The four main steps in the life cycle of custom surgical trays are:
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 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.
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.
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.
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.
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.
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.
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.
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.
A surgeon’s tray is one of his or her most important tools in operation. Several questions should be asked before you decide on even the proper family of trays you’ll need. This is why custom trays are so popular today. Before customizing yours, ask yourself:
Generally, surgeons are looking for trays that are:
When ordering custom trays, be sure to get them from a source which has a solid history of steady, accurate delivery. Medicine is an endlessly necessary function of modern society. As such, the needs of medical facilities increase as the population does. Though shipping, purchasing, and reprisal occur in a cyclic way, there are perpetual demands for equipment; especially of the disposable sterilized variety. As a result, it is not uncommon for custom procedural packs or custom trays to become lost, or mixed up, during shipment. Sometimes custom trays are purchased in bulk, and individually wrapped in a sterilized way containing all necessary operational equipment. But when the first custom trays are opened from the shipment, it is found the items inside do not correspond to the items requisitioned. Such mix-ups are going to be more common among manufacturers who are new to the market, or are perhaps overloaded with clientele. To avoid this, you should order custom trays in dual shipments and keep firm records of contents when they arrive. The better organizations will certainly ship the right items without additional expense to the surgical practice in question. Such errors should not happen, but they are subject to human imperfection, and so they cannot be curtailed; only recognized and planned for.
While it is possible to find custom trays that are reusable, and so won’t ever ship with the wrong contents, sterilization can be difficult on-the-fly, and unless some unique system be devised by your practice, will not be something that can be accomplished as quickly as simply opening a pre-sterilized pack. Still, some delicate procedures may require direct reusable customization.
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.
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.
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.
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.
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.
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.
A 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.
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.
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.
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.
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.
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.
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.
A 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.
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.
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.
There are four main steps involved in processing custom trays, and five total ones. Those steps are:
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.
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.
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.
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.
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.
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.
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.
Sterilization is as old as medicine. For ages, man has either consciously or remotely know the relationship between dirt, microbes, infections and decay. The battle against decay and infections has pushed doctors and scientists into developing different sterilization methods geared towards eradicating and keeping off any form of microbes on a surface, custom trays or a substance. The most popular procedure include heat treatment and chemical sterilization.
Chemical sterilization comes in when the device in use, or the target substance, is sensitive to heat. This could be rubber or plastic custom trays. Most of the chemical sterilizers are highly reactive low temperature gases or liquid that will either be in direct contact with the target substance or interact with it through a semi-porous membrane or custom strays.
A variety of chemical sterilization procedures exist to cater for sterilant-item compatibility. Choosing the right sterilization chemical will help you avoid contamination or chemical damage to the item you wish to sterilize.
The most common procedures that will work with custom trays in the lab include
Ethylene oxide is a highly toxic, flammable, reactive gas that is appropriate for custom trays sterilization at relatively low temperatures. It’s high penetration rates gives it the power to seep through different custom trays, for instance thin plastic membranes, making it appropriate for thorough equipment sterilization.
The fact that the gas doesn’t work so well on dried microorganisms limits its use as a general purpose sterilizer. A relative humidity of 40 to 90 percent is necessary to improve efficiency and you must let the sterilized equipment lie for a while to get rid of all the ethylene oxide from the custom trays.
The most popular aldehyde that dominates the custom trays chemical sterilization arena is formaldehyde. This water-soluble gas is easy to deploy using special gas apparatus. It is effective on a wide range of viruses, fungi and bacteria. It will disinfect custom trays and other equipment when dissolved in water while a controlled gaseous discharge can disinfect the air inside rooms.
Direct contact with the skin could result into inflammation or eczemas.
Alcohols are a perfect protection against bacteria and fungi. Even though they cannot kill bacteria spores, their rapid action and relatively safe handling makes them the one-touch sterilant of choice during surgical, laboratory or general skin and hand disinfection. The most popular alcohols used in this case are
Phenol, or simply carbolic acid, is a popular protein denaturing sterilization chemical that could work in specific substance sterilization. They are relatively weak and will rarely perform well against spores and viruses. Their moderate effect on organic materials makes them suitable for disinfecting products rather than applying on used equipment and apparatus.
Last on the list of popular chemical sterilization options is chlorine and iodine. These halogens are a popular general microbicidals that are strong enough to kill spores and are rarely use to sterilize custom trays. Chlorine will sterilize and disinfect many things, from water to equipment and surfaces. The less strong iodine often mixes with potassium iodide with alcohol to create tincture of iodine that is used to disinfect skin and small wounds.
