What's New

Our Essential Performance Guidance Updated

posted May 2, 2018, 9:21 AM by Frank O'Brien   [ updated May 3, 2018, 10:37 AM ]

ep template
After many more years applying the Essential Performance (EP) and Basic Safety (BS) requirements, we've updated our guidance on EP and BS.  We've added new sections of how the Risk Managment process documents EP (and BS), EP Alarms, the EP (and BS) Verification Test Plan, and Examples covering a wide cross section of medical equipment.  The Test Plan section includes comments on IEC 60601-1-2:2014, the EM Distubance standard, and the lack of the Single Fault Condition exclusion. We've updated the sections on definitions, a template for EP, and the EP process flow chart.  You can access the updated EP guidance here.

Device Conformity and Testing Acquires Assets of O’Brien Compliance Management

posted Apr 4, 2018, 2:27 PM by Frank O'Brien   [ updated Apr 11, 2018, 3:40 AM ]

Device Conformity and Testing, LLC has acquired the test equipment, standards catalog, and customer information of O’Brien Compliance Management, LLC.

Gregg Edwards, owner and Principal Engineer of Device Conformity and Testing, says, “We now have all the tools we need to be a leader in safety compliance consulting and testing.”

Frank O’Brien, owner and Principal Engineer of O’Brien Compliance Management, explains, “I’ve worked with Gregg over the years and know him to be one of the finest compliance engineers. I’m thrilled to see Gregg carry the safety mission forward. I’ve told him I’m available to help smooth any transition issues for those customer choosing to continue working with Device Conformity and Testing.”

Device Conformity and Testing is a new consulting firm and testing laboratory located in Devens MA. Since January 2018 they have been helping clients with all aspects of safety compliance. Prior to forming Device Conformity and Testing, Gregg worked 25 years in the compliance field, both for third party laboratories, and product manufacturers.

O’Brien Compliance Management, LLC, located in Chelmsford, MA, has assisted over 200 customers with their testing and compliance needs, over the last 15 years. Their fully equipped safety test laboratory was accredited as a Partner Test Laboratory by TUV Rheinland. Frank will remain a provider of IEC 60601 training services, and will stay active with IEC 60601 committee work through 2019, at which time Frank will be fully retired.

For more information please go to www.devconform.com.

When Is an Alarm Not an Alarm?

posted Mar 6, 2018, 8:22 AM by Frank O'Brien   [ updated Mar 6, 2018, 11:48 AM ]

There’s been discussions about whether a medical equipment signal (visual, and if necessary auditory) is an actual alarm signal or just an information signal. The current work on Amendment 2 to IEC 60601-1-8, which is in the committee draft 1 (CD1) phase, seeks to better inform these discussions.

First of all, an alarm signal must signal a potential or actual exposure to harm to the patient for which operator awareness or response is required. The severity of harm and the required response time (immediate, prompt, or delayed) define alarm priorities. There are new notes to the priority definitions to clarify how they affect the clinician’s normal workflow (e.g., dressing change, line insertion).
  • A high-priority alarm condition requires an interruption of the caregiver’s current workflow.
  • A medium-priority alarm condition requires replanning of the caregiver’s current workflow.
  • A low-priority alarm condition requires planning of the caregiver’s future workflow.

Alarm systems themselves can present a hazard. Alarm priorities must be consistent with the expected interruption to workflow to avoid alarm fatigue (desentization) and alarm flooding (too many to timely manage). For example assigning a high priority, when the response time of low or medium priority would be sufficient to address the hazardous situation is generating an alarm signal for a response that’s clinically nonactionable. To avoid alarm fatigue and alarm flooding, the draft standard also includes requirements to avoid false positive and false negative alarm conditions, and nuisance alarm signals (disruptions to workflow aren’t justified by the benefit). The hope is alarm priority assignments by particular standards and manufacturers’ own risk assessments might improve to reduce the number of clinically nonactionable alarms.

Examples of information signals, which are independent of the detection of a hazardous situation include:
  • The decreasing tonal frequency of the auditory information signal of some pulse oximeters. The decreased tone is “alarming” to the operator, but in itself is not an alarm signal.
  • An electrocardiograph waveform display indicating ventricular fibrillation (“alarming” to the operator, not itself alarm signal).
  • A heart rate display of 20 beats per minute (“alarming” to the operator, not itself alarm signal).
  • Fluoroscopy beam-on indication
  • HF surgical output is energized indication
  • Non-time-critical equipment state indicators

In summary, alarms are risk controls, intended to affect a clinician’s normal workflow. Information signals are also risk controls, as they provide information for safety, but are not necessarily intended to affect a clinician’s normal workflow.

For more information on Amendment 2 to 60601-1-8 contact your national committee. In the US, the contact is Hae Choe at AAMI, hchoe@aami.org. An excellent article on alarm priorities and disruptions to work flow is “Understanding Caregiver Workflows: A Proposal for Alarm Condition Priorities”, by F. E. Block III, and F. E. Block Jr., which appeared in Biomedical Instrumentation & Technology, March/April 2016, 50(2), pp.114-116.

