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What is Nomenclature for Medical Devices?

The nomenclature of medical devices is a coding and naming system used to generically classify and identify all medical devices and related health products. According to different classification and nomenclature systems, there are between 5,000 to 24,000 different types of medical devices. They range from the very simple to complex, inexpensive to costly.  The number and types of devices are increasing exponentially.

 

Which characteristics are required for a standardized nomenclature for medical devices?

Countries and other stakeholders need a globally accessible, transparent and harmonized nomenclature system for medical devices.

WHO recognizes the availability of multiple systems and offers a platform towards convergence. The lack of such a system is impeding progress towards access to medical devices, which has an negative impact on efforts to facilitate emergency interventions and, more broadly, achieve universal health coverage.

 

 

What do you understand by ‘medical devices’?

Medical devices include all types of health technologies (except for vaccines and medicines) required for prevention, diagnosis, treatment, monitoring, rehabilitation and palliation. These are indispensable for universal health coverage, monitoring well being and addressing outbreaks or emergencies.

Some types of medical devices include:

Types of Medical Devices	Examples of Medical Devices
Single Use Devices	Syringes, Catheters
Implantable	Hip Prothesis, Pacemakers
Imaging	Ultrasound and CT scanners
Medical Equipment	Anesthesia Machines, Patient Monitors, Hemodialysis Machines
Software	Computer Aided Diagnostics
In vitro Diagnostics	Glucometer, HIV Tests
Personal Protective Equipment	Mask, Gowns, Gloves
Surgical and Laboratory Instruments	Scissors, Knives, etc

 

   

Why is there a need for a standardized nomenclature for medical devices?

The multiple nomenclatures in existence makes it difficult to communicate important information between individuals and organizations, which can result in health, economic and social impact. It complicates procurement, supply and trade, and tracking of medical devices.

Some important information negatively impacted by an absence of a standardized nomenclature include:

•     Patient safety
•     Intended use of medical devices
•     Regulatory status
•     Technical information
•     Adverse events
•     Availability
•     Others

 

A standardized classification and nomenclature of medical devices will serve as a common language for recording and reporting medical devices across the whole health system at all levels of health care, and for a whole range of uses. Hence, the WHO is working towards a globally accessible, transparent and harmonized  nomenclature system.

 

Standardization of naming medical devices is also essential for:

1.     Streamlining procurement
2.     Grouping and evaluating innovative technologies
3.     Classifying for regulatory approval (registration)
4.     Supporting device descriptions for universal health coverage benefits packages
5.     Ordering and grouping of devices in electronic health records and other health information systems

 

 

What is WHO and nomenclature for medical devices?

Several systems exist today to name and classify medical devices. Each system is used by a different group of professionals depending on the needs of that group. Such needs include:

1. Regulatory approval
2. Procurement and supply
3. Customs operation
4. Inventories and maintenance, among others

 

Some countries and organizations have developed their own national systems that are not compatible across systems.

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In 2010 and 2017 WHO conducted surveys asking about Nomenclature systems. As many as 174 countries responded.  About half of the responding member states (52%, n=90), use at least one official nomenclature system for medical devices. 

In contrast, 84 member states did not have any official national nomenclature (49%). More information can be found in the Global Atlas of Medical Devices (2017). This Atlas is currently being updated (2021). 

The GAMD 2021 (including information by country on the use of nomenclature systems for medical devices), was open for consultation until December 2021. 

Up-dates on nomenclature systems for medical devices from member state's Ministries of Health have been included. 

Please find further information in the  WHO GAMD website.

 

In resolution WHA60.29 (2007), WHO was requested  to work with interested Member States and WHO collaborating centres on the development of guidelines and tools relating to health technologies (in particular medical devices). Such guidelines and tools were to include norms, standards and a standardized glossary of definitions. 

All stakeholders were to use a transparent and evidence-based process.

