Multidata Systems International

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Multidata Systems International is a maker of radiation therapy products based in St. Louis, Missouri. Their major product lines include realtime dosimetry or RTD, which includes 3D water phantoms, Film dosimetry and air scanners. Since 2003, Multidata has been under a Consent Decree of Permanent Injunction entered by the U.S. District Court for the Eastern District of Missouri for the US FDA. The consent decree prohibits the company from designing, manufacturing, processing, and distributing medical devices, among other restrictions. [1]

Contents

Products

Multidata Systems was started in 1980 to provide medical physics solutions for radiation oncology. The RTD Real Time Dosimetry product line includes 1D and 3D water phantoms (field analyzers) for measuring the output of a treatment machine as used in radiation therapy. Three-dimensional datasets are required for the commissioning of such treatment machines, for the subsequent modeling of the radiation beam in the treatment planning software and for the calculation of dose to be delivered. A water phantom or field analyzer may also be used for periodical quality assurance measurements on an annual or semi-annual basis.

Other RTD equipment includes software and phantom accessories for a wide variety of quality assurance tasks in clinical radiation therapy, including the verification of treatment plans and tools for the documentation and comparison of delivered and planned dose.

The DSS (decision support system) treatment planning system followed RTP-123 and RTP/2 as one of the most widely used treatment planning systems commercially available. The DSS was widely popular due to its speed and the transparency of its calculation methods. The RTSuite product was designed to integrate plan verification methods with other planning and dosimetry tools in one user interface.

The software-driven MultiCut block mold cutting system is designed for cutting molds for the production of shielding blocks as used in radiation therapy.

History

Founded in 1979 in St. Louis, Missouri by Arne Roestel, the company entered the market with the first computerized water phantom system (a scanner for measuring radiation fields as used in hospitals for radiation therapy) while developing and building computers using the all new multi-tasking microprocessor technology. The company name “Multidata” reflected this focus and its founder’s mission to develop the industry’s first desktop computer for microcomputer-controlled instrumentation.

In 1982, the company introduced the first software-driven scanning system (CDS-III Clinical Dosimetry System, for film and water based scanning), obsoleting the external controller hardware previously required to interface with scanning instrumentation. The company collaborated to make radiation field datasets scanned with the dosimetry system compatible for use with the Memorial Sloan Kettering treatment dose calculation service, a project which later evolved into its first own radiation treatment planning software, RTP-123, released in 1987. Subsequent product generations included RTP/2, DSS (Decision Support System), DSS/2, DSS/3 3D for CRT and RTSuite.

Accident

A software product of the company was involved in an accidental overexposure of patients in Panama in 2001 when the treatment planning software RTP/2 (vers. 2.11, 1991) reportedly contributed to 28 patients receiving excessive amounts of radiation at the Instituto Oncologico Nacional in Panama City. At least eight patients died, while another 20 received overdoses likely to cause significant health problems. The physicians, who were legally required to double-check the computer's calculations by hand, were indicted for murder. [2]

A panel of experts designated by the International Atomic Energy Agency delivered a comprehensive report in August 2001, finding that the software permitted incorrect forms of data entry which in turn had led to miscalculation of treatment times. [3] Multidata began a recall and in-field correction of its radiation treatment planning software in September 2001 with the issue of a software correction and detailed description of the cause and circumstances of the incorrect data entry.

Related Research Articles

<span class="mw-page-title-main">Radiation therapy</span> Therapy using ionizing radiation, usually to treat cancer

Radiation therapy or radiotherapy, often abbreviated RT, RTx, or XRT, is a therapy using ionizing radiation, generally provided as part of cancer treatment to control or kill malignant cells and normally delivered by a linear accelerator. Radiation therapy may be curative in a number of types of cancer if they are localized to one area of the body. It may also be used as part of adjuvant therapy, to prevent tumor recurrence after surgery to remove a primary malignant tumor. Radiation therapy is synergistic with chemotherapy, and has been used before, during, and after chemotherapy in susceptible cancers. The subspecialty of oncology concerned with radiotherapy is called radiation oncology. A physician who practices in this subspecialty is a radiation oncologist.

