IMDA eNews 040423

The latest news affecting you and your customers…

from the Independent Medical Specialty Dealers Association

Airway management market growing

The global market for medical devices for airway management is expected to reach $2.93 billion in 2025, with an annual growth rate of more than 6%, according to venture firm BHV Partners, Barcelona, Spain. BHV recently launched a startup company in Valencia, Spain – Conus Airway – to develop medical devices intended to reduce the risks associated with respiratory tract surgery, to improve results in different areas such as a complex anesthesia and narrowing of the respiratory system, to minimize the risk of cross-contamination between patients and medical staff, and to increase efficiency in managing this type of surgery. The startup will develop devices based on technology designed by Carlos Gutiérrez, MD, head of the pediatric thoracic surgery department at the University and Polytechnic La Fe Hospital of Valencia.

Medical device packaging matters

Defective packaging bags for many Exactech joint replacement devices have led to increased risk of revision surgeries and bone loss related to excessive device wear/failure, reports the FDA. All of the devices contain a plastic component which should be in packaging that contains multiple oxygen barrier layers as indicated in the package specification. The recalled devices were packaged in defective bags that were missing one of the oxygen barrier layers that protect devices from oxidation. Defective bags may allow oxygen from the air to contact the plastic (polyethylene) component before it is implanted into a person’s body. If a large amount of oxygen contacts the plastic component before the device is implanted, it may lead to oxidation of the plastic component over time.

AI-enabled medical devices face new regulations

The FDA is considering how to best regulate software components of AI-enabled medical devices, reports MedTech Dive. The idea of a “predetermined change control plan,” i.e., a way to enable software to “learn” and change within set boundaries, dates back to 2019. For example, a company that makes software that recommends ideal ventilator settings for a patient might want to change the machine learning model to optimize its performance for a particular subset of patients. On March 30, the FDA released a draft guidance document with information to be included in a predetermined change control plan that may be provided in a marketing submission for artificial intelligence/machine learning (AI/ML)-enabled devices.

Pediatric ICU stays more common

The strongest contributing factor to the rising proportion of pediatric hospitalizations involving ICU care is the increasing frequency with which children with medical complexity are being hospitalized, according to research in JAMA Pediatrics. The proportion of children admitted to an ICU with chronic comorbidities increased by nearly 25% over 19 years, and children without chronic medical conditions are now the minority of ICU patients. Particularly notable is that the proportion of children admitted with preexisting dependence on technology — such as feeding tubes or chronic respiratory support — almost doubled.

Nanoparticles as cystic fibrosis treatment

Engineers at MIT and the University of Massachusetts Medical School have designed a new type of nanoparticle that can be administered to the lungs on an inhalable basis, where it can deliver messenger-RNA-encoding proteins for treatment of cystic fibrosis and other diseases of the lung. Messenger RNA holds great potential as a therapeutic for treating a variety of diseases caused by faulty genes, according to researchers. One obstacle to its deployment thus far has been difficulty in delivering it to the right part of the body, without off-target effects. (Injected nanoparticles often accumulate in the liver.) The research was funded by Translate Bio, the National Institutes of Health, the Leslie Dan Faculty of Pharmacy startup fund, a PRiME Postdoctoral Fellowship from the University of Toronto, the American Cancer Society, and the Cystic Fibrosis Foundation.

FDA works to minimize cyberattacks of medical devices

has identified an increasing number of vulnerabilities posed by medical devices
that run on outdated software and devices that lack adequate security features,
according to PwC. Devices that are susceptible to cyberattacks
include insulin pumps, implantable cardioverter defibrillators, mobile cardiac
telemetry, pacemakers and intrathecal pain pumps. Threat actors may compromise
these devices by directing them to give inaccurate readings, administer
incorrect drug doses or otherwise endanger patient health. Because of the
federal omnibus appropriations bill signed into law Dec. 29, 2022,
manufacturers seeking FDA approval of a connected medical device now must 1)
submit a plan to monitor, identify and address post-market cybersecurity
vulnerabilities, 2) design, develop and maintain processes to provide reasonable
assurance that the device and related systems are cybersecure, and 3) provide a
software bill of materials that includes commercial, open-source and
off-the-shelf software components.