Posts in Recall

Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies

January 9th, 2019 Posted by ISO 14971, Recall, RISK Assessment, Risk Management, Safety 0 thoughts on “Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies”

Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies. The software, when used with the medical device Navigation System, provides 3D images of a patient’s brain to help neurosurgeons navigate surgical tools and implants used during surgery.

The Software glitch may affect the intended use of the device. This new risk, the following does not include reported problems that included a patient death potentially linked to the case.

It was a Class 1 recall alert for MRI-guided surgery device. Class 1 recalls, the highest severity level, involve product problems that can cause death or serious injury.

Hazard: The software displays incorrect information during biopsy procedures that could result in serious or life-threatening patient harm. During the procedure, the software monitor may show that the tip of the surgical tool has not reached the target and could prevent the neurosurgeon from accurately seeing the location of the tools in the patient’s brain.

Failure Cause: The offset appears to have been caused by an interaction between the device probe and the MRI environment

Failure Effect/ Harm: The surgeon could potentially insert the tool too deeply, damaging the patient’s healthy tissue, brain or blood vessels.

Risk Control (RISK-5005):

 

Preventing Potential Recall by Testing Right Your Product

June 23rd, 2018 Posted by Recall, Risk Management, Safety, Tip Of The Week, Validation and Verification, Workshops 0 thoughts on “Preventing Potential Recall by Testing Right Your Product”

On the QA Geek Week giving the following lecture based on a selected example of recalls researched by Orcanos to provide some preventive actions methods on the validation and verification methodology. These recalls give an example of how to pay attention to simple observational engineering faults that could harm the patient. All are true stories that just happened during 2017 – 2018 years which were already reported the increase in recalls during Q1 2018. The numbers shows that it is to be the largest recall quarter since 2005. Orcanos R&D effort is to continue to be a market leader by daily investigating these events and integrating into actions in Orcanos ALM/QMS system, helping to prevent the next recall to our customers.

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Tip of The Week – How You Can Be The Best Recall Specialist

April 26th, 2017 Posted by 21 CFR Part 11, ISO 13485, Recall, Services, Tip Of The Week 0 thoughts on “Tip of The Week – How You Can Be The Best Recall Specialist”

Recall Specialist – Medical Devices

Author: Rami Azulay (ALM/Medical Specialist at ORCANOS)

Are you eager  to join an innovative organisation? Do you want to play an integral role   helping clinicians improve  healthcare outcomes for patients? Have you always wanted to join a driven, entrepreneurial organisation that promotes from within? Then your ideal role is that of a Recall Specialist!

As a Recall Specialist, you will be required to provide Product Field Action, which means you will given direct access to all product design documents and verification, and validation protocols in order to perform effective  investigations. You will need access to both production and  manufacturing evidence documents on the device performance during production and  methods which support  the QC process. You will need access to the reporting entity so as to be able  to collect missing information needed to execute your CAPA process and of course, access to the support groups on Tier 1, 2, 3 and 4. These tiers support and manage a diverse range of medical devices. These tasks are only able to be carried out  through a collaborative working environment; not just in the human resource level, but also between the tools and repositories that hold that information.

The key duties of the recall specialist include: The regular reporting, follow-up and processing of regulatory actions, which require more time outside of your day to day tasks. While tools such as ORCANOS | MEDICAL system can provide you with proactive notifications based on Artificial Intelligence (AI) built into the system that compare your execution activity with the regulation and compliance to your organization standard operational procedure (SOP).  This will involve actioning on all aspects of Product Hold (PH) and Product Field Actions (PFA), and enacting the Universal Recall Procedure (Post Market Surveillance) to ensure the appropriate maintenance or removal of nonconforming products from the marketplace. Again ORCANOS | MEDICAL includes with the same system a Post Market Surveillance system call ORCANOS | SERVICE CENTER which act as gateway between the market to the manufacture or the distributor. It allows secured data communication between all parties, of course the AI system will cover regular reporting and follow up on actions, on that same system as well.

It is preferred that the Recall Specialist hold a tertiary science/engineering degree or equivalent. Such academic knowledge coupled with access to relevant and accurate information adds to the effectiveness of the Recall Specialist. ORCANOS Cloud based system, which is validated and 21 CRF Part 11 compliant, makes the world a much smaller place. Information that is needed is easily accessible  from anywhere – either from the event area (if you need to travel for investigation), or from your office where you communicate with other professionals, and information needs to be  secured as you work on  a quality event.

Having a single tool that can manage  all these activities R&D->Quality->Manufacturing->Support in one place, reduces lessens the learning curve for the recall specialist who has to be acquainted with multiple systems, reduces the cost of licensing which   enables access to  secured information needed to work efficiently. .

This role provides an exciting opportunity acting in the center of all things, using advanced tools and methods that can guide and protect the organization interest which will follow by constant recognition for creating a positive workplace environment. If you are looking to take your career within QA and post market to the next level this could a sure way to go.

Why there is a change in the approach regarding labeling as RISK mitigation

July 24th, 2013 Posted by 510(k), CE Marking, FDA, IEC60601, ISO 14971, Recall, RISK Assessment, Risk Management 0 thoughts on “Why there is a change in the approach regarding labeling as RISK mitigation”

A recent recall on Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: class 1 recall – mislabeled packaging – See more at: http://www.healthcarepackaging.com/trends-and-issues/regulatory/bryan-medical-tracoe-mini-30mm-tracheostomy-tube-class-1-recall/ has proven some of the justification regarding the change in approch when putting labeling as part of the RISK mitigation. In the above case in the RISK assessment we should expect to see that not just labeling should be used to differentiate between the different devices but also packaging and coloring could be a good way to use on the device. Such mistake in labeling could affect patient safety since an oversized tracheostomy tube may cause permanent injury to the trachea. This product may cause serious adverse health consequences, including death. When we come to RISK assessment and decide to use labels as mitigation we may want to consider mistakes in packaging and address such cases as well or even perform change by design to avoid use of the device on the wrong application.

FDA puts highest-risk category on infusion pump recall

July 2nd, 2013 Posted by Recall 0 thoughts on “FDA puts highest-risk category on infusion pump recall”

Recently the FDA start building new guidance for infusion pumps medical devices. Such product shall require more concern on their RISK assessment. There are in the market different solution for infusion pumps some are fully mechanical and some has embedded hardware and software. 

Those more advanced products requires higher attention on the integration between the system and in that manner to be able to isolate each sub system by its verification and validation procedure as well to include the integration test that treat the product as complete.

Since in some product there are replaceable parts it may come that displacement of those replaceable parts may cause increased flow of the fluid into the patient and in that way put patient in higher risk.

What type of mitigation can be suggested to reduce that risk?

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