Medical physics deals with the application of the concepts and methods of physics to the prevention, diagnosis and treatment of human diseases with a specific goal of improving human health and well-being. Since 2008, medical physics has been included as a health profession according to International Standard Classification of Occupation of the International Labour Organization.

<span class="mw-page-title-main">External beam radiotherapy</span> Treatment of cancer with ionized radiation

External beam radiotherapy (EBRT) is the most common form of radiotherapy. The patient sits or lies on a couch and an external source of ionizing radiation is pointed at a particular part of the body. In contrast to brachytherapy and unsealed source radiotherapy, in which the radiation source is inside the body, external beam radiotherapy directs the radiation at the tumour from outside the body. Orthovoltage ("superficial") X-rays are used for treating skin cancer and superficial structures. Megavoltage X-rays are used to treat deep-seated tumours, whereas megavoltage electron beams are typically used to treat superficial lesions extending to a depth of approximately 5 cm. X-rays and electron beams are by far the most widely used sources for external beam radiotherapy. A small number of centers operate experimental and pilot programs employing beams of heavier particles, particularly protons, owing to the rapid dropoff in absorbed dose beneath the depth of the target.

A radiation therapist, therapeutic radiographer or radiotherapist is an allied health professional who works in the field of radiation oncology. Radiation therapists plan and administer radiation treatments to cancer patients in most Western countries including the United Kingdom, Australia, most European countries, and Canada, where the minimum education requirement is often a baccalaureate degree or postgraduate degrees in radiation therapy. Radiation therapists can also prescribe medications and radiation, interpret tests results, perform follow ups, reviews, and provide consultations to cancer patients in the United Kingdom and Ontario, Canada . In the United States, radiation therapists have a lower educational requirement and often require postgraduate education and certification in order to plan treatments.

Radiation dosimetry in the fields of health physics and radiation protection is the measurement, calculation and assessment of the ionizing radiation dose absorbed by an object, usually the human body. This applies both internally, due to ingested or inhaled radioactive substances, or externally due to irradiation by sources of radiation.

<span class="mw-page-title-main">Nuclear medicine</span> Medical specialty

Nuclear medicine or nucleology is a medical specialty involving the application of radioactive substances in the diagnosis and treatment of disease. Nuclear imaging, in a sense, is "radiology done inside out" because it records radiation emitting from within the body rather than radiation that is generated by external sources like X-rays. In addition, nuclear medicine scans differ from radiology, as the emphasis is not on imaging anatomy, but on the function. For such reason, it is called a physiological imaging modality. Single photon emission computed tomography (SPECT) and positron emission tomography (PET) scans are the two most common imaging modalities in nuclear medicine.

Technicare, formerly known as Ohio Nuclear, made CT, DR and MRI scanners and other medical imaging equipment. Its headquarters was in Solon, Ohio. Originally an independent company which became publicly traded, it was later purchased by Johnson & Johnson. At the time, Invacare was also owned by Technicare. A Harvard Business Case was written about the challenges that precipitated the transition. The company did not do well under Johnson & Johnson and in 1986, under economic pressure following unrelated losses from two Tylenol product tampering cases, J&J folded the company, selling the intellectual property and profitable service business to General Electric, a competitor.

Artronix Incorporated began in 1970 and has roots in a project in a computer science class at Washington University School of Medicine in St Louis. The class designed, built and tested a 12-bit minicomputer, which later evolved to become the PC12 minicomputer. The new company entered the bio-medical computing market with a set of peripherals and software for use in Radiation Treatment Planning and ultrasound scanning. Software for the PC12 was written in assembly language and FORTRAN; later software was written in MUMPS. The company was located in two buildings in the Hanley Industrial Park off South Hanley Road in Maplewood, Missouri.

PC12 by Artronix was a minicomputer built with 7400-series TTL technology and ferrite core memory. Computers were manufactured at the Artronix facility in suburban St. Louis, Missouri.

