An FDA Perspective On Medical Device EMC and Wireless - Jeff Silberberg

Center for Devices and
Radiological Health
An FDA Perspective on
Medical Device EMC and
Wireless
Jeffrey L. Silberberg
US Food and Drug Administration (FDA)
Center for Devices and Radiological
Health (CDRH)
Jeffrey L. Silberberg, MSEE
Senior Electronics Engineer

FDA/CDRH
Office of Science and Engineering
Laboratories
Secretary, IEC SC62A MT23
May 8, 2015 Wireless Electronics and Electrical Medical Devices 2

Summary
 Medical device EMI continues to be reported
 Most reports involve active implanted
devices
 Defibrillators
 Pacemakers
 Neurostimulators
 Infusion pumps
 RF wireless technology in healthcare is

proliferating
Summary (cont’d)
 RF Wireless Technology
 FDA guidances
 Coexistence
 FDA participates in many standards activities
 FDA currently recognizes (among many
others)
 IEC 60601-1-2 Ed. 3
 IEC 60601-1-2 Ed. 4
 Many 60601-2-X and 80601-2-X standards

Summary (cont’d)
 FDA coordinates with FCC on EMC and

wireless issues
 Completeness/quality of EMC information in
regulatory submissions varies
 It saves time and money to get it right the
first time!

Topics
 Introduction
 Medical device EMI reports
 FDA research
 FDA standards activities
 FDA recognition of IEC 60601-1-2
 RF Wireless Technology in Medical Devices
 Regulatory issues
 Conclusions

Introduction
 U.S. Food and Drug Administration (FDA)
Center for Devices and Radiological Health
(CDRH)
 We assure that patients and providers have
timely and continued access to
 safe, effective, and high-quality medical
devices
 safe radiation-emitting products.
 medical
 occupational
 consumer products
CDRH Coordination with FCC
 New wireless technology that could affect

medical devices
 Rules changes that could affect medical
devices
 New medical applications of wireless
technology
 More on this later

Laboratories
 Assesses state-of-the-art of device technology
 Performs leading-edge research
 Develops novel test methods and performs testing
 Participates in the development of consensus
standards
 Consults with other offices in CDRH
 Reviews of regulatory submissions
 Enforcement actions
 Problem identification and resolution

Experiences
 We continue to receive reports of medical device
electromagnetic interference (EMI)
 Most reports involve implanted ICDs, pacemakers,
neurostimulators, and infusion pumps
 Proliferation of RF wireless technology
 In medical devices
 In hospitals
 WLAN and telemetry
 RFID
 EMC information in regulatory submissions is
often incomplete and has errors
Sources of EMI Information
 Mandatory reports
 Voluntary reports
 Compliance (enforcement) actions
 Professional contacts
 Device and system professionals
 EMC engineers and consultants
 Hospital engineers
 Trade and professional organizations
 Consensus standards groups
 Published literature
Mandatory reporting requirements –
Medical Device Manufacturers
 Medical-device-related
 Deaths
 Serious injuries
 Malfunctions that caused or could have
caused the above
 To the FDA

Mandatory reporting requirements –
User facilities
 Medical-device-related deaths
 to both the FDA and the manufacturers
 Medical-device-related serious injuries
 only to the manufacturer

Voluntary reports
 MedWatch
www.fda.gov/safety/medwatch/default.htm
 Reporters can include
 Healthcare professionals
 Patients
 The general public
 MedSun
 Hospitals

MAUDE Database
 Manufacturer and User Facility Device
Experience Database
 Includes manufacturer, user facility, and
voluntary reports
 Searchable at
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfM
AUDE/search.CFM
 In 2013 there were more than 630,000 individual
reports entered into MAUDE

MAUDE Search Screen

Maude Simple Search Screen

Recent MAUDE data
Slide courtesy MDR Analyst Karen Nast

A quick search of 2014 reports
 (Simple) text search on 12/18/2014 for
“electromagnetic interference”
 Over 500 reports found for 2014
 Almost all were for implanted devices, primarily
 Cardioverter defibrillators (ICDs)
 Pacemakers
 Neurostimulators
 Infusion pumps
 Some implants had “EMI detection”

 Some “EMI detections” were due to lead wire
problems

Pacemaker and ICD Sensing Characteristics
 Pacemakers and ICDs must be able to sense low-level
signals to be able to perform their intended use
1V
Pacemaker Sensing Curve
100mV
Sense
10mV ICD Sensing Curve
1mV Reject Reject
100uV
10uV
1 10 100 1000
Slide courtesy Seth Seidman Frequency (Hz)

A quick search of 2014 reports (cont’d)
 In a more thorough EMI search, many
additional related search terms would also be
used that were not used for this quick
(simple) search, e.g.
 Electromagnetic compatibility
 EMI
 EMC
 Interfer
 Incompatible
 Incompatibility
 Some of the reports found appeared to be
confirmed or reproducible actual EMI
problems
 Many mentions of “EMI” were NOT confirmed
EMI problems. Examples:
 Implantable cardioverter defibrillator - A secure
sense warning was observed during device
interrogation. Electromagnetic interference was
suspected. The device was reprogrammed. The
patient condition was good.

