FDA Panel Seeks Answers About Effective Reprocessing of Endoscopes
August 5th 2015In mid-May, the Food and Drug Administration (FDA) convened a special meeting of the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee as a continuance of its examination of end-user challenges associated with reprocessing endoscopes including duodenoscopes. In previous communications, the FDA has expressed its concerns regarding the risks to patients if flexible endoscopes and their accessories are not cleaned properly and reprocessing guidelines not followed. The agency has also held several stakeholders' meetings and workshops, including with the Association for the Advancement of Medical Instrumentation (AAMI) that focused on factors affecting reprocessing of reusable medical devices and established clarion themes that began to outline key challenges and priority actions. In addition, in mid-March, the FDA issued its Final Guidance that addressed mandates for manufacturers relating to validation methods and labeling of medical devices that are reprocessed.
Tackling the Tough Issues Related to Flexible Endoscopes: A Q&A with Sharon Van Wicklin
August 5th 2015The Association for periOperative Registered Nurses (AORN) is currently updating its guideline on flexible endoscope reprocessing. ICT spoke with Sharon Van Wicklin, MSN, RN, CNOR, CRNFA(E) CPSN-R, PLNC, a perioperative nursing specialist for AORN who is responsible for this undertaking. She shares her thoughts about the opportunities and challenges associated with revising a guideline of this magnitude.
MedStar Washington Neonatal ICU Achieves Three Years Without a Central Line Infection
August 4th 2015The neonatal intensive care unit (NICU) at MedStar Washington Hospital Center reached a remarkable safety milestone on July 31 -- three years with zero central line-associated bloodstream infections (CLABSIs) in its tiniest and most vulnerable babies. While three years CLABSI-free is extraordinary for any intensive care unit, what makes this accomplishment so remarkable is that these babies “are so small and fragile it makes it easier for infection to spread,” says Zacharia Cherian, MD, chairman of neonatology at MedStar Washington Hospital Center. “In addition, their immune systems are still immature, so fighting off infection is much more difficult than for a healthy baby.”
Brain Infection Study Reveals How Disease Spreads From Gut
August 4th 2015Diagnosis of deadly brain conditions could be helped by new research that shows how infectious proteins that cause the disease spread. The study reveals how the proteins -- called prions -- spread from the gut to the brain after a person or animal has eaten contaminated meat. Scientists say their findings could aid the earlier diagnosis of prion diseases -- which include variant Creutzfeldt-Jakob disease (vCJD) in people and bovine spongiform encephalopathy (BSE) in cows.
Infection Prevention Role Stress: A New Look at the Underlying Causes Within the Profession
August 4th 2015The need for infection prevention, as a multidisciplinary function, is a longstanding and widely acknowledged component of safe healthcare. Accreditation and regulatory standards specify that this function must be an organized program coordinated by an individual qualified to assure that the necessary assessments, priorities, key metrics are achieved. This individual must also assure that the program supports the provider’s mission, aligns with its safety culture, and is effectively and efficiently integrated into its operational and care delivery systems. Decades of pub-lished literature, conferences and online educational programs are available to support these requirements.
Spanning Boundaries in Infection Control
August 4th 2015In the Oxford Dictionary “boundary” is defined as “a line that marks the limits of an area; a dividing line; a limit of a sphere of activity.” “Spanning” is defined as “extend across.” I’m sure we would all agree that organizational boundaries are common in healthcare, and transcending these boundaries presents endless opportunities to build powerful alliances to advance APIC’s mission to create a safer world through prevention of infection.
Follow Policies and Procedures for Rigid Container Filters
August 4th 2015Q: Recently, we ran out of the single-use filters for our rigid containers. I learned the staff was making their own filters out of packaging material (see photo below). What advice can you provide when something like this happens?
Reflections on My First 18 Months as a Sterile Processing Technician
August 4th 2015May 2015 marked my 18th month of working as a sterile processing technician. A lot has happened during the past year and a half, so this is a good time to reflect on what I have learned about this important but behind-the-scenes profession in the healthcare industry.
New Malaria Vaccine Reflects the Pioneering Efforts of Researchers From NYU Langone Medical Center
August 3rd 2015When the highly influential European Medicines Agency announced its recommendation to approve what could be the world’s first licensed vaccine against malaria in infants and children, there was much celebrating in the research community at NYU Langone Medical Center. For it was, in many respects, the culmination of the life’s work of Ruth Nussenzweig and Victor Nussenzweig, the husband and wife team whose research over the past half-century against malaria has brought them international acclaim – and which contributed greatly to this latest breakthrough.
On-Chip Processor the First Step in Point-of-Care Tuberculosis and Asthma Diagnostics
August 3rd 2015A device to mix liquids utilizing ultrasonics is the first and most difficult component in a miniaturized system for low-cost analysis of sputum from patients with pulmonary diseases such as tuberculosis and asthma. The device, developed by engineers at Penn State in collaboration with researchers at the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, and the Washington University School of Medicine, will benefit patients in the U.S., where 12 percent of the population, or around 19 million people, have asthma, and in undeveloped regions where TB is still a widespread and often deadly contagion.