Filter posts by category

Design Control

Design Controls, 21 CFR 820.30, ISO 13485, Clause 7.3, Do It By Design, Waterfall Diagram, Verification and Validation, V&V, IOVV, Stage-Gate process, Design History File and DHF.

Avoiding Clinical Evaluation Report (CER) Pitfalls

1 Comment / Design Control / By

This article explains the key steps to preparing a successful clinical evaluation report (CER) for the submission of a technical file for medical device CE Marking.

Photo for Clinical Evaluation Report Blog 1024x931 Avoiding Clinical Evaluation Report (CER) Pitfalls
Once someone shows you the most efficient path, climbing the wall no longer seems so challenging.

Essential requirement 6a, the clinical evaluation report (CER), is required for all medical devices that are CE Marked. Up until the Medical Device Directive (MDD) was modified in 2010 (i.e., 2007/47/EC), only high-risk devices required a clinical evaluation report. After the MDD was changed, a CER was needed for all medical devices–even Class I devices that do not require a Notified Body. To help manufacturers understand the expectations and comply with this requirement, a guidance document was released for clinical evaluations in December of 2009 (i..e., MEDDEV 2.7/1 rev 3). MEDDEV 2.7/1 indicates that are there are three options for preparing a clinical evaluation report:

  1. perform a clinical study and summarize the results,
  2. perform a literature search of clinical study articles, or
  3. a combination of the first two options.

Preparing clinical evaluations are tedious but not necessarily challenging. I like to compare the preparation of clinical evaluation reports to bouldering problems. Once someone shows you the most efficient path, climbing the wall no longer seems so challenging.

Literature Search Protocol (TMP-004)

Section 6.1 of the guidance document indicates that a literature search protocol should be used to identify, select, and collate clinical study articles for a literature search. Critical elements of your search protocol should include: which search databases you selected and why, intended use and indications for the use of the device, similar devices that are on the market and a comprehensive date range starting with the earliest clinical studies or the last date of a previous clinical evaluation. Your search protocol should specify inclusion and exclusion criteria, and you will need a systematic method for tracking your results.

I created a protocol template, TMP-004, which I use to perform clinical literature searches. The protocol includes suggested databases for literature sources, a list of adverse event databases, and a database for clinical investigations that should be included in your search. The protocol also includes criteria for evaluating the results of the search. Evaluation criteria should consist of the type of clinical study, the number of patients, the study design, etc.

Qualified Individuals

To conduct a clinical evaluation, you need a cross-functional team–as you should have for all post-market surveillance and risk management activities. One of the team members should be an expert in the design of the device or similar devices. Another person should be an expert in performing literature searches to ensure that the review of the literature is comprehensive. Finally, the team needs at least one person with a clinical research perspective to evaluate the clinical data critically. The qualifications of these individuals should be described in an appendix of your clinical evaluation report, and typically this is done by providing a copy of each person’s resume or curriculum vitae. The omission of these qualifications or the failure to rely upon clinical experts to review the data is a common nonconformity raised by technical reviewers from Notified Bodies.

Selection of Databases

When you are writing a literature search protocol, it is essential to specify why you selected certain search databases and to ensure that you include more than one database. Each literature search database has different strengths and weaknesses. Suppose you are not sure which databases to choose and why this is an indication that you need assistance with the literature search methodology. This is typically part of the process for teaching doctoral candidates how to prepare for writing their dissertation. Therefore academic credentials of the individuals contributing to the post-market surveillance activities are relevant.

Selection of Key Words

Often certain keywords are more common in the title of clinical study articles than others, and these keywords can help narrow the number of literature search results dramatically. Therefore, it is recommended to perform some preliminary searches with different keywords to get a sense of which terms will be the most efficient in helping you to identify the articles that meet your inclusion criteria. These terms can also be used to exclude large numbers of articles that are not relevant. For example, if there are a large number of porcine studies in the literature, you might exclude the term “porcine” to ensure that animal studies involving pigs are excluded from your search results.

Inclusion & Exclusion Criteria

Many times articles will mention a keyword or the name of a device, but the device is only mentioned as an accessory in a study rather than being the focus of the study. If the article only says the device but doesn’t include clinical data regarding its use, then the article should be excluded. Only human studies should be included in your results, and if there are a large number of published studies, you may purposely choose to exclude articles with the terms “case study” that may only include one or two patients.

