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Tag Archives: medical devices


What is the Trade Agreement Act (TAA)?

Image result for taa trade agreement

The Trade Agreements Act, or TAA, applies to GSA contracts which are vehicles for selling products on a federal, state, or local level. GSA contracts include pre-set terms, conditions and pricing that make the sales process more simple. The products that are discussed as part of these GSA contracts must comply with the Trade Agreements Act (TAA). All health products and other related products that fall under the GSA contracts apply.

Compliant Countries

When a health product is being considered for the Trade Agreements Act, that product needs to have been completed on a manufacture level in an approved country, otherwise compliance does not occur. There is an approved list of locations that fall under this category and these products can then become part of an approved GSA contract. The list is pretty extensive, making this process a bit simpler than it may originally sound.

Services

In addition to health products, other related services apply to the Trade Agreement Act. What is taken into consideration is where the legal address of the company is located rather than where the services themselves are provided. As long as that address is located in an approved country or location, TAA compliance is secured.

Enforcement

The government attempts to provide strict enforcement when it comes to these GSA and TAA related products. While there may occasionally be a product or company that is located in a non-approved TAA country, a large percentage of the products and services are compliant. There are currently more than 20,000 contracts and products that are part of this act. Steps are being taken to improve upon the process of checking and enforcing compliance. Often times, when companies or products are overlooked by the GSA, reports are made by other compliant businesses that are unhappy with their competitor’s non-compliance. An investigation then takes place and if necessary, the products or services are removed. Confidentiality is ensured when a report is filed in order to protect the integrity of the other party that filed the report.

While the Trade Agreement Act, or TAA, relates to a wide variety of different products and services, health-related products fit onto this list as well. Achieving compliance on a GSA and TAA level allows health product companies to take their business to the next level and secure some pretty large clientele. Gaining leverage with the Department of Health and some other big organizations can bring in far more revenue than occurs when just sticking with smaller, privately owned companies.

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How Does The TAA Pertain To Surgical Trays?

The Trade Agreements Act of 1979 was passed by Congress to serve several purposes. Firstly, it aims to foster international trade and expand the United States’ ability to engage in trade deals. Secondly, it hopes to further define and better enforce trading rules and regulations. Finally, the act also approved agreements made in a previous act in 1974.

In reference to surgical trays, the part of the Trade Agreements Act (TAA) that is most applicable is the goal of opening international trade deals because it defined various products as compliant if they are manufactured in the United States or in one of the other countries listed in the agreement as a “designated country”. Designated countries include places the United States has an existing free trade agreement with, countries that participate in the World Trade Organization Government Procurement Agreement, “least developed countries”, as well as Caribbean Basin countries.

Due to the requirement put forward by the TAA that all goods and services procured by the federal government (or any government-funded agencies including most hospitals) must be manufactured in either the United States or a designated country, it can be difficult sometimes to insure compliance if there is uncertainty about where products like surgical trays originated or were actually constructed.

On occasion, the TAA will run a compliance check and investigate the origin of an acquired product or service. In these instances, a company or hospital in fact, may have to provide evidence that their surgical trays have been manufactured in the United States or a designated country, or they will be subject to punishment under the rules and regulations of the FAA.

In the specific case of surgical trays, the easiest and most obvious step toward compliance would be simply to make sure that the trays you have purchased originate from one of the countries specified in the list of designated countries. However, surgical trays present a unique issue that may also come up under the FAA: sometimes the customized items contained on surgical trays are new or unavailable from one of the designated countries. CPT Medical, Inc. provides a solution to this issue: “You need to know that the vendors of the tools you’re purchasing have updated the part numbers for their products in the DAPA Management System.” This insures that the part numbers for any pieces on your surgical trays are registered and thus are able to be tracked or investigated by the FAA. CPT Medical, Inc. further has internal procedures that includes verification from manufacturers of place of product production.

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.

How Custom Procedure Packs Reduce Emergency Surgery Response Times

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An Emergency, No Matter What Level

In the health profession, every emergency surgical procedure performed requires different medical instruments and tools. An emergency can be life-threatening where time is of the essence, or the situation is still an emergency, but there is time to treat the patient.

