Medical Device Risk Management
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US hospitals to treat medical device malware with AC power probes - The Register

US hospitals to treat medical device malware with AC power probes - The Register | Medical Device Risk Management | Scoop.it
'WattsUpDoc' is a stethoscope that detects viruses in sealed-box medicomputers
Avraham Harris's insight:

Could computerized medical instruments require one day the WattsUpDoc as a mandatory external inrterface /  apparatus?

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Compliance, medical device software safety

Compliance, medical device software safety | Medical Device Risk Management | Scoop.it
Attend the Software and Cybersecurity Risk Management for Medical Devices Workshop, May 11-12, 2015 in Bethesda, Maryland.
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This Software Risk Management workshop is a must if you have a spare $1,797

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Banned in the US ... the Atrium ADVANTA V12 balloon expandable covered ... - NEWS.com.au

Banned in the US ... the Atrium ADVANTA V12 balloon expandable covered ... - NEWS.com.au | Medical Device Risk Management | Scoop.it
EXCLUSIVE
Avraham Harris's insight:

here's one example of a recent recall of the company's intra-aortic balloon pump,, due to a faulty fan assembly that might cause the pump to suddenly fail, leading to a whole list of potential injuries or even death.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm396903.htm

 

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Company Update (NYSE MKT:ISR): IsoRay, Inc. Cancer Fighting Isotope ... - Smarter Analyst

Company Update (NYSE MKT:ISR): IsoRay, Inc. Cancer Fighting Isotope ... - Smarter Analyst | Medical Device Risk Management | Scoop.it
IsoRay, Inc.(NYSEMKT:ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, announced it will host a booth at the Annual Meeting of the American Brachytherapy Society (ABS).
Avraham Harris's insight:

According to a technical manual of WHO on Radiotherapy risk profile, the following are some hazards that may be applicable to radiation therapy delivery devices:

1) Wrongly applied immobilization device

2) Wrong immobilization device

3)  Patient identification error,

4) delivery staff miscommunication

5) Incorrect placement of positioning device,

6) error in placement of shielding blocks

7)  Insufficient target volume

8)  inhomogeneous dose distribution

9) Data transfer/data generation errors

10) Errors related to radiation beam, delivery Gantry/Collimator angle, isocentre, shielding, bolus, wedges, monitor units, field size

11)  calculation errors

12) Omission or incorrect placement of accessories

13) Incorrect patient setup details,

and more...

read the technical report here: http://www.who.int/patientsafety/activities/technical/radiotherapy_risk_profile.pdf

Do IsoRay's devices mitigate these potential hazards?


Need Risk Management advise for Medical devices? visit my website at: www.QA-Regulatory.com


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Hacking Vulnerable Medical Equipment Puts Millions at Risk - InformationWeek

Hacking Vulnerable Medical Equipment Puts Millions at Risk - InformationWeek | Medical Device Risk Management | Scoop.it
Hospitals and medical device manufacturers need to start doing more to detect and thwart incoming attacks on networks and devices.
Avraham Harris's insight:

The US Department of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) cited 300 medical devices from 40 companies that had unchangeable passwords. If an attacker were to obtain a list of these passwords, he could theoretically log in and change critical settings, with unfortunate consequences.

This and other vulnerabilities exist in certain medical devices with Wifi or Bluetooth access, making cybersecurity a high priority for hazard analysis of such devices.

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Applying Risk Management concepts to Medical Device Software

http://www.techgig.com/expert-speak/Applying-Risk-Management-concepts-to-Medical-Device-Software-363 This webinar gives an introduction to Use of Risk Manage...
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As usual, I am not advocating . . .

Actually, I recommend my own training course on Risk Management

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Crestwood mom first in area to get new hybrid implant for high-frequency ... - STLtoday.com

Crestwood mom first in area to get new hybrid implant for high-frequency ... - STLtoday.com | Medical Device Risk Management | Scoop.it
Device helps with sensorineural hearing loss, also called ski-slope loss because of the curve shape on a hearing test.
Avraham Harris's insight:

The new Cochlear Nucleus Hybrid L24 Cochlear Implant System class III device has been approved by the FDA recently.

Twenty-two patients in the 50 patient study developed profound or total low-frequency hearing loss. Some patients underwent additional surgery to get a standard cochlear implant or adjusted their hybrid system.

“While the risk of low-frequency loss is a concern, the FDA determined that the overall benefits of the device outweigh the risk for those who do not benefit from traditional hearing aids,” the FDA wrote in its approval.

This is an example of an overall risk-benefit assessment for a class III device.