Addressing Risks

Your clinical evaluation report (CER) is intended to assess the safety of your device by identifying any potential risks that you may have overlooked in your risk analysis and to help you estimate the severity of harm and the probability of occurrence for those harms. It is recommended to perform a preliminary hazard identification and risk analysis before conducting the clinical evaluation to identify the most likely risks associated with the device. Each of these risks should be mentioned explicitly in the clinical evaluation–even if the clinical study data does not identify the risk. If a specific risk is identified during your hazard identification with no clinical data to support the safety of the device related to that risk, then it may be necessary to conduct a clinical study or a post-market clinical follow-up (PMCF) study to evaluate the risk further.

Review of Post-Market Surveillance

When your device is first submitted for CE Marking, you may not have any clinical history with the device, and it is only possible to estimate risks. For this reason, it is important to include post-market surveillance information about similar products as an input to your clinical evaluation process. After your product is launched, you will have a complaint handling data and adverse event data specific to your device. Therefore, you should periodically review the post-market surveillance data and compare it with the initial risk estimates. If the results are similar, then the risk analysis does not need to be updated immediately. If the post-market surveillance results are substantially different from your risk estimates, you should update your clinical evaluation report earlier than planned and update your risk analysis. I recommend stating this conclusion in each report summarizing post-market surveillance data–including a specific recommendation to maintain the current plan for the frequency of conducting clinical evaluations or a recommendation to change the schedule.

Appraisal of Clinical Literature

Your appraisal of clinical literature needs to be systematic and documented. Technical reviewers expect clinical data that supports and detracts from the conclusion that your device is safe and effective for the desired indications. Therefore, you should not exclude articles simply because the findings are negative. You need to include appraisal criteria in your protocol to ensure that the evaluation of literature search results is objective and systematic. I have included a recommended grading system for clinical study articles in my procedure for clinical evaluation reports (i.e., SYS-041). The graded results of each article identified are then summarized in the Appendices of the clinical evaluation report (CER).

Review and Update of Clinical Evaluation Reports (CERs)

Preparing a clinical evaluation report (CER) is time-consuming, but the report is also a living document. Therefore, you need to have a post-market surveillance plan for each medical device or device family that specifies the frequency of performing a review and update of your clinical evaluation report (CER). Depending upon the nature of your device and the amount of clinical history you have with that device, you may also need to conduct a post-market clinical follow-up study (PMCF). Any post-market surveillance that you conduct should be included as an input to the clinical evaluation report. This is why my literature search protocol includes adverse event databases.

Procedures & Templates

If you are looking for a procedure and literature search protocol for preparing a clinical evaluation report (CER), please click here. If you are interested in learning more about post-market surveillance and post-market clinical follow-up (PMCF) studies, we also have a webinar on this topic.

Photos shown in this article are two of my sons, Alex Beshay (13) and Bailey Packard (14), at this weekend’s bouldering competition at PETRA Cliffs in Burlington, VT. Every member of our family is an avid rock climber, including my 3-year-old daughter.

Avoiding Clinical Evaluation Report (CER) Pitfalls Read More »

Updates on Electrical Safety Standards for Medical Devices-IEC 60601

Leave a Comment / Design Control / By / , , ,

This blog summarizes updates on electrical safety standards for medical devices for standard IEC 60601.

electrical saftey 1 Updates on Electrical Safety Standards for Medical Devices IEC 60601

OSHA finally approved some Nationally Recognized Test Laboratories (NRTL) to AAMI ES 60601-1 (equivalent to IEC 60601-1 edition 3.1 or 3rd ed + A1). Leo Eisner posted a blog summarizing this change (http://bit.ly/OHSA-NRTL-Approval-Update) on January 7, 2015. The blog identifies which labs can issue NRTL Marks and which test labs have OSHA approval in progress. UL 60601-1 is still an approved standard that an approved NRTL can issue an NRTL test mark to, but a few of the NRTLs are now authorized to issue an NRTL Mark to AAMI ES 60601-1 3rd edition + Amendment 1.

