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Processed vs. Unprocessed Medical Devices

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Medical Devices

Medical devices refer to a list of equipment used by doctors, nurses, and licensed technicians every day, in countless numbers medical fields, and in a countless number of situations.

Medical devices can be simple, such as disposable, simple test strips, tongue blades, bedpans, or custom trays, to a complicated and complex heart/lung machine, pacemakers, and everything in between including but not limited to,

  • Electrical Equipment
  • Instruments
  • Appliances made of soft or hard material
  • Custom Trays designed for any number of purposes
  • Monitoring Equipment
  • Life Sustaining Equipment

Medical devices are necessary tools professionals use on patients every day, such as in the following examples,

  • Performing Countless Tests
  • Diagnosing an Illness or Disease
  • Therapy Sessions
  • Prevention of Diseases
  • Custom Trays for many sterile and nonsterile procedures
  • Treating Conditions and Injuries
  • Compensatory Equipment
  • Surgeries

According to the FDA, medical devices are categorized into three divisions Class I, II, and III, (low to high risk.) Each class offers risks and FDA regulations, in regards to safety and the effectiveness each display.

For example, the scope of custom trays in the medical arena number to nearly 2,000 types and designs, in all sizes for sterile and nonsterile procedures.

These custom trays make up specific items used in specific procedures. Each item on these custom trays must have an FDA number and be registered.

Processed Medical Devices

For example, you are a manufacturer and want to introduce new custom trays on America’s marketplace; you must adhere to a series of steps to attain clearance for the medical device to be sold in the United States. The FDA gives you this permission to sell your custom trays in the United States.

Processed medical devices are devices cleared by the FDA for use on patients. These processed medical devices include proper instructions, labeling, corresponding therapeutic product, generic equivalents, and similar equivalents. The FDA has a comprehensive list of all processed medical devices including custom trays.

Each of these processed medical devices met a stringent definition of that medical tool, no matter its use or branch of medicine.

Unprocessed Medical Devices

The FDA considers any medical device that has not gone through the stringent process for registration certification as being an unprocessed medical device, including various types of custom trays.

Medical devices that have not passed through the FDA’s systematic series of actions for certification nor passed a safety test for patient use are considered unprocessed.

Before you put a medical device on the United States marketplace, there are detailed steps you must go through.

When you want to sell a medical device new to the market, you the manufacturer must go through stringent steps to process your their medical device.

These devices can be Class I, II, or III categories. You must file a Premarket Notification with the FDA. While the FDA may not approve this device, the FDA may give you clearance to sell the device in the United States.

If you change a current product such as custom trays, on the market, you must follow this process especially if it changes the way in which the device operates and it’s safety issues.

You must propose the device’s intention for use, design of the instrument, and it’s suitability for the intended purposes as stated. This process helps to categorize the device in the class of I, II, or III. The device receives a specific code and number.

You receive your registration certificate in the form of an FDA post on their government website, for example, your custom trays. This post is your only registration and is now cleared to sell your custom trays.

Custom Trays Benefit in the Healthcare Market

CategoryFeatured-SurgicalTheatre4People

Used for many different procedures and purposes, surgical trays can be customized and used by all medical care facilities. The sterilized instruments in these trays remain clean and in tact until they are ready to be used. With a variety of different custom tray options available, a facility can keep on hand what they will need. This convenient product can be very beneficial in the healthcare market and it is also typically very cost effective.

Customization

A custom tray can be ordered from most surgical tray manufacturers. Each tray will contain specific tools that are used for a specific procedure and these items can be chosen by each individual client. Just a few custom tray packs include items for the following:

  • Saline flush
  • C-section
  • Angiography
  • Laparoscopy
  • Pacemaker battery replacement
  • Tracheotomy

Timely

Depending on the medical setting, many times a surgical pack is needed in a very short amount of time. Someone’s life may be at risk and it would take precious seconds to stop and find specific tools that would be needed in order to complete some sort of procedure. With a custom tray, everything you need is in one location, sanitized, sterilized and ready to be used. You simply grab the pack and go.

Cost Effective

The cost for custom medical trays is of course, a bit higher than a standard pack. However, it is important to make sure you have all the right tools needed to get the job done. Some clients opt to purchase standard packs for common, non-life threatening procedures and then custom trays can be purchased for other, more intricate procedures.

Date of Use

Each tray pack comes with a shelf life date that recommends when the item should be discarded and replaced. This date often has to do with the sterile nature of the items inside and it is in best interest of the facility and the patients to adhere to this date. Luckily, these packs usually last for quite a long time.