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FDAnews Announces: Save The Date for 12th Annual Medical Device Quality ... - Virtual-Strategy Magazine (press release)

FDAnews Announces: Save The Date for 12th Annual Medical Device Quality ... - Virtual-Strategy Magazine (press release) | Medical Device Risk Management | Scoop.it
Over the past 11 years, thousands of device professionals have attended Medical Device Quality Congress (MDQC) and benefited from the unmatched educational sessions presented by FDA officials and industry experts.
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IMDRF: “Software as a Medical Device”: Possible Framework for Risk Categorization and Corresponding Considerations

IMDRF: “Software as a Medical Device”:  Possible Framework for Risk Categorization and Corresponding Considerations | Medical Device Risk Management | Scoop.it
On September 18, 2014, IMDRF (formerly GHTF) posted a new document on their website: “Software as a Medical Device”:  Possible Framework for Risk Categorization and Corresponding Considerations Rea...
Avraham Harris's insight:

This IMDRF guidance should be used together with  FDA's Guidance on Mobile Medical applications - http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf; General principles of Software Validation - http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085371.pdf,

and Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices -http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM401996.pdf

To name a few.

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AT TCT, Medtronic, Edwards Report Good TAVR Data, St. Jude Falters | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

AT TCT, Medtronic, Edwards Report Good TAVR Data, St. Jude Falters | MDDI Medical Device and Diagnostic Industry News Products and Suppliers | Medical Device Risk Management | Scoop.it
Medtronic's CoreVale Transcatheter Aortic Valve Replacement System Analyst reports emerging from the annual meeting of Transcatheter Cardiovascular Therapeutics in Washington D.C. show that leading companies are proving that TAVR is a safe and effective approach to treat severe aortic stenosis.  Those include data from both Medtronic and Edwards Lifesciences, the only two companies that have approved transcatheter aortic valve replacement products in the U.S. But St.
Avraham Harris's insight:

When clinically validating TAVR products, such as St. Jude's Portico device, should 4D CT scan have been the normal procedure for all patients? Or should St. Jude have treated such cases of suspected reduced valve leaflet mobility exactly as they are doing - to do comprehensive testing only if and when such events show up.

This is a good example to highlight the question of ALARP vs. AFAP.

If we were allowed to continue applying AFAP in its strictest sense without any consideration of economic factors, then each pt. should have had 3D CT. If ALARP were allowed, then the strategy of St. Jude would be acceptable. In either case, St. Jude m/p engaged in this trial well before the EN ISO 14971:2012 Annex Z's came to be.

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Boston Scientific Loses $73.4M Verdict in Mesh Trial

Boston Scientific Loses $73.4M Verdict in Mesh Trial | Medical Device Risk Management | Scoop.it
A Dallas jury has awarded $73.4 million in the first trial to go against Boston Scientific Corp. over one of its pelvic mesh devices.
Avraham Harris's insight:

Do we need a better reminder of the importance of proper risk management than the faulty design of the Boston Scientific transvaginal sling mesh device that has now cost the company 73.4 million dollars in damages (and may well cost them more in upcoming months?)

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Do Data From Wearables Belong In The Medical Record? - Forbes

Do Data From Wearables Belong In The Medical Record? - Forbes | Medical Device Risk Management | Scoop.it
Do Data From Wearables Belong In The Medical Record?
Avraham Harris's insight:

Here is one article that sums up much of what Risk Management is all about.

It highlights the questions:

How accurate do wearable devices need to be?

Is high data volume helpful or harmful (garbage in, garbage out)

What are the social hazards involved in this kind of systematic data collection?

To what extent do human factors need to be considered in order to ensure high quality data is obtained?

And other very valid points to consider in the use and utilization of these wearable devices and their data for medical care and research.

What other Issues should be considered in managing risk of these (still) new devices?

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Seminar on ISO 14971 Medical Device Risk Management-ComplianceOnline.com - Insurance News Net

Seminar on ISO 14971 Medical Device Risk Management-ComplianceOnline.com - Insurance News Net | Medical Device Risk Management | Scoop.it
The two day seminar led by former senior FDA official Harvey Rudolph will be held on September 11 and 12 in Chicago, IL.. Harvey Rudolph is an independent risk management consultant specializing in process development and training in risk management.
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Updates to good old IEC 62304 !

Updates to good old IEC 62304 ! | Medical Device Risk Management | Scoop.it
Here is a summary of the main changes in Amendment One of IEC 62304 - to appear during 2015:ScopeIn the past, manufacturers tried to sneak away from IEC 62304 by just saying, “we only have an FPGA / simple signal-processor / embedded controller and...
Avraham Harris's insight:

External risk reduction measures could reduce safety classification for Medical Device software

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Attacking Brain Tumors in the OR and the Laboratory - Innovate Physician Winter 2012 - Newsroom - Barnes-Jewish Hospital

Attacking Brain Tumors in the OR and the Laboratory - Innovate Physician Winter 2012 - Newsroom - Barnes-Jewish Hospital | Medical Device Risk Management | Scoop.it
.@BarnesJewish neurosurgeons achieve a better risk-benefit analysis with intraoperative MRI http://t.co/PNxhBJ6eW8 #glioma #BrainTumor
Avraham Harris's insight:

The new Monteris stereotactic guidance system uses innovative technology to allow making smaller incisions to reach the tumor, controlling risks that arise from deeper incisions.

