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Tag Archives: Commissioning Custom Trays


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.

Proper Processing of Custom Trays

CPTBlog-BANNER-different-types-surgical-trays1

Order of Operations For Custom Tray Processing

There are four main steps involved in processing custom trays, and five total ones. Those steps are:

  • (preemptory) Commissioning A Series of Custom Trays
  • Sterilization
  • Packaging
  • Storage
  • Monitoring

Commissioning Custom Trays

Custom trays must first be commissioned by a practice in need of them. Such practices often tabulate their regular operational expenses and requirements, then put together orders based on the proclivities of operating surgeons. This is not really part of the overall process, as it carries the highest level of individualization. It is integral to recipients receiving the right trays, however.

Sterilization

Custom trays must be properly sterilized or they’re useless. This procedure usually has several methods. Primarily, the trays and the equipment which will be stored on them are washed with water and a cleaning, detergent-like solution. Then they are visually and microscopically examined to ensure no microorganisms have remained resident on the trays. Once they’ve passed this rigorous inspection, they’re sent off to packaging.

Packaging

Custom trays must be packaged such that they’ll not only survive the trip from the place of configuration to the place of utilization, but such that they will remain sterile while stored. This means that packaging should be of a top-tier variety that recommends itself. Additionally, that packaging should be designed such that it conforms to a given tray’s eccentricities. Some equipment will have sharper edges than other equipment, and so must be stored accordingly. Contents should not shift during transit–though there will regularly be instances of this, as even the best packaging can’t prevent physics from intervening.

Storage

Custom trays should not be stored too near the ceiling or walls. Sometimes they can be stacked atop one another, but then again sometimes this is a bad idea. Microorganisms will collect in some statistical number on the exterior of the trays, so they should be secured in as sterile an environment as possible. Additionally, some trays may not be stackable atop one another, as their particular tools would break through packaging over time. Finally, packaging must be done in such a way that the trays are continually accessible for purposes of monitoring.

Monitoring

Because pathogens, microorganisms, and other invading unknowns have a statistical probability of contaminating trays, orders of them must be monitored while in storage to ensure they remain sterilized. A non-sterilized tray could spell the death of a patient. Additionally, if water or some other contaminant gets into storage, it could sour the whole lot of them should there be no means of localized sterilization on-site. All these things are preventable if everything is being closely monitored, but are likely to occur if trays are left unchecked in some sterilized storage closet somewhere. Entropy will allow microorganisms in, no matter how secure that storage area is. Monitoring custom trays over time is essential to ensure they are fit for use later on.

Disposal

Unless you’ve any kind of sterilization equipment on-site, custom trays must be entirely disposed of after use. That said, there are often disposal options which allow certain equipment that can be re-sterilized to be sent back to the tray packaging organization. This is going to vary between agencies, and depend on the items used on the trays, as well as how they were used. Oftentimes tools used with patients can never be reused in the same facility unless they’ve been completely recycled or something of that ilk.

Tray Management Facilitates Use

Order three families of tray. Those for immediate use, those for backup use, and a backup set for your backups in case all else fails. This provides perpetual utility.

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.

What is the Order of Operations for Custom Tray Processing

cpt_advantage_procedure

Processing Custom Trays Correctly

Processing custom trays requires six primary steps:

  • Getting A Custom Tray Series Commissioned
  • Proper Sterilization
  • Packaging
  • Safe Storage Of Trays
  • Continual Monitoring of Trays
  • Final Disposal

The Commissioning

First, you should determine your needs as regard surgical trays. What kind of trays are necessary, and what kind of unique items would you like included in them? How many will you need, and will you have more than one series to maintain operations should the unthinkable happen? Once you’ve properly configured your needs, then it’s time to commission an order.

Sterilization

A tray that hasn’t been sterilized is a tray that you cannot use. This is an integral component of the custom tray. Custom trays are often sterilized through several different procedures. Which is used for your specific custom trays may depend on the organization from whom you commission their development. It makes sense to order custom trays from a group whose methods you find suitable to your practice. Most will be transparent in this area, so feel free to ask how their sterilization procedures work.