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O’Brien Compliance Management is offering the following IEC 60601 training courses:
  • London, 17-19 Apr 2018, Safety training
  • San Francisco, 21-24 May 2018, Safety and EMC training
  • Boston, 16-19 Oct 2018, Safety and EMC training

The Safety training is 3 days, and the EMC training is 1 day. You can attend either, or both with a 10% discount. Each year our course continues to evolve to stay up to date with the latest standards, interpretations, regulatory guidance, and feedback from over 1,300 past participants. Our instructors have over 35 years experience and participate on committees drafting the IEC 60601 requirements. Early bird discounts expire 6 weeks prior (20%) and again 3 weeks prior (10%). For more information and to register see here.

Frank retiring

posted Oct 31, 2017, 8:26 AM by Frank O'Brien   [ updated Apr 4, 2018, 2:27 PM ]

Frank O'Brien, our founder, will be retiring from active consulting and testing starting in Jan 2018. The company will remain a provider of IEC 60601 training services. Frank will also stay active with IEC 60601 committee work through 2019. After 2019, Frank and OBCM will be winding down to full retirement.

We're finishing the work we have now. We're not taking on any new work.  

We can recommend the following Consultants/Labs that could help you out.

Device Conformity and Testing (acquired OBCM test laboratory assets)
Devens, MA
Gregg Edwards, Manger/Principal Engineer, Tel 978 697 4665
Deb Carlson, Project Manager, Tel 508 498 4839

MECA
Located in Wisconsin
Brian Biersach (sales and engineering)
(262) 347-3436
www.mecassociates.us
Accreditations

Eisner Safety Consultants
located in Portland OR
Leonard (Leo) Eisner, P.E.
Principal Consultant
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

TUV Rheinland
Littleton MA
Richard Kilroy (sales)
Greg Chase (Engineering)
978-266-9500 ex 4225
rkilroy@us.tuv.com
Accreditations

Interek
Boxboro MA
http://www.intertek.com
978-263-2662
Rayshon Payne (Sales)
Bill Sterns (Engineering)
Accreditations

Curtis Straus a BV company
Littleton MA
Anissa Herrick (Sales)
Steve Henderson (Engineering)
978-486-8880
anissa.herrick@us.bureauveritas.com
Accreditations

We have a full list of test and consulting service providers here.

What's New for Medical EMC?

posted Sep 12, 2017, 10:48 AM by Unknown user   [ updated Sep 12, 2017, 12:02 PM ]

Amendment underway to the Electromagnetic Disturbances standard

Early 2017, work began on Amendment 1 to IEC 60601-1-2:2014, edition 4.0, the medical electrical equipment collateral standard for electromagnetic disturbances.  With Amendment 1, the edition will become 4.1 and target publication date will be late 2019.

 The "Short List" items for the electromagnetic disturbances standard are summarized below:

·        Perform conducted and radiated emissions testing using multiple AC input voltages

·        Clarification of voltage dips and Interrupts to with respect to the min./max voltage rating

·        Delete the exemption for testing short SIP/SOP cables for conducted immunity testing

·        Consider the use of IEC 61000-4-39 for Close Field Proximity testing

·        Clarify the emissions requirements for devices used on aircraft

·        Simplify Annex E (Special Environments)

·        Simplify Annex F (Risk Management)

·        Add a low frequency (<150 kHz) magnetic Immunity test requirement

·        Update references to CISPR standards

·        Correct an error for the voltage dips and interrupts testing (Table 5 note r) as it contradicts similar note in Table 1


The Kobe agreement (Nov 2015) and voting in Frankfurt (Oct 2016) by the TC62 National Committees established a “Short List” of safety critical issues, which will be addressed in the next amendments to the IEC 60601 general standard and all of the collateral standards.

Darryl Ray a member of IEC TC 62, SC 62A Maintenance Team 23, the committee responsible for this work, can be contacted for further questions. 

Darryl, together with OBCM, is offering along with Safety Training an EMC Training Seminar in Boston, November 2017.  

For more details click here.

New 2017 Training Schedule

posted Feb 2, 2017, 9:06 AM by Unknown user   [ updated Sep 14, 2017, 8:43 AM ]

Our Training for Integrating medical device safety into the design process

IEC 60601/ISO 80601, ed 3.1 and 2.2 families will be held in 3 locations this year

May 23-25
Sept 12-14 
Nov 7-9

Thanks for coming....

posted Oct 27, 2016, 1:00 PM by Unknown user

Thanks to everyone who came out to our open house always a nice time and a little info/education as well. For those of you who missed it here is Franks presentation

what's new, shocktober 2016

 

OBCM Open House

posted Sep 29, 2016, 9:05 AM by Unknown user

Shocktober 
Wednesday October 19, 2016
5pm to 8pm

We cordially invite you to join us for our annual Open House

  • Frank O'Brien will give a brief talk on regulatory changes in 2016
  • We will have Lab demos  
  • There will be plenty of food and drinks at Apriles Restaurant's upstairs Bar (located in the same building as us)  
  • Also, giveaways so make sure to bring your business cards. 

