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The Life Cycle of Custom Trays

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The four main steps in the life cycle of custom surgical trays are:

  • Decontamination
  • Packaging
  • Storage
  • Monitoring

The Decontamination Process

The instruments and the trays which carry the instruments must all be decontaminated properly before custom trays can be sent out to clients. This is done with a solution of water that has either been mixed with specialized cleaning solutions or some family of detergent before cleaning commences. Such solutions keep foreign materials from lingering on the equipment before it’s placed into a machine that mechanically washes and dries equipment. After this, items are inspected at the visual and microscopic level to ensure cleanliness before they’re shifted to packaging. Packaging also plays a small role in the decontamination process, as if it is not done correctly, custom trays will definitely be contaminated during transit or storage. Packaging of custom trays must be designed to ensure decontamination is a single step, and not a problem which continues to crop up.

Packaging

Packaging must cover the entire tray and be done in a sterilized environment where foreign disease-ridden agents don’t have the ability to penetrate. Proper packaging is intensive and will stand the test of time, because some trays are used immediately, others are maintained on site as backup measures in the event a shipment delay or there’s some emergency which increases their demand.

Storage

Trays after being properly packaged, it is mandatory that trays be correctly stored. They should be away from the ceiling, away from the floor, and away from the walls. Custom trays should be allowed air circulation. It should be easy to monitor and clean the custom trays adequate. Avoid storing custom trays in wet areas that have a higher instance of contamination.

Monitoring

Continually monitor the status of your trays as they are stored. Additionally, methods of sterilization must be monitored to ensure that they are indeed effective. A number of methods are contemporarily used in order to facilitate this. There are mechanical monitors that keep tabs on temperature and pressure charges, and there are also chemical indicators which have been designed with heat sensitivity or chemical presence. Oftentimes these monitors are placed on exterior packaging. Additionally there are biological indicators which can be used to tell whether or not the sterilization process has been lethal to spores or other infections materials.

Having A Trustworthy Option

Decontamination involves packaging, storage, and monitoring. Because of the microscopic nature behind pathogens which may infect and complicate a surgery, there are often areas where previously-successful measures may prove non-effective. In such scenarios, regular monitoring and proper storage can catch a failure of traditional sterilization procedures. A good way to think of it is like this: sterilization isn’t a destination, it’s a journey. Just like your custom trays will travel from the place where they are packaged to where they will eventually be used. Initial sterilization will have a number of stages between first measures utilized and final operation. To ensure you get the most out of your custom trays, check the steps of the agency you use and be sure of their process.

What is the Trade Agreement Act (TAA)?

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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.

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.

Proper Processing of Custom Trays

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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 to Manage Custom Trays

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Custom procedure trays provide an allowance for you to design your own tray to make sure it’s filled with surgical supplies and equipment you will require throughout your medical operations. Custom procedure trays are necessary since surgery methods may differ in particular scenarios. However, custom procedure trays are instruments that pose a danger not only to humans but also to the environment because they are not biodegradable. You must, therefore, be careful how you manage custom procedure trays s they can turn out to be detrimental to the patients, health facility staff and the hospital environment at large.

Custom procedure trays, like other hospital equipment, if not properly managed, can be highly infectious and hazardous for human health through their ability to spread diseases. Nevertheless, this infectious attribute of custom procedure trays can always be prevented through indulging carefully in hospital waste management. Here is a brief overview of how custom procedure trays can be effectively managed.

• Microwave treatment

Microwave treatment is one of the numerous medical waste disposal techniques that could result in achieving the best possible results in matters regarding proper management of custom trays. This method uses heat to decontaminate waste such as an old custom procedure tray before disposal. The waste management system can only work with custom procedure trays and other solid medical equipment since the moisture in the microwave works wonders in ensuring deep penetration. Therefore, most types of waste required to be managed in this manner, including custom trays, should be shredded and mixed with water so as to achieve the best results.


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How to Manage Custom Tray

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Image is from Medline

The healthcare sector contributes a lot to the pollution of the environment which goes a long way in affecting the general human health. It contributes paradoxically to a myriad of environmental problems while concurrently forcing people to deal with the harmful effects it poses. This is due to the technology application in the industry as well as products and various applications. A custom tray, for instance, is one instrument that poses a danger not only to the environment but also to humans since it’s not biodegradable. This fact makes the health sector to maintain their standards of the sustainable organization.

