The Time is Ripe for an Alternative to Automated Hazardous Drug Compounding – Medical Device and Diagnostics Industry

As technology has progressed, automation has been successfully introduced into several areas of healthcare practice, such as surgery and data processing, providing a range of benefits from greater efficiency to cost-saving opportunities. However, one area in which automation is not currently being utilized to its fullest potential is with the compounding and preparation of medications, particularly hazardous drugs (HDs).

Working with such drugs often chemotherapy medications without the correct protective measures has been shown to increase the risk of healthcare workers developing a range of negative health outcomes, from infertility and birth defects to some forms of cancer. Personal protective equipment (PPE) such as protective clothes and goggles are used, and recent years have seen the introduction of Closed System Transfer Devices (CSTDs) for manual drug compounding, preparation, and administration. However, these are currently not being used at all in automated compounding systems.

If HDs are compounded in automated systems using standard syringes, the entire compounding environment can become contaminated by drug vapors, aerosols and droplets escaping from these syringes, putting healthcare workers at considerable risk of HD exposure, and acting counterproductively against one of the potential benefits of automation namely, increased safety.

The origins of drug compounding robots

Offering an extra layer of protection previously lacking, the first CSTDs successfully reduced HD exposure, and within a decade became a core component in HD handling, recommended by leading organizations including the National Institute for Occupational Safety and Health (NIOSH). The natural next step in increasing safety and efficiency was to create a compounding robot. However, the original concepts were flawed from the outset.

Conceptionally, compounding robots should act as a CSTD in reducing environmental contamination. Yet, while the original robots were created to improve accuracy and reduce errors, they were not designed to prevent leakage. This led to drugs contaminating the IV bags, membranes of vials and connectors and to the escape of vapors, contaminating the compounding environment within the robot that must be regularly accessed by healthcare workers and support staff for cleaning and maintenance. The result was that the final products, usually an IV bag or syringe, were also contaminated.

Isolators, which utilize a pass-through box or cabinet to (theoretically) maintain complete separation from the outside environment, encounter a similar issue if a CSTD is not used. This is because the final products are not shielded from drug leaks and vapors that may escape while inside the isolator, resulting in contaminated IV bags being removed from within the isolator and spread around the facility.

There are other significant issues associated with compounding robots in their current state, such as inefficiencies of time and wastage. A lack of uniformity in vial sizes and shapes slows down the entire process as the robot has to locate the needle space and gauge the depth of each vial it grabs with its mechanical arm. Additionally, the varying shapes of vials can mean that the robot is unable to remove the entire contents of medication, losing significant amounts of costly medication in the process. These points may seem insignificant but are of paramount importance, as each treatment can cost tens of thousands of dollars and are patient-specific, not for general mass use.

Why the inclusion of completely closed systems is essential for robotic systems

For robotic systems to be viable options for compounding hazardous drugs, they need to be fully closed. Therefore, the safety measures recommended when humans are manually compounding HDs must also be integrated into automated systems. In particular, integrating CSTDs within the robot for the compounding process would provide health workers handling the products a higher level of protection than is currently offered.

Other advantages of CSTD-enabled robots will follow, such as increased compounding efficiency as all vials become uniform with vial adaptors on each bottle, allowing the robots to grab any vial, regardless of size, via the adaptor piece. Additionally, automated systems incorporating CSTDs, if designed with efficiency in mind, can offer higher throughput because not tiring as humans do, they can safely maintain a high rate of compounding for prolonged periods.

Closed automated compounding systems can also be used to protect both patients and healthcare workers operating elastomeric pumps or cassettes which are used for infusing medication, ranging from antibiotics to chemotherapy drugs. Robots can prepare these doses and inject drugs directly into the pumps within a fully closed system, avoiding all human contact with the drugs until necessary.

Conclusion

Compounding safety standards have increased in recent years, after much research and education and as governing bodies have championed the use of better and more rigorous safety equipment such as CSTDs. The next step for compounding will be the common use of automation, which must include CSTDs as a central part of the compounding process. This should be used in tandem with current protective principles for manual compounding to guarantee that healthcare workers and patients alike are kept safe, while simultaneously increasing productivity and lowering overall cost.

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The Time is Ripe for an Alternative to Automated Hazardous Drug Compounding - Medical Device and Diagnostics Industry