A monitor unit (MU) is a measure of machine output from a clinical accelerator for radiation therapy such as a linear accelerator or an orthovoltage unit. Monitor units are measured by monitor chambers, which are ionization chambers that measure the dose delivered by a beam and are built into the treatment head of radiotherapy linear accelerators.

<span class="mw-page-title-main">Instituto Oncológico Nacional</span> Hospital in Panama, Panama

The National Oncologic Institute or ION is a specialized hospital for cancer treatment, located in Panama City, Panama. Between August 2000 and March 2001, patients receiving radiation treatment for prostate cancer and cancer of the cervix received lethal doses of radiation, resulting in eight fatalities.

<span class="mw-page-title-main">Radiation treatment planning</span>

In radiotherapy, radiation treatment planning (RTP) is the process in which a team consisting of radiation oncologists, radiation therapist, medical physicists and medical dosimetrists plan the appropriate external beam radiotherapy or internal brachytherapy treatment technique for a patient with cancer.

Image-guided radiation therapy is the process of frequent imaging, during a course of radiation treatment, used to direct the treatment, position the patient, and compare to the pre-therapy imaging from the treatment plan. Immediately prior to, or during, a treatment fraction, the patient is localized in the treatment room in the same position as planned from the reference imaging dataset. An example of IGRT would include comparison of a cone beam computed tomography (CBCT) dataset, acquired on the treatment machine, with the computed tomography (CT) dataset from planning. IGRT would also include matching planar kilovoltage (kV) radiographs or megavoltage (MV) images with digital reconstructed radiographs (DRRs) from the planning CT.

Radiobiology is a field of clinical and basic medical sciences that involves the study of the action of ionizing radiation on living things, especially health effects of radiation. Ionizing radiation is generally harmful and potentially lethal to living things but can have health benefits in radiation therapy for the treatment of cancer and thyrotoxicosis. Its most common impact is the induction of cancer with a latent period of years or decades after exposure. High doses can cause visually dramatic radiation burns, and/or rapid fatality through acute radiation syndrome. Controlled doses are used for medical imaging and radiotherapy.

<span class="mw-page-title-main">PET-CT</span>

Positron emission tomography–computed tomography is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session, which are combined into a single superposed (co-registered) image. Thus, functional imaging obtained by PET, which depicts the spatial distribution of metabolic or biochemical activity in the body can be more precisely aligned or correlated with anatomic imaging obtained by CT scanning. Two- and three-dimensional image reconstruction may be rendered as a function of a common software and control system.

Tissue-to-air ratio (TAR) is a term used in radiotherapy treatment planning to help calculate absorbed dose to water in conditions other than those directly measured.

The computed tomography dose index (CTDI) is a commonly used radiation exposure index in X-ray computed tomography (CT), first defined in 1981. The unit of CTDI is the gray (Gy) and it can be used in conjunction with patient size to estimate the absorbed dose. The CTDI and absorbed dose may differ by more than a factor of two for small patients such as children.

<span class="mw-page-title-main">Cone beam computed tomography</span>

Cone beam computed tomography is a medical imaging technique consisting of X-ray computed tomography where the X-rays are divergent, forming a cone.

Computational human phantoms are models of the human body used in computerized analysis. Since the 1960s, the radiological science community has developed and applied these models for ionizing radiation dosimetry studies. These models have become increasingly accurate with respect to the internal structure of the human body.

Xie George Xu was the Edward E. Hood Chair Professor of Engineering at Rensselaer Polytechnic Institute (RPI), Troy, New York, United States, before he relocated in 2020 to China and joined the faculty of the University of Science and Technology of China.

References

  1. "Discontinue Use of Multidata Systems International Corp. Radiation Therapy Devices - Letter to Health Care Providers". US FDA. 20 October 2016. Retrieved 21 October 2016.
  2. Garfinkel, Simson (November 8, 2005). "History's Worst Software Bugs". Wired . Retrieved September 6, 2020.
  3. International Atomic Energy Agency, A Panel of Experts (2001). Investigation of an Accidental Exposure of Radiotherapy Patients in Panama/Report of a Team of Experts, 26 May – 1 June, 2001 (PDF). Vienna, Austria: International Atomic Energy Agency.