You must, therefore, be careful how you manage a custom tray as it can turn out to be detrimental to the health facility staff, the patients themselves and not to forget the hospital environment. Among the first issues you could consider is the creation of awareness among the hospital staff and the general public when it comes to the extent of damage a custom tray, among other hospital equipment, can pose when not disposed of properly. The various technicians and sanitary workers must be trained properly to know how to combat the menace.

Among other hospital equipment, a custom tray, if not properly managed, can be hazardous and highly infectious for human health by its ability to spread diseases. The infectious attribute of this equipment can always be avoided by taking up the hospital waste management carefully. Here’s a quick overview of how a custom tray can be managed.

  • Chemical treatment

This is one of the most effective on-site management for a custom tray. It usually works to deactivate and decontaminate among others, a custom tray, instead of packaging and taking them to another facility for the management. Often while using a custom tray in the theater, there is going to spills of body fluids in it. This means, if you carry them over to other places with the body fluids in them, you run the risk of causing infections to the patients and staff in the facility. The best way to handle it in such a situation is to treat it not far from where you have used it. In some other instances, you may need to shred the tray first before you can treat it with chemicals.

Chemicals including chlorine, sodium hydroxide, or calcium hydroxide can be especially handy in doing this. Worth noting is that these products can sometimes produce undesired by-products and off-gas VOC’s when used in the treatment of custom trays among other equipment. As such, this is a process that has to be executed by knowledgeable staff to avoid creating, even more, problems to the environment and hospital staff. If you deem this method as not comfortable, you can opt for solidifying agents that will solidify the liquid in the custom tray and after that taking the waste to your medical waste removal professionals for disposal.

  • Microwave treatment

This method uses heat to decontaminate waste like an old custom tray before disposal. The waste management system can only work with the custom tray and other solid medical equipment since the moisture in the microwave works magic in ensuring deep penetration. So, most types of waste that need to be managed in this manner, including a custom tray, should be shredded and mixed with water so as to get an excellent result

There are numerous medical waste disposal techniques you can take up to manage a custom tray. Try the above for best results.

 

Proper Storage for Custom Surgical Trays

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Image is from Healthcare Purchasing News

A custom surgical tray is one of the most crucial equipment in a hospital setup. Essential as it is, this equipment should be taken care to enhance their longevity. Taking care of surgical instruments before keeping them is the surest method of protecting your tools. The ones that take care of properly last longer. Proper storage of instruments comes after you have properly cleaned them.

Preparation before storage

Preparation for storing the tray involves three levels;

  • Cleaning

This is the initial step of storing your tray. Ensure you clean all the body fluids, blood, and other tissues. Dirt like dry soil may even damage your tray or make it tough to use. After washing, rinse the tray in cold, clean water. Avoid using hot water as it can cause protein substances to coagulate. You can soak the tray in cold water mixed with an enzymatic detergent. The detergent will help in dissolving the proteins on the instrument surface as well as breaking the oils. After that, you can now clean the tray in cold water manually. If there as an alternative for manual cleaning like mechanical cleaning, you can opt for it. Normally, mechanical washing involves the use of a washing machine to wash the tray. The machine cleans through multiple levels. Cold water is for removing the debris. Then a hot water bath followed by a blow dry with hot air. Use gloves as you do the cleaning, plastic apron, eye protection and a mask.

  • Disinfecting

For high-level disinfection, both thermal are available. Boil the instrument in a 100 degrees water for some time, preferably one minute. Only some few bacterial spores don’t die during the boiling; it is imperative to remember that boiling will not sterilize equipment. Just submerge the tray into the boiling water. When you notice the temperature of the water exceeding one hundred degrees, turn down the heat so it can boil gently. After a minute, remove the instrument from the boiling water using a pair of disinfected tongs. It is important to remember here not to remove the tray in the water as it cools since it can be decontaminated.