Custom surgical and medical trays are important for many different medical facilities and locations. Whether it be for a hospital, ambulatory center, surgical center, medical office, dental office, etc. It is far more convenient to not have to order separate products and try to keep them organized within a facility. Not to mention, keeping them accessible and nearby. These trays free up more time so that staff can focus more on what is important, and that is the patients.

When is Chemical Sterilization Most Appropriate?

surgical tools

In all laboratories and hospitals, sterilization is a must. This is because viruses, bacteria, fungi, and other disease-casing agents cannot be totally killed by disinfection. What disinfection can only do is to remove them the way we remove dirt and germs in our kitchen. It only removes such agents, but it does not kill and eliminate them.

Sterilization is the primary and recommended method of cleaning all equipment, tools, and devices that are repeatedly used such as surgical instruments, biopsy forceps, and a custom tray. These objects are prone to any type of contagious disease, which can be transmitted by these tools and objects if not sterilized.

Types of Sterilization

There are two types of sterilization processes. These are:

  • Heat Sterilization
  • Chemical Sterilization

Heat Sterilization

Heat sterilization is the most recommended method of sterilization used for many decades already. This is because pathogens and other harmful bacteria are killed at a certain heat temperature. Some tools that are small can be soaked with boiling water. This will ensure that even the hardest to reach areas are sterilized.

In the case of larger and more complex devices and equipment in which sterilization with boiling water does not apply; steam sterilization is used. Steam sterilization distributes the heat all over the surfaces. This method can instantly kill and eliminate stubborn bacteria, fungi, and pathogens. It is also a proven method to clean all hospital and laboratory equipment and devices regardless of size and shape.

There are instances that steam sterilization is not applicable. Some devices and equipment are vulnerable to moisture and steam. Devices and equipment with a complex electronic system is a good example. The modern alternative to sterilizing them is through infrared sterilization. This type of heat sterilization kills all disease-causing agents in an instant.

Chemical Sterilization

Nowadays, there are a lot of modern hospital and laboratory instruments and tools such as a custom tray that are susceptible to heat. This means they have some components that should not be exposed to high temperature. These components are rubber, plastic, glass, and other similar elements.

To sterilize them without using heat, the recommended alternative is through chemical sterilization. Chemical sterilization is the process of using low temperature chemicals to kill, eliminate, and remove all germs, viruses, and bacteria. This can be in the form of gas or liquid chemicals.

Chemical sterilization uses the following elements and compounds:

  • Silver
  • Peracetic Acid
  • Hydrogen Peroxide
  • Phthalaldehyde
  • Glutaraldehyde and Formaldehyde
  • Bleach
  • Ozone

The above chemicals are used in many different ways and processes. Some can be mixed with other chemicals. Others are directly applied. There are also cases that some of them can be used along with steam sterilization.

Hospital and laboratory instruments don’t have to get heated only to sterilize them. Chemical sterilization can do the job without heating them. However, not all instruments and equipment can be sterilized in this method. This is because there are some equipment or devices that contain some elements that may react violently with the above chemicals. Before using a chemical sterilization process with these types of devices, it is recommended you check the manufacturer’s instructions from both manufacturers of chemicals and devices to be sterilized.

Chemical sterilization is now becoming the most recommended method of the sterilization. Many hospitals and laboratories are beginning to reduce the use of disposable instruments. Hospitals and laboratories are also now using a custom tray instead of disposable ones. And there are such instruments that should not be heated because they may have been made of plastic or glass. This is where chemical sterilization is appropriate.

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Distinguish between processed and unprocessed medical devices

Medical Devices

Medical devices refer to a list of equipment used by doctors, nurses, and licensed technicians every day, in countless numbers medical fields, and in a countless number of situations.

Medical devices can be simple, such as disposable, simple test strips, tongue blades, bedpans, or custom trays, to a complicated and complex heart/lung machine, pacemakers, and everything in between including but not limited to,

  • Electrical Equipment
  • Instruments
  • Appliances made of soft or hard material
  • Custom Trays designed for any number of purposes
  • Monitoring Equipment
  • Life Sustaining Equipment

Medical devices are necessary tools professionals use on patients every day, such as in the following examples,

  • Performing Countless Tests
  • Diagnosing an Illness or Disease
  • Therapy Sessions
  • Prevention of Diseases
  • Custom Trays for many sterile and nonsterile procedures
  • Treating Conditions and Injuries
  • Compensatory Equipment
  • Surgeries

According to the FDA, medical devices are categorized into three divisions Class I, II, and III, (low to high risk.) Each class offers risks and FDA regulations, in regards to safety and the effectiveness each display.

For example, the scope of custom trays in the medical arena number to nearly 2,000 types and designs, in all sizes for sterile and nonsterile procedures.

These custom trays make up specific items used in specific procedures. Each item on these custom trays must have an FDA number and be registered.

