BIOMEDICAL SAFETY.

1. You produce an iontophoresis to deliver the ionic drugs, belong to which class this
device is? explain!
IIa/b because it administers energy in an attempt to deliver drugs to the body through
using the natural voltage gradient of the human skin. It falls under rule 11. ​Is it
hazardous? If yes, IIB, if not IIA

2. You produce a fluoroscopy, belong to which class this device is? explain!
IIb, because it emits radiation and is a diagnostic tool (rule 10). ​(correct)

3. What does 510K mean? belong to which class is this step?

A 510K is a premarket notification made to FDA to demonstrate that the device to be
marketed is safe and effective ​by doing a comparison to the devices that perform similar
function and has been legally marketed.​ This step belongs to class II medical devices.
4. Explain 3 ways to minimize the radiation absorbed dose?
- Adjust  frame  rate,  energy  per  frame  and  collimation  throughout  the 
procedure:  assign a nurse with that specific task. ​Unclear, find more that are 
specified in the slides 
- Shield  yourself  (ideally  behind  a  cabin  or  suspended  system  that  also 
protects your head) and shield other cathlab personnel. 
- Report  the  procedural  effective  dose in the patient chart and to your team at 
the  end  of  the  procedure:  daily  feedback is the best motivator to improve on 
radiation dose reduction. 
 
5. Pick one type of dosimetry and explain the way it works!
● Luxel is a dosimeter in the form of a badge, it is usually worn on the torso area of
highest likely exposure. It is able to detect X-rays, gamma rays and energy beta
emitters. It make use of optically stimulated luminescence to measure the
radiation, it is a method of measuring the ionizing radiation to which a person is
exposed by means of a device that contains a radiation-sensitive crystalline
material, in this case an aluminium oxide crystal. The material stores the
radiation's energy by changing structure. The crystal will then absorb the energy of
x-rays and measure the dose of ionizing radiation received.
correct

6. Explain the concept of Specific Absorption Rate and how to obtain it?
● Specific Absorption Rate measures the amount of RF energy that is absorbed into
the body.
● Using a standardized model filled with liquids that stimulate the density of body’s
various organs. The device is later then tested in various positions against the body
and the head to observe and record the effect. The aim of this experiment is to
determine the compliance of different devices at its highest operational level in all
the frequency bands within the normal condition that is carried out.
 ● SAR compliance is evaluated with electric field measurements
inside tissue equivalent liquids. It is determined according to
this equation:
● Where E is the magnitude of the measured electric field, ​δ is
the conductivity and ​ρ is the mass density of the tissue equivalent media. The unit of
measurement is the rate of energy absorption per unit mass at a specific location in the
tissue media (W/Kg or mW/g).
(correct)

7. Explain in detail why baby is susceptible to radiation!

Unborn babies are more susceptible to the health effects of radiation, especially in
the very early weeks immediately following conception, since they are comprised
of fewer cells, which are dividing rapidly, and therefore more likely to be
disrupted by the effects of radiation. In turn, their development can be greatly
impacted.

Many reasons as I explained :

-Smaller head and thinner skull means less block towards the radiation
-Actively developed brain -> disrupted brain development at such early stage will
slowly create problems later
-Owing many stem cells -> stem cells are undifferentiated cells. They are more
susceptible and reactive towards radiation than mature cells.
-Higher water content in the brain which acts as a good medium and makes
radiation travels even quicker.

8. Explain the difference between microshock and macroshock! Give one example of
each!
- Macro-shock : LARGE CURRENT. An electrical current applied
externally enters into direct contact with the body. ​Distributed current to the whole
body hence it possesses lower current density. It is less threatening.
Example: Malfunctioning electrical or electricity-using mechanical equipment
capable of delivering a strong current, or which operates at a high voltage.
- Micro-shock : SMALL CURRENT. Dangerous to susceptible
patient under a certain condition. ​Direct access to the heart hence very small
current can highly cause ventricular fibrillation.
 Example: Saline Drips ​catheter​, ​pacemaker
9. Explain how protective grounding work!
A GFCI protection device operates on the principle of monitoring the imbalance of
current between the circuit's ungrounded (hot) and grounded (neutral) conductor. It does
not monitor the grounding conductor, and so it will still operate in a circuit without a
ground.

In a typical 2-wire circuit, the current returning to the power supply will be equal to the
current leaving the power supply (except for some small leakage). If the difference
between the current leaving and returning through the current transformer of the GFCI
protection device exceeds 5mA (51mA), the solid-state circuitry opens the switching
contacts and de-energizes the circuit (see Figure, above). This will always happen as long
as the GFCI is in working order. However, GFCIs fail more often than most people think.
And they give no outward sign that they are no longer providing their protection.

