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MLSO - Medical Laser Safety Officer > ANSI Z136.3 - General Information > Flashcards

ANSI Z136.3 - General Information Flashcards

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USMLE® Step 1 flashcards
1
Q

What laser classifications require administrative controls?

A

1M, 2M, 3B, 4

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2
Q

What laser classifications require training?

A

3B, 4

1M, 2M are application dependent based on ANSI Z136.1-2014, section 4.1

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3
Q

What laser classifications require an LSO?

A

3B, 4

1M, 2M are application dependent based on ANSI Z136.1-2014, section 4.1

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4
Q

What laser classifications require engineering controls?

A

3B, 4

1M, 2M are application dependent based on ANSI Z136.1-2014, section 4.1

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5
Q

What is the national standard for classification for …

Class 1

IAW ANSI Z136.1-2014

A

Any laser, or system constaining a laser, that cannot emit laser radiation at levels that are known to cause eye or skin injury during normal operation.

This does not apply to maintenance and/or service states requiring access to higher-class lasers enclosed or embedded in Class 1 systems.

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6
Q

What is the national standard for classification for …

Class 1M

IAW ANSI Z136.1-2014

A

Considered incapable of producing hazardous exposure unless viewed with collecting optics.

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7
Q

What is the national standard for classification for …

Class 2

IAW ANSI Z136.1-2014

A

Visible lasers considered incapable of emitting laser radiation at levels that are known to cause skin or eye injury within the aversion response time of the human eye (0.25 s).

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8
Q

What is the national standard for classification for …

Class 2M

IAW ANSI Z136.1-2014

A

Emits in the visible portion of the spectrum, and is potentially hazardous if viewed with collecting optics

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9
Q

What is the national standard for classification for …

Class 3R

IAW ANSI Z136.1-2014

A

A laser system that is potentially hazardous under some direct and secular reflection viewing conditions if the eye is appropriately focused and stable.

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10
Q

What is the national standard for classification for …

Class 3B

IAW ANSI Z136.1-2014

A

Medium-powered lasers (visible or invisible) that present a potential eye hazard for intrabeam (direct) viewing or for viewing specular (mirror-like) reflections.

Class 3B lasers do not present a diffuse (scatter) reflection hazard or significant skin hazard except for higher-powered Class 3B lasers operating in certain wavelength regions.

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11
Q

What is the national standard for classification for …

Class 4

IAW ANSI Z136.1-2014

A

High-powered lasers (visible or invisible) that present a potential acute hazard to the eye and skin for both direct (intrabeam) exposure and for exposure to diffuse (scatter) reflections.

Class 4 lasers also present a potential hazard for fire (ignition) and by-product emissions from target or process materials

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12
Q

Who is required to supply the HCLS laser hazard classification?

A

Manufacturer

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13
Q

What is required if a HCLS does not have a hazard classification or the HCLS has been modified?

A

The classification shall be determined by the LSO

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14
Q

What is the “stepwise procedure for hazard classification”?

A
  1. Determine the hazard class of the HCLS as certified by the manufacturer in accordance with 21CFR1040.10
  2. Comply with the control measures recommended for the appropriate laser class
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15
Q

What are the two broad categories of hazards that HCLSs can be divided into?

A
  1. Retinal hazard region (roughly 400 nm to 1400 nm), in which a focal image on the retina presents the main hazard
  2. Those in the ultraviolet and far-infrared regions, in which the main hazard is to the cornea and skin
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16
Q

Federal Regulations

A

Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has the responsibility for implementing and enforcing 21CFR1040.10 and the sections of the Food, Drug and Cosmetic Act applicable to medical devices.

17
Q

Non-governmental Controls

A

The Joint Commission (TJC)
Association of Surgical Technologists (AST)
Association of periOperative Registered Nurses (AORN)
American Society for Lasers in Medicine and Surgery (ASLMS)
Academy of Laser Dentistry (ALD)

These non-governmental organizations have recommended practices, guidelines, or position statements associated with their disciplines and laser uses.

18
Q

Deputy Laser Safety Officer (DLSO)

A

If deemed necessary, a DLSO should b e appointed b y management or the LSO to perform the duties and fulfill the responsibilities of the LSO when the LSO is not available.

For facilities with multiple divisions or locations, a system of DLSOs may be deemed necessary.

The DLSO can be the laser user, laser operator, or other trained person responsible for the laser safety program.

19
Q

Laser Safety Site Contact (LSSC)

… sometimes referred to as the Laser Safety Specialist (LSS)

A

The LSSC/LSS oversees the safe laser use in specific areas where a laser is used and for which the LSSC/LSS is responsible.

An LSSC/LSS may not be needed where the laser is used only in one location and the LSO is available.

20
Q

LSO Specific Responsibilities

Hazard Classification

A

The LSO shall ensure that all lasers and laser systems in the HCF have been labeled by the manufacturer to indicate the appropriate hazard classification in accordance with the federal regulations.