  • Sterilizing

Sterilization does away with all microorganisms. Autoclaving is a common method of sterilizing this equipment. However, you can use dry heat or chemical sterilants.

Cleaning is meant to remove dirt and other biological material that may have been present on the tray’s surface. It is easy to clean these instruments manually or using mechanically using water, detergent, and other enzymatic materials. Cleaning it thoroughly since biological materials can remain on the surface to and be a hindrance to subsequent steps of sterilization and disinfection.

Disinfecting this equipment can be done in multiple levels including; low-level disinfection, intermediate level disinfection and high-level disinfection.

  • Low-level disinfection removes all vegetative bacteria, fungi, lipid virus and some non-lipid viruses from the tray surface in ten minutes or less.
  • Intermediate-level disinfection kills tubercle bacilli, and lipid enveloped viruses, fungus spores, and some no lipid enveloped viruses and mycobacteria.
  • High-level disinfection destroys all the organisms killed by the low and high-level disinfection levels aside from killing fungus spores

Sterilization kills all microorganisms certain chemical sterilants can be used as HLD disinfectants when used for shorter exposed durations. You can use autoclaving to do the disinfection.

After all the cleaning, disinfection, and sterilization, keep your tray in a place where they are not exposed to any more dirt and contaminants. If you don’t maintain the tray a safe place, you are going to pose a great danger in infecting the patient.

Difference Between Moist Heat and Dry Heat for Custom Trays

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Image is from Medline.com

A custom tray is a medical equipment that requires you to sterilize so as to kill the bacteria and other disease-causing organisms present on the surface. If left unsterilized, the patient could be exposed to several harmful microorganisms which may end up causing more harm. As such, a custom tray has to be free from germs always and more especially during the procedure. Sterilization of a custom tray can be achieved in two ways:

• Dry heat

Despite being a method that has been used for many years, dry heat method has often been misunderstood. Unlike in moist heat sterilization method where high temperature is used in performing sterilization, here heated air is used to achieve the same. Additionally, the temperatures in this method are relatively higher than in the moist heat method. The disease-causing microorganisms are killed through the destructive oxidation process. This process helps to terminate large biomolecules such as proteins. The organism will eventually die due to the destruction of some of the most vital components of the cell. It is, however, most suitable for the equipment which is resistant to heat

• Moist heat sterilization

For moist heat sterilization, water at high-pressure level is used for sterilizing instruments like a custom tray, and the process is carried out in autoclaves. Although the temperature of steam in this method of sterilization is relatively lower than its dry heat counterpart, the pressure helps to effect sterilization properly. The moist heat destroys the structural proteins of the disease-causing organism on the surface of a custom tray. Eventually, this results in the death of the organisms on the surface of the custom tray. This method is effective in that it takes a shorter time to complete the whole sterilization process and in low temperatures too.

• Dry heat and steam heat efficacy

While you can achieve the same results in many loads, including a custom tray, with both methods, certain tasks are impossible while using a steam autoclave like loads that are hydrophobic or ones that will be damaged when exposed to moisture. As well, dry heat is useful for instruments such as a custom tray, which may experience corrosion.

Even as you can use dry heat method on a myriad of equipment, including a custom tray, it is, by no means, all purpose. Liquids, for instance, unlike a custom tray, cannot be sterilized using the method and neither can be growth media. Unlike a custom clay, dense loads are a problem too since the convection process does not penetrate them.

• Dry heat sterilizer versus steam autoclave efficiency

Although many loads like a custom tray can be sterilized by using either moist or dry heat, steam sterilizers consume less time and energy compared to dry heat. For a resistant spore to be killed by dry heat, the load in a dry heat sterilizer must be brought to 170 degrees centigrade and maintained there for as long as one hour. On the other hand, a steam autoclave only needs to be raised to 121 degrees centigrade for as short as fifteen minutes. This is because the steam is an excellent conductor of heat and is, therefore, able to permeate loads. As a result, there is significant cost saving when you use a steam heat sterilizer compared to dry heat sterilizer.

The above are some of the basic differences between dry and moist heat sterilization methods. Using either of them, ensure your equipment are properly sterilized. A custom tray is particularly one instrument you don’t want to forget to sterilize.

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.