 Example mentions of “EMI” that were NOT

confirmed EMI problems (cont’d)
 Implanted cardioverter defibrillator - A review
of the device data was completed by an engineer
and because the source of EMI cannot be
confirmed, must consider the possibility that the
device malfunction [sic].
 Programmer - The electromagnetic interference
tape was slightly lifted and was also replaced.

Apparent EMI problem examples
 MDR Report Key 3626655, Rec. 02/13/2014
 Event Description: It was reported the patient
had electromagnetic interference due to use of
their electric razor. The patient had felt their
stimulation turn on and off when they used the
electric razor. It was stated the report showed 48
activations and a previous time of 170
activations. It was noted the close proximity of
the electric razor to the implantable
neurostimulator was likely the cause of the
high activation count.
Apparent EMI problem examples (cont’d)
 MDR Report Key 4149571 (cont’d)

 Event description (cont’d): Additional information
was received indicating that electromagnetic
interference was conclusively identified as the
cause of low impedance measurement as it was
determined that patient has weekly electric
stimulation therapy.

 Event Description: There was an
electromagnetic interference issue that occurred
approximately two days prior to the initial report.
The patient went through a theft detector in a
shop, received strong stimulation, and the lead
at the cervical level displaced. Impedance
testing and reprogramming were performed. The
implantable pulse generator (IPG) had a
power on reset, which was resolved through
reprogramming. The patient experienced pain
and less than 50% therapy relief at the lead
location. There was no patient injury.
EMI report examples (cont’d)
 Ventilator
 MDR Report Key 2949491 Rec Jan 31, 2013
Respiratory therapist was standing in front of a
high-frequency oscillatory ventilator. She had
noticed that there was a change in delta-p and
mean airway pressure was fluctuating by 10.
Behind the therapist were 7 staff members using
[smart phones]. When [they were] asked to
move away from the ventilator, the delta-p
stopped fluctuating. Manufacturer response:
known issue documented in operator’s manual.
EMI report examples (cont’d)
 Ventilator (cont’d)
 Manufacturer said that the root cause of the
reported event was EMI from cell phone use by
the end user. EMI causes erroneous pressure
readings that are not due to fluctuations in the
actual pressure but are the effect of EMI on the
components of the measurement circuits. Mfr
continued that as the reported event was caused
by the device being exposed to higher than
normal EMI, an investigation is not required.

Adverse events reported to FDA
 Provide a qualitative snapshot of adverse
events
 Vary in quality and usefulness
 Include both coding of problems as well as
narrative text
 Can be coded with multiple problem codes
Slide courtesy MDR Analyst Karen Nast

FDA adverse event report caveats
 Under-reporting of events
 Insufficient or inadequate information
 Inability to establish causality
 Inability to establish rate of adverse events
 Lack of denominator data
 “Trends” in numbers should be interpreted
cautiously
 One report can be important
Adapted from a slide by MDR Analyst Karen Nast

MedSun
 Medical Product Safety Network
www.fda.gov/medicaldevices/safety/medsunmed
icalproductsafetynetwork/default.htm
 Participants
 Clinical sites
 Participation is voluntary
 Feedback
 Follow-up

EMI information from EMC professionals
 Noise in the image or ECG trace (conducted
EMI)
 Telemetry dropouts (radiated EMI)
Artifacts in the Image Noise in the ECG Trace Telemetry Dropouts
Slide courtesy EMC engineer Dara McLain

Examples of published EMI reports
 Gimbel et. al., Electronic Article Surveillance
Systems and Interactions With Implantable
Cardiac Devices: Risk of Adverse Interactions in
Public and Commercial Spaces
Mayo Clin Proc. 2007;82:318-322,
A 71-year-old man with a biventricular ICD
reported receiving 2 ICD shocks while shopping
in the automotive center of a large commercial
retail store. There was an electronic article
surveillance (EAS) pedestal near the checkout
counter.
Example of EMI identification in
published research
 Remko van der Togt et al., Electromagnetic
Interference From Radio Frequency
Identification Inducing Potentially Hazardous
Incidents in Critical Care Medical Equipment,”
Journal of the American Medical Association,
June 25, 2008, Vol. 299, No. 24, pp. 2884 –
2890.