The best place to confirm if a Safety Test Lab is an approved NRTL for your medical device is by confirming the notifications published in the U.S. Federal Register. You can also visit the OSHA NRTL website (https://www.osha.gov/nationally-recognized-testing-laboratory-program), but the OSHA website is updated less frequently. Eventually, UL will formally announce the withdrawal of UL 60601-1, and OSHA will take steps to withdraw that Standard from their list of Approved Standards.

On January 14, 2015, Leo Eisner posted a second blog (https://eisnersafety.com/2015/01/14/pre-release-of-iec-60601-2-52-1st-ed-amendment-1-medical-beds/#.VOzViE33-iw) on the topic of IEC 60601-2-52 Medical beds as a pre-release. He discusses the actual changes between the 1st edition and 1st edition + A1. This version is the pre-release before the updated Standard is issued as an International Standard (IS), and it is currently available as a Final Draft International Standard (FDIS). IEC website (http://bit.ly/buy-IEC60601-2-52-amd1-ed1) states: “By purchasing this FDIS now, you will automatically receive, also, the final publication.” The voting period ended on February 13, 2015, and the FDIS should be published shortly after (forecasted to be published on March 27, 2015).

Leo’s blog summarizes each of the changes to the Standard. Among the changes, there is a specific requirement to include hazards related to patients taller than 185 cm (like me). These hazards should be included in the risk management file. The new symbols required to identify the requirements for an “adult” are below: 

electrical Saftey 2 Updates on Electrical Safety Standards for Medical Devices IEC 60601

I find this new symbology particularly interesting because there are many medical devices where users frequently select the incorrect size for the patient. Consistent internationally recognized symbology for weight and height would be helpful for these devices, and bariatric specialty devices could benefit from the use of the last symbol.

If you need additional support for any of the IEC 60601 series of standards, please contact Rob Packard by email or phone (+1.802.281.4381) to discuss your specific needs.

Updates on Electrical Safety Standards for Medical Devices-IEC 60601 Read More »

IEC 60601-1 patient applied parts for Medical Electrical Equipment-Notes 1-2-3

7 Comments / Design Control / By / , ,

In this blog, “IEC 60601-1 patient applied parts for Medical Electrical Equipment-Notes 1-2-3,” the author uses many figures to explain critical concepts. 

Note 1: Figures that explain APPLIED PART concepts

In IEC 60601-1, Figures 3 and 4 (shown below) are used to show where different parts of ME EQUIPMENT are located, and to help explain some of the defined terms in a pictorial way.

fig 3 AM IEC 60601 1 patient applied parts for Medical Electrical Equipment Notes 1 2 3

 

fig 4 IEC 60601 1 patient applied parts for Medical Electrical Equipment Notes 1 2 3

In both figures, the APPLIED PART is intended to come into contact with the PATIENT. Figure 3 shows a CLASS I medical device as per sub-clause 3.13. The device is PROTECTIVELY EARTHED (i.e., grounded), in addition to providing BASIC INSULATION. Figure 4 shows a CLASS II medical device per sub-clause 3.14. The device is not PROTECTIVELY EARTHED. Instead, Figure 4 shows how the design uses two levels of protection, which is a basic tenet of the IEC 60601-1 standard. The two levels of protection used are either DOUBLE or REINFORCED INSULATION.

Figures A.1 to A.7 provide examples of the way APPLIED PARTS and PATIENT CONNECTIONS are identified to apply the requirements for PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT. APPLIED PART circuits can provide isolation to other parts of the circuitry in the medical device, and these figures present several options for compliance with SPACINGS (i.e., CREEPAGE and AIR-CLEARANCE), DIELECTRIC WITHSTAND (i.e., HiPot test) and INSULATION requirements. The following discussion is limited to Figures A.1 and A.2. For additional information about Figures A.3-A.7, purchase a copy of IEC 60601-1, edition 3.0 (http://bit.ly/IEC60601-1) or edition 3.1 (http://bit.ly/IEC60601Consolidated).

a 1 IEC 60601 1 patient applied parts for Medical Electrical Equipment Notes 1 2 3

Figures A.1 and A.2 show an ECG monitor that includes the monitor, PATIENT cable, PATIENT leads, and ECG electrodes. The critical elements of figure A.1 are:

1)     the APPLIED PARTS includes the electrodes and those parts of the PATIENT leads, or PATIENT cable that need to physically contact the PATIENT in NORMAL USE (sub-clause 3.8 definitions),

2)     application of RISK MANAGEMENT might id other parts of the PATIENT leads or PATIENT cable that needs to treated as APPLIED PARTS because of the probability they will come in contact with the PATIENT, (sub-clause 4.6 requirements), and

3)     the PATIENT CONNECTIONS consist of the ECG electrodes, which are part of the same function of the APPLIED PART.