Processed Medical Devices

For example, you are a manufacturer and want to introduce new custom trays on America’s marketplace; you must adhere to a series of steps to attain clearance for the medical device to be sold in the United States. The FDA gives you this permission to sell your custom trays in the United States.

Processed medical devices are devices cleared by the FDA for use on patients. These processed medical devices include proper instructions, labeling, corresponding therapeutic product, generic equivalents, and similar equivalents. The FDA has a comprehensive list of all processed medical devices including custom trays.

Each of these processed medical devices met a stringent definition of that medical tool, no matter its use or branch of medicine.

Unprocessed Medical Devices

The FDA considers any medical device that has not gone through the stringent process for registration certification as being an unprocessed medical device, including various types of custom trays.

Medical devices that have not passed through the FDA’s systematic series of actions for certification nor passed a safety test for patient use are considered unprocessed.

Before you put a medical device on the United States marketplace, there are detailed steps you must go through.

When you want to sell a medical device new to the market, you the manufacturer must go through stringent steps to process your their medical device.

These devices can be Class I, II, or III categories. You must file a Premarket Notification with the FDA. While the FDA may not approve this device, the FDA may give you clearance to sell the device in the United States.

If you change a current product such as custom trays, on the market, you must follow this process especially if it changes the way in which the device operates and it’s safety issues.

You must propose the device’s intention for use, design of the instrument, and it’s suitability for the intended purposes as stated. This process helps to categorize the device in the class of I, II, or III. The device receives a specific code and number.

You receive your registration certificate in the form of an FDA post on their government website, for example, your custom trays. This post is your only registration and is now cleared to sell your custom trays.

 

Different types of sterilizations for surgical trays


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Methods Of Sterilization


One of the reasons custom trays have become so popular in medicine is because they can be used immediately; they’re pre-packaged and pre-sterilized exactly for this purpose. The world is not always ideal, though; and the proper means of sterilization can be complicated and must be thorough. Meanwhile, custom trays definitely have a high quotient of convenience, and have quickly become a preferred option by a ubiquity of practices. Beyond this method of maintaining operational equipment, the CDC specifies two primary means by which trays become sterilized:

  • Steam Sterilization
  • Flash Sterilization

This writing will give a quick exposition of both sterilization methods, then look at how sterilization in conjunction with custom trays may actually provide the best possible scenario for continuous operations. What good are custom trays if you run out and no shipment is available for a month? Custom trays are convenient and life saving, but unless there is some additional means of support, they can actually end up being a crippling agent in the end.

Steam Sterilization


In a nutshell, steam sterilization is the preferred method. It is environmentally sustainable, clean, and effective. Heat is one of the most trustworthy means of sterilization. Since the heat is moist with steam, it also helps preserve equipment while sterilization is taking place. There’s nothing toxic about steam sterilization, and it is relatively inexpensive considering. Additionally, it kills bad micro-organisms very quickly, and is also able to end spores from molds or fungi. This method also penetrates fabrics without destroying them, and can allow for their sterilization. The only downside is that the process has a history of causing some corrosion as well as lubricant combustion; especially as regards hand pieces used in dental work. It can also reduce light output on some devices, like laryngoscopes. Steam sterilization is accomplished through direct exposure of items requiring sterilization to steam of a requisite temperature to be properly threatening to microbial life. Four main things define this method: pressure, temperature, time, and the steam itself.

Flash Sterilization


Flash sterilization is temperature and pressure. It’s original definition was that an item which has been unwrapped should be kept at one hundred and thirty-two degrees celsius three minutes at between twenty-seven and twenty-eight pounds of pressure. This requires what’s called a gravity displacement sterilizer. Depending on the caliber of sterilizer purchased, and the item being sterilized, time will fluctuate. This process can be very effective, but is complicated and definitely has costs involved which may make custom trays all the more recommendable.

Why Combining All Three Is The Best Approach


Custom trays, steam sterilization and flash sterilization are all great methods of ensuring that your practice remains clean. But if you only have one method or another, you don’t have any kind of protection should the worst come to the worst. What if you don’t use custom trays, and the steam machine breaks? Well, then you’ve got flash sterilization. But what if both machines go on the fritz the same day due to a power surge which causes a fuse shortage that nobody can hunt down for half the day? You could lose lives in such a scenario. That said, if you’ve got custom trays somewhere on the premises, then there’s no issue. But too, you can’t trust solely in custom trays; what if you fun out, or a shipment is late? So, in an ideal world, a medical practice performing surgery is going to use a combination of custom trays, steam sterilization procedures, and flash sterilization procedures. This will allow for the greatest financial retention while incorporating secondary means of necessary support