Ensuring Proper Packaging

Packing for custom trays is integral to their successful deployment. You’re ordering trays that won’t just travel from the place where they were put together and sterilized, they’ll have to remain sterile until it’s time to use them. This means they must be optimized for storage such that they can stand to be idle for long periods of time. When you choose a custom tray provider, you should be sure that they provide top-tier packaging. Such packaging must additionally match the idiosyncrasies of a given tray. A procedural pack for spinal work will be different than that used in orthodontia; but both custom trays need to be rugged and able to remain clean with storage.

Facilitating Storage

Find an open room where trays can be stored without being too near the walls or the ceiling. Walls are going to have varying microbial and insect life near them, the ceiling may leak. Even in secure environments, both areas are weak points to a room’s sterility. Consider tray idiosyncrasies as well. There are certain trays that cannot be stacked one atop the other, as they’ll end up compromising each other’s sterility. The last thing to consider is how accessible said packages are. You’re going to need to monitor them before they go to surgery.

Monitoring

Between microorganisms, insects, and other life too small for the eye to readily detect, there are a ubiquity of compromising factors which could inhibit your custom trays. Leaks, as mentioned previously, may come from the ceiling. If you can devise a covering to protect custom trays against this, it’s certainly recommendable. But even if you have the perfect storage environment, you’re going to encounter individual changes. Maybe some equipment was being moved and knocked through the storage door, contaminating the trays. Anything could happen, so be sure you monitor the trays you’ve purchased very closely.

Final Disposal

After trays have been used, they must be completely disposed of; and in a way that’s preferably not harmful to the environment. Hazardous materials must be handled accordingly; especially as many of them will involve organic contaminants.

A Final Consideration

Once you’ve figured out how many custom trays you will need, you’re going to want a second tier of them in storage in case you over-reach said need. Economic crisis can diminish patients, economic stimulus can multiply them, and disaster can exponentially increase them. Three tiers of trays is recommendable for the most trustworthy stability in operations.

 

When is the Trade Agreements Act (TAA) applicable in the production of surgical trays?

What Is The TAA?

The Trade Agreement Act was passed on the twenty-sixth of July, 1979. It was a congressional act whose purpose primarily pertained to negotiations made between the United States and foreign powers as regards trade agreements. Specifically, the trade act of 1979 governs agreements which were made between the US and other countries during the Trade Act of 1974. The purposes of this act are mainly implementation of 1974 agreements, but the act still has effect today. This is because it was also designed to help open up the trading system of the world with expanded commerce opportunities conducted under improved international trade regulation and enforcement. While written with open language, this language can have a restrictive nature when it comes to the acquisition of goods or services that will be used in federal contracts. This happens when those managing a project decide to run it through a TAA compliance check. Generally, products remain compliant so long as they’re manufactured in either the US or one of a list of designated countries that are allowed. The complete list of countries can be obtained from the Federal Acquistion Regulation (FAR) 52.225-5.

  • Canada
  • Mexico
  • Singapore
  • Australia
  • Countries in the WTO GPA (World Trade Organization Government Procurement Agreement)
  • Afghanistan
  • Bangladesh
  • Laos
  • Ethiopia
  • The Caribbean Basin (Aruba, Haiti, Costa Rica)

How Does The TAA Pertain To Surgical Trays?

So long as surgical trays you’ve purchased are produced in any of these countries, they should, by default, be TAA compliant. The difficulty comes with the implements that are contained in those trays. Sometimes medical breakthroughs come in the form of a new surgical tool that just hasn’t made its way into mainstream. In order to be sure that all equipment on your custom medical trays passes a TAA compliance check, you need to know that the vendors of the tools you’re purchasing have updated part numbers for their products in the DAPA Management System. Information to be included in the update pertains to the country from which a given product has been sourced.

Maintaining Health Requires Direct Attention

The health of your community could depend on whether or not you’ve received the proper order of custom surgical trays. Such trays are usually sterilized beforehand, and are already configured in ways surgeons can immediately utilize. Streamlined surgical tray procedures can facilitate quicker operation, leading to faster recovery and better health over time

When does a custom medical procedure tray expire? What determines the expiration date?

cpt_advantage_procedure
Custom medical trays are an exceptional product that make the flow of a medical office or facility so much more efficient and successful. The customization of the product allows for specific tools to be included in each kit; tailoring certain procedures to the needs of the medical professional using them. However, most people don’t consider that these custom trays actually have an expiration date and there are a number of factors that go into determining what this expiration date will be. Such determining factors are usually put into place by the Food and Drug Administration and followed by the company that is manufacturing the custom trays.

