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, 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.

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 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.  

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.

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  

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.