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Category Archives: Radiopharmaceuticals

Medical Logistics Summary

Write That Down! Documentation and Compliance in Medical Transportation

While the subject of documentation and record keeping often goes undiscussed or explored, it is an administrative reality that everyone is familiar with. Let’s be honest – documentation, filing, records, and miscellanies admin tasks aren’t always the most exciting parts of jobs, conversations, or our days. However, when it comes down to it, there is extreme importance on documentation and compliance within various governing bodies and organizations. The concept and action of documentation ensures that standards are being met and that all communication is clear and uncomplicated.

Why Documentation?

First off, documentation has incredible importance not only in maintaining the smooth running of operations and communications, but also in compliance. State and federal regulations for both ground and air transportation have certain standards that medical companies, organizations, providers, and institutions need to keep up with in order to maintain compliance. 

There is a base level of documentation and standards required in order for an organization to be running smoothly. Failure to report and document information threatens the integrity and safety of those involved. This can affect individuals specifically as well as the company or organization as a whole. Losing trust or compliance with governing bodies can also be detrimental and result in revoked licenses or certifications as well as destroying industry reputation. 

Government Bodies and Requirements

As a medical logistics and transportation program, our clientele ranges from those more in the transportation business, to researchers, to medical products, to suppliers, providers, and medical and emergency facilities. Therefore, compliance requirements can vary depending on the client and products being transported or worked with. However, there is value in understanding why documentation is required and the purpose of compliance in any case or situation. 

FAA: The Federal Aviation Administration uses compliance as a means of identifying any safety issues and deviations from standards to apply corrective actions and measures as quickly as possible. 

DOT: The Department of Transportation utilizes compliance to maintain and develop safe transport of vehicles, cargo, shipping containers, etc. Meeting and exceeding the standards DOT has surrounding safety-sensitive issues results in compliance.

NRC: The United States Nuclear Regulatory Commission gives licenses and certifications based on compliance and requirements met. Failure to meet compliance results in revoked licenses and suspensions from the commission. 

TSA: the Transportation Security Administration also highlights safety as a huge reason for extensive compliance requirements. In situations such as providing on-board couriers and air transportation, these compliances are essential. Without them, there’s not a chance that air transport will even be an option.

DHS: the Department of Homeland Security emphasizes, you guessed it, the safety and security of all parties involved in transportation processes. No surprises here! 

IATA: International Air Transport Association has an incredible number of partnerships with governments, airports, transportation companies, etc. Therefore, their main goal with compliance is to ensure that all bodies have the essential information needed.

A common thread in looking through all of these governing bodies’ compliance statements and standards is the issues of safety and communication. Documentation and upkeep are essential in maintaining these compliance standards, and therefore maintaining the integrity of organizations and the safety of all parties involved in operations. 

Compliance and Its Importance

Essentially, all organizations must maintain regulatory compliance. This is a set of procedures and regulations that support the governing body’s requirements. Most compliance within the medical transportation world is aimed at supporting high-quality transportation, safety, and data security. The transportation world, specifically medical transportation, involves a high number of logistics to maintain the integrity of products being transported as well as patient safety if patients are being transported. Therefore, a lot of thought and safety checks are involved in these processes. All of these need to be documented and recorded to ensure that all operations are running smoothly. The governing bodies that are overseeing some of these processes and transports need this information as well to ensure that safety and security standards are being met. Failure in compliance can result in several serious consequences ranging from financial effects and fines to destroyed reputations. 

MediOps Makes it Easier

One of the priorities of Medi-Ops is innovative and future-forward thinking. Because of this, our custom software allows us to maintain documentation requirements for our clients without them having to record documentation of their own. One less task and worry for our clients means that we are not only taking care of medical logistics needs but taking that extra step where clients can truly know that every aspect and detail – from big orders and transportation needs down to documentation – is being taken care of. This allows them to focus on the crucial medical work they are completing without having to spend extra time on admin tasks.

The technology and software that allow Medi-Ops to maintain documentation are the same systems that provide transparency and tracking of shipments. Clients are easily able to track and see shipments in real-time, knowing that every detail and requirement is being taken care of.