Example regulatory investigation
 Ambulatory insulin infusion pump

exhibited lockup in use
 Manufacturer was able to mitigate
problems by increasing ESD immunity to
30 kV

An EMC recall case study:
EMC conformity gone wrong
 Date Recall Initiated: March 17, 2008
 Date Posted: July 23, 2008
 Recall Number: Z-1902-2008
 Product: Model X extracorporeal blood
circulation system
 Reason for Recall: Stops pumping:
Interruption of Model X support may occur
when using a Model Y Electrocautery Unit
 See Appendix for more information
FDA/CDRH/OSEL EMC research
 Immunity testing, immunity test method

development
 Susceptibility of patient cables of automatic
external defibrillators (AEDs) below 80 MHz
 Comparison of results of conducted and
radiated immunity testing
 Pacemakers and ICDs with cell phones
 Powered wheelchairs
 Ventilators
OSEL EMC and wireless research
 Pacemakers, ICDs, and nerve stimulators

with security systems
 Wireless technology / wireless coexistence
 Working with University of Oklahoma at
Tulsa
 C63.27 Round robin
 RFID (readers) and medical devices

FDA/CDRH/OSEL EMC research –
publications
 Seidman S. et al.: In vitro tests reveal sample
radiofrequency identification readers inducing
clinically significant electromagnetic
interference to implantable pacemakers and
implantable cardioverter defibrillators, Heart
Rhythm, vol. 7, no. 1, pp. 99-107, 2010

FDA/CDRH/OSEL EMC research –
publications (cont’d)
 Seidman, Seth J., and Guag, Joshua W.: Ad
hoc electromagnetic compatibility testing of non-
implantable medical devices and radio
frequency identification, BioMedical Engineering
OnLine, http://www.biomedical-engineering-
online.com/content/12/1/71, 11 July, 2013
 Seidman, Seth J. et al.: Design of Unique
Simulators to Evaluate Medical Device
Susceptibility to Radio Frequency Identification
Exposure, 2014 IEEE Electromagnetic
Compatibility Magazine, Vol. 3, Quarter 1
A few of the many CDRH standards
activities
 AAMI
 2010 data
 AIM REG HCI
 240 representatives
 ASC C63®
 30 standards
development  ASTM
organizations  IEC
 500 standards  ISO
activities
 RESNA

CDRH EMC and wireless activities
 AAMI
 Wireless coexistence TIR working group
 FDA co-chair
 Document development in process
 Working group – EMC test protocols for
cardiac rhythm management
 FDA co-chair
 Working on EMC section of a standard
for cochlear implants
CDRH EMC activities (cont’d)
 RFID
 Working with Association for Automatic
Identification and Mobility (AIM Global)

RFID Experts Group (REG) on protocol for
testing immunity of medical devices to
RFID systems
 Protocol (test method) completed
 Circulated to the REG for comment
4 May 2015
 Comments due 22 May 2015
CDRH EMC activities (cont’d)
 C63® standards
 C63.12, limit and test level setting
 C63.16, ESD
 C63.27, wireless coexistence
 IEC standards
 IEC TR 60601-4-2, Medical electrical
equipment – Part 4-2: Guidance and

interpretation – Electromagnetic immunity;
performance of medical electrical
equipment and medical electrical systems
CDRH EMC activities (cont’d)- IEC
 IEC TR 60601-4-2
 Scope: The IMMUNITY of medical electrical
equipment and medical electrical systems
 Immunity test levels
 -1-2: reasonably foreseeable maximum
 -4-2: typical, the same for home and hospital
 Scheduled to be circulated for comment

8 May 2015
 IEC 60601-1-2 Ed 5

Standards recognition
 Declaration of conformity to consensus
standards recognized by FDA can be used in
regulatory submissions
 Recognition and Use of Consensus
Standards; Final Guidance for Industry and
FDA Staff, issued 20 June 2001
http://www.fda.gov/medicaldevices/devicereg
ulationandguidance/guidancedocuments/ucm
077274.htm

Search for recognized standards
http://www.accessdata.fda.gov/scripts/cdrh/cfdoc
s/cfStandards/search.cfm
 Enter “Standard Designation Number”
 Click “Search”

Standards recognition (cont’d)
 Clicking on the title opens the supplementary
information page for that recognition
 Date of Standard
 Address of Standards Organization
 CDRH Office and Division Associated with
Recognized Standard
 Devices Affected
 Processes Affected:
 510(k), PMA, PDP, HDE, GMP, Design
Controls
Standards recognition (cont’d)
 Supplementary information page (cont’d)
 Type of Standard
 Extent of Recognition
 Portion of standard recognized
or entire standard
 Any transition dates from older version(s)
 Related CFR Citations and Product Codes

 Relevant Guidance
 FDA Technical Contacts

Recognition of IEC 60601-1-2
 Ed. 2 and Ed. 2.1 no longer recognized
 Ed. 3 will be recognized until April 1, 2017
 (Subject to change)
 Ed. 4 recognized as of June 2014