Figure A.2 below shows the required F-TYPE APPLIED PART insulation incorporated in the medical device itself. The components within the dotted line form the PATIENT circuit.

a 2 IEC 60601 1 patient applied parts for Medical Electrical Equipment Notes 1 2 3

Note 2: Parts that are not APPLIED PARTS may need to be treated as an APPLIED PART

Sub-clause 4.6 and Annex A, sub-clause 4.6, provide additional details that apply to the following paragraph below.

Parts of medical devices that are not APPLIED PARTS, but which touch the PATIENT during the NORMAL USE of the device, may need to be treated as APPLIED PARTS. In this case, the part shall not be marked as an APPLIED PART. A RISK ASSESSMENT PROCESS needs to be conducted to determine whether the parts that come in contact with the PATIENT but aren’t APPLIED PARTS should meet the requirements of APPLIED PARTS. Figures A.4 through A.7 all have a statement that roughly states: “The application of RISK MANAGEMENT might identify some parts of the device/system as having to be treated as APPLIED PARTS because of the probability they will come in contact with the PATIENT.” If your RISK ASSESSMENT determines that sub-clause 4.6 is applicable, then all applicable requirements and tests for APPLIED PARTS should be applied to the parts identified in the RISK ASSESSMENT—except for sub-clause 7.2.10 for marking of APPLIED PARTS. These requirements apply to this standard and the relevant collateral and particular standards in the 60601 series of standards. An example of the type of parts that could fall under sub-clause 4.6 could be computer system interface cable (I/O).

Note 3: Definition of associated term PATIENT CONNECTION

A PATIENT CONNECTION is part of the APPLIED PART, as shown in figure A.1. Sub-clause 3.78 defines a PATIENT CONNECTION as: “Individual point on the APPLIED PART through which current can flow between…PATIENT and ME EQUIPMENT in NORMAL…or SINGLE FAULT CONDITION.” In this example, the conductive part of the ECG electrode is considered the PATIENT CONNECTION.

partial a1 IEC 60601 1 patient applied parts for Medical Electrical Equipment Notes 1 2 3

IEC 60601-1 assumes the PATIENT is earthed as a NORMAL CONDITION per sub-clause 8.5.4, 4th dashed item because there are many opportunities in the normal operation of medical electrical devices where the PATIENT can accidentally become grounded. Therefore, some PATIENT LEAKAGE CURRENT tests are configured with the LEAKAGE CURRENT measuring device (see Figure 12) directly connected to earth on one side and passing thru the measuring device to the APPLIED PART circuit that is being tested. The boxed-in area in Figure 15 is the portion of the PATIENT LEAKAGE CURRENT test measuring circuit that is connected from the PATIENT CONNECTION (item 4) thru the measuring device to earth (left-hand corner of the figure—symbol sometimes called “upside-down Christmas tree”).

fig 12 IEC 60601 1 patient applied parts for Medical Electrical Equipment Notes 1 2 3

 

fig15 IEC 60601 1 patient applied parts for Medical Electrical Equipment Notes 1 2 3

Leo Eisner is the owner and founder of Eisner Safety Consultants (http://bit.ly/LeoEisner). If you need help with IEC 60601 compliance, email Leo directly at Leo@EisnerSafety.com or call him at +1 (503) 244-6151.  You can also connect on LinkedIn at http://bit.ly/ConnectwithLeo.

 

IEC 60601-1 patient applied parts for Medical Electrical Equipment-Notes 1-2-3 Read More »

IEC 60601-1 Definition of Patient Applied Parts

6 Comments / Design Control / By / ,

iec 60601 1 me IEC 60601 1 Definition of Patient Applied Parts

This article reviews the IEC 60601-1 definition of patient applied parts for medical electrical equipment. It includes examples, as well.