All in all, the reality of documentation importance can’t be dismissed – from both a practical standpoint to a compliance standard. That’s why Medi-Ops cares enough to develop technology to further support clients in this aspect of medical fieldwork. No detail is too small to develop future-forward and innovative ways to approach and address it.

medi-ops radiopharmaceuticals

Radiopharma & Transport Networks

This year brings a big happy birthday to the radiopharmaceutical industry – turning 69! The continuous development within this field brings innovative changes specifically in cancer drugs and transportation networks. The world of nuclear medicine is small in comparison to other medical specialties but is growing rapidly as light continues to be shed on the unbelievable feats that diagnostic and therapeutic pharmaceuticals achieve. The effects and benefits of what nuclear medicine can do are truly undeniable. 

While the FDA began regulating radiopharmaceuticals as drugs in the 1970s, it would be a decade later that the exploration of oncological imaging and therapy use began in the 1980s. The next decade of the 90s brought further research and rapidly growing use of nuclear medicine (specifically in PET imaging). In this century, leaps and bounds in nuclear medicine have been made – from Time Magazine’s invention of the year as the PET/CT scan machine in 2000 to progressive FDA regulations and continued development in the industry, the best of nuclear medicine is yet to come.

With the extraordinary strides in medicine that radiopharmaceuticals have brought come many challenges – specifically in the safe transport of radiopharmaceuticals with time and radiation considerations. These forms of treatment are radioactive after all, which sounds scary, but really just means that transporting these products requires an extra level of attention and care than regular medical transport. 

The Radiopharmaceutical Industry

In the nuclear medicine world, radiopharmaceuticals can be used for diagnostic and therapeutic purposes. While diagnostic radiopharmaceuticals contain less radiation than therapy radiopharmaceuticals, both are composed of radioisotopes. These diagnostic procedures within nuclear medicine allow closer, more detailed imaging of specific organs and parts of the body through gamma scans (A.K.A scintigraphy). Both dynamic and static images can be produced, creating optimal specificity in diagnosis. Discoveries of future uses of radiopharmaceuticals in oncology and cardiology prognosis continue to be unveiled. In addition, there is a constant stream of drug development and testing on projected uses of radiopharmaceuticals.

The production of radiopharmaceuticals requires handling large quantities of radioactive substances in addition to chemical processing. Because of this, processing facilities in compliance with manufacturing practices, quality assurance, and control systems are essential for safe production. These products require registration with relevant health authorities as well as careful radioactive material transport. 

Cancer Drugs

The incredible ability of radiopharmaceuticals to detect and treat tumor cells provides for the unearthing of new cancer treatments. Radiopharmaceutical therapy in cancer treatment allows radioactive substances to target specific diseased cells, delivering radiation directly to the tumor and affected area. In specific targeting of cancer cells through therapeutic radiopharmaceuticals, side effects and harmful factors surrounding cancer treatments can be reduced. 

Transportation Networks

Now that we’ve had a refresher on the radiopharmaceutical industry and cancer drugs, let’s get into the interesting stuff. As always in medical transportation, there are imperative needs when moving products from one place to the other – Safety. Speed. Efficiency. Specifically with radiopharmaceuticals, complicated transportation networks are necessary to have in place to maintain the integrity of the product. 

Transportation processes of radioactive material are incredibly regulated. Radiopharmaceuticals are transported via Type A packaging, where extensive testing is done on the packages used to maintain and protect the product without releasing its contents. These tests are thorough! They include an hour of water spray, free fall testing onto a hard, flat surface, compression of five times the weight of the package, and penetration tests where heavy bars are dropped on the package from heights of over 3 feet. Once these packages prove themselves worthy after all of this testing, they are ready to serve their purpose in transporting these drugs all over the world. In addition to package regulations, a series of requirements for each mode of transportation (highway, rail, air, and water) are also in place through government transportation regulations.

While most radioactive materials aren’t allowed on commercial flights, radiopharmaceuticals are eligible for air carrier transportation. These products are volatile and require immediate transportation, qualifying for both ground and air transportation depending on the specific situation. Because radiopharmaceuticals have a short half-life, swift transportation efforts are imperative. Depending on the destination, a next flight out or air charter method of transport is typically preferred in these time-critical transportation cases. 

While nuclear medicine is still a relatively small field, the growth and development, particularly in radiopharmaceuticals, are skyrocketing. Transporting these products is an intricate process requiring the utmost level of safety and efficiency. With the right processes and procedures, radiopharmaceuticals are traveling around the world, changing lives and the world of medicine for the better.