Biomedical Engineering Reference
In-Depth Information
risk management step 3: implementation
of control measures
Establishing Control Measures
Control measures are the actions taken by healthcare person-
nel, to prevent injury or exposure to identifi ed hazards. Once
hazard-based risks are identifi ed, and the potential of expo-
sure to those risks assessed, the user can develop and imple-
ment control measures. These measures translate into policies
and procedures, which have clear statements of scope (Who
does the policy affect?), rationale (Why is it necessary?), who is
responsible for implementation and enforcement, and how it
should be monitored.
Each policy should be updated on an annual basis, when
new systems, accessories, or clinical applications are intro-
duced, and whenever a new regulation or standard is pub-
lished. It is the responsibility of the LSO to enforce compliance
with all control measures.
Once control measures are written and approved by the
facility, inservice should be offered to all employees. Copies of
all policies and procedures should be distributed, so that
everyone can read them. Some facilities require each person to
sign a checklist stating that they have received and read the
procedure manual, as a supplement to the documentation of
safety training.
There are three kinds of control measures:
assess all systems, and validate the knowledge and skills of all
personnel involved in the laser practice. The LSO can be a phy-
sician, a nurse, a practice manager, or a consultant, biomedical
engineer, or other properly qualifi ed person.
The LSO is the contact person and spokesperson for the
laser program, should there be an audit, a medicolegal situa-
tion, a compliance inspection, or questions from accrediting
bodies.
There must be only one LSO but in his or her absence from
the facility during any use of the laser, there should be some-
one designated as a deputy LSO, who has equal levels of
authority and knowledge. The duties of the LSO will vary
depending on the size and scope of the laser facility; however,
standards do require the LSO to be responsible for:
1. advising facility administration;
2. hazard evaluation [determination of the nominal
ocular hazard area (NOHA)];
3. implementing appropriate control measures;
4. approving all policies and procedures;
5. approving and maintaining all protective equip-
ment;
6. approval of all signage and labels;
7. authorization of laser technicians and service pro-
viders;
8. ensuring that all staff members are properly edu-
cated and trained;
9. investigating all accidents and incidents;
10. ensuring that a periodic audit is conducted, docu-
mented, and followed-up with remedial actions.
1. Engineering controls: These are inbuilt safety fea-
tures supplied by the manufacturer in compliance
with International Electrotechnical Commission
(IEC) standards. These include guarded footswitch,
audible and visible emission indicators, stand-by
control, emergency off control, housing interlocks,
and beam attenuators.
2. Procedural controls: standard operating procedures,
or SOPs, in standards, and policies and procedures
in hospitals. These are operational activities, specifi c
to equipment and practice, and include ocular pro-
tection, fl ammability hazard prevention, controlled
access, management of plume, control of electri-
cal hazards, and control of the delivery system and
beam emissions.
3. Administrative controls: These constitute the infra-
structure of the laser safety program. These must
be in place before the laser can be used, and include
appointment of an LSO, organization of a laser safety
committee, development of documentation tools, ed-
ucation and training of all personnel, compliance with
Occupational Health and Safety rules, development of
a formal audit and technical management plan.
The LSO is often responsible for technology assessment and
advising users on potential laser purchases, as well as on com-
pliance with standards and regulations. In some situations,
especially in a private practice, the physician who owns and
runs the practice or clinic seems to be the likely candidate for
LSO. A careful analysis of the duties of the LSO must be made
before making this decision, remembering that if the laser is to
be used by several clinicians, the LSO must be available during
all use, and must be responsible for safety regardless of who is
operating the system. This may determine who is selected for
the position.
It can often be a better decision to assign a permanent offi ce
professional, such as the nurse or physician's assistant, to serve
as the LSO, as he or she will be on site all the time and can work
with all the laser users in the practice. There are no rules as to
who may serve as LSO; only that the person identifi ed be
appropriately trained and empowered to establish procedures
and to enforce compliance.
Compliance with occupational health and safety (OH&S)
is an important component of a laser safety program. There
are no specifi c OH&S guidelines for assessing a facility's level
of compliance. Assessments are usually made under a broad,
generic, general duty clause, which says in summary
that there is a shared duty between an employer and an
employee for establishing and maintaining a safe working
environment.
The employer has a duty of care to provide the proper safety
equipment, appropriate education, and training, and a work
environment free of known and potential risks and hazards.
The employee has a duty of care to access the training, use the
A written safety plan should be completed and kept in a
topic at the laser use site. This should include all policies and
procedures, verifi cation of education and training of all per-
sonnel, samples of documentation forms, and audit reports.
Everyone involved should become familiar with this topic, as it
is the medicolegal documentation of safe practices.
The Laser Safety Officer
The LSO is the person who is responsible for the management
of risk, and the authority to ensure compliance with all appli-
cable standards and rules. This person should be competent to