Choosing the right chemical disinfectant for the right job will not only ensure total sterilization but also keep the integrity of your equipment and their intended use. The best way to staying on top of this is by understanding how each sterilant works, its strengths and weaknesses from the word go.
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.
Sterilization is a process of eradicating live microorganisms from substances. It is done to preserve things for a long time and kill germs. If something is not sterilized, it may cause infection to those who use it. Therefore, it should not be taken for granted. There are several methods of sterilization, including:
This is the most common type of sterilization because the heat used kills all microbes. The extent of sterilization is affected by the duration of heating and heat temperature. As the temperature goes up, the duration of heating goes up. The heat method of sterilization can be further divided into two:
Here, heat is applied through boiling and includes methods like pasteurization, using steam, and boiling. Boiling is done for metal devices such as surgical scissors, custom trays, and needles. The substances are boiled to kill any microbes. Pasteurization, on the other hand, is a method for heating milk to 60 or 72 degrees thrice or four times.
When using steam, the substances being sterilized are subjected to steam in autoclave steam heating equipment. The process uses temperatures of up to 115 degrees for an hour. It is the most common method for sterilizing drugs because it can kill the bacterial spores, which are inert bacterial forms.
Substances are subjected to flaming, incineration, hot air ovens, or radiation sterilization. In flaming, metallic devices such as needles or scalpels are placed over a flame for several minutes. The flame will kill all microbes directly. Incineration is used especially for inoculating the loops utilized in microbe cultures. The loop’s metallic end is burnt red hot on a flame, killing all microbes.
The radiation method involves the exposure of packed materials to radiation. There are two types of radiation: non-ionic and ionizing radiation sterilization. The former is safe to the person doing the procedure while the latter requires the operator to wear protective gear. The hot air method is ideal for dry materials such as glassware and powder. They are placed inside the racks of a hot air oven until sterilized.
In this method, the items are subjected to sterilization through toxic gasses. When sterilizing heat sensitive liquids, you should use bacterial filters. Three types of filters are used in this type of sterilization:
The type of filter that you choose depends on the substance that you want to sterilize. When using gas to sterilize, cost factors as well as chances of explosion should be considered. The gasses used are usually very toxic and should be used with caution. If you want to sterilize surgical instruments, the most effective methods are autoclave, boiling, and incineration.
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A procedure pack’s contents may best be summarized with the term “custom tray”. A custom tray will generally be customized by the surgeon, orthodontist, or dentist who is using it. If, for example, you were working on the spine, common inclusions in a given spine pack are:
Whatever kind of custom tray you choose, you have the ability to add whatever necessary items you would like. A procedure pack can be fitted with the regular needs of a specific procedure as outlined in textbooks from varying sources. Additionally, you can make your own custom tray that includes more items. You may have some patients who require additional neuro sponges, and the forty of varying sizes included in regular packs may not cut it. Perhaps you prefer to have additional syringes in your custom tray, because you’ve had several close calls where such were needed in a hurry. Perhaps there are even items in this spine pack that you feel have been left out, and you’d prefer to add them. With a custom tray, you have that ability.
While it is possible for you to create your own custom tray at your practice with a minimum of difficulty, the problem is you’ll have to source items like those listed on your own time. Many medical practices have a supply division that manages such resources. Oftentimes in these scenarios, supplies are bought and paid for by clinics through a variety of vendors at different prices. If surgical procedural packs are made on-site, it may require the allocation of medical workers’ time. As a matter of fact, you’ll likely need several employees just to ensure each custom tray has the right equipment and is properly sterilized.
Or, you can cut out all that unnecessary infrastructure and instead order procedure packs that fit your clinic’s regular patients. While you may get outliers, then you can use local staff to put together surgical equipment for such a statistically minimal scenario. For everything else, it makes plenty of sense to order custom trays fitted to your needs in advance. You should have several custom tray families; one for backup, and one for regular use. A third group is not a bad idea either, should difficulties manifest.
With the ability to consolidate local resources and ensure each custom tray you order fits your specifications, it’s easy to see the appeal of this medical innovation. Having a custom tray or procedure pack handy in an emergency could very well save a person’s life. While it makes sense to maintain sterilization means on any facility, it also makes sense to plan for situations where there’s no time to book an appointment. Life doesn’t always stick to a schedule book.
Between the convenience of off-site resource consolidation and presentation, the savings that are rendered to your practice’s infrastructural and purchasing divisions, and the benefit of having immediate access to necessary surgical supplies in a possible emergency, there are a lot of things which recommend custom trays. More than being available, their customizable quality ensures you get what you need, when you need it, how you like it.