Posts in Risk Management

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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Risk Management

April 30th, 2018 Posted by Risk Management 0 thoughts on “Risk Management”

In an ever growing world of products that continuously affect our safety, safety becomes a critical aspect that must be addressed in product delivery. This can be achieved using industry best practice, and tools that will assure safety and risk were addressed before shipping the product.

Most recalls show that too little is done too late for managing risk, and that is why it is a challenge. Risk analysis is a must — such as failure mode and effects analysis (FMEA) for medical devices, or automotive safety integrity level (ASIL)  in case your product integrates into the automotive industry. While risk analysis is important, it also complicates your product requirements. With FMEA, you need to prioritize risk and decide what to mitigate, eliminate, or accept. Complying with ASIL, you need to classify risk using ISO 26262.

Orcanos provides a fully integrated risk management system that allows you to easily manage your product risk and assure traceability for risk mitigation.

The Orcanos system enables the following:

  • Manage and track requirements of all types (hardware, software etc.)
  • Mitigate risk using FMEA analysis
  • Create a full traceability matrix for compliance
  • Support multiple types of mitigations, such as IFU, user manual, training etc.
  • Manage impact of change on product safety

Ready to manage risk?  Visit us at www.orcanos.com

The third-leading cause of death in US most doctors don’t want you to know about

March 1st, 2018 Posted by ISO 14971, Risk Management, Safety 0 thoughts on “The third-leading cause of death in US most doctors don’t want you to know about”

ORCANOS released a new RISK management system ver. 3.0.0.135 (ISO 14971) based on 2017 recalls by the FDA

December 16th, 2017 Posted by ISO 13485, ISO 14971, Requirements Management Tool, RISK Assessment, Risk Management, Safety 0 thoughts on “ORCANOS released a new RISK management system ver. 3.0.0.135 (ISO 14971) based on 2017 recalls by the FDA”

ORCANOS released a new RISK management system (ISO 14971), based on recent RECALL CLASS 1 by the FDA, to include RISK analysis covering recent incident of potential flammability of battery used by the device. The new release includes also mitigation procedure for that case as well.

Hazard: Battery overheated on the device unit while charging in standby mode during a routine procedure

Failure Cause: Manufacturing Failure

Failure Effect/ Harm: System flammability causing fire or wrong function

Risk Control (RISK-2277): Register for the free trial on: https://lnkd.in/ghv8YX6

Please share with us more ideas on this topic.

 

Related Links

Risk Management

Quality Management

Document Control Software (ISO 13485)

What is ISO 14971

 

WHITE PAPER ACHIEVING ISO 26262 COMPLIANCE WITH ORCANOS ALM and QMS

December 8th, 2017 Posted by ISO 14971, Risk Management, Validation and Verification 0 thoughts on “WHITE PAPER ACHIEVING ISO 26262 COMPLIANCE WITH ORCANOS ALM and QMS”

ISO 26262 is an automotive standard that places requirements on the quality of software, for which tools such as ORCANOS ALM and QMS are ideally positioned to enforce. With the highest adoption in the industry and a strong heritage in safety-critical applications, ORCANOS ALM and QMS have been certified as being “fit for purpose” to be used as tools by development teams wishing to achieve ISO 26262. This document describes the parts of the standard that are addressed by using ORCANOS ALM and QMS.

Read More: https://www.linkedin.com/pulse/achieving-iso-26262-compliance-orcanos-alm-qms-rami-azulay/?published=t

סדנה מעשית בהבטחת איכות ורגולציה של מכשור רפואי

June 4th, 2015 Posted by 510(k), CE Marking, FDA, Risk Management, Software Lifecycle Management, Test Management 0 thoughts on “סדנה מעשית בהבטחת איכות ורגולציה של מכשור רפואי”

2015-06-04_12-31-49

2015-06-04_12-36-35

How does medical device classification really being set?

September 11th, 2013 Posted by 510(k), CE Marking, Pre Market Approval (PMA), Risk Management 0 thoughts on “How does medical device classification really being set?”

It is not feasible economically nor justifiable in practice to subject all medical devices to the most rigorous conformity assessment procedures available. A graduated system of control is more appropriate. In such a system, the level of control corresponds to the level of potential hazard inherent in the type of device concerned. A medical device classification system is therefore needed, in order to apply to medical devices an appropriate conformity assessment procedure.

The classification of medical devices is a ‘risk based’ system based on the vulnerability of the human body taking account of the potential risks associated with the devices. This approach allows the use of a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness and local vs. systemic effect.

According to the ISO 62304 Section 4.3 it is being said:

Software safety classification shall be done in accordance to the following guidance:

a) The MANUFACTURER shall assign to each SOFTWARE SYSTEM a software safety class (A, B, or C) according to the possible effects on the patient, operator, or other people resulting from a HAZARD to which the SOFTWARE SYSTEM can contribute. The software safety classes shall initially be assigned based on severity as follows:

Class A: No injury or damage to health is possible
Class B: Non-SERIOUS INJURY is possible
Class C: Death or SERIOUS INJURY is possible

If the HAZARD could arise from a failure of the SOFTWARE SYSTEM to behave as specified, the
probability of such failure shall be assumed to be 100 percent. If the RISK of death or SERIOUS INJURY arising from a software failure is subsequently reduced to an acceptable level (as defined by ISO 14971) by a hardware RISK CONTROL measure, either by reducing the consequences of the failure or by reducing the probability of death or SERIOUS INJURY arising from that failure, the software safety classification may be reduced from C to B; and if the RISK of non-SERIOUS INJURY arising from a software failure is similarly reduced to an acceptable level by a hardware RISK CONTROL measure, the software safety classification may be reduced from B to A.

 

Where the Lines Blur

For more than 90% of products, classification is very clear. Still, certain products cause confusion, and what may seem like an ordinary device might be considered a medical device or a drug (or combination, such as a drug-eluting stent) depending on claims and how it is used.

In conclusion, the first regulatory step toward European device compliance is to determine whether your device is considered to be a device and, if so, what the classification will be for Europe. You simply cannot let this determination be based on the US classification of your device.

 

 

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.

QPack Medical Webinar, October 2012

November 11th, 2012 Posted by IEC 62304, ISO 13485, ISO 14971, Requirements Management, Risk Management, Software Lifecycle Management, Test Management, Validation and Verification 0 thoughts on “QPack Medical Webinar, October 2012”
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