Classification of medical electrical devices was discussed in a previous blog (http://bit.ly/IEC60601-FAQ). At the same time, this article focuses on APPLIED PARTS—one portion of the “Protection Against Electric shock” classification in sub-clause 6.2 of IEC 60601-1. ALL CAPITAL LETTERS identifies a defined term for the IEC 60601 series of standards within this blog.

All clause references in this blog are to both IEC 60601-1:2005 (3rd edition) and IEC 60601-1:2005 (3rd edition) + Amendment 1:2012 (http://bit.ly/IEC60601-1am1), or the consolidated version IEC 60601-1:2012 ed. 3.1, but the actual text comes from edition 3.1 (http://bit.ly/IEC60601Consolidated).

Definition

To understand what an APPLIED PART is, we first need to understand its definition. Sub-clause 3.8 states that an APPLIED PART is “part of ME EQUIPMENT that in NORMAL USE necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function.”

Examples

An APPLIED PART can be a blood pressure cuff or a SpO2 sensor of a multi-parameter monitor, the tabletop of an MRI, and many other parts of ME EQUIPMENT that manufacturers intend to come into contact with a PATIENT during NORMAL USE.

iec 60601 1 me 2 IEC 60601 1 Definition of Patient Applied Parts

Electrical-medical devices can have different types of APPLIED PARTS or more than one of the same type (e.g., multi-parameter monitors frequently have temperature sensors, and blood pressure monitoring components in the base configuration and other APPLIED PARTS can be added). As discussed in the previous blog (http://bit.ly/IEC60601-FAQ), APPLIED PARTS can have six different classifications: TYPE B, BF, or CF (and each can be DEFIBRILLATION PROOF). Each of these classifications also has an associated symbol.

The requirements for an APPLIED PART are more stringent because it has to be assumed that the PATIENT’s immune system is depressed. So, the probability of HARM is increased for a sick PATIENT, rather than for a healthy OPERATOR. Therefore, the standard aims to reduce the severity of HARM by requiring more stringent limits upon LEAKAGE CURRENTS. The computer equipment standard (IEC 60950-1 Information Technology Equipment Standard) applying to your home or business computer allows for higher limits for LEAKAGE CURRENTS because the computer equipment standard assumes the user is healthy—just like medical equipment operators.

The level of HARM to a PATIENT by an APPLIED PART can be adversely affected if a PATIENT is not conscious (e.g., during general anesthesia), because the PATIENT may be unable to react while they are unconscious. Therefore, understanding a device’s intended use (i.e., what the device is intended to do), and indications for use (i.e., the environment of use, part of the anatomy and intended population), is critical when you are conducting RISK ANALYSIS and USABILITY ANALYSIS of a device. 

Three Notes About the IEC 60601-1 Definition of Patient Applied Parts

There are three (3) notes associated with the definition of APPLIED PART:

  1. Sample figures that show APPLIED PARTS in different system configurations
  2. Parts of the device that are not APPLIED PARTS, but in NORMAL USE necessarily come into physical contact with the PATIENT, shall be treated as APPLIED PARTS, but is not allowed to be marked as an APPLIED PART; and
  3. The associated term PATIENT CONNECTION

The sample figures related to the first note, Figures 3 & 4 and figures A.1 to A.7 of Annex A, show APPLIED PARTS in different system configurations. These figures provide guidance and a rationale for why and what is happening. The second note is important because any part that necessarily comes into physical contact with the PATIENT, for the equipment to perform its function, will also need to be tested as if it were an APPLIED PART. Still, it will not be allowed to be marked as such. The third note regarding PATIENT CONNECTION, in sub-clause 3.78 & Annex A for 3.78, is the part of the APPLIED PART that is intended to contact the PATIENT that current flows through. The next blog will review all three notes in greater detail.

If you need help with the IEC 60601 series of Standards, email Leo Eisner (http://bit.ly/ConnectwithLeo) directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the owner and founder of Eisner Safety Consultants (http://bit.ly/LeoEisner).