If the manufacturer does not label a laser or laser system, the LSO shall ensure that the product is properly classified and that the correct classification label is affixed.

21
Q

LSO Specific Responsibilities

Hazard Evaluation

A

The LSO shall ensure that a hazard evaluation of the laser treatment controlled areas (LTCA) has been performed prior to laser operation.

This shall include evaluation of the potential hazards of the laser as used in the LTCA using the hazard and safety guidance as provided by the HCLS manufacturer and by taking into consideration the laser use environment and people using the laser.

In some cases, the LSO may perform a hazard evaluation and determine the laser hazard.

22
Q

LSO Specific Responsibilities

Hazard Response

A

The LSO, or designee, shall immediately inform the user of imminent danger from a laser hazard.

23
Q

LSO Specific Responsibilities

Control Measures

A

The LSO shall …
1. ensure that control measures as prescribed by the HCLS manufacturer or as determined by the LSO are in effect
2. recommend or approve substitute or alternate control measures when the primary ones are not feasible or practical
3. periodically evaluate the effectiveness of the selected controls.

24
Q

LSO Specific Responsibilities

Procedure Approvals

A

The LSO shall establish and enforce Policies and Procedures (P&Ps) for HCLS use.

These P&Ps should include maintenance, service, and procedural checklists and any laser safety related items reflected in the HCF P&Ps used by operating personnel.

25
Q

LSO Specific Responsibilities

Protective Equipment

A

The LSO shall ensure that appropriate protective equipment is …
1. available
2. in good working order
3. is used correctly

26
Q

LSO Specific Responsibilities

Signs and Labels

A

The LSO shall ensure that the wording on area signs and equipment labels are in accordance with ANSI Z136.3, section 4.7.

27
Q

LSO Specific Responsibilities

Facilities and Equipment

A

The LSO shall approve the HCLS installation and equipment prior to use to ensure that it is consistent with the manufacturer’s safety recommendations and labeling contained in the user’s manual.

Modifications of existing facilities or HCLS equipment shall be reviewed by the LSO.

Modifications to the equipment shall comply with FDA regulations.

A hazard evaluation of modified equipment shall be prepared, and shall be retained on file by the LSO.

The LSO shall ensure that qualified personnel carry out periodic maintenance and service, and that records of this maintenance and service are maintained.

28
Q

LSO Specific Responsibilities

Training

A

The LSO shall ensure that appropriate laser safety education and training is provided to all laser users including providers, clinicians, staff, technicians, students, and other health care personnel (HCP).

The LSO shall ensure maintenance of records of laser safety education and training of those HCP as specified in ANSI Z136.3, section 5.

29
Q

LSO Specific Responsibilities

Records

A

The LSO shall ensure that the necessary records required by applicable government regulations are maintained.

Other records documenting the maintenance of the safety program, such as training records, audits, and standard operating procedure (SOP) approvals, shall be maintained.

30
Q

Location Types

Unrestricted location

A

Access to an open beam is unrestricted.

Examples include home and premises open to the public including offices and spas.

31
Q

Location Types

Restricted location

A

Access to an open beam is not accessible to the public.

Examples include secured areas within hospitals, such as operating room areas that are not open to the public and entry is secured by physical means.

32
Q

Location Types

Controlled location

A

Access to any area where open beams are in use is controlled and entry is limited to authorized persons who have received adequate training in laser safety and proper use of the system.

33
Q

Stepwise procedure for determining a laser use environment

A
  1. Determine the hazard class from the devise warning-label (device certification-label)
  2. Determine the type of location. Type type of location will determine the degree of control measures required for each of the hazard classifications or access levels.
  3. Determine and apply the relevant control measures required for the appropriate hazard level
34
Q

When considering a third party laser, what things shall the LSO verify are in the terms of agreement between the third party provider and the HCF?

ANSI Z136.3, Section 1.4.2

A
  1. Credentials. The credentials of the third party laser operators meet the facility’s policy.
  2. Equipment. The HCF has received written validation of the maintenance, service, cleaning, and condition of the equipment.
  3. Documentation. Data and elements of documentation collected by the third party are appropriate, meet the HCF policy, and can be verified by facility HCP.
  4. Training. All HCP expected to be in the room with the third party laser have had adequate safety control training on the laser and accessory equipment in order to ensure a laser safe environment for all personnel and the patient during the device operation.
  5. Assessment. Assessment should be performed through a thorough intake procedure, exceeding biomedical testing for electrical leakage, and include the condition of the HCLS and all delivery systems and accessory devices to be used, credentials of the technician, credentials of the provider, inventory of accessories (e.g., fibers, filters), documentation forms, and staffing requirements and assignments for personnel to be present in the room.

MLSO - Medical Laser Safety Officer (5 decks)

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