 Extent of Recognition
Complete standard with the following

exceptions:
 In Subclause 8.9, Table 8 on Page 39: The
citation of Note b) under “Conducted
disturbances induced by RF fields” (4th Row)
is not recognized.
Recognition of IEC 60601-1-2 (cont’d)
 Ed. 4 Extent of Recognition (cont’d)
 Exceptions (cont’d)
 Please note the following corresponding
titles, subtitles or provisions:
 Subclause 8.9: IMMUNITY TEST LEVELS
 Table 8: Signal input/output parts PORT
 Note b): SIP/SOPS whose maximum cable
length is less than 3 m in length are
excluded
 4th Row: Conducted disturbances induced
by RF fields
Recognition of 60601-2-X and 80601-2-X
standards
 Many are recognized
 Examples
 IEC 60601-2-10:2012, Medical electrical
equipment - Part 2-10: Particular requirements
for the basic safety and essential performance
of nerve and muscle stimulators
 ISO 80601-2-12:2011, Medical electrical
equipment - Part 2-12: Particular requirements
for the safety of lung ventilators - Critical care
ventilators
RF Wireless Guidance
 Accessible at
http://www.fda.gov/medicaldevices/deviceregulation
andguidance/guidancedocuments/ucm077210.htm
 Motivation
 Increasing use of RF wireless in healthcare
 Increasing congestion (e.g., in ISM bands)
 Medical devices can be both source and recipient
of disturbances
 Need for awareness of potential pitfalls
 By FDA reviewers
 By manufacturers

RF Wireless Guidance (cont’d)
 Methods
 Risk-based approach
 References to FDA Quality System

Regulation

 Considerations for design, testing, and use of
wireless medical devices
 Selection and performance of wireless
technology
 Wireless quality of service (QoS)
 Wireless coexistence
 Security of wireless signals and data
 EMC of the wireless technology
 Information for proper setup and operation
 Considerations for maintenance

 Recommendations for Premarket
Submissions for Devices that Incorporate RF
Wireless Technology
 Description of device
 Risk-based approach to verification and
validation
 Test data summaries
 Labeling related to wireless medical devices

 EMC
 Because IEC 60601-1-2:2007 exempts RF
receivers from immunity testing in the
exclusion band, the medical device’s wireless
communication(s) should be actively
transmitting during EMC immunity testing.

Wireless coexistence
 FDA reviewers have been asking manufacturers
for wireless coexistence testing
 since at least 2004
 No standardized test method

 FDA asked C63 to develop a test method
October 2010
 Assigned to SC7, Spectrum Etiquette
October 2011
 Designated C63.27, Chair: Steve Berger
 Participants from government, industry,

academia
Example wireless coexistence test setup
Example wireless coexistence test setup from draft C63.27
Wireless coexistence conclusions
 C63.27 development in progress

 AAMI wireless coexistence TIR in progress
 Good cooperation and division of labor
 C63: Test methods
 AAMI
 Medical intended use
 Risk management
 Guidance on pass/fail criteria

FDA wireless activities (cont’d)
 Meetings/working with FCC

 (And also with SAE) on wireless
charging of electric vehicles (wireless

power transfer)
 FCC/FDA Joint Workshop on Wireless
Medical Test Beds
 March 31, 2015

FDA wireless activities (cont’d)
 Mobile Medical Applications Guidance

 http://www.fda.gov/ucm/groups/fdagov-
public/@fdagov-meddev-
gen/documents/document/ucm263366.pdf
 Those that are not medical devices
 Those that are medical devices that FDA
“intends to exercise regulatory discretion”
 Those that are medical devices that FDA
plans to regulate

Experience with EMC information in
regulatory submissions
 Submissions with little or no EMC information
 Submissions with incomplete EMC
information
 Only certification submitted
 EMC test report submitted
 But evidence of conformity with labeling
requirements is missing
 For RF receivers, no indication whether
passed immunity in exclusion band or
exemption was used
regulatory submissions (cont’d)
 EMI missing from list of hazards
 ERP not specified for transmitters
 Immunity pass/fail criteria were not based on
Essential Performance
 Product-specific pass/fail criteria not specified
 Test failures
 No wireless coexistence testing for
transmitter / receiver or testing inadequate

regulatory submissions (cont’d)
 Some submissions include complete EMC
information and meet all requirements of
referenced standards
 Some manufacturers go above and beyond the
requirements
 One manufacturer of surgical device
controllers worked with chip manufacturer to
 reduce RF output power of remote control
 reduce risk of outside wireless detecting and

causing problems with system
Deficiencies in test planning
 Essential Performance not specified

 Pass/fail criteria listed, “if associated with BS
and EP,” but EP not specified
 Pass/fail criteria A/B/C/D specified
 Intended use environments not specified
 Default hospital test levels used for all
environments (Ed 3)