It makes no difference if the individual is already a patient in the hospital or awaits care in the hospital emergency room; time is of the essence in any urgent medical situation.

Who Uses Sterile Procedure Packs?

Each emergency requires a different set of medical tools and equipment to meet the emergency situation at hand. For instance, if the patient needs stitches the doctor would not use the same instruments for a patient requiring a tracheotomy. A surgical pack necessitates care in the following atmospheres.

  • Hospital emergency room
  • On the hospital medical floor
  • In the surgical operating room
  • On emergency ambulances
  • Extended care facilities
  • Doctors’ offices
  • Medical clinics and more
  • Podiatrists
  • Dentist
  • Eye clinics

Benefits of Using Prepackaged Procedure Packs

Individualized and specialized tools found in a surgical pack expedites the patient’s treatment. If it were not for a particular surgical pack already made up and designed for specific emergency situations, the professional would have to hunt for each tool to meet the situation at hand.

A surgical pack allows for all tools in one single sterile package. The medical professional does not have to hunt for and gather the needed tools together when time is of the essence.

The benefits to having a sterile surgical pack ready for hospital personnel are as follows.

  • Saves the hospital time and money
  • Saves the doctor and nurse time
  • The patient receives the needed care promptly
  • Increases efficiency
  • Increase quality of patient care
  • Allows for better inventory management of medical equipment and the cost of using these tools for each procedure
  • Significantly reduces the amount of storage needed for equipment
  • Increases medical emergency response times

Autoclaving a Thing of the Past

Years ago hospitals sterilized all of their medical tools and equipment through a process called autoclaving. A sterilization room with autoclaves was where these packs were put together to store in moment’s notice.

Medical Manufacturers’ Role in Procedure Packs

These days’ medical manufacturers receive orders from health facilities to design and put together a particular surgical pack for all sorts of medical emergencies. The manufacturer is always looking to the medical community for support on how they can put a surgical pack together more efficiently, in a cost-effective manner.

It is through the efforts of the health community and health manufacturer they can provide to doctors and nurses the right surgical pack for the right time and place.

pre-packaged surgical pack is all set and ready to go with all the necessary sterilized tools needed to meet all emergencies. Those appointed the responsibility of ordering a surgical pack no longer have to account for every item or order each item individually as that person can now order the complete surgical pack.

What is Included in Procedure Packs

The list of sterile tools that medical professionals use every day is enormously wide and varied. The list below is just a few of the items found in a surgical pack.

  • Surgical swabs
  • Suture
  • Suture needles
  • Forceps
  • Dressings
  • Surgical blades
  • Sterile field drapes

Thanks to the combined efforts of medical professionals and manufacturers, a surgical pack has all the tools for the medical professional to meet the surgical needs of all patients.

An Emergency, No Matter What Level

In the health profession, every emergency surgical procedure performed requires different medical instruments and tools. An emergency can be life-threatening where time is of the essence, or the situation is still an emergency, but there is time to treat the patient.

It makes no difference if the individual is already a patient in the hospital or awaits care in the hospital emergency room; time is of the essence in any urgent medical situation.

Who Uses Sterile Procedure Packs?

Each emergency requires a different set of medical tools and equipment to meet the emergency situation at hand. For instance, if the patient needs stitches the doctor would not use the same instruments for a patient requiring a tracheotomy. A surgical pack necessitates care in the following atmospheres.

  • Hospital emergency room
  • On the hospital medical floor
  • In the surgical operating room
  • On emergency ambulances
  • Extended care facilities
  • Doctors’ offices
  • Medical clinics and more
  • Podiatrists
  • Dentist
  • Eye clinics

Benefits of Using Prepackaged Procedure Packs

Individualized and specialized tools found in a surgical pack expedites the patient’s treatment. If it were not for a particular surgical pack already made up and designed for specific emergency situations, the professional would have to hunt for each tool to meet the situation at hand.

A surgical pack allows for all tools in one single sterile package. The medical professional does not have to hunt for and gather the needed tools together when time is of the essence.

The benefits to having a sterile surgical pack ready for hospital personnel are as follows.

