Tuesday, February 23, 2021

Anatomy of the eye

Hi Friends!!!


In our previous anatomy and physiology session we have discussed about Lung Anatomy, Function and Disease, Anatomy of Kidney, Functions of Kidney, Anatomy of Liver, Functions of Liver, Anatomy of brain, Gait Cycle. Please check out for the link below.


Functions of Kidney


Lung Anatomy, Function and Disease


Anatomy of  Kidney


Anatomy of Liver


Functions of Liver


Anatomy of the Brain



Being a healthcare professional, it is very important to have knowledge about human eye.


In today’s topic we are going to discuss about anatomy of the eye.


Let's get into the topic.


ANATOMY OF THE EYE


The eyes are the organs of sight. The eyes are about an inch in size. The eyes are complex organs which are made up of many parts. The anatomy of eyes includes cornea, pupil, iris, sclera, conjunctiva, lens, retina, optic nerve, macula, choroid and vitreous body.


Let’s discuss in detail about each part of the eye.



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CORNEA


The cornea is the front window of the eye. A clear dome over the iris. The cornea transmits and focuses the light into the eye.


IRIS


The iris is the coloured part of the eye which helps to regulate the amount of light that enters into the eye. When the light is low, the iris opens up the pupil to let more light into the eye. When the light is more, the iris closes to let less amount of light into the eyes.


PUPIL


The pupil is the dark aperture present in the iris which determines how much light is let into the eyes. The pupil changes its size to alter the amount of light entering into eyes. The size becomes smaller for brighter light and larger for low light.


SCLERA


The sclera is the dense connective tissue of the eyeball which forms the white visible portion of the eyeball. The muscle that moves the eyeball are connected to sclera. The sclera is a tough covering with which the cornea forms the external protective coat of the eye. The sclera continues with the stroma layer of the cornea. The thickness of the sclera ranges from about 0.3mm to 1.0mm


CONJUNCTIVA


The conjunctiva is a clear, thin membrane which covers a part of front surface of the eye and inner surface of the eyelids. The main function of the conjunctiva is to keep the front surface of the eye moist and lubricated. The conjunctiva has two segments, bulbar conjunctiva and palpebral conjunctiva.


The bulbar conjunctiva covers the anterior part of sclera. It stops at the junction between sclera and cornea. It does not cover cornea.


The palpebral conjunctiva covers the inner surface of both upper and lower eyelids.


LENS


The lens in the eye is used to focus the light onto the retina. The lens is a transparent structure located directly behind the pupil. The lens which is enclosed in a thin transparent capsule helps in automatic focus of near and approaching objects through a process called accommodation. It acts as an autofocus camera lens.


The Cataract is a problem when lens become cloudy which can be corrected by replacing cloudy lens with artificial plastic lens.


RETINA


The retina is a light sensitive nerve layer which makes the inner lining located on the back of the eyeball. The retina converts optical images into electronic signals. The retina has two types of photoreceptor cells, the rods and cones.


The rods react well in low light providing black and white vision. The human eye contains about 125 million rods. The cones react in medium and bright light providing central and colour vision. There are about 6 to 7 million cones in the eye.


OPTIC NERVE


The retina sends light as electrical signals through the optic nerve to the brain. The optic nerve is made up of millions of nerve fibres which transmit these impulses to the brain.


MACULA


The macula is the central part of retina which contains the special light sensitive cells. These light sensitive cells allow us to see the finer details clearly in the centre of visual field.


CHOROID


The choroid is a layer of the eye containing blood vessels which lines the back of the eye. The choroid is located between the retina and the sclera.


VITREOUS BODY


The vitreous body is a clear, jelly like substance which fills the back part of the eye.


Now I hope you have acquired some knowledge about Anatomy of the eye. We will meet again with another valuable healthcare topic.


NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.


Check out for this blog about Computed Tomography,  X ray, MRI scan, ECG.


Generations of CT Scanners


COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS


x ray machine working principle


components of x ray tube


MRI scan 


MRI With Contrast


Brain MRI


Types of MRI scanners


ELECTROCARDIOGRAM


12 Lead ECG Placement


HOW TO READ AN ECG


Holter Monitor


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Tuesday, February 2, 2021

Gait Cycle

 Hi Friends!!!