Deficiencies in testing
 Min and max mains voltages not used for
EFT/burst; surge; and voltage dips, short
interruptions and voltage fluctuations tests
(Ed 3)
 Entire system not included in the test and/or
subsystems not simulated adequately
Deficiencies in the test report

 Essential Performance not specified, etc.
(see test planning)
 Photos not legible
Deficiencies in labeling
 Statements and warnings omitted
 Performance determined to be EP
 Stacking/adjacent warning
 “Special precautions… put into service
according to the EMC information…” (Ed 3)
 Accessories statement and warning
 Portable and mobile RF communications
equipment can affect medical electrical
equipment (Ed 3)

Deficiencies in EMC guidance tables (Ed 3)
 Guidance tables (four) missing
 Calculation of equation coefficients e.g.,
.
not completed
 Rounding not as specified by 60601-1-2
 Conducted and radiated RF separation
distance equations not aligned with
compliance levels
 Compliance level and EMC guidance not
modified when higher immunity test levels are
used
Guidance and manufacturer’s declaration – electromagnetic immunity
The Model 006 is intended for use in the electromagnetic environment specified below. The customer or the user of
the Model 006 should assure that it is used in such an environment.
IEC 60601 TEST Compliance
I MMUNITY test
LEVEL level Electromagnetic environment – guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the Model
006, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1,2 P
Conducted RF 3 Vrms 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m d = 1,2 P 80 MHz to 800 MHz

IEC 61000-4-3 80 MHz to 2,5 GHz 3 V/m
d = 2,3 P 800 MHz to 2,5 GHz
where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as deter-
mined by an electromagnetic site survey, a should be
less than the compliance level in each frequency
range. b
Interference may occur in the vicinity of equipment
marked with the following symbol:
(Ed 3)

Conclusions
 Medical device EMI continues to be reported
 Most reports involve active implanted
devices
 Defibrillators
 Pacemakers
 Neurostimulators
 Infusion pumps
 RF wireless technology in healthcare is

proliferating
Conclusions (cont’d)
 RF Wireless Technology
 FDA guidances
 Coexistence
 FDA participates in many standards activities
 FDA currently recognizes (among many
others)
 IEC 60601-1-2 Ed. 3
 IEC 60601-1-2 Ed. 4
 Many 60601-2-X and 80601-2-X standards

Conclusions (cont’d)
 FDA coordinates with FCC on EMC and

wireless issues
 Completeness/quality of EMC information in
regulatory submissions varies
 It saves time and money to get it right the
first time!

Jeffrey L. Silberberg, MSEE
Senior Electronics Engineer

FDA/CDRH
Laboratories
1-301-796-2584
jeffrey.silberberg@fda.hhs.gov
Secretary, IEC SC62A MT23

Thank you for your
attention!
Questions?
Appendix
Supplemental material
An EMC recall case study:
EMC conformity gone wrong
 Date Recall Initiated: March 17, 2008
 Date Posted: July 23, 2008
 Recall Number: Z-1902-2008
 Product: Model X extracorporeal blood
circulation system
 Reason for Recall: Stops pumping:
Interruption of Model X support may occur
when using a Model Y Electrocautery Unit

EMC recall case study: System details
 Includes primary and backup pump consoles

 Was claimed to conform to IEC 60601-1-2:
2007 (Ed. 3)
 Manufacturer claimed system was tested for
immunity to electrosurgical units (ESU) / HF
surgical equipment
 Designed to stop and alarm if problem
detected with pump motor

EMC recall case study: Adverse events
 At least three adverse event reports
 Argentina (1), UK (1) and Spain (1)
 System performed OK in OR
 Patient moved to ICU, was bleeding
 ESU used in ICU in monopolar coagulate
mode
 Pump stopped and alarmed – “Motor Fail”
 Required restart, taking several minutes
 No reported patient injury
 RF coupled to device through the blood
EMC recall case study: EMI incident details
 Manufacturer said:
 Pump stopping and alarming was OK
 Performed as intended
 Recommended user mitigation

 “Switch” to bipolar mode
 Reboot
 Warning: Don’t use Model Y ESU with

Model X blood pump

EMC recall case study: EMI incident details
 FDA said:
 Pump is intended to pump blood
 Pump monitoring system was mistaken
 No problem with pump motor
 EMI was detected erroneously as a pump

problem
 Patient at risk during reboot
 Backup console equally susceptible
 Further coagulation might be needed
 Please mitigate via design modification
EMC recall case study (cont’d)
 Nine hospitals had ONLY Model X blood pump
and ONLY Model Y ESU!
 Recommended using Model Y in bipolar mode
only when Model X in use
 The fallacy of fail-safe
 Some say that safe failure is OK in hospitals
because of the availability of other equipment;
however,
 Other equipment might have the same
susceptibility
 Some hospitals might not have alternatives