  • Saves the hospital time and money
  • Saves the doctor and nurse time
  • The patient receives the needed care promptly
  • Increases efficiency
  • Increase quality of patient care
  • Allows for better inventory management of medical equipment and the cost of using these tools for each procedure
  • Significantly reduces the amount of storage needed for equipment
  • Increases medical emergency response times

Medical Manufacturers’ Role in Procedure Packs

These days’ medical manufacturers receive orders from health facilities to design and put together a particular surgical pack for all sorts of medical emergencies. The manufacturer is always looking to the medical community for support on how they can put a surgical pack together more efficiently, in a cost-effective manner.

It is through the efforts of the health community and health manufacturer they can provide to doctors and nurses the right surgical pack for the right time and place.

pre-packaged surgical pack is all set and ready to go with all the necessary sterilized tools needed to meet all emergencies. Those appointed the responsibility of ordering a surgical pack no longer have to account for every item or order each item individually as that person can now order the complete surgical pack.

What is Included in Procedure Packs

The list of sterile tools that medical professionals use every day is enormously wide and varied. The list below is just a few of the items found in a surgical pack.

  • Surgical swabs
  • Suture
  • Suture needles
  • Forceps
  • Dressings
  • Surgical blades
  • Sterile field drapes

Thanks to the combined efforts of medical professionals and manufacturers, a surgical pack has all the tools for the medical professional to meet the surgical needs of all patients.

Moist Heat Methods

CPTBlog-BANNER-sterilize-tools

Heat therapy is beneficial for a number of different therapies. It can be used at home to treat minor discomfort or it can be used post-operatively as a way to increase blood flow to a certain area to aid in healing. The most effective moist heat methods are those that can maintain an appropriate temperature on their own without burning the patient while still providing enough heat for effectiveness. Ultimately you want the temperature to be warm enough to be absorbed deep down into the muscular level and moisture can help with this process.

The Difference

Moist heat and dry heat are both used for heat therapy. Dry heat is usually administered by way of an electric heating pad, sauna, etc. This therapy is designed to draw moisture out of the body and some people find it more comfortable and helpful. Moist heat on the other hand, is applies through a moist heating pack, hot bath or hot water bottle. Moist heat tends to provide more relief on a deeper level and is a bit easier to provide consistent temperatures.

Moist Heat Methods

Moist heat can be included in custom trays and can be applied a number of ways. These methods include:

  • Hot water bottle (Filled with a certain temperature of water and then applied to the body).
  • Heated gel packs (microwaved or heated in water; will remain warm for up to thirty minutes at a time).
  • Moist heat wraps (Can be used right up against the skin and can be concealed by clothing. Several hours of relief can be found with this method).

A medical professional can always advise the best ways to utilize moist heat methods no matter what the need may be. The duration that the heat should be applied as well as the frequency varies with each injury and is based off the magnitude of the issue. Usually, fifteen to twenty minutes is the amount of time that moist heat methods are applied; every two to three hours. Custom trays in medical facilities can include moist heat packs for post operative use to keep patients comfortable and promote healing faster. There are instances when cold therapy is recommended as well. Sometimes medical professionals like to alternate these treatments. For outpatient therapy, many patients have a preference when it comes to heat therapy and sometimes it takes trial and error to find out what will work the best for long term relief.

 

Understanding Affordable Care Act

web_timeline

The question is,

“Do you understand the Affordable Care Act?”

“Does anyone understand this health care act?”

This law is one of the least understood legislation in Government history. Government officials do not understand this law.

The Affordable Care Act or Obama Care was signed into law before anyone even reads this law in full. While Obama Care was a promise of a better health care system, it has not proved true.

This law has been complicated and confusing to all who try to understand what it says. You probably found this law confusing and frustrating, found costs rising, and in the end decided not to buy into a plan at all and go without health care coverage risking a penalty of at least $600.00

Every part of the medical community is affected by the Affordable Care Act in negative ways. Thousands of custom procedure trays used every day see rising costs.

One thing is for certain, and that is this law significantly and negatively impacts all medical supplies, like custom procedure trays.

There is an incredible mound of paperwork, making up this law. This hard to understand law affects everything and everyone medical, including custom procedure trays.

