Healthmark Receives ISO 13485:2016 Certification

Healthmark Industries is pleased to announce that they have received ISO 13485:2016 certification. ISO 13485:2016 is designed to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. 

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Malinda Elammari Joins Healthmark Industries

Healthmark Industries is proud to announce Malinda Elammari as a Clinical Education Specialist for Healthmark Industries where she will provide clinical expertise on medical device processing, SPD education, and standards.  Prior to joining Healthmark, she has had over 20 years of experience as a Central Services and Surgical Tech professional. Most recently responsible for sterile processing education and quality control ...

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BD Announces the Voluntary Recall of Specified Lots of ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator in the United States and U.S. Territories

BD (Becton, Dickinson and Company), a leading global medical technology company, is voluntarily recalling specified lots of the ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator (2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) to the user level due to a defective applicator. The product is used as an antiseptic for the preparation of the patient’s skin prior to surgery ...

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Companies Enter Partnership for Blood Test to Detect Colorectal Cancer and Pre-Cancer

SUNNYVALE, Calif., and ROSWELL, Ga.—CellMax Life, a molecular diagnostics company with proprietary technology for pre-cancer and cancer detection blood tests, and Sebela Pharmaceuticals, a market leader in gastroenterology, recently announced the closing of a strategic development and commercial collaboration agreement, as well as CellMax’s Series C financing. The financing will be used to accelerate the clinical development of CellMax’s multimodal ...

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FDA is Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes

This week the U.S. Food and Drug Administration announced it is investigating numerous medical device reports (MDRs) describing patient infections and other possible contamination issues associated with reprocessing urological endoscopes, including cystoscopes, ureteroscopes and cystourethroscopes—devices used to view and access the urinary tract. Reprocessing these types of medical devices involves both cleaning and high-level disinfection or sterilization so the devices ...

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