In our previous anatomy and physiology session we have discussed about Lung Anatomy, Function and Disease, Anatomy of Kidney, Functions of Kidney, Anatomy of Liver, Functions of Liver, Anatomy of brain. Please check out for the link below.


Functions of Kidney


Lung Anatomy, Function and Disease


Anatomy of  Kidney


Anatomy of Liver


Functions of Liver


Anatomy of the Brain


Being a healthcare professional, it is very important to have knowledge about human body.


The understanding of human walking pattern is important for healthcare professionals.  In today’s topic we are going to discuss about Gait Cycle.


Let's get into the topic.


GAIT CYCLE


The gait cycle is a style or manner of walking. The gait cycle involves repetitive pattern of steps and strides. The following are the important terminologies of gait cycle.


STEP

The step is a single step in walking pattern.


STRIDE

The stride is a whole gait cycle.


STEP TIME

The step time is a time gap between heel strike of one leg and heel strike of another leg.


STEP WIDTH

The step width is the space between the two feet while walking.



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WHAT ARE THE PHASES OF GAIT CYCLE?

The following are the phases of gait cycle.


1. Initial phase

2. Loading response

3. Mid stance

4. Terminal stance

5. Pre swing

6. Initial swing

7. Mid swing

8. Late swing


These Phase are categorized under two major phases as following. Let’s discuss in detail about each phase.


STANCE PHASE

The stance phase is a period of time the foot is on the ground. The 60% of gait cycle falls under stance phase. The Stance Phase covers initial phase, loading response, mid stance, terminal stance, pre swing.


INITIAL PHASE

The initial phase covers 3% of the gait cycle. This phase is also called as heel strike. In this phase, the foot heel hits the ground first.


LOADING RESPONSE

The loading response covers 3 – 12% gait cycle. In this phase, the rest of the leading foot hits the ground. The knee flexes slightly and absorbs the shock when the foot falls flat on the ground. In this stage, the foot which falls flat on ground becomes supporting foot. This phase is also called as support stage.


MID STANCE

The mid stance covers 12 – 31% of the gait cycle. In this phase, the elevation and forward movement of the opposite limb occurs.


TERMINAL STANCE

The terminal stance can cover during 31 – 50% of gait cycle. The terminal phase begins when the supporting limb’s heel rises of the ground and continues till the opposite heel touches the ground.


PRE SWING

The pre swing phase covers during 50 – 62% of gait cycle. This phase is the transition phase between stance and swing phase. This phase is from the initial contact of opposite limb to the opposite limb falling flat on the ground. Here the supporting foot is pushed and lifted of the ground.      

                                                                    

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SWING PHASE

The swing phase is a period of time the foot is off the ground. The 40% of gait cycle falls under swing phase. The Swing Phase covers initial swing, mid swing, late swing.


INITIAL SWING

The initial swing covers during 62 – 75% of gait cycle. In initial phase, the advancement of the supporting limb begins with forward movement of the limb. The hip, knee and ankle are flexed to support the limb advancement and create the clearance of foot over ground.


MID SWING

The mid swing covers during 75 – 87% of gait cycle. In mid swing phase, the limb advancement continues and peak level advancement is reached by thigh.


TERMINAL SWING

The terminal swing is the final phase of gait cycle and covers from 87 – 100% of gait cycle. In terminal swing phase, the shank makes the final advancement and the supporting foot is positioned for initial foot contact to start the next gait cycle.


Now I hope you have acquired some knowledge about Gait Cycle. We will meet again with another valuable healthcare topic.


NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.


Check out for this blog about Computed Tomography,  X ray, MRI scan, ECG.


Generations of CT Scanners


COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS


x ray machine working principle


components of x ray tube


MRI scan 


MRI With Contrast


Brain MRI


Types of MRI scanners


ELECTROCARDIOGRAM


12 Lead ECG Placement


HOW TO READ AN ECG


Holter Monitor


DON’T FORGET TO FOLLOW THIS BLOG PAGE


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If you find this blog post knowledgeable, 

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Sunday, January 17, 2021

NANOROBOTS IN HEALTHCARE


Hi Friends!!!


Nanorobots is one of the emerging technologies in the field of healthcare. As it is important for us to be update with latest technologies, here we are going to learn about Nanorobots.


Let’s get into the topic.

