FDA's new rules for Unique Device Identification
The FDA published its new rules on the much-anticipated Unique Device Identification (UDI) today, which will see medical devices provided with uniquely identifiable information and data capture technology.
The eagerly awaited decision, which has been in the works since 2007, will require everything from bedpans and pace makers to cardiac stents and prostate specific antigen testing kits to carry both a unique identifier (in readable text) as well as automatic identification and data capture technology in the form of bar codes or radio frequency identification.
To read the latest edition of Healthcare Global, click here
- Cranberry Juice can help prevent urine infections
- Infants not feeling fine in the summertime
- Seaweed could protect against tooth decay
The FDA will provide a Global Unique Device Identification Database, on which all UDI numbers and their relevant details will be stored. This database will be accessible to both members of the public seeking to know more about a device, as well as members of the industry.
The choice of automatic identification technology will be left to the device manufacturer, following extensive safety tests conducted by the FSA which has determined that radio frequency technology is safe to use with medical devices.
The initial system will simply capture basic details, such as the device’s make and model as well as the date and location of manufacture. In the future, however, there is the potential to track a device’s use and its journey through the supply chain.
Following the publication of the UDI ruling, the industry now has 120 days to provide feedback , after which the agency will have six months to provide the final rules. After this stage, there will be a phased-in implementation of the technology, where manufacturers of Class Three devices (those deemed to pose the highest risk to health and safety) must comply with the final regulations within one year. Class Two device manufacturer will have three years to meet the new requirements, and Class One manufacturers will have five years.
Under the new rules, medical device manufacturers much provide the identifiable information on the packaging or on the device itself if the device is likely to be removed from its packaging.
Introducing Dosis - the AI powered dosing platform
Cloud-based platform Dosis uses AI to help patients and clinicians tailor their medication plans. Shivrat Chhabra, CEO and co-founder, tells us how it works.
When and why was Dosis founded?
Divya, my co-founder and I founded Dosis in 2017 with the purpose of creating a personalised dosing platform. We see personalisation in so many aspects of our lives, but not in the amount of medication we receive. We came across some research at the University of Louisville that personalised the dosing of a class of drugs called ESAs that are used to treat chronic anaemia. We thought, if commercialised, this could greatly benefit the healthcare industry by introducing precision medicine to drug dosing.
The research also showed that by taking this personalised approach, less drugs were needed to achieve the same or better outcomes. That meant that patients were exposed to less medication, so there was a lower likelihood of side effects. It also meant that the cost of care was reduced.
What is the Strategic Anemia Advisor?
Dosis’s flagship product, Strategic Anemia Advisor (SAA), personalises the dosing of Erythropoiesis Stimulating Agents (ESAs). ESAs are a class of drugs used to treat chronic anaemia, a common complication of chronic kidney disease.
SAA takes into account a patient’s previous ESA doses and lab levels, determines the patient’s unique response to the drug and outputs an ESA dose recommendation to keep the patient within a specified therapeutic target range. Healthcare providers use SAA as a clinical decision support tool.
What else is Dosis working on?
In the near term, we are working on releasing a personalised dosing module for IV iron, another drug that’s used in tandem with ESAs to treat chronic anaemia. We’re also working on personalising the dosing for the three drugs used to treat Mineral Bone Disorder. We’re very excited to expand our platform to these new drugs.
What are Dosis' strategic goals for the next 2-3 years?
We strongly believe that personalised dosing will be the standard of care within the next decade, and we’re honored to be a part of making that future a reality. In the next few years, we see Dosis entering partnerships with other companies that operate within value-based care environments, where tools like ours that help reduce cost while maintaining or improving outcomes are extremely useful.
What do you think AI's greatest benefits to healthcare are?
If designed well, AI in healthcare allows for a practical and usable way to deploy solutions that would not be feasible otherwise. For example, it’s possible for someone to manually solve the mathematical equations necessary to personalise drug dosing, but it is just not practical. AI in healthcare offers an exciting path forward for implementing solutions that for so long have appeared impractical or impossible.