IEC 60601-1 Definition of Patient Applied Parts Read More »

Regulatory Consulting Firm Selection

Leave a Comment / Design Control / By / , , ,

Things to consider for regulatory consulting firm selection: 1) the project scope, 2) personality, 3) qualifications, and 4) budget.

choosing a consultant 300x300 Regulatory Consulting Firm SelectionRegulatory Consulting Firm Selection

This article reviews four key considerations of regulatory consulting firm selection. Even if you already have a vice president of regulatory affairs, you still might need external regulatory consulting expertise. Regulatory consultants specialize in just the regulations and most have sub-specialties because it is impossible to know the medical device regulations in every country. Another reason for hiring a regulatory consultant is that you do not have enough bandwidth to conduct the regulatory work internally. Regardless of the scope of the project, this is a strategic decision rather than a tactical one. Regulatory approval impacts your company’s ability to sell devices and therefore a few months of delay can result in a six or seven-figure loss. In addition, the cost of the regulatory consulting fees is likely to be at least five figures. Finally, a purchasing decision of this magnitude will require C-suite approval and your Board of Directors and/or investors may get involved. Here are four critical areas to consider:

1. Defining the scope of the regulatory consulting project

Ensure that the scope, timeline, roles of the consultant/internal company team, and deliverables are crystal clear during consultant interviews and defined within the consulting contract. Do you need advice or suggestions to be carried out by your internal team? Or is “hands-on” work required (writing procedures, conducting training, executing audits, etc.)? I’ve discovered that “hands-on” can mean something entirely different to your company and the consultant. If it’s not clear who is doing the actual work, your internal resources may end up doing the work that was intended for the consultant.

Once the project scope has been clearly explained, ask the prospective consultant to provide a brief document describing how they would approach the project. This will be helpful later on when drawing up the contract. Ask which software or systems the consultant will be using to keep your project on track. A consultant who does not have any version of project management on their laptop, or is unfamiliar with such tools, is a red flag.

Make sure you select a consultant or consulting firm that matches the size of your project. Select and interview three to five companies, based on the size and complexity of the project. If the project primarily involves working at your location, consider the additional cost and travel time from where the consultant(s) is located. If the project allows for working remotely, focus more on the project management aspects mentioned in the previous paragraph, and how your company will communicate with the consultant.

2. Personality of the consultants

When you are making a regulatory consulting firm selection, don’t base your decision on word of mouth, or someone that you pick randomly online. Interviewing is an essential part of the selection process. Be wary of a consultant who talks more than listens, especially if the conversation is about their illustrious career. The consultant you speak with should be focused on the scope of your project and ask questions about your company’s capabilities. You are the client and ultimately your team will be the hero that brings a new medical device to market. The consultant you hire is an experienced guide that has learned from success and failures. Ideally, the consultant will be able to explain the process in simple terms and help you identify critical tasks in the project. Be wary of the consultant that answers every question with “It depends.” If your team’s style of project management and communication doesn’t fit the consulting firm’s style, keep looking.

3. Qualifications of the regulatory consulting firm

Don’t limit interviewing to the experience of the lead consultant or owner of the consulting firm. Make sure that you also have a resume or CV for each of the other consulting members that will be working on your project. Imagine the dismay of your internal team when you discover that the owner of the consulting firm has hired friends or former colleagues with little or none of the needed expertise. To prevent this scenario from occurring, include a technical person on the interview team to challenge the expertise of the consultant. This will help you identify a firm that knows all the right buzzwords but lacks the knowledge to accurately implement the deliverables and reduce regulatory risk within your company. Ideally, the consulting firm will have a step-by-step plan and they are able to identify the biggest potential obstacles.

You can ask for and check references for past clients for whom they have done similar work, but people seldom give you the name of a referral that will speak negatively about them. Ask for examples of work reports that the consultant has completed for other clients—with any confidential information removed. This is critical in determining if the final job will be “fluff” or real solutions for your company. It will also avoid the “one size fits all” procedures and processes that can rarely be beneficial for your company’s needs. Ask for examples of “out of the box” thinking and best practices that they’ve implemented. How do they remain current on the regulations and standards?