  

WHO standardized nomenclature for medical devices

A standardized international classification coding and nomenclature of medical devices could link to WHO’s other international classification systems, such as the International Statistical Classification of Diseases and Related Health Problems, the International Classification of Functioning, 

Disability and Health and for health products, the International Non-proprietary Name for medicines, in order to support organized and standardized information for policy-makers and managers. 

In March 2011 WHO convened representatives from the nomenclature agencies to search for convergence in Nomenclature of Medical Devices which has not been achieved to date.

 

 

WHO consultations on nomenclature for medical devices

Since 2010, WHO has conducted several consultations on issues related to medical devices, including discussions during WHO’s  past Global Fora on medical devices (in 2010, 2013, 2017 and  2018), and country surveys to determine country needs. 

WHO has also developed guidance documents on:

1.  How to formulate policies on medical devices
2.  Effective donation of medical devices
3.  How to select, assess, manage and procure relevant devices

In all the above-mentioned Fora, documents or consultations, the topic of lack of standardized nomenclature was noted.

 

 

WHO request for collaboration on nomenclature for medical devices

In 2018,  WHO published a Request for input and collaboration towards international classification, coding and nomenclature of medical devices, that included the principles of governance, classification and access of information. 

WHO received 43 comments from Member States and other organizations. Since then, WHO has been searching for a solution that complies with those principles, which are summarized below.

Governance

    Organizational and review structures should be in place to ensure that all stakeholders from different regions are able to provide feedback according to global needs.

 

Classification, coding and nomenclature characteristics of Medical Device

The following are required:

1.      Transparent methodology and processes
2.      Transparent mechanism for regular updates (e.g. once per year)
3.      Hierarchies grouped into categories and subcategories to meet stakeholder needs
4.      Medical devices used outside highly regulated countries
5.      Mutually exclusive terms
6.      Availability of terms in other languages

 

Access to information

 

Information should:

• Be freely available and considered a global public good
•  Support unique device identifier system
•  Be accessible through simple and intuitive search
•  Be available for use in all health-related data base systems
•  Be capable of being referenced and used by regulators, procurers, managers and all users of medical devices (hospitals/health care workers and patients)

    

 

Which characteristics are required for a standardized nomenclature for medical devices?

Countries and other stakeholders need a globally accessible, transparent and harmonized nomenclature system for medical devices.

WHO recognizes the availability of multiple systems and offers a platform towards convergence. The lack of such a system is impeding progress towards access to medical devices, which has an negative impact on efforts to facilitate emergency interventions and, more broadly, achieve universal health coverage.

 

2019-2021 WHO Executive Board sessions related to a standardized nomenclature for medical devices

 On 29 May 2019, the report Standardization of Nomenclature for Medical Devices EB145/3 was presented in Executive Board 145 with recommendations on international classification, coding and nomenclature for medical devices. 

The nomenclature system can be used in all Member States and supports: patient safety, access to medical devices for universal health coverage, preparedness for emergency support and emergency response, efforts to improve quality in healthcare and the achievement of Goal 3 of sustainable development. 

The webcast of the school management presents the declaration of the member states 

    On 23 January 2021, the WHO Executive Board 148 discussed report EB148/13 on the standardized nomenclature of medical devices. The report proposes that WHO will not create a new medical device nomenclature or adopt its own system, but align with the European medical device nomenclature, which will support the regulation, control and management of medical devices to improve access. 

Statements by Member States are available on the Executive Board webcast 148. Member States require information and consultation meetings. 

The first meeting for Member States will take place on 12 April 2021 and further meetings will be held with other stakeholders.

    In April 2021, WHO updated the analysis of the existing nomenclature of medical devices requested by Member States. The analysis will be updated as more information becomes available.

 

 

What are the Different Types of Medical Equipment?

i. Diagnostic Equipment

The doctor or technician looks for any abnormalities in the affected organs or body parts that are causing the symptoms. 

A diagnostic medical device is any type of device or equipment that is used in a hospital setting for the sole purpose of diagnosing a patient's condition. 

Based on the symptoms described by the patient, a diagnostic examination is performed with the appropriate equipment for the internal examination of the patient. 

