How to Design the Means of Protection for Home Use Unit

Eamon

Involved In Discussions
#11
Personally I like the idea of applying common sense via risk management, but I am not sure that invoking the ubiquity of non-medical electrical devices, though possibly persuasive in front of one particular reviewer, is the best way to go.

Here are two possible avenues to criticize this approach:

1) Certification for use in a home healthcare environment (60601-1-11) does not relax requirements but rather imposes additional ones, and in no way precludes operation in a hospital environment.

2) Even given the likelihood of operation in an environment where other electrical devices are present which are not 60601-1 compliant, doesn't the medical standard prescribe that devices conforming to it themselves present a lower level of risk, regardless of the presence of other risks?

The conflict between the standard and common sense arises from the notion embedded in 60601-1 that anyone in the role of a "patient" must be more rigorously protected than he would be in another role, regardless of his condition.

This heightened concern for diminishing patient risk makes sense under the worst-case assumption (about the patient's state) that he is weakened, immobilized or unconscious, and connected up to potentially hazardous equipment.

However in some cases the very nature of the equipment practically guarantees that anyone performing a given operation, whether deemed patient or operator, is in quite a normal state compared to the worst case assumption. So indeed a heightened concern for electric shock risk makes no sense in the scenario of a (certainly conscious and responsible) patient-operator plugging a battery charger into a piece of diagnostic equipment.

The approach I would take to risk management, if I had to invoke it to justify use of a charger with higher touch current, would be to would argue that all patients are not equal, and that a higher touch current simply does not represent a heightened risk to any "patient" who is operating diagnostic equipment on his own behalf.

In the future perhaps the standard should either clarify conditions under which the patient and operator may be the same person, and specify that operator protection may apply in some such cases; or else make the distinction between various levels of "patient", with regard to his ability to react to and survive hazardous events.
 
Last edited:
Elsmar Forum Sponsor
P

petruchio

#12
Thanks for your input on this. I've added some comments below in italics.

1) Certification for use in a home healthcare environment (60601-1-11) does not relax requirements but rather imposes additional ones, and in no way precludes operation in a hospital environment.

I disagree fundamentally on this point : home healthcare means just that and should not be construed to mean any more; the statement of intended use covers that. That aside, the notion of heaping safety upon safety is at variance with the principles of risk management which the 3rd ed is supposed to enshrine.

2) Even given the likelihood of operation in an environment where other electrical devices are present which are not 60601-1 compliant, doesn't the medical standard prescribe that devices conforming to it themselves present a lower level of risk, regardless of the presence of other risks?

Medical devices certainly shouldn't create greater levels of risk than non-medical products where these can be compared; it makes no sense, however, to have an imbalance between them if the use environment is the same.

petruchio
 

Peter Selvey

Staff member
Super Moderator
#13
Just quickly looking through the thread, so sorry if someone has said the same thing before.

From a "interpretation" point of view, I think it's OK to consider MOOP and MOPP based on the part, rather than the person. So it's possible that the same person could contact the equipment and be both operator and patient at the same time, with different MOOP/MOPP assessments depending on the part.

So for example, a home use NIBP, the applied part would be the air filled cuff subject to MOPP requirements, while the controls, battery compartment, dc adapter and connector would all be operator, subject to MOOP requirements.

While the standard is not 100% clear on this point, the basic rationale for MOPP clearly supports the interpretation. The special requirements for MOPP have been developed with a lot of worst case assumptions: long term, low impedance electrical contact with the patient; and a potentially immobile, drugged or unconscious patient.

These conditions are rarely true for real applied parts, so it results in a lot of overkill in practice, but that's just life. But in the case of home use equipment, I think it's reasonable to exploit the grey zone towards common sense, rather than overkill.
 
Thread starter Similar threads Forum Replies Date
DuncanGibbons Section 8.3 relevant for design organisations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
R Is a FAIR required on parts that we design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
J Significant change related to design and intended use EU Medical Device Regulations 3
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
U NOC - What is considered a "design change" EU Medical Device Regulations 5
Q PPT used as Design Review ISO 13485:2016 - Medical Device Quality Management Systems 3
D Design Verification Sample Size vs Repeats Statistical Analysis Tools, Techniques and SPC 9
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
D Design controls - Inputs, outputs, V&V, DHF, DMR ISO 13485:2016 - Medical Device Quality Management Systems 10
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 9
R DFA & DFM - Examples for Design for assembly and design for manufacturability Lean in Manufacturing and Service Industries 2
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 2
A Design History File - Not ready to share the design drawings or Bill of Material US Food and Drug Administration (FDA) 2
W Need for current design or process control FMEA and Control Plans 2
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Qualification and Validation (including 21 CFR Part 11) 5
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
DuncanGibbons How is the arrangement between Design and Production organisation envisaged? EASA and JAA Aviation Standards and Requirements 4
L Design & Development of a SERVICE Service Industry Specific Topics 13
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A AS9102B - 3.6 Design Characteristics and form 3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P Design FMEA - Detection Rating criteria ISO 14971 - Medical Device Risk Management 3
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
T Design Input detail & specificity ISO 13485:2016 - Medical Device Quality Management Systems 4
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
D Design Transfer Template capturing Customer Specific Requirements Other Medical Device Related Standards 3
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
M Looking for a Presentation on Design for Excellence (DfX) Manufacturing and Related Processes 2
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
R Design and Manufacture Guidelines for Surface Mount Technology Misc. Quality Assurance and Business Systems Related Topics 9
optomist1 Design Exclusion, but now we might have an outsourced Product Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Relabeler for patent expired product - design control responsibilities? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Supplier of design and manufacture process ISO 13485:2016 - Medical Device Quality Management Systems 10
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A Design process goal for ISO 9001 Manufacturing and Related Processes 23

Similar threads

Top Bottom