4. Budget for a regulatory consulting firm

Cost should not be the only determining factor in selecting a consultant. When you’re choosing someone to pave your driveway, you may be able to get away with this. When choosing a regulatory consultant for your medical device company, you want several bids, and you want to ensure that each party is bidding against the same scope and deliverables. However, choosing the least expensive bid over the one with the most expertise and best reputation may cost your company more in the long run if the work isn’t properly done or completed on time.

Contracts must be very specific with regard to milestones, timelines, and deliverables with respect to the payment schedule. What recourse does your company have when a consultant assures you during the interview process that they can meet your every need and then doesn’t? No company wants to have to pay for work that hasn’t been done and may never get done.

If the regulatory consultant is working on-site, be clear about work accommodations – office, cube, conference room, phones, access to printers and company databases, so that there are no misunderstandings once the job starts or excuses for why the work can’t get done “under these conditions.” 

Conclusion

Making the best regulatory consultant firm selection is critical. If you are careful in your selection of a regulator consulting firm, you should expect an earlier market launch and a predictable process.

Regulatory Consulting Firm Selection Read More »

IEC 60601 Medical Electrical Equipment Classification: FAQs

8 Comments / Design Control / By / , , ,

IEC 60601 medical electrical equipment classification frequently asked questions are discussed in this blog. 

subclause IEC 60601 Medical Electrical Equipment Classification: FAQs

All clause references in this blog are to both IEC 60601-1:2005 (3rd edition) and IEC 60601-1:2005 (3rd edition) + Amendment 1:2012, or the consolidated version IEC 60601-1:2012 ed. 3.1, but the actual text comes from edition 3.1.

Note 1: ALL CAPITAL LETTERS identifies a defined term for the IEC 60601 series of standards within this blog.

Note 2: The current version of IEC 60601-1 is now ed 3.2.

What are the various classifications that are used in IEC 60601-1, edition 3.1?

The table at the beginning of this blog posting identifies the five parts of the Classification section. Each classification is described in more detail below.

Why do I need to classify my product for IEC 60601-1, 3rd ed.?

The standard says you have to classify “…ME EQUIPMENT, or parts thereof, including applied parts…” as noted in sub-clause 6.1. But a more practical reason you would want to classify your products that fall under the scope of IEC 60601-1 is it is a helpful tool in identifying the requirements that apply to the device and helps us in determining the test plan for the product to be tested.

What is an applied part?

The definition of an APPLIED PART is in sub-clause 3.8 of the standard. It states that an APPLIED PART is “part of ME EQUIPMENT that in NORMAL USE necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function.” So, it can be a cable, lead, electrode, or many other parts of an ME EQUIPMENT, or an ME SYSTEM that is intended, by the manufacturer, in its NORMAL USE to come in contact with the PATIENT.

What are the classifications for Protection Against Electric Shock?

Two classifications fall under sub-clause 6.2 of the standard: 1) the power source, and 2) applied parts. Power sources can be an external power source and is either classified as a class I or class II ME EQUIPMENT or an internal power source, which is classified as INTERNALLY POWERED MEDICAL EQUIPMENT.

Power Sources – External Class I, External Class II, or Internal

Class I provides its protection against electric shock by having an additional safety ground (known as PROTECTIVELY EARTHED) that is connected to the internal and/or external conductive parts (metal) of the power source. Class II provides its protection against electric shock by having an additional layer of insulation beyond that of BASIC INSULATION (a single layer of insulation) and is provided either by DOUBLE INSULATION (two layers of insulation) or by REINFORCED INSULATION (the same as for DOUBLE INSULATION, but as one insulation system that is twice as thick, typically). An internal power source is usually a battery.

Applied Parts – B, BF, CF (also defibrillation-proof)

The second classification for protection against electric shock is for APPLIED PARTS. APPLIED PARTS are classified in one of six ways, and a product can have more than one type of APPLIED PARTS. The classifications for applied parts are type B, BF, or CF. Each of these three classifications can be DEFIBRILLATION-PROOF APPLIED PARTS for a total of 6 classifications. There are six separate symbols for these APPLIED PARTS, and they are noted in the table below, which comes from Table D.1 of Annex D of the standard.

symbols IEC 60601 Medical Electrical Equipment Classification: FAQsWhy do we have classifications for protection against electric shock?