Recall:
IEC 60601-1-2:2007 considerations
 Tested for “ESU immunity” by performing IEC
61000-4-3 (radiated RF immunity) test down to
150 kHz
 ESU emissions are broadband, IEC 61000-4-3
is narrowband
 Could not have met IEC 61000-4-3’s field
uniformity requirement
 Test lab should have known better than to
test down to 150 kHz with radiated RF

Recall:
60601-1-2:2007 considerations (cont’d)
 IEC 60601-1-2:2007 says that patient simulators
should not be grounded
 6.2.1.7 PATIENT simulation [from 60601-1-2]
…The simulator used shall not provide an
intentional conductive or capacitive connection to
earth during testing, except as otherwise specified
in a subclause of this collateral standard.
Unintentional capacitance between the PATIENT
coupling point and earth should be no greater than
250 pF.

Standards considerations (cont’d)
 IEC 60601-1-2 (all editions): PATIENT

COUPLING includes via conductive fluids
 IEC 60601-2-2 (Ed. 4 and later) includes an
annex on testing immunity to ESU

EMC recall case study Summary
 Mitigation by design is best
 Conformance to standards is important
 Patient simulator requirements of 60601-1-2
 Field uniformity requirements of 61000-4-3
 ESU immunity recommendations of 60601-2-2
 Particular (“Part 2”) requirements and test
methods are needed for ESU immunity of
external blood pumps (and other devices)
 The manufacturer fixed the problem with a
software upgrade

AIM/REG/HCI test method details
 Minimum and maximum occupied BW
 Compliance criteria: 8.1 of 60601-1-2:2014
 IEC 61000-4-3 methods and modified calibration
procedure
 Calibrate uniform field area using commercially-
available signal generator
 Replace sig gen with custom RFID sig gen and
validate at one point
 HF test levels based on 2.5 cm separation
distance
 LF and UHF test levels based on 20 cm
separation distance
Test specifications
RFID SPECIFICATION FREQUENCY TEST LEVEL
ISO 14223 134.2 kHz 65 A/m
ISO/IEC 14443 Type A 13.56 MHz 7.5 A/m
ISO/IEC 14443 Type B 13.56 MHz 7.5 A/m
ISO/IEC 15693
13.56 MHz 5 A/m
(ISO 18000-3 Mode 1)
ISO/IEC 18000-3 Mode 3 13.56 MHz 12 A/m
ISO/IEC 18000-7 433 MHz 3 V/m
ISO/IEC 18000-63 Type C 860-960 MHz 54 V/m
ISO/IEC 18000-4 Mode 1 2.45 GHz 54 V/m
Wireless Electronics and Electrical

May 8, 2015 Medical Devices 100
RF Wireless Guidance – Considerations
 Information that should be provided to users
 The specific RF wireless technology type,
characteristics of the modulation, and effective
radiated RF power
 Specification of each RF frequency or
frequency band of transmission and the
preferred frequency or frequency band (if
applicable), and specification of the bandwidth
of the receiving section of the equipment or
system in those bands

(cont’d)
(cont’d)
 Applicable FCC labeling
 A warning that other equipment could interfere

with the medical device or device system,
even if the other equipment complies with
CISPR emission requirements.
 Information about the needed quality of
service and security

(cont’d)
(cont’d)
 Functions and performance of the wireless
data transmissions including data throughput,
latency, and data integrity
 Information about any limitations on the
number, output power, or proximity of other in-
band transmitters used in the vicinity that
might adversely impact a device’s operation

RF Wireless Guidance – Premarket
submissions
 Device description should include
 Description of wireless technology and
functions
 How the design of the device’s wireless
functions assures timely, reliable, accurate,
and secure data transfer
 If wireless is used for alarms, alarm
description, priority, and how RF wireless-
related risks are managed/mitigated

submissions (cont’d)
 Device description should include (cont’d)
 Whether other wireless products or devices
are able to make a wireless connection to the
device. If so, identify them and explain how
the medical device functions are protected
from adverse effects of such connections

 Test data should include
 Tests performed
 Reference to applicable medical device, RF

wireless technology, and EMC standards
 Explanations for any deviations
 Operating modes used and explanation of

their significance
 Pass/fail criteria
 Statement that modifications made to pass

testing will be made to production units
 Labeling should include
 A summary of the medical device wireless
functions and specific wireless technology
incorporated into the medical device
 A summary of the operating characteristics of
the wireless technology, effective RF radiated
power output and operating range,
modulation, and bandwidth of receiving
section

 Labeling should include (cont’d)
 A description of the wireless QoS needed for
safe and effective operation
 A description of the recommended wireless
security measures
 Information addressing wireless issues and
what to do if problems occur
 Information about any wireless coexistence
issues and mitigations

 Appropriate EMC and telecommunications
standards compliance and test results
 Appropriate RF wireless communications
information such as those required by FCC
rules
 Warnings about possible effects from RF
sources in the vicinity of the device (e.g.,
electromagnetic security systems, cellular
telephones, RFID or other in-band
transmitters).
 Labeling required by applicable EMC and
wireless standards

 Implanted neurostimulator for incontinence -
The caller was with the patient and trying to
interrogate stimulator with clinician programmer
and getting telemetry failure message. Caller also
states they cannot interrogate stimulator using
patient programmer. Caller states they are in
room where they typically interrogate devices and
were not near EMI (electromagnetic interference).

