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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.

Processed vs. Unprocessed Medical Devices

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Medical Devices

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

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

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

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

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

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

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

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

Processed Medical Devices

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

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

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

Unprocessed Medical Devices

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

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

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

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

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

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

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

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

How Custom Procedure Packs Reduce Emergency Surgery Response Times

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An Emergency, No Matter What Level

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

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

Who Uses Sterile Procedure Packs?

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

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

Benefits of Using Prepackaged Procedure Packs

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

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

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

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

Autoclaving a Thing of the Past

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

Medical Manufacturers’ Role in Procedure Packs

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

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

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

What is Included in Procedure Packs

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

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

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

An Emergency, No Matter What Level

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

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

Who Uses Sterile Procedure Packs?

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

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

Benefits of Using Prepackaged Procedure Packs

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

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

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

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

Medical Manufacturers’ Role in Procedure Packs

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

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

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

What is Included in Procedure Packs

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

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

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

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.

5 Reasons to have a custom surgical pack

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A custom surgical pack contains single-use devices that are necessary when medical clinicians are carrying out procedures. All these devices are packaged in a sterile pack that is delivered into surgeries. The medical device industry works with doctors and other medical clinicians in designing and delivering surgical pack in a timely and efficient manner. A surgical pack has a selection of components that includes; drapes, surgical swabs, sutures, surgical blades and wound dressing. Specialized devices such as cardiac catheters and implants can also be included. There are many benefits that come with using customized surgical packs, below are five reasons why you should consider a customized surgical pack.

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rol leaving patients less vulnerable to Healthcare Associated Infections.

  • By increasing the patients’ throughput and reducing response time, surgical packs improve the quality of service.
  • Since all the components are in one pack, they simplify batch traceability.
  • Due to the broad uptake of surgical packs, many procedures have been standardized across several institutions that use them, therefore, driving up quality.
  • Guidelines can be easily formulated by healthcare providers to properly assess themselves against set standards that may be deemed too rigid.
  • 4. Environmental

    The amount of waste generated by units can be reduced by up to 50%.

    5. Improves Efficiency

    The increased efficiency means that more procedures can be done in one day since the time for preparation is considerable. The waiting time for patients can be reduced, and their procedures carried out earlier.

    Custom Procedure Trays Improve Productivity

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    Custom trays are not only important for medical practitioners, but they are also important for anyone who needs to perform a medical role. The most important thing with your medical custom trays is understanding that if at any time someone actually does need something, they need to have what works the best and they need to have what is going to be the most efficient from every step of the way. With custom trays medical professionals can have just that, however, you need to be aware of a few of the following items.

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    ine regardless of who delivers them and who packs them, you also have to consider the general service you receive. When there are questions you need answered, changes in the order and packing preferences, or even just contact that you need to have in order to retain a strong relationship with your supplier, there are more than enough reasons why any business relationship needs to have strong communication. There are more than enough reasons to ensure you have strong communication and a great reputation with your suppliers, but at the end of the day you want to make sure you are simply receiving a quality product with the service that actually backs it up as well with your custom trays.

    Certifications and Partners

    Not only do you need to be aware of the product in general, but when it comes to custom trays you also have to understand you are getting a product certified by the professionals. There are more than enough players in the medical community, but there are absolutely more than enough ways to get checked out as well. When it comes to having top quality custom trays in the medical and surgical community as well, there are reasons you want to be known and one of those reasons is by the partnerships you have and the endorsements you have earned for your product.

     

    Does the Surgical Pack Reduce Costs


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    Image is from ROi

    Qualified experts in cost management for Operating Rooms agree that the most cost effective innovation within the medical arena that has also been most productive in increasing quality of treatments plus eliminating waste is the implementation of surgical custom trays. Waste reduction is achieved by reducing overstocking, a custom trays improvement that also saves in personnel duties. The consequent reduction of medical hazard waste improves minimalizing of our carbon footprint while simultaneously increasing the treatment success for individual procedures and the more complicated surgical procedures.

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    cedure that is undertaken.

    • Single Use Products

    Sterile materials which are required for single use are packed in efficiency boosting single use individual custom trays. Compact custom trays save time and prevent unnecessary waste in performing those specific single use Operating Room procedures, and the custom trays are also quickly available for any repetitive procedures performed.

    Summary of Custom Tray Cost Reduction

    Your facility’s carbon footprint reduction and securing sustainable environmental practices without undermining any and all safety factors represents both a local and global importance. Custom surgical tray implementation always will drastically reduce the amount of packaging material and waste issues when compared to the use of individually packed and arranged instruments for your procedures. Packaging material weight due to the Operating Room’s implementaton of custom trays alone is reduced by 58%, usually resulting in one less waste bag in the Operating Room’s larger medical procedures. That reduction of one waste bag results in a reduction of the hospital’s global carbon footprint as well as your facility’s operating costs.

    The combined and assessed impact of custom trays’ utilization in reducing excess procurement stocking while effectively diminishing the carbon impact of medical waste can only be estimated, but the estimation suggests that the green earth improvement caused by this one professional innovation of custom trays in the Operating Room is of monumental global importance.

    How do custom surgical trays maximize efficiency

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    Custom surgical trays are every clinical staff’s favorite because they help get the job efficiently done. Medical facilities have appreciated the use of such surgical trays because they have noticed a great positive difference in their own medical service delivery. Patients’ lives have been saved, staff have become more efficient and the general environment around the hospital has adopted a more professional and efficient air. How do custom surgical trays maximize such efficiency within a medical facility?

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    sts

    Custom trays have been known to minimize costs within a medical facility. Overall pricing costs of surgical equipment have reduced thanks to bulk ordering of these procedure trays. Wastage of time and unneeded medical items has been eliminated and many other costs. This has resulted to many medical facilities saving good amounts of money and spending it on other aspects that promote more efficiency in medical service delivery.

    More Income Generated

    Medical facilities have also had more patients seeking their services thanks to well organized staff with all the necessary equipment required. This of course translates to more income for medical facilities, something that makes the facility improve the quality of their services. With more income a medical facility will also hire more medical staff to cater for an increasing number of patients.

    More Quality Control

    Many providers of custom surgical trays will hardly have delivery errors. However, in the event such an error occurs, the providers tend to make up for their mistake and deliver the correct procedure trays on time without passing on the expense to the medical facility. Because of that, many of the providers always ensure that all customized trays contain the exact content ordered and in the best quality.

    Efficiency in the Operating Theatre

    Customized procedure trays have been known to help in reducing complexity and costs, save time and contribute to maximum efficiency in the operating theatres. Most theatre staff absolutely love the simplicity, the convenience and most of all the efficiency associated with the customized trays. These kinds of procedure trays make their work easier; it is actually a way of “working smart” for the medical professionals.

    It is evident that customized trays promote efficiency in most medical facilities. Service delivery in the end is what counts and with the right surgical equipment, it is easier for the medical professionals using them to carry out their duties.