Two Bright spots to the ACA

  1. Preexisting conditions do not impact your coverage or ability to gain health coverage.
  2. You can keep your doctor

The ACA signed into law so that you could get low-cost health care coverage. You may never find a plan that fits your needs or budget, so you do not buy anything.

The biggest drawback to this plan is if you do not purchase a plan you pay a penalty of up to at least $600.00. If you cannot afford this health care coverage, you certainly cannot afford the penalty.

Originally, each state had to complete the Affordable Care Act process. Some states were confused, and many lacked the understanding of the law forcing the government to step in and complete their process.

The Affordable Care Act is not uniform across all states. While this scheme helps some Medicaid recipients in some states, it does not help Medicaid recipients in other states.

For businesses everywhere who offer health care plans it meant,

  • Lots of new rules
  • Possible benefits?
  • Lot of reporting requirements
  • Higher cost to employers and employees
  • Higher drug costs
  • Cutting the cost of custom procedure trays

Lots of Facts and Myths

  • Doctors are confused
  • Patients are confused and anxious
  • Doctors must deliver care differently
  • Doctors receive reimbursement differently
  • Rises in the cost of medicine
  • Rising cost of custom procedure trays
  • Businesses are worse off
  • Develop innovations such as customizing and sterilization of custom procedure trays on site

Will Things be Worse or Better in 2017?

You can only hope that an Obama Care replacement as promised by the new 2017 Government happens.

The Trump promise is,

  • Make health care simple and easy to understand
  • Affordable for everyone
  • Easy to understand
  • Acceptance of pre-existing conditions
  • Cheaper medicines
  • You can keep your doctor

Even Custom Procedure Trays are Affected

The medical community strives to improve patient care, lower facility costs, and increase the quality of care. For instance, developing on-site custom procedure trays and cut the cost from a middleman.

These new rules affect everyone in the health care field, from doctors to hospitals, to clinics, dentists, eye care, medicine, medical equipment such as custom procedure trays, essential to quality patient care.

President Elect Trump promises to make health care simpler, easier to read, and genuinely affordable for everyone, lowering costs for medical supplies like custom procedure trays, and medicine, by replacing this hard to understand ACA.

Different Ways of Packaging Custom Trays?

surgicalpack

Custom surgical trays are highly famed for their convenience. Their ability to bundle multiple functionality onto one tray not only makes them theater friendly but also makes the easier to transport and dispose. Since custom tray designers will always have packing and racking in mind, they will put them in the best packing options possible.

Interested in Custom Trays? Request a Quote!





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that clinic management has to instill when storing and preparing traditional trays.

This extends over to disposal. The custom tray can go back to the packaging it came in or you can slip them into clinical bags ready for disposal. If you are lucky, choose something that allows you to repackage without posing a biohazard. This will help you tap deeper into the benefits of custom trays.

Packaging a custom tray stock might sound like a complication to anyone who was used to traditional surgical supplies and trays. However, the fact that the manufacturer has adapted everything to suite your use case means that the trays will store away almost naturally.

This is why custom trays more of a convenience. They are a perfect way to increase efficiency in the operation room by limiting the number of procedures needed to get the right equipment from the store, use it and dispose it off safely.

Three Levels for Storing Custom Trays

surgicalpack

It is always important to ensure that the custom procedure trays are stored in the right conditions so that they can always be available when required for use. As a general rule, it will involve maintaining the sterility of the products, proper arrangement of the products and keeping track of the product.

Custom procedure trays are mostly stored at the point of use, may it be a clinic or operating theater. However, regardless of the location, there should be a designated storage area which is always monitored to ensure that all custom procedure trays are maintained properly. There are three levels for storing this equipment.

Interested in Custom Trays? Request a Quote!





Request A Quote


e technical person that is mandated to regulate such equipment. The manufacturer is also required to ensure that the recommended safety and quality assurance tests are carried out for all the custom procedure trays. They should also clearly state the correct use of each tool. The medical practitioners should also ensure that the product is sterile by checking that;

  • the packaging is intact
  • the product is within the expiry date
  • the product has a sterilization indicator that confirms that it has undergone the right sterilization process.