Interoperative MRI (iMRI) allows better detection of tumor margins, reducing the frequency of repeat operations.

With groundbreaking innovations to control risk, brain surgery is becoming safer and the risk-benefit ration is decreasing. 

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Mentor Graphics Announces Nucleus RTOS Safety Critical Certification - MarketWatch

Mentor Graphics Announces Nucleus RTOS Safety Critical Certification - MarketWatch | Medical Device Risk Management | Scoop.it
Mentor Graphics Announces Nucleus RTOS Safety Critical Certification MarketWatch The Nucleus SafetyCert RTOS has been designed, validated and documented to be used in the development of safety-related software for the highest safety integrity...
Avraham Harris's insight:

This real time operating system (RTOS) may be one possible risk control for ensuring safety and reliability of medical device software.

Need medical device software Lifecycle process advice? Visit me at www.QA-Regulatory.com and tell me about your project.

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Medical Device Risk Management, ISO 14971, Compliance Training Seminar

Medical Device Risk Management, ISO 14971, Compliance Training Seminar | Medical Device Risk Management | Scoop.it
Medical Device Risk Management Training - Attend seminar on Medical Device Risk Management & Learn how to implement ISO 14971 framework.
Avraham Harris's insight:

Or, try my full day course. see my website at: www.QA-Regulatory.com

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Mike Zeevi in MDDMI 62304 Commity Observer

Consult and contract for medical device companies in software validation, risk management and SQA. The job includes preparing, monitoring and auditing the so...
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Some of the latest trends in Medical Software from the FDA, Shared by Mike Zeevi

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Risks of Additive Manufacturing: A Product Safety Perspective | EMDT - European Medical Device Technology

Risks of Additive Manufacturing: A Product Safety Perspective | EMDT - European Medical Device Technology | Medical Device Risk Management | Scoop.it
Additive manufacturing offers myriad benefits for the medical device industry. But there are still certain risks and unknowns associated with the burgeoning technology.
Avraham Harris's insight:

The risks of additive manufacturing  (or 3-D printing) for medical devices and applications is proportionate to the complexity of the device to be manufactured.

Everyone understands the importance of validation, both for software and for device manufacturing processes. Such validation will entail a higher and higher acceptance threshold, the more complex and medically critical the device is. 

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Blood tests in the works for breast cancer - Waterbury Republican American

The Republican-American Newspaper, Waterbury, Connecticut
Avraham Harris's insight:

"those not expected to get the disease again can be spared the toxic and expensive treatment" BUT "We need to prove this is as good as we think it is."

Associate Prof. Park has got it right: strong business case, coupled with necessary caution.. 

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Post-election day: Whats it mean for health IT MU 2 numbers disappointing ... - Politico

Post-election day: Whats it mean for health IT MU 2 numbers disappointing ... - Politico | Medical Device Risk Management | Scoop.it
Post-election day: Whats it mean for health IT MU 2 numbers disappointing ...
Avraham Harris's insight:

Google Glass, which is increasingly being used in medical settings, may partially obstruct peripheral vision. But it bears further research to determine statistical and clinical significance.

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FMEA - What it is and how it works

A brief overview of Failure Mode and Effects Analysis, with an example and explanation.
Avraham Harris's insight:

Here's a nice 22 minute training for you - free on YouTube.

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New Study on Implants Calls for Stricter Regulations | EMDT - European Medical Device Technology

New Study on Implants Calls for Stricter Regulations | EMDT - European Medical Device Technology | Medical Device Risk Management | Scoop.it
A new study published in BMJ finds that novel implants often don’t represent an improvement compared to older models. The authors call for a “major overhaul” in device regulation.
Avraham Harris's insight:

How does this impact risk management?

The overall benefit-risk analysis certainly must take into consideration the superior performance, expected, for a new device compared with existing therapeutic modalities.

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Privacy Policy Pitfalls for Wearable Tech

Privacy Policy Pitfalls for Wearable Tech | Medical Device Risk Management | Scoop.it
No one really reads the privacy policies included with wearable devices, but everyone really should.
Avraham Harris's insight:

So, get out of your shoes as manufacturer, and slip on the consumer's pair to consider these risks to you as end-user.

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