EM Safety; EU and FDA effective dates

posted Aug 3, 2016, 10:46 AM by Frank O'Brien   [ updated Aug 3, 2016, 11:34 AM ]

The FDA recently extended the effective date for the EM Disturbances collateral, IEC 60601-1-2:2014, 4th edition, to align the date with the recently announced EU harmonized standard date. Here’s a summary of upcoming FDA and EU effective dates.

Medical Electrical Equipment Standard

FDA effective date

EU effective date (DOCOPOCOSS)

Electromagnetic Disturbance, IEC 60601-1-2:2014 (ed 4)

31 Dec 2018


Announced 5 Jul 2016, extended from 1 Apr 2017,

31 Dec 2018, (EN 60601-1-2:2015)


Announced 13 May 2016


The scope of IEC 60601-1-2:2014, is safety, i.e. freedom from unacceptable risk.  During immunity testing, the medical electrical equipment under test must maintain basis safety and essential performance.  In some cases immunity levels are higher than currently specified in IEC 60601-1-2:2007.

The impact of transitioning

For a summary of the newer requirements in IEC 60601-1-2:2014, where new testing may be needed, see our prior news post here.

How Effective Dates Work

With FDA effective dates, these apply when seeking device clearance (510(k) or approval (PMA)). They don’t apply for products already cleared/approved for US market.

With EU effective dates, these apply to all products placed on EU market after date.

EM Compatibility

There's also a technical report, IEC TR 60601-4-2:2016, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems. The scope of this technical report is EM compatibility. During immunity testing, the medical electrical equipment under test must maintain intended functionality. Immunity levels are a bit less than safety immunity levels. This technical report describes how to meet both EMC and EM Safety (IEC 60601-1-2) in one set of tests.

Other safety standard effective dates

For other related effective dates, see our prior news post here.

FDA EMC guidance

In a future post we'll describe FDA's 11 July 2016 EMC guidance document for manufactures seeking device approval.

A FAQ for medical equipment with intentional radios

posted May 31, 2016, 9:19 AM by Frank O'Brien

Some terms:


Term

Meaning

Intentional radio

radio transmitter such as for WiFI, Bluetooth, RFID, cell phones

R&TTED

Radio and Telecommunication Terminal Equipment Directive, 1999/5/EC

RED

Radio Equipment Directive,  2014/53/EU

MDD

Medical Device Directive, 93/42/EEC


Harmonized standards for RED and R&TTED, http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/rtte/index_en.htm


Q1. What’s the effective date for RED?


A1: On 13 Jun 2017, all electrical medical equipment with intentional radios placed on EU market will need to comply with RED, (except radios that fall within the exceptions listed in Annex I: amateur, marine, airborne, R&D).  The R&TTED will be no longer valid.


Q2: Can a new electrical medical device with an intentional radio be placed on the market in compliance with R&TTED up until 13 Jun 2017?


A2: Yes.  It probably wasn’t the intention for new equipment, as the R&TTE is repealed on 13 Jun 2016, but the period between 13 Jun 2016 and the 13 Jun 2017 effective date for the RED is being treated as a transition period for new and legacy equipment being placed on market.


Q3: Does RED take full responsibility for the medical device?


A3: No, the medical device will still need to comply with the MDD and its harmonized standards, including the safety standard series EN/IEC 60601/ISO 80601, its EMC collateral, EN/IEC 60601-1-2, and the reference standards to which the collateral refers, including, series EN/IEC 61000-x-x.


The radio portion will need to comply with the RED and its harmonized standards, including  EN 300 328-x and the EN 301 489-x standards.


Q4: What’s listed on the Declaration of Conformity (DoC)?


A4: The DoC must declare conformity to both the MDD, and RED.  The MDD DoC does not require harmonized standards be listed on the DoC (rather these are in technical file).  Article 18, and Annex VI of RED requires that the “harmonized standards, or other technical specifications” be part of DoC.


Q5: Has an analysis been done to summarize the worst case radio/EMC standards to which medical devices with intentional radios need to comply?


A5: No.  An analysis will need to be done on a case by case basis.  In the case of a radio module certified and tested, all the work with respect to the RED directive has been already done. The compatibility of the module with the medical part is then evaluated with the safety tests, EMC tests, etc. for the whole combination, for example by application of the EMC standards listed as harmonized standards under the MDD.


Q6: Can OBCM help with further questions?


A6: Yes.


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Regulatory Safety Consulting and Testing Services

At OBCM we help medical device manufacturers speed up their regulatory and safety approvals

Each year, our 3 day IEC 60601-1, ed 3.1 training course is offered in the US on the east and west coasts; and in Europe. The course continues to evolve to stay up to date with the latest standards, interpretations, regulatory guidance, and feedback from over 1,100 past participants.

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