 

What are the most common types of diagnostic equipment used in laboratories and medical clinics?

Below are some of the most common types of diagnostic equipment used in laboratories and medical clinics:

• Medical imaging devices: The visual image produced by the device is used for clinical analysis and medical intervention. 

Medical imaging is a type of technology used to create a visual representation of the inside of the human body.  

There are many medical imaging devices such as radiography (X-ray machine), computed tomography (CT scan), magnetic resonance imaging (MRI scan), ultrasound and echocardiography to name a few.

• In addition to medical imaging devices, there are other medical devices that are used to diagnose patients. Some examples include patient scales, stethoscopes, Doppler and pulse oximetry.

 

ii. What is Durable Medical Equipment (DME)?

Use of this device must be prescribed by a physician and is designed for medical purposes. This type of medical equipment is mainly used to provide therapeutic benefits for certain conditions or diseases. It is a long-lasting and reusable device that can be used in the hospital or at home for patient care.

There are different types of durable medical equipment as:

•          Manual wheelchairs or electric wheelchairs

•          Hospital beds

•          Walkers, crutches, canes (or any similar type of mobility assistive equipment)

•          Traction equipment

•          Pressure mattresses

•          Insulin pumps

•          Breast pumps

•          Nebulizers

•          Patient Lifts

•          Bili lights and blankets

•          Kidney machines

•          Stationary or portable oxygen tanks

•          Oxygen Concentrators Ventilators

The term ‘durable’ is derived from the fact that these types of equipment have been tested for quality.

They are designed to provide support for the safety and comfort of the patients.

They should be able to deliver just that. Some of the common features of durable medical equipment include non-slip features and load-bearing strength.

Since this equipment is prescribed by the physician for the benefit of the patient, the cost of acquiring one is often covered by health insurance plans.

 

 

iii. What is Treatment Equipment?

Treatment equipment is any type of medical device or tool that is designed to treat a specific condition. It utilizes modern technology in order to address any abnormalities to restore function in the affected organs or tissues within the body.

This can also include the surgical supplies designed to provide treatment for certain conditions that require surgical intervention.

Below are common examples of medical treatment equipment that you will find in hospitals and clinics:

•          LASIK Surgical Machines: The use of LASIK technology is used primarily for the treatment of eye conditions. It is designed for use on patients suffering from myopia, hyperopia, or astigmatism.

•          Medical Lasers: Laser is a revolutionary technology introduced in the medical field for the treatment of various medical conditions. 

It is a device that emits a wavelength of electromagnetic radiation for clinical applications.

These settings are to be determined by the attending physician during treatment.

These wavelengths vary when it comes to energy level and pulse duration.

•          Infusion Pumps: This type of treatment equipment is used in a hospital setting. 

It is designed to infuse medication, fluids, and other forms of treatment to the patient’s circulatory system. 

This machine is reliable because it injects controlled amounts of fluids into the patient’s system over a given period of time. 

This machine is used intravenously but you can also find epidural or arterial infusions. 

 

Meanwhile, treatment equipment used for surgical procedures include the following:

•          Diagnostic scopes

•          Surgical caps, gowns, gloves, or glasses (for the surgical team)

•          Gauze and drapes (for patients)

 

 

iv. What is Life Support Equipment?

As the name implies, life support equipment are those medical devices intended to maintain the bodily function of a patient. Without life support, it will be difficult for the patient’s organ systems to function on their own. 

There are a variety of life support machines in the medical field today, such as the following:

•          Heart-lung Machines: These are also known as cardiopulmonary bypass (CB) devices, this type of equipment temporarily functions as the heart or lungs of a patient during surgery.

 It is known as a form of extracorporeal circulation.

 It facilitates in the circulation of blood and oxygen throughout the patient’s body.

•          Medical Ventilators: This type of device is designed to move breathable air in and out of the lungs.  

There are two types of medical ventilators. One is hand-operated using a bag valve mask. The other is run and operated by a computer.  

It is used on patients who have difficulty breathing, or who are incapable of delivering an adequate supply of oxygen throughout the body. 

