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FDA Seeks ‘Remanufacturing’ Feedback from Biomeds

A little more than a month ago, the FDA released the draft guidance “Remanufacturing of Medical Devices” and asked healthcare technology management professionals, original equipment manufacturers, third-party repair organizations and more to submit comments.

United Imaging Goes “All-in” for Nashville

United Imaging makes its debut at HealthTrust University and its in-person debut at AHRA in Nashville over the next two weeks. At both events, the company will focus on several unique aspects of how it solves pervasive pain points in procuring and owning medical imaging equipment.

TechNation Asks Biomeds to Share Right to Repair Issues

TechNation is proud to support and be an advocate for the Right to Repair movement in the healthcare technology management and health care community. A new web form specifically allows biomeds everywhere to report incidents when an original equipment manufacturer...

Delivering precision solutions for a changing world

Change has been the one constant in nuclear medicine from the beginning, with the steady arrival of new radiopharmaceuticals, new technologies and an evolving regulatory environment. Today, as nuclear medicine expands rapidly beyond diagnostics and into novel...

Radiation Monitoring, Safety Market Recovery Expected

The “Medical Radiation Detection, Monitoring and Safety – Global Market Trajectory & Analytics” report predicts growth.

The global market for medical radiation detection, monitoring and safety is expected to slump by 4.6% in the year 2020 and thereafter recover to reach $1.2 billion by the year 2027, trailing a post COVID-19 compound annual growth rate (CAGR) of 4.7% over the analysis period 2020 through 2027.

Radiation monitoring remains an integral part of good health practice in medical facilities performing radiation therapy and diagnostic activities. Stringent safety regulations aimed at safeguarding the health of patients, medical physicists, radiologists and nuclear medicine technicians has long been the primary growth driver.

The pandemic has necessitated the prioritization of health care infrastructure for COVID-19 patients, affecting other patients across the world. As a result, hospitals across the world have been advising patients to delay elective and non-urgent diagnostic imaging and surgical procedures, including X-ray, CT, MRI and many other radiation and radiologically dependent procedures. Consequently, the consumption of radioactive material for these procedures has been witnessing significant slowdown. Suspension of diagnostic and therapeutic radiology services amid the COVID-19 pandemic has significantly impacted medical radiation detection, monitoring and safety. With low patient throughput in radiology labs worldwide, the market is expected to slump by a painful -4.6% in the year 2020.

The majority of radiation exposure in the medical field is on account of fluoroscopic imaging, which leverages X-rays to achieve cinematic and dynamic functional imaging. Fluoroscopy finds applications in several specialties such as gastroenterology, vascular surgery, interventional cardiology, interventional radiology, urology and orthopedics. In comparison to other medical diagnostic procedures, cardiac cath labs with electro-physiology and angiography result in the highest X-ray radiation dose. There is long-term exposure for lab technicians and physicians in these areas to low levels of scatter radiation.

While the benefits obtained from using X-rays in these labs surpasses the risks, the staff is prone to the scattered radiation from the skeletal structure of the patient. X-rays constitute high energy photons in the electromagnetic spectrum. X-rays have the capability to ionize atoms and breakdown molecular bonds. This ionization generates free radicals, which are chemically active compounds that can cause indirect damage to the DNA. Patients and medical staff can have exposure to X-ray radiation through direct exposure to the beam or due to scattered X-rays. As scattered X-rays lose a portion of their energy in the scattering process, the energy resulting in the tissues from scattered X-rays is lesser than that from the source of the X-ray.

Radiation doses are expressed in three ways. The absorbed dose refers to the radiation that results in an object and is calculated in mGy (milligrays). The comparable dose is measured, taking into consideration the radiation exposure specific to the organs and the sensitivity of the organ to the radiation, and is measured in mSv (millisieverts). The effective dose is also expressed in mSv. 20mSv/annum is about 2-3 pelvic and abdominal CT scans or background radiation of 7-9 years. Exposure over this limit averaged over a period of five years has been linked to a 1 in 1,000 lifetime risk of deadly cancer.

For physical protection from radiation various kinds of personal protection equipment (PPE) can be used. Certain fluoroscopy suites include lead acrylic shields (ceiling-suspended), which can lower doses to the neck and head (by a factor of 10). Portable rolling shields can safeguard personnel in interventional settings and operating rooms. If used accurately, mobile shields are said to lower the effective radiation dose by over 90%.

In situations where shielding with the use of a physical barrier is not possible, personnel need to use leaded aprons for safety. These aprons are made available in various thicknesses such as 0.5mm, 0.35mm and 0.25mm. Aprons that go around the body are considered to be better than front aprons, due to the former’s better coverage. •

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