 A critical alarm was heard. The healthcare
provider (HCP) thought the pump might have
been empty. However, the HCP later interrogated
the pump, which revealed that multiple motor
stalls occurred, for ~ 3 hours. The stalls only
occurred on some days. On [date], the patient
was in the emergency room due to the event. The
patient did use a microphone/amplifier but not all
of the time. The patient’s wife was going to try to
rule out any electromagnetic interference that
could have caused the stalls. The device system
was used to deliver compounded baclofen.
 Event description: [Mfr] received information that
this implantable cardioverter defibrillator and
right ventricular lead exhibited low, out of
range shocking lead impedance measurement
of 0 ohms detected via the patient remote
monitoring system. A review on shock
impedance trend revealed a measurement of
greater than 200 ohms, but no alert was
received.

Older EMI report examples
 Implanted pacemaker, in a hospital

 During breast surgery, the doctor was using
the 9900 electrosurgery generator and the
patient’s pacemaker stopped working.
Cardiopulmonary resuscitation (CPR) was
used to resuscitate the patient.

Older EMI report examples (cont’d)
 External pacemaker, public place

 The device manufacturer reported that while a
female patient (age unknown) was being
transported by helicopter, “the patient’s pacing
was intermittently interrupted by radio
frequency interference. The patient
subsequently died”.

Older EMI report examples (cont’d)
 IV syringe pump
 MDR Report Key 829521 Rec March 12, 2007
User and biomedical technician noted excessive
60 cycle interference on the ekg waveform
making the waveform unreadable. The biomed
tech unplugged all the [model] syringe pumps
from ac power and noted that the 60 cycle
interference was removed from the ekg
monitor.

Example EMI reports (cont’d)
 Implanted spinal cord stimulator, public
place
 The patient walked through the theft detector
at a university library and received a shock
that knocked him to the floor. The implanted
device was reset to "0" by the shock. The
patient sustained no known injury. The device
was reprogrammed and it is functioning
properly. The health care provider stated that
the security system was reportedly “set too
high”.
 Pulse oximeter
 MDR Report Key 504200 Rec January 6, 2003
Upon transporting a pt intra hosp, pulse oximeter failed in
battery mode. Personnel switched oximeter to a.c. power.
Hosp investigation team tried to duplicate the malfunction.
Fully charged oximeter from ICU would not malfunction
when a two-way radio was keyed next to it. But, when
using oximeter with slightly discharged battery,
malfunction was duplicated. Keying two-way radio approx
one foot [30 cm] from unit created an internal reset
problem and keying two-way radio adjacent to oximeter
caused complete shutdown. Manufacturer’s initial report
suggests effects of EMI contributed to the failure and this
may be related to a low battery/poor battery circuitry.

 Infusion pump
 MDR Report Key 679280 Rec February 21, 2006
The facility reported an infusion pump with over
infusion. Reportedly a displayed rate changed
during pt infusion. The pt's cell phone rang and the
nurse at the bedside noticed that rate of pitocin was
displayed at 120ml/hr rather than the prescribed rate
of 20 ml/hr. The change was noticed in less than
one minute and there was no harm to the pt. A new
pump was put on the pt. According to the hosp. rep,
the event history did not show any buttons being
pressed for the rate change.

 Infusion pump
 MDR Report Key 736554 Received June 19, 2006
The facility reported a pump that stopped
infusing during patient use. The pump was
infusing heparin, at which time the patient's
family member used a cell phone in close
proximity to the pump. The pump then stopped
infusing. There was no patient injury or medical
intervention according to the hospital rep.

Case Studies Slide courtesy Dara McLain
Conducted EMI Reproduced
– Ultrasound Artifacts
Spectrum Analysis of a noisy power
supply from a patient monitor
Actual

Case Studies – HVAC Controllers
Slide courtesy Dara McLain
Broadband noise caused by variable

speed controllers used in the air
handling system. An adjustment on
the controller provided by the
manufacturer significantly reduced
the interference.
Facilities had this new system

installed in a newly constructed wing
and 1) did not review EMC
documentation, and 2) did not notify
Clinical Engineering of this
installation.
Interference began at the same time as installation of this new HVAC system,
and continued for 11 months before mitigation was achieved.