As a rule of thumbs, custom procedure trays that have stayed for long without being used should be considered a product of overstocking and a proper assessment undertaken on its future. Other ways in which the product quality may be maintained include;

  • Designing the storage area in such a way that the packs are not damaged and still allow for flexible rotation of stock
  • Shelving should allow for easy access when cleaning. It should also be airy.
  • The products being stored should be at least above the floor level away from water and direct sunlight.

Lack of proper management of this areas may have an adverse effect on the integrity of the custom procedure trays and may render them unsuitable for use.

Understanding Affordable Care Act

web_timeline

Image is from HHS.gov

The question is,

“Do you understand the Affordable Care Act?”

“Does anyone understand this health care act?”

Interested in Custom Trays? Request a Quote!





Request A Quote

  • You can keep your doctor
  • The ACA signed into law so that you could get low-cost health care coverage. You may never find a plan that fits your needs or budget, so you do not buy anything.

    The biggest drawback to this plan is if you do not purchase a plan you pay a penalty of up to at least $600.00. If you cannot afford this health care coverage, you certainly cannot afford the penalty.

    Originally, each state had to complete the Affordable Care Act process. Some states were confused, and many lacked the understanding of the law forcing the government to step in and complete their process.

    The Affordable Care Act is not uniform across all states. While this scheme helps some Medicaid recipients in some states, it does not help Medicaid recipients in other states.

    For businesses everywhere who offer health care plans it meant,

    • Lots of new rules
    • Possible benefits?
    • Lot of reporting requirements
    • Higher cost to employers and employees
    • Higher drug costs
    • Cutting the cost of custom procedure trays

    Lots of Facts and Myths

    • Doctors are confused
    • Patients are confused and anxious
    • Doctors must deliver care differently
    • Doctors receive reimbursement differently
    • Rises in the cost of medicine
    • Rising cost of custom procedure trays
    • Businesses are worse off
    • Develop innovations such as customizing and sterilization of custom procedure trays on site

    Will Things be Worse or Better in 2017?

    You can only hope that an Obama Care replacement as promised by the new 2017 Government happens.

    The Trump promise is,

    • Make health care simple and easy to understand
    • Affordable for everyone
    • Easy to understand
    • Acceptance of pre-existing conditions
    • Cheaper medicines
    • You can keep your doctor

    Even Custom Procedure Trays are Affected

    The medical community strives to improve patient care, lower facility costs, and increase the quality of care. For instance, developing on-site custom procedure trays and cut the cost from a middleman.

    These new rules affect everyone in the health care field, from doctors to hospitals, to clinics, dentists, eye care, medicine, medical equipment such as custom procedure trays, essential to quality patient care.

    President Elect Trump promises to make health care simpler, easier to read, and genuinely affordable for everyone, lowering costs for medical supplies like custom procedure trays, and medicine, by replacing this hard to understand ACA.

    Three Levels for Storing Custom Trays

    surgicalpack

    It is always important to ensure that the custom procedure trays are stored in the right conditions so that they can always be available when required for use. As a general rule, it will involve maintaining the sterility of the products, proper arrangement of the products and keeping track of the product.

    Custom procedure trays are mostly stored at the point of use, may it be a clinic or operating theater. However, regardless of the location, there should be a designated storage area which is always monitored to ensure that all custom procedure trays are maintained properly. There are three levels for storing this equipment.

    Interested in Custom Trays? Request a Quote!





    Request A Quote


    at is mandated to regulate such equipment. The manufacturer is also required to ensure that the recommended safety and quality assurance tests are carried out for all the custom procedure trays. They should also clearly state the correct use of each tool. The medical practitioners should also ensure that the product is sterile by checking that;

    • the packaging is intact
    • the product is within the expiry date
    • the product has a sterilization indicator that confirms that it has undergone the right sterilization process.

    As a rule of thumbs, custom procedure trays that have stayed for long without being used should be considered a product of overstocking and a proper assessment undertaken on its future. Other ways in which the product quality may be maintained include;

    • Designing the storage area in such a way that the packs are not damaged and still allow for flexible rotation of stock
    • Shelving should allow for easy access when cleaning. It should also be airy.
    • The products being stored should be at least above the floor level away from water and direct sunlight.

    Lack of proper management of this areas may have an adverse effect on the integrity of the custom procedure trays and may render them unsuitable for use.