You will find this machine used in intensive care unit patients or home care patients.

•          Incubators: An incubator is a medical apparatus used for neonatal intensive care. 

It is often used in conjunction with a few other medical equipment such as an oxygen hood and ventilator.

It is designed to mimic the environmental conditions suitable for newborn babies. 

 

•          Dialysis Machine: Dialysis is the method of removing excess solutes or toxins from the blood. 

It is a type of renal replacement therapy. 

Dialysis machines are essential for those who have kidney damage or lost kidney function. 

It is used on people whose kidneys have been damaged and are incapable of performing these functions. 

 

 

What is Medical Laboratory Equipment?

The use of medical laboratory equipment is often seen in medical clinics or diagnostic laboratories.

These types of equipment are intended for the analysis of blood, urine, genes, and other biological material.

What are the are the most common medical laboratory equipment used in the medical field?

Below are the most common examples of medical laboratory equipment used in the medical field:

•          Microbiological systems

•          Blood gas analyzers

•          Chemistry analyzers

•          Blood collection supplies

•          Electrolyte analyzers

•          Differential counters

•          Drug testing analyzers

•          Coagulation analyzers

•          Urinalysis analyzers

•          Hematology analyzers

As medical technology continues to evolve, you can expect that there will be more types of medical equipment emerging.

This is good news to patients who can expect quality medical care and diagnosis utilizing the latest in medical technology.

 

Discussion at the 24th WHO World Health Assembly on the nomenclature of medical devices

    Although there is general agreement that a standardized nomenclature should be used for all member states, as an element to support the evaluation, regulation, purchase and management of medical devices, the discussions are polarized: a set of countries that promote - a proprietary system - and a number of countries with this proposal disagreed and asked the WHO for advice on a relevant approach that takes into account existing systems.

    As requested by Member States at the 145th session of the Executive Board, WHO will not create a new nomenclature, but will choose from available ones to work towards convergence.

    The WHO Secretariat was asked by the EB in January to hold an information meeting with Member States - one on 12 April with all Member States and 3 other meetings with: Andean countries, the European Commission, the Medical Devices Consultative Group and other NGOs approved by FENSA and biomedical engineers, and presented by IMDRF.

    Further information meetings and consultations will be held from June to September 2021 with stakeholders: regulatory authorities, industry, health care providers and managers, and Member States. The WHO hopes to have a new report in October with the results of the investigation and consultation ready to present for discussion before the next EB 150.

WHO needs help from Member States to find similarities between available systems, including between the proprietary Global Medical Device Nomenclature system, the European Medical Device Nomenclature and other important nomenclature systems, to ensure international classification, coding and nomenclature. available especially in this. at a time when access to medical supplies is essential to respond to an outbreak and to strengthen health systems.

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 Hair Extensions or Wigs and their Usage

Most of the women do not have the long tresses, due to different reasons, and for them, hair extensions are the best option. Everyone likes beautiful long, fit and healthy hair that makes them look young and sexy. Those who have natural long hair, then people envy you. Hair extensions add volume and length to your hair and give the effect of streaks if you do use different colored hair extensions. People always have wanted their hair to look good. It is not only women but men also want to use hair extensions. People also call them wig. Most Africans have small gizzled hair and want long and straight hair. Many people have black or blond hair but want hair of other color. They also do not want to use hair color as this may spoil their scalp health. In all such cases hair extensions or wigs can be used.

 

Are there any rules for using hair extensions?

Avoid lubricating the scalp and roots, as this can cause hair extensions or wigs to disappear. Do not twist your hair or tie a long ponytail. That is why the lower part of the hair is pulled out. Make sure you do not pull your hair aggressively, even if hard tangled hair is removed. 

When to remove extended hair?

Do not continue hair extensions for four weeks or more. Or if your hair has grown more than 2 inches.

 

Who is the Best Hair Extensions seller?

vvfit.in is the best hair extensions seller in the global market. It is retailer as well as wholesaler. It is an exporter form India as well.

