Lumafield’s Post

Smiths Medical ASD Inc. is recalling Medfusion model 4000 syringe pump due to issues associated with earlier software versions of the medical pump. What is remarkable is the number of software versions that may have issues: • Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2) • Re-administered Loading Dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2), • Incorrect Critical Data Failure Alarm, • Interruption of Bolus or Loading Dose Delivery (v1.0.0, v1.1.0, v1.1.1, v1.1.2), • Incorrect Total Bolus/Loading Dose Displayed (v1.1.0, v1.1.1, v1.1.2), • Volume Limit Before Bolus/Loading Dose Complete (v1.1.2), • Drug Library Lower Limit Displayed Incorrectly (v1.6.0, v1.6.1), • Depleted Battery Alarm (All versions previous to v1.6.5), • Loss of Wireless Connectivity (v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4), • PharmGuard Server Password (v2.3, v2.4, v2.5). Given that the problems start with V1.0.0. one can only assume that the risks were considered acceptable but now "The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death". However, there have been no reported deaths and 1 injury. Perhaps some of my learned friends can share insights into how this came about with issues in virtually every version of software. #fda #recall #medicaldevices #medicaldevice #pump

Explore the principles and applications of Vacuum Decay and Helium Leak Testing for ensuring the integrity of ophthalmic product packaging. Compare sensitivity, speed, and integration into production lines to make informed quality assurance decisions. Don't miss this essential guide for pharmaceutical manufacturers and quality control professionals. Like, share, and subscribe for more insights into packaging integrity testing! #OphthalmicProducts #VacuumDecay #HeliumLeakTesting https://lnkd.in/gMP8XxkU

(Benefit-Risk Management / Medical Devices / Updated FDA Draft Guidance for Remanufactured Medical Devices) Let's start with the basic question what is "remanufacturing"? What is device "servicing"? Remanufacturing is the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use. Servicing is the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use. Enjoy the guidance. #fda #cdrh #medicaldevices #remanufacturing #servicing.. To better understand, try using a "car" analogy to put things into context. Happy Friday!

⚕ European regulations about Medical Devices (Reg. EU 2017/745) and In-vitro Diagnostics (Reg. EU 2017/746), since their publication in 2017, have undergone several extensions. ↔ Extended deadlines for DEHP applications under new EU regulations mean changes that affect compliance and safety for manufacturers as well as end consumers. ✏ For more information about the compliance of your Medical Device or In-vitro Diagnostic with all European regulations, contact our expert at: [email protected] #DEHP #MDR #IVDR #DispositiviMedici #RegulatoryAffairs #Chemsafe

Manufacturing health products and selling in the United States means obtaining approval from the FDA. That is, solid results must be guaranteed. The FDA wants strong clinical evidence to support the safety and effectiveness of products. And to get them, there are no shortcuts. The US regulatory body is wasting no time and requires a 90 to 180 day review process. Yes, complying with their regulations is demanding. Manufacturing, packaging, labeling: it all counts. Against this backdrop, we at Biovac wanted to submit ourselves to the scrutiny of the FDA. And the result is that we comply with the strictest international standards for the coating of surgical implants, ensuring quality and safety in each product that leaves our facilities. Today we are proud to announce that we have obtained the prestigious MAF Certificates 3627, and 3779. MAF Certificates are essential documents that compile all FDA-mandated validation tests for implant coatings. These certificates guarantee that Biovac meets the rigorous quality and safety standards established by the FDA for the marketing of medical devices in the United States. Discover the quality of Biovac. Safety guarantee in each coating #hydroxyapatite #Surgicalimplants #Prosthesis #Osseointegration #Biovacwithyou

Routine sterility assurance testing is a critical part of the manufacturing process. This type of testing is used to identify any potential contamination during the manufacturing process and confirm the effectiveness of the sterilisation methods. Curious to learn more? Visit our webpage to delve deeper into Sterility Testing for Medical Devices & IVDs: http://spkl.io/60414muN3 #TUVSUD #medicaldevicesafety #TestingExcellence #RegulatoryCompliance #sterilitytesting

