IMDA eNews 102523
The latest news affecting you and your customers…
from the Independent Medical Specialty Dealers Association
Strokes diagnosed in ambulances
A special brain-wave cap under development can diagnose stroke in the ambulance, allowing the patient to receive appropriate treatment faster, reports the Amsterdam University Medical Centers. The cap allows an EEG to be carried out in the ambulance and show whether the patient is experiencing an ischemic stroke and whether the blocked cerebral blood vessel is large (in which case it must be removed mechanically) or small (in which case the patient would receive a blood thinner). To develop the brain-wave cap into a product and bring it to the market, Amsterdam UMC founded TrianecT, a spin-off company, in 2022.
EtO claims settled in Georgia
Medical equipment sterilizer Sterigenics agreed to pay $35 million to settle 79 claims which alleged that the firm’s use of ethylene oxide at its Smyrna, Georgia, facility put nearby neighborhoods at risk. In a statement Sterigenics continued to deny any liability. Some lawsuits in Cobb County remain open.
Contract manufacturers playing bigger role in device market
Contract manufacturers have embedded themselves into nearly every industry, and the medical device sector is no exception, says Neal Walters from the manufacturing consulting firm Kearney, in a recent issue of SupplyChainBrain. COVID-19 and other recent supply chain disruptions have only served to boost original equipment manufacturers’ reliance on outsourcing. Contract manufacturers are becoming more of an end-to-end player in the world of medical devices. They are getting involved in every stage from product design through final manufacture — and, in some cases, the logistics of delivery, he says.
AI-powered monitor helps manage pain
Israel-based Medasense Biometrics says its AI-powered patient monitor can help clinicians manage physiological pain in the OR and high-acuity settings, reports Medical Design & Outsourcing. In conscious patients, current approaches often rely on subjective assessments of pain, which can be influenced by individual perception and expression, leading to potential delays in intervention and inconsistent care, according to company founder Galit Zuckerman-Stark. Medasense says its technology offers clinicians data to inform their perioperative pain management decisions. In February 2023, the FDA granted marketing authorization to the company for its PMD-200 monitor through a De Novo grant. The device is currently used in Europe, Canada, Australia, Israel, Turkey, the United Arab Emirates and Latin America. It can work alone or connected to Philips and Mindray patient monitors.
Product, equipment shortages harming patients
Ongoing medication, medical supply and medical equipment shortages are harming patients, according to a July 2023 survey issued by the patient safety organization ECRI and its affiliate, the Institute for Safe Medication Practices. The nearly 200 respondents said care quality has been broadly affected in surgery and anesthesia (74%), emergency care (64%), pain management (52%), cardiology (45%), hematology and oncology (44%), infectious diseases (39%), and obstetrics and gynecology (37%).
Disparities in occult hypoxemia
Black patients have higher rates of occult hypoxemia compared with White patients, even after adjustments for underlying differences in arterial blood gas (ABG) distributions, according to a study in Critical Care, reports Pulmonology Advisor. Arterial hypoxemia was defined as Sao2 of less than 88%, and occult hypoxemia was Sao2 less than 88% when peripheral capillary oxygen saturation (Spo2) was at least 92%. The total occult hypoxemia rate was divided into the distribution of underlying Sao2 and the race-specific sensitivity of the pulse oximeters for detecting Sao2 less than 88%.
Manufacturers Forum: Show your stuff in Orlando
Are you a developer of an innovative medical technology? Do you need a sales force to introduce it to clinical decisionmakers in hospitals? If so, you will find them at the 2024 IMDA/HIRA Conference in Orlando, Florida, March 4-6. IMDA members focus on new technologies, i.e., the devices and equipment that fly under the radar of GPOs but which will become the standard of care when fully implemented. And they know the key players to talk to about those technologies. Set up a booth at Manufacturers Forum at the Conference for just $1,650 (for booth and attendance at all conference sessions). The cost is even lower if you join MDA as an allied member. Click here for more information.