 

Is it okay to swim when you have extended hair or wig?

Swimming is not a problem if you have extended hair. Make sure that your hair does not get wet with water for a long time and wash immediately with salt water or chlorine. Make sure you wear a bathing cap. Before putting on the cap, consider a loose ball and then put on a bathing cap.

 

Do you know the difference between temporary and permanent hair extensions?

Temporary hair extensions / Wigs: Can be removed daily or weekly. These include clip-in pieces, wefts and ties, to which large pieces of hair are added.

Semi-permanent hair extensions / Wigs: lasts six to eight weeks. He added small pieces of hair as a hair extension.

Permanent hair extensions / Wigs: Wear them for many months. The beach is connected to the beach.

 

 

Are hair extensions bad for your natural hair?

Continuously putting and removing the temporary hair extensions can damage the hair. Used occasionally, they would not cause damage. They will need refitting when your natural hair grows out and starts getting pulled and damaged.

If you opt for permanent hair extensions, then ensure you use the correct products and methods as also do the proper post-care to have them last forever.

 

Who doesn't need wigs hair extensions?

Those who suffer from active hair loss should stay away from hair extensions. If you have small hair, then there is no need to use wig hair extension. The ideal condition is to combine natural hair density with hair extensions. If you have fine hair, add a small amount of extended hair and those with thick hair can lengthen the hair a lot. 

How do you know what hair extensions to buy?

If you only want to change your appearance for a specific occasion, choose a temporary hair extension. If you are looking for a hairstyle that will last for a variety of occasions such as a wedding, etc. Try semi-permanent hair extensions. If you want to change your appearance forever, choose a permanent hair extension.

 

How much does the extension cost here?

Now the cost of hair extensions is so subjective. Permanent hair extensions can take 2 to 3 hours to hang, and therefore cost even more. 

Temporary ones are the smallest, semi-permanent ones are more expensive and permanent ones are the most expensive. 

With permanent hair extensions, the cause of time also comes into play.

How long have the extensions been here?

It will depend on the type of hair extensions you use, the quality of the product and the care you give to your hair and hair extensions.

 

Why there is need to use hair extensions?

Hair extensions create a layer between natural hair and products like equipment. The main reason for hair extensions is to increase hair length. They can also cover poor quality hairstyles. Hair extensions can also increase hair volume. 

If you want to add color and size to your hair, you can use different hair colors to extend your hair without dyeing natural hair. Sheet hair is made to look thicker, for example by lengthening hair. 

Using hair extensions is also a way to change your hairstyle without having to cut and change natural hair. Nothing boosts confidence when beautiful hair sits right around the scalp. 

Swapping hair on your shoulder is a sign of wonder and hair extensions can help you become a wonder. Using too many chemical heavy products and hair tools that involve heat can damage your natural hair.

 

What is Real and Synthetic Hair Extension?

Hair extensions can be made with real hair or with synthetic fibres that emulate hair. Real hair, of course, is the hair extension type that will look the most ideal and ‘real’ but it also faces the problems that any real hair face frizziness, etc. 

Hair extensions made of synthetic fibres are more durable but have a plastic-y look to them. Real hair extensions are costlier than synthetic hair extensions but last longer.

 

What are the Types of hair extensions?

There are 5 types of hair extensions ... keratin application hair extensions, weaving, hair extensions tape, duct tape and clip. The keratin process follows the extension of the scalp hair with a dry keratin-based "glue" at one end and a dry hot / cold treatment. 

Weaves are hair extensions that are sewn with a needle and can last up to 3 months. 

The hair extensions that are on the glue are the same, but the glue is used to attach the hair extensions to the hair. 

Tape hair extensions are extensions that attach to the hair band from the bottom of the top layer. 

Clip-on hair extensions are temporary, where the upper end of the extension is a clip used to extend natural hair.

 

What is Color Coding for Hair Extension?

Hair extensions can be done with real hair or synthetic fibers that mimic hair. While using different colored hair extensions may seem more interesting, you need to check how they look on your natural hair. They do not combine naturally as an ombre, burgundy or balayage hair colors. 