About Expiration Dates

The expiration of any product applies to the amount of time that a product is safe to use and will function how intended. If used after the expiration date is up, this can be a risk to the patient or consumer. When dealing with custom trays, the expiration date usually will be determined based on what exactly is in each tray. Certain items may last longer than others. For example, a tray with metal tools in it will last much longer than a tray that has something like a battery intended for a pacemaker.

What Determines An Expiration Date?

Ideally, items are analyzed in order to conclude when degradation of the products would occur. Degradation is present when there is a risk involved with continuing use of the products. Every product is different when it comes to expiration date so there are not always pre-set parameters that outline how an expiration date should be set. Serious consequences just aren’t worth it in these instances and the kit should either be returned or disposed of. There are typically five different sections that medical-grade products fall into when being assessed and that includes:

  • Physical
  • Chemical
  • Therapeutic
  • Toxicological
  • Microbiological

Physical Breakdown

Over time, with the packaging or the items in the tray change their composition?
This applies to viscosity, elasticity, appearance, strength, etc. Storage conditions may affect the product integrity and this is often listed on the exterior of the package as it applies to an expiration date.

Chemical Breakdown

A custom medical procedure tray will expire based on ingredients that may be present that are known to break down over time. Also, does the packaging break down over time in a way that would compromise the safety of the tray?

Microbiological

Medical procedure trays must stay sterile in order to be safe to use. Over time, this can change based on storage factors and the amount of time that passes. Sometimes preservatives are used and those have their own expiration date. Sometimes, special inspections need to be done periodically to ensure the sterile nature of the tray is in tact.

Therapeutic Breakdown

When expiration is considered, will the tools or device included in the procedure tray be able to function after a certain point?

Toxicological Breakdown

If the expiration date reaches its full maturity, will the product become toxic or unsafe?

Custom medical trays can be very simple or very elaborate with some trays dealing with minor conditions while others are used for more complex surgical procedures and such. When the expiration date is set according to proper standards and a medical facility follows these guidelines, the tools in the custom trays will work how they were designed. While there are other factors that may go into a natural defect with a tray, shelf life or expiration dates generally mean the product will be structurally in tact when needed.

What is the Trade Agreement Act (TAA)?

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.

Proper Processing of Custom Trays

CPTBlog-BANNER-proper-processing-of-custom-trays

Order of Operations For Custom Tray Processing

The four primary main steps involved in processing custom trays are:

  • Commissioning A Series of Custom Trays
  • Sterilization
  • Packaging
  • Storage
  • Monitoring

Commissioning Custom Trays

Custom trays must first be commissioned by a practice in need of them. Such practices often tabulate their regular operational expenses and requirements, then put together orders based on the proclivities of operating surgeons.

Sterilization

Custom trays must be properly sterilized or they’re useless. This procedure usually has several methods. Proper applications of sterilization, and monitoring, and record keeping requirements can provide proper sterilization, patient safety and cost effectiveness.

Packaging

Custom trays must be packaged such that they’ll not only survive the trip from the place of configuration to the place of utilization, but such that they will remain sterile while stored. This means that packaging should be of a top-tier variety that recommends itself. Additionally, that packaging should be designed such that it conforms to a given tray’s eccentricities. Some equipment will have sharper edges than other equipment, and so must be stored accordingly.

Storage

Custom trays should not be stored near the ceiling or walls. They should be secured in as sterile an environment as possible. Additionally, some trays may not be stackable atop one another, as their particular tools would break through packaging over time. Finally, packaging must be done in such a way that the trays are continually accessible for purposes of monitoring.

Monitoring

Because pathogens, microorganisms, and other invading unknowns have a statistical probability of contaminating trays, orders of them must be monitored while in storage to ensure they remain sterilized. Additionally, if water or some other contaminant gets into storage, it could sour the whole lot of them. These things are preventable if everything is being closely monitored. Monitoring custom trays over time is essential to ensure they are fit for use later on.

Disposal

Custom trays must be entirely disposed of after use.

Tray Management Facilitates Use

Order three families of tray. Those for immediate use, those for backup use, and a backup set for your backups in case all else fails. This provides perpetual utility.