Case Studies - HVAC Control Circuitry Relay
Normally Normally
Open Closed
Due to relays in HVAC circuitry that were either not rated for the current through them, or
incorrect for the circuit design, the plastic body melted and caused the normally closed condition
to be slightly open, resulting in arcing. There were two main hallways with an HVAC relay circuit
for each room, more than 60 relays that any one of them could produce broadband interference
of up to 15 minutes in length.

Case Studies
Patient Room Hair Dryer
In-room hair dryers found during a pre-installation RF Survey. Not all hair dryers emitted noise.
Defective hair dryers functioned [in]correctly. The proposed wireless system would not have
functioned properly due to this noise.

Case Studies Slide courtesy Dara McLain
Automated Door Mechanism
Broadband noise from automated door into the NICU. These solenoids had degraded over time.
Replacement was recommended.

Case Studies – Lighting Dimmers
Hallway lighting controlled by automated dimming at specified times. System
cabinets were not equipped with any shielding, though the system
documentation called for it. All dimmer switches are potential broadband
sources.
A broad frequency span shows the Only the weak signals are affected at
arcing characteristics of the dimmers. the time the noise occurs.
Recommendations: Install shielding on the dimmer system control cabinets.

Case Studies
Elevator Controls
Doctor’s office building – elevator
motor control circuitry* with
excessive noise emissions (only
one of two elevator control circuits
emitted noise).
This noise was conducted onto

the power line. It radiated as well,
but the building had no wireless
systems.
*These elevators had brushless

motors.

Case Studies – Co-channel Occupancy
Slide courtesy
Dara McLain
Two wireless systems programmed to the same frequencies in use, interfering with each
other.
Unknown to Clinical Engineering, the offending system field service tech reprogrammed
the system transmitters. The affected system company resolved the issue at the
customer’s expense.

An FDA Perspective On Medical Device EMC and Wireless - Jeff Silberberg

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Center for Devices and

Senior Electronics Engineer

May 8, 2015 Wireless Electronics and Electrical Medical Devices 2

 RF wireless technology in healthcare is

May 8, 2015 Wireless Electronics and Electrical Medical Devices 4

 FDA coordinates with FCC on EMC and

May 8, 2015 Wireless Electronics and Electrical Medical Devices 5

May 8, 2015 Wireless Electronics and Electrical Medical Devices 6

 New wireless technology that could affect

May 8, 2015 Wireless Electronics and Electrical Medical Devices 8

 Problem identification and resolution

May 8, 2015 Wireless Electronics and Electrical Medical Devices 9

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May 8, 2015 Wireless Electronics and Electrical Medical Devices 19

May 8, 2015 Wireless Electronics and Electrical Medical Devices 20

Slide courtesy MDR Analyst Karen Nast

May 8, 2015 Wireless Electronics and Electrical Medical Devices 21

 Some implants had “EMI detection”

May 8, 2015 Wireless Electronics and Electrical Medical Devices 22

1mV Reject Reject

May 8, 2015 Wireless Electronics and Electrical Medical Devices 23

May 8, 2015 Wireless Electronics and Electrical Medical Devices 25

 Example mentions of “EMI” that were NOT

May 8, 2015 Wireless Electronics and Electrical Medical Devices 26

 MDR Report Key 4149571 (cont’d)

May 8, 2015 Wireless Electronics and Electrical Medical Devices 28

May 8, 2015 Wireless Electronics and Electrical Medical Devices 31

Slide courtesy MDR Analyst Karen Nast

May 8, 2015 Wireless Electronics and Electrical Medical Devices 32

May 8, 2015 Wireless Electronics and Electrical Medical Devices 33

May 8, 2015 Wireless Electronics and Electrical Medical Devices 34

Slide courtesy EMC engineer Dara McLain

May 8, 2015 Wireless Electronics and Electrical Medical Devices 35

May 8, 2015 Wireless Electronics and Electrical Medical Devices 38

 Ambulatory insulin infusion pump

May 8, 2015 Wireless Electronics and Electrical Medical Devices 39

 Immunity testing, immunity test method

 Pacemakers, ICDs, and nerve stimulators

 RFID (readers) and medical devices

May 8, 2015 Wireless Electronics and Electrical Medical Devices 42

May 8, 2015 Wireless Electronics and Electrical Medical Devices 43

May 8, 2015 Wireless Electronics and Electrical Medical Devices 45

Identification and Mobility (AIM Global)

 C63.27, wireless coexistence

equipment – Part 4-2: Guidance and

 -4-2: typical, the same for home and hospital

 Scheduled to be circulated for comment

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 Related CFR Citations and Product Codes

May 8, 2015 Wireless Electronics and Electrical Medical Devices 54

 Ed. 4 recognized as of June 2014

Complete standard with the following

May 8, 2015 Wireless Electronics and Electrical Medical Devices 59

 References to FDA Quality System

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