 

WHAT ARE NANOROBOTS?


The Nanorobots or Nanobots was invented by Adriano Cavalcanti. The nanorobots are made of components which are at the size of nanometer. These nanorobots are programmed to carry out a specific task.


When it comes to healthcare, nanorobots have just started to create a revolution. The scientists predict that in 10 years injecting nanorobots into our bloodstream will become a common practice to improve our health condition.

 

Image Courtesy: analyticinsight.net

 

HOW ARE NANOBOTS MADE?


The nanobots can be made using materials like proteins, polynucleotides and other inorganic materials like metals, diamond.  The properties of nanobots surface plays a key role in determining the solubility of nanobots and its level of interaction with other macromolecules and cell surfaces. The size of nanobots has its contribution in the motion of nanobots towards a desired direction.


The nanobots in healthcare needs to do two specific tasks. One is identifying a specific targeting tissue and other is travelling towards that specific tissue. To perform these function, the nanobots ideally consists of a transporting mechanism, sensors, internal processor and fuel unit.


The sensors are used to identify a specific targeted tissue. It might be a chemical sensor, biological sensor, thermal sensor, optical sensor, magnetic sensor, mechanical sensor. The biological sensors detect the presence of specific tissues based on the biological reaction between the cells.


The transporting mechanism uses a propulsion equipment in nanobots which consists of miniature nanomotors and fuel unit to keep the nanobots alive till the completion of intended activity.


These transporting mechanism derives energy from reactions in the medium, electricity, acoustic and magnetic fields. The direction and speed of nanobots can also be controlled by external computers with the use of super conducting magnets. And the internal processor is used to coordinate all these activities as per the set programmable standards.


The MRI can be used to visualize the movement of nanobots inside human body.

 

NANOROBOTS IN CANCER TREATMENT


The use of nanorobots in cancer treatment has giving a hope for cancer patients and healthcare professionals all around the world in treating the deadly disease. Cancer is caused due to uncontrolled dividing of cells. The current treatment available is usage of chemotherapy to stop dividing of cells. But one of the disadvantages of chemotherapy is that it can also affect nearby good cells.


This is a scenario where nanobots comes into play. The nanobots exactly targets the specific cancer cells.


The nanorobots after entering into the human bloodstream, identifies and travels near the cancerous tumours. Then the nanobots delivers the blood clotting drugs near the blood vessels entering the group of tumor cells. The blood clotting drugs cuts off the blood entering into the tumour cells thereby helping to shrink the tumour cells and decreasing their spread.


In 2018, researchers also tested this technique in mice. They were successful in reducing cancer cells by cutting of the blood supply into the cancer cells using nanobots.


OTHER HEALTHCARE ADVANCEMENTS OF NANOBOTS


The nanobots are supposed to completely replace the usage of pacemaker in treating the heart conditions in future. This can be possible, because of their miniature nature the nanobots can work of years inside human body without any wear and tear.


Here is one of the most futuristic idea. Research is happening to trace the brain signals using nanobots. Researchers are looking for possible ways to drop nanobots inside the brain using minimally invasive surgery.


Research is going on to use nanobots as artificial red blood cells, white blood cells and platelets.


Now I hope you have acquired some knowledge about Nanorobots. We will meet again with another valuable healthcare topic.


NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.


Check out for this blog about Computed Tomography,  X ray, MRI scan, ECG.


Generations of CT Scanners


COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS


x ray machine working principle


components of x ray tube


MRI scan 


MRI With Contrast


Brain MRI


Types of MRI scanners


ELECTROCARDIOGRAM


12 Lead ECG Placement


HOW TO READ AN ECG


Holter Monitor


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Saturday, January 9, 2021

MDSAP Adverse Events and Advisory Notices Reporting - Part 8

 Hi friends!!!


In our previous blog we had a introduction about Medical Device Single Audit Program, MDSAP Audit Cycle, Management process Audit, Device marketing authorization and facility registration, MDSAP Measurement, Analysis and Improvement Process. Please check out for the link below.