If there is a fault at the circuit then the current would simply choose the least resistance
pathway directly to the ground instead of flowing through the human body.

10. Explain the work principle of ground circuit interuptor!

The main purpose of PPGB is to expeditiously actuate overcurrent protective devices
(OCPDs) while simultaneously limiting voltage to which workers are exposed to safe
levels. When a circuit has been properly grounded for the protection of workers — and it
accidentally becomes energized — the voltage on the system sags to near zero. However,
the grounding cables cannot carry these massive amounts of current for more than a
fraction of a second. Therefore, the workers' lives depend upon the OCPDs that protect
the circuit (to de-energize it) before the grounding cables melt open and voltage levels
return to unsafe levels.

GCI monitors both cold and hot wire to make sure the current of both are equal. When
there is a fault current and GCI senses a difference, the power is immediately interrupted
without warning. This is very safe but not really handy to be applied to life sustaining
devices in the operating room.

11. Explain the work principle of Line Isolation monitor! including its advantage
and disadvantage!
Line isolation system (isolation transformer + line isolation monitor) protect persons
from electrocution by turning a normal “grounded system” (that exists outside the
operating room), which only needs a single fault to cause electrocution into a “protected”
system in which two faults are needed to deliver a shock. The line isolation monitor
determines the degree of isolation between the two power wires and the ground and
predicts how much current could flow if a second short-circuit were to develop. An alarm
goes off if an unacceptably amount of current to the ground is possible (i.e. the “isolated”
system is no longer isolated, but rather is grounded, thus only one additional fault could
result in a shock).

Advantages: it protects from macro-shock

Disadvantages: it doesn’t protect from the micro-shock
correct

12. Explain the work principle of electrocautery! what is the possible hazard?
Very high frequency current that will cut or coagulate tissue depending on the waveform.
A direct or alternating current is passed through a resistant metal wire electrode,
generating heat. The heated electrode is then applied to living tissue to achieve
hemostasis or varying degrees of tissue destruction. The current does not pass through
the patient; thus, the procedure can be safely used in patients with implanted electrical
devices such as cardiac pacemakers, deep-brain stimulators and implantable
cardioverted-defibrillators.
Since electrocautery device can deliver heat at a single temperature or range of
temperatures between 100-1200￮C. Histologic properties of the tissue to be treated, the
area and depth of destruction desired, possible complications, and capabilities of the
different electrocautery devices must be considered.

Possible hazard: burns, transmission of infection

Correct

13. Explain how do we create faraday cage for MRI room!

a conductive box used to shield out stray electromagnetic interference. We cover walls,
ceiling, and floors with a certain metal.
Correct

14. Explain what is magnet quench? what is the purpose of magnet quench?
Magnet quench in MRI is is loss of superconductivity when its temperature is raised. ​In the
event that somebody pushes the emergency stop button or there is an equipment fault, the liquid helium boils
off rapidly accompanied by a loud banging or hissing sound, safely expelled from the building by means of a
dedicated venting system.
Correct

15. What are the hazard of RF? how to minimize it?

The radio-frequency field may induce currents in wires that are adjacent or on the patient,
causing skin burns. It may induce currents in intra-cardiac leads, resulting in inadvertent cardiac
pacing. Prolonged imaging may cause the patient's core body temperature to rise. ​skin to skin
contact may lead to electric current induced by a closed conductive loop formed by skin-to-skin
contact on the body surface also causes thermal injuries.

Physicians and MRI technologists need to be aware of the bio-effects of radiofrequency fields
because RF-fields can cause tissue heating in the human body.

Biological Effects Due to Magnetic Field For the static magnetic fields currently used in MRI up
to 2 Tesla, there are no known biological effects. The majority of studies show no effects on cell
growth and morphology. Data accumulated by the National Institute for Occupational Safety, the
World Health Organization, and the US State Department show no increased risk for leukemia
or other cancer. Some reversible biological effects have been observed on human subjects
exposed to 2.0 T and above. These effects include fatigue, headaches, hypotension and
irritability. ​This paragraph is unnecessary

