edge base required for safe laser program implementation.
Documentation
Of all “safety” procedures, documentation should become a
priority. Logs, operative records, audit reports, policies, repair
and maintenance records, and committee minutes all contrib-
ute to claims that a clinician established and enforced a laser
safe practice. Without proper documentation, there is no fac-
tual, objective, or sustainable support for that claim.
Inaccurate, incomplete, and absent documentation is an
area of liability for many laser clinicians around the world.
More and more emphasis is being placed on compliance with
known safety standards, and it is an imperative in today's liti-
gation-conscious environment.
Each facility must develop its own forms and decide on its
own requirements for collecting data. Sample forms are found
here, to assist in this task, but it must be clearly stated that they
should not be copied and used as such, and MUST be format-
ted to refl ect individual practice, and the results of each prac-
tice's risk assessment.
Documentation should be included in the formal audit pro-
cess, with a focus on identifying areas not being completed
properly.
Education and Training
Education (didactic knowledge) and training (operational
skill) equip clinicians with the foundation information needed
to establish a laser-safe environment. This is an individual
responsibility without universal criteria, and with varied levels
of resources available in different regions of the world. There
are no authorities, boards, examinations, agencies, or organi-
zations that can credential or certify anyone in laser use or
laser safety, with a very few exceptions. Even if an organization
claims to be able to certify, it is still the responsibility of the
facilities or practitioners to individually approve that certifi ca-
tion, as meeting their own criteria and standards. Course cer-
tifi cates can only verify attendance at a program. Some courses
offer written examinations, which validate a certain level of
knowledge, but competency and operational skills must be
validated with the user's own device in a suitable manner. Edu-
cation must be an ongoing effort to stay current with the tech-
nology through journals, conferences, networking, and
professional organizations.
A comprehensive program should include the following
topics with ample time for discussion, and relevant questions:
Safety is Everyone's Responsibility
Routine audit, troubleshooting, training, policy and proce-
dure development, and compliance enforcement are duties of
the LSO, but case by case, day by day, patient by patient, laser
safety depends on each and every healthcare professional's
commitment and vigilance.
Lasers can offer patients a wonderful range of treatment
options, from standard of care to experimental innovation.
Laser users are constantly challenged to redefi ne who they are,
what they do, and their scope of practice, with each new laser
system or application.
It must be remembered that every new system may demand
a new look at safety policies and procedures, and that only
through teamwork, communication, and respect for the tech-
nology, can we establish the foundation for a truly effective
laser safety program.
1. Biophysics and Tissue Interactions of all Wave-
lengths
2. Instrumentation and Delivery Systems
3. Clinical Applications
4. Standards, Regulations, and Professional Recom-
mended Practices
5. Control Measures (Administrative, Engineering,
and Procedural)