Medical Device Single Audit Program - Part 1


MDSAP Audit Cycle - Part 2


MDSAP Management Process Audit - Part 3


MDSAP Management Process Audit - Part 4


MDSAP Device Marketing Authorization and Facility Registration - Part 5


MDSAP Measurement, Analysis and Improvement - Part 6


MDSAP Measurement, Analysis and Improvement - Part 7


In today's blog we will discuss in detail about Medical Device Single Audit Program (MDSAP) CHAPTER 4 -  Medical Device Adverse Events and Advisory Notices Reporting.


MDSAP is a common Medical Device auditing program followed by countries like Australia, USA, Brazil, Canada and Japan. Therefore it is important for every healthcare professionals who wish to market their product in the above mentioned countries to know in detail about MDSAP.


Let's get into the topic.


CHAPTER 4 – Medical

Device Adverse 

Events And Advisory

Notices Reporting


Task 1 – Notification of Adverse Events

Task 2 – Notification of Advisory Notices


Let’s discuss in detail about each tasks.




Task 1 – Notification of Adverse Events


Ensure that the medical device organization has implemented the procedure for identifying device related events which meets the reporting criteria set by applicable regulatory authorities.


Ensure that the medical device organizations procedure has special features to review the complaints to determine whether reporting to applicable regulatory authorities is required or not.


APPLICABLE REGULATORY STANDARDS AND CLAUSE


ISO 13485:2016: 4.2.1, 7.2.3, 8.2.2, 8.2.3


AUSTRALIA


Therapeutic Goods (Medical Devices) Regulations 2002 Schedule 3 Part 1 Clause 1.4(3)(c)(i).


As per Australia’s TGA, Medical Device manufacturers are required to implement effective post marketing system that includes provision for adverse event reporting.


The reporting timelines as per TGA are as follows.


1. The event that represents a serious threat to public health should be reported to regulatory authorities within 48 hours.


2. The event that led to the death or serious deterioration in the state of health of a patient should be reported within 10 days.


3. The event that the recurrence of which might lead to the death or serious deterioration in the state of health of a patient should be reported within 30 days.


BRAZIL


RDC ANVISA 67/2009 – Art. 6º

Ensure that the medical device organization has procedure for correct and prompt identification of adverse events. The safety and performance of the device has to be improved based on the results of investigation.


RDC ANVISA 67/2009 – Art. 5º

As per Brazil regulations, Ensure that the medical device organizations top management has appointed specific person responsible for post marketing surveillance system.


RDC ANVISA 67/2009 – Art. 8º

Ensure that the medical device organization is reporting to the notified bodies about the adverse events and other problems.


RDC ANVISA 67/2009 – Art. 8º

Ensure that the legal representative in brazil for an international manufacturer is aware of the health hazards and possibility of death while using a medical device.


CANADA


Medical Device Regulations SOR/98-282, Section 59-61.1


Ensure that the medical device manufacturer and importer is making a preliminary and final report to the ministry concerning any incident happening inside or outside Canada involving a medical device sold in Canada.


Reporting should be made in case of failure of the device, deterioration of its efficiency and inadequacy in labelling or instructions for use.


Reporting should be made in case of death or serious health deterioration to user, patient or public.


As per CMDR 60 (1) (a) (i), Ensure that the medical device organization is aware of the incident and should report about the incident within 10 days from the date of receiving information about the incident.


Ensure that the medical device Manufacturer has made effective arrangements to submit preliminary reports to the concerned Ministry and that the reports shall contain the details as per CMDR 60 (2).


Ensure that the medical device Manufacturer has submitted final reports to the concerned Ministry in writing in accordance with the timetable established under CMDR 60(2)(h) and that the reports shall contain the details as per CMDR 61 (1).


JAPAN


As per MHLW, Marketing authorization holders are required to maintain a effective post market surveillance system as per domestic Japanese regulatory requirements and QMS requirements.


Ensure that the persons operating the registered manufactured site shall reporting the adverse events coming under PMD Act Article 228-20.2 to the marketing authorization holder as per MHLW MO169: 62.6, instead of directly reporting to the regulatory authorities.


FDA


Ensure that the medical device organisation has implemented procedures for reporting to FDA about incidents involving death, serious health issues etc.


The medical device organisation shall report to FDA within 30 days from the day, they are aware of the incident.


Ensure that the medical device organisations, medical device reporting (MDR) files contain information regarding all the documents, decision making processes used to determine whether a incident is reportable or non-reportable to FDA. Copy of all MDR forms and all the information related to adverse events shall be submitted to FDA.