Real hair is the type of hair extension that looks most ideal and "real", but it is also related to the problems that every real hair has when it comes to frizz and so on. Choose basically the same hair extensions as your natural hair.

 If you use real hair extensions, you can apply them first and then dye your hair in case of both natural and extensions, according to your choices. 

Real hair extensions are more expensive than synthetic hair extensions, but they last longer.

 

Keep it routine based

Do you have enough time for the care that hair extensions need? Do you spend time in extreme weather conditions? How busy is your routine? Do you use a lot of heat-based hair products? Depending on your answers to these questions, you need to decide on hair extensions and the type you want to use. For example, if you use a lot of heat-based tools or go to hot yoga, hair extension with tape will not work and hair extensions with keratin will. But if you still want to change your hair color, then the option of applying keratin will not work and hair extension with tape can be a better bet.

 

Care notice

If you can extend your hair, you need to take care of it. And you need to make sure that the hair extensions you get are good for your hair. 

Choose the right and light hair extensions so that it doesn't attract, weaken or damage your hair. 

For proper hair care and hair extensions, it is necessary to have daily care, good hydration and use natural products without drying chemicals. Hair extensions require a lot of care. 

Find out what you want hair extensions to gain, and also find out about various factors related to hair extension types, their qualities, aftercare, etc. before you decide on hair extensions. If you will have hair extensions included, choose an expert who knows knowledge about hair extensions for best results. 

After applying extended hair, it is advisable to make hair adjustments so that everything looks natural.

 

Hair health

If your natural hair is damaged, it is better if you prefer it in a better condition. Talk to a hair professional and straighten your hair and then choose a hair extension application. Also, research your hair and choose a hair extension type with the advice of a hair expert. This will make your hair look healthy.

 

After care

Hair extensions, like your natural hair, require proper care. For a perfect look, extended hair should be washed, blow-dried and treated regularly. Using curative or smoothing treatments, such as straightening or curling hair, can hide the problem. It's a waste of time, but the look and feel of the post is what you're looking for. 

Over time, the ends of extended hair can become uncontrollable, making the extensions visible from natural hair. Products that are identical

What will work on your natural hair may not work on hair extensions. You need to get hair products to help keep your hair and hair extended beautiful. Using a well-mixed brush, make sure that your hair, naturally and elongated hair, is without scrubbing. 

If you feel that your natural hair is drier than normal because the products do not reach the roots of natural hair, split your hair and use a rinse-free hair conditioner spray to ensure that all hair remains hydrated. 

To keep your hair healthy, you need a non-tear sulfate shampoo and a moisturizing conditioner or mask.

 

Comfort under all circumstances

If at any time you feel that your hair is pulling (no one is pulling it!) Or you feel pain in the scalp, check the extended hair for hair, hair, hair, hair, hair, hair, hair, hair, hair, hair, hair, hair With or without hair extensions, it is important to keep your hair as healthy as possible. Take care of our hair especially after hair extensions and you will show a beautiful mane. If your scalp itches, play well with your hair; the shampoo may have washed the roots badly.

 

What are the Mistakes to Avoid in case of Hair Extensions?

Using poor quality hair extensions: Make sure the hair extensions you use are of good quality. It can be expensive, but it will definitely take a long time.

Larger strands for smaller parts: Each strand is attached with a strand of natural hair. Using a longer strand of hair can lead to pregnancy and pulling of natural hair.

Make sure you match the hair extension color: You need to find the color that best suits your natural hair. Hair extensions are prepared in advance with a specific hair color or strands.

Mixing hair extensions into real hair: Hair extensions that are too visible in color, texture and cut do not look good. Mix to look good.

Make sure you do the right care routine: Try simple daily routines, such as tying hair to an empty pony or free night flight and completely drying the hair to the roots. Save hair damage and keep the scalp healthy. Ask a salon expert how to take care of your hair and hair extensions and follow the advice provided.

 

 

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