Routine sterility assurance testing is a critical part of the manufacturing process. This type of testing is used to identify any potential contamination during the manufacturing process and confirm the effectiveness of the sterilisation methods. Curious to learn more? Visit our webpage to delve deeper into Sterility Testing for Medical Devices & IVDs: https://lnkd.in/eUj8cy7n #TUVSUD #medicaldevicesafety #TestingExcellence #RegulatoryCompliance #sterilitytesting

In India, medical devices are classified into four categories based on their intended use, risk level, and complexity. Class A: Low-risk devices such as bandages, gloves, and walking aids Class B: Moderate-risk devices such as surgical instruments, diagnostic equipment, and syringes Class C: High-risk devices such as implantable devices, cardiac stents, and ventilators. Class D: Very high-risk devices such as drug-eluting stents and heart valves. Contact us: +91 9343390988 | [email protected] | www.mindsync.co.in #mindsyncindia #wearemindsync #medical #medicaldevices #pharmaceutical #pharma #hospital #toothbrush #thermometer #oximeter #uterinedevice #legalmetrology #compliance #quality #legalmetrologyregistration #calibration #weights #measurements #weightsandmeasures #modelapproval #business #legalservices #BIS #BIScertification #BISfasteners #BISaluminium #BISplywood #hexscrew #hexbolt #hexnuts #compliance #regulatory #businessexcellence #compliancemastery

Morty needed two cups of coffee after seeing this one. But at least he stayed on brand, despite the regulatory kerfluffle. 😁 It seems that when Cardinal bought the Covidien portfolio from Medtronic last year, they rebranded the Monoject disposable syringes with the Cardinal name. That's typical, you may say. Most companies DO rebrand products after an acquisition like that one. Ah yes, but do they also change the dimensions of the products without telling anyone - including the FDA? That's apparently what happened with Monoject Single-Use Luer Lock syringes distributed between June 2022 and August 2023. These syringes are commonly used with syringe pumps to administer medication, and the change in dimensions has resulted in performance issues - overdoses, underdoses, delays in therapy, and pump occlusion alarms. To date, Cardinal has received 15 reports of delayed therapy due to syringe infusion pumps not recognizing syringes, and 13 reports of inaccurate volume/rate dispensing, including some injuries. Not surprisingly, the FDA labelled this a Class I recall, and has suggested that the Cardinal-branded syringes NOT be used with syringe pumps. The Covidien-branded syringes are fine and can be used as before. Somewhere, somehow, something in the design validation process was overlooked - how else could you produce a syringe with different dimensions than the original? I'll say it again, even though it's apparently falling on deaf ears - Quality. Management. System. And I don't mean QMS by the pen, either. Morty may want to add a little Bailey's to his coffee before reading any more recall notices. Read the original article here: https://lnkd.in/dA6MdSV5 #medicaldevices #regulatoryaffairs #compliance #FDA #qualitymanagementsystem #recalls

Did you know that obtaining approval from the FDA to manufacture health products in the United States leads to rules and regulations dating back to 1938 and 1962?   The first law was enacted in response to a series of tragedies related to food and drug safety in the first half of the 20th century. The 1938 Act gave the FDA the authority to inspect manufacturing facilities, regulate advertising and labeling of products, and take action against fraudulent or dangerous products.   The Food, Drug, and Cosmetic Law Amendments Act of 1962 strengthened drug regulation in the United States. Required manufacturers to demonstrate the effectiveness of drugs before FDA approval, introduced FDA review and prior approval for new drugs, established Good Manufacturing Practices (GMP) requirements to ensure quality in production, and improved standards for drug labeling and advertising.   A law from 1938 and a 1962 amendment that are still in force. What does this mean? That American legislation is carved in stone. They are laws without fissures.   Today I am proud to announce that we have successfully met this challenge by meeting the strictest international standards for surgical implant coating. This achievement is a reflection of our commitment to quality and safety in each product that leaves our facilities.   Biovac already has the prestigious MAF Certificates 3627, 3628 and 3779, essential documents that compile all the validation tests required by the FDA for implant coatings.   We continue to advance our commitment to offering the best in implant coating technology.