Ensure that the medical device organisation evaluates events in accordance with the QMS requirements to make FDA consider the submitted MDR files in compliance with 21 CFR 803.


Ensure that the MDR files submitted to FDA contains UDI number that is printed on the device label.


The MDR files submitted to the FDA shall be submitted electronically via the Electronic Submissions Gateway (ESG) using eSubmitter or the AS2 Gateway-to-Gateway using HL7 ICSR XML software.


Task 2 – Notification of Advisory Notices


Ensure that the medical device organisation submits the advisory notices to the regulatory authorities within the stipulated timelines. Verify that the medical device organisation is keeping all the records related to advisory notes and satisfying all the record keeping requirements as per applicable regulatory bodies.


APPLICABLE REGULATORY STANDARDS AND CLAUSE


ISO 13485:2016: 4.2.1, 7.2.3, 8.2.3, 8.3.3


AUSTRALIA (TGA)


As per Australia’s TGA, medical device organisation shall establish a effective PMS system for recovery of products.


TG Act 41FD

All details regarding the recall of products shall be reported to TGA by the manufacturer or Australian sponsor in a timely manner.


TG(MD)R Reg 5.8

Meanwhile sponsors are required to provide all the details about conformity assessment procedure to the manufacturer.


BRAZIL


RDC ANVISA 67/2009 - Art. 6º, RDC ANVISA 23/2012 – Art. 1º, Art. 5º

The medical device organisation shall implement procedure to identify when field actions (recalls) are required.


RDC ANVISA 23/2012 – Art. 4º; Art. 6º, Art. 10, Art. 11, Art. 16 

Describes the record keeping activities of medical device manufacturers.


RDC ANVISA 23/2012 – Art. 4º, Art. 6º, Art. 7º, Art. 13, Art. 14, Art. 15

In order to perform field actions and recalls, medical device organisation shall provide evidence justifying that their product does not comply with the requirements of safety and effectiveness.


RDC ANVISA 67/2009 – Art. 8º

In case of international manufacturer, the legal representative in Brazil should be aware of the recalls performed on the devices exported to brazil by international manufacturer.


CANADA


Medical Device Regulations SOR/98-282, Section 63 – 65.1.


The medical device manufacturer or importer shall provide the required details on or before undertaking a recall to the applicable ministry as per CMDR 64.


The medical device manufacturer shall also report the results of the recall and corrective actions taken to the applicable ministry as per CMDR 65.


In case the reports were submitted by the importer, manufacturer shall write to the applicable ministry stating that the manufacturer had permitted the importer to prepare and submit the reports to the ministry as per CMDR 65.1.


JAPAN


PMD Act 68-11

The marketing authorization holder shall report to the applicable regulatory bodies about the advisory notices issued.


MHLW MO169: 29

The person operating the manufacturing site does not need to directly report to regulatory authorities about the advisory notices, whereas it is important for him to report to marketing authorization holder so that they can communicate to regulatory authorities.


UNITED STATES (FDA)


21 CFR 806: Medical Devices; Reports of Corrections and Removals


Reports regarding the recalls or corrective action shall be submitted to FDA within 10 days from the date of initiation of recall or corrective action.


Ensure that the medical device organisations report contains the UDI that appears on the device label or on the device package, or the device identifier, Universal Product Code (UPC), model, catalog, or code number of the device and manufacturing lot or serial number of device or other identification number.


The medical device manufacturer are supposed to maintain records of recalls even when there is no requirement to report to FDA.


Now I hope you have acquired some knowledge about MDSAP Chapter 4 - Medical device adverse events and advisory notices reporting. We will discuss in detail about remaining chapters of Medical Device Single Audit Program in our future blogs.


NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.


Check out for this blog about Computed Tomography,  X ray, MRI scan, ECG.


Generations of CT Scanners


COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS


x ray machine working principle


components of x ray tube


MRI scan 


MRI With Contrast


Brain MRI


Types of MRI scanners


ELECTROCARDIOGRAM


12 Lead ECG Placement


HOW TO READ AN ECG


Holter Monitor


DON’T FORGET TO FOLLOW THIS BLOG PAGE


DROP YOUR MAIL ID TO GET IMMEDIATE UPDATES


If you find this blog post knowledgeable, 

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