● To minimize the risk of synthetic fibers in clothes acting as a current inducer, all
patients having a MR exam must be changed into hospital provided clothing
(gowns) prior to imaging.
● All patients having a MR exam must be padded during imaging in accordance to
manufacturer guidelines to minimize skin to skin, and skin to magnet bore
contact.
● All patients must be provided a working alert device (squeeze ball), to able to
communicate with the MRI technologist during imaging when in distress.
● use insulation material of 1 cm or thicker to prevent skin-to-skin contact and the
formation of closed-loops from touching body parts,
● remove metallic objects contacting the patient’s skin (e.g., jewelry, drug delivery
patches with metallic components),
● allow only devices, equipment, accessories (e.g., ECG leads, electrodes), and
materials that have been thoroughly tested and determined to be MRI safe
● not to allow the wire or cable to form a conductive loop with itself or with the
subject.
​correct
16. What are the hazard of gradient coil? how to minimize it?
The most common hazard for gradient coil is the noise. For anatomical imaging, the noise is
mostly of low frequency and has a "buzzing or rumbling" sound; for EPI, the noise can be of
very high frequency (600-1400 Hz) and sounds like a loud "pinging". Generally, the higher
gradients used with higher magnetic fields and with EPI produce more intense noise. Prolonged
exposure to this noise will damage the unprotected ear.

● All subjects should therefore wear hearing protection, in the form of earplugs AND
headphones, during scanning (both are recommended for 3T).
● The musical playing is also may be used to reduce the annoying noise from gradient coil

correct

17. Explain how do we produce laser!

firstly , the laser consists of a tube filled with atoms that are the active medium, an
external source energy bumps the atoms into ‘excited’ states.
Two reflecting mirrors are placed at the ends of the tube to confine the photons to the
tube, one of the mirrors is made totally reflecting and the other is made slightly
transparent to allow a part of the laser beam to escape.
Steps involved in the production of a laser(excitation until laser):
-the electron in the metastable state jumps to a lower level releasing a photon.
-this photon interacts with another electron in the metastable state. This interaction
produces another photon of the same wavelength and same phase.
-these photons are reflected by the mirror and the laser beam comes out through the
partially transparent mirror.
correct

18. Which criteria should we take into consideration to choose laser for tumor
removal?
The criteria are :
-Laser wavelength that has highest penetration depth.
-can be used as LITT(Laser-Induced Interstitial Thermotherapy)
Laser that fulfilled this criteria is Nd:YAG laser because it has 1064 wavelength to
penetrate. LITT works by inducing the site of tumor with laser and destroy the tumor by
heating it to a certain level.
correct
19. What are the complications of using laser for skin ablation? how to minimize
those complications?
Ablative laser treatments work mainly on the epidermis (surface skin cells)
Complications:
- Permanent hypopigmentation
- Pseudomonas infection
- Bullous reactions
- Vascular proliferation
- Scar formation
- Postinflammatory hyperpigmentation
- Permanent depigmentation (after deeper surgery)

minimize:
- shortest time as possible to minimize the heat
- selecting more superficial approach in areas with thinner skin and in skin types prone to
pigmentary changes. ​correct

20. Explain how laser can cause the damage to retina!

When light enters the eye, it is focused by the lens on the retina at the back of the
eye, The damage happens when the focused light is too strong or lasts for too long,
and heats the part of the retina that contains pigment, or color (cones and rods).
That pigment absorbs the light just like dark clothing, and just like dark clothing
radiates, it radiates heat, The heat can burn the eye and permanently damage the
retina. If the laser light is brief or weak, it may not produce the same heat or
long-lasting damage, but instead could create a small after-image, which is a
bright spot that prevents normal vision.

● The ​directionality ​of a laser beam permits the ray to be focused to an

extremely small spot on the retina.
● A collimated laser will be concentrated by a factor of 100,000 when passing
from cornea to retina.
● Wavelength of 400-1400 nm are particularly dangerous to retina
correct
21. Explain the possible hazard in operating room! How do we minimize the hazard
at the operating room?
The most common possible hazard in operating room is about electricity. Static
electricity, fault electrical switches, electric shock, power failure, and many more.
Protective the ground, Ground Fault Circuit Interuptor (GFCI), Line Isolation Technique,
and Line Isolation Monitor, there are could be the solution to minimize the hazard at the
operating room. ​correct

22. ​What are the current faced drawbacks in ICU? Explain concisely the solution!
In ICU there are so many devices that critical patients needed. At the moment, the data
that collected is limited, ​raw, and disintegrated hence difficult to be interpreted.
Moreover, there is a condition that the doctor need the previous data. ​These conditions
often result in error, ​misinterpretation​, also misdiagnosis. ​Finally, It is difficult to control
all the patients if, for one patient there are three until six or it could be more devices that
used. The solution that suggested are provide better prognostic information, must be able
to acquire all the data into single integrated system to avoid human error, use informatics
based suite of translational tools to analyze data, also present information to clinicians to
help decision making.