Protection against electrical shock is important because electric shock is one of the main areas of concern in most electrical safety standards as the shock hazard can cause harm to the OPERATOR or PATIENT or even death. The main reason is we want to protect the PATIENT, who may have a depressed immune system from getting an electric shock that could injure or potentially kill the PATIENT. The depressed immune system makes them more likely to be harmed by an electric shock. We also want to consider the OPERATOR of the device, but they should not have a depressed immune system, so the worst-case to consider is the PATIENT.

What are the classifications for protection against harmful ingress of water or particulate matter?

There is a wide variety of these classifications (per sub-clause 6.3 of IEC 60601-1), and they are based on the standard IEC 60529 titled “Degrees of protection provided by enclosures (IP Code).” The IP Codes range from IP00 to IP68, which means respectively no protection against contact and ingress of objects along with not being protected against liquid ingress (IP00) to No ingress of dust; complete protection against contact along with protected against the effects of continuous immersion in water (IP68).  Table D.3, 2nd row (copied below), in the IEC 60601-1 standard details all the classifications in a summary list.

ipnn IEC 60601 Medical Electrical Equipment Classification: FAQsWhy do we have classifications for protection against harmful ingress of water or particulate matter?

The reason we want to protect the ENCLOSURES of the device is to protect against ingress of these items (liquids and particulates), so they reduce the possibility of causing a hazard, such as a short based on bridging the electronics of the device causing potentially a fire hazard, a shock hazard, a thermal hazard, or other potential hazards.

What are the classifications for methods of sterilization?

For any part of the ME EQUIPMENT or its parts intended to be sterilized needs to be classified per the requirements of sub-clause 6.4. Classifications are based on the types of sterilization methods used in the medical device industry currently such as ethylene oxide (EtO), irradiation by gamma radiation, and moist heat by autoclave. The standard also mentions “…other methods validated and described by the MANUFACTURER.” Classification of sterilization methods is critical because each sterilization method presents unique environmental conditions that can adversely affect the ME EQUIPMENT. For example, EtO Sterilization frequently includes a vacuum cycle which may not be suitable for embedded batteries.

Why do we have a classification for suitability in an oxygen-rich environment?

The RISK of fire in an OXYGEN RICH ENVIRONMENT is considered to exist when a source of ignition is in contact with ignitable material (i.e., flammable materials) and there is no barrier (i.e., a solid enclosure) to prevent the spread of fire.

What are the classifications for modes of operation?

There are two modes of operation described in IEC 60601-1, edition 3.1: 1) CONTINUOUS OPERATION, and 2) non-CONTINUOUS OPERATIONS. When a device is classified as non-CONTINUOUS OPERATION, there is some type of duty cycle involved, so the device is rated properly. A duty cycle means the device is rated to be on for a certain period of time and off for a certain period of time. Many times the duty cycle is required, so a device may pass the EXCESSIVE temperatures in the ME EQUIPMENT test in sub-clauses 11.1.1 & 11.1.2 so as not to exceed the limits of the test requirements.

The Author

Leo Eisner 2024 IEC 60601 Medical Electrical Equipment Classification: FAQsIf you have questions about this topic or need help with compliance to the IEC 60601 series of Standards, you can email Leo Eisner (the “60601 Guy”) directly at Leo@EisnerSafety.com or call Leo at +1-(503)-244-6151. He is the owner and founder of Eisner Safety Consultants.

IEC 60601 Medical Electrical Equipment Classification: FAQs Read More »

What is the IEC 60601 Scope?

19 Comments / Design Control / By / , ,

This blog explains the IEC 60601 scope to help you determine if and how IEC 60601-1 applies to your medical electrical equipment.60601 300x274 What is the IEC 60601 Scope?

The first question to ask about IEC 60601 Scope

One of the first questions clients ask before a project starts is, “Does this medical electrical product fall under IEC 60601-1?” Another common question clients ask is whether IEC 60601-1 applies to battery-operated medical devices. To answer these questions, we must review and understand the scope (sub-clause 1.1) of IEC 60601-1 to determine if and how the IEC 60601-1 Standard applies to a medical electrical product.

The title of IEC 60601-1:2005 (3rd edition) is Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. The IEC 60601-1 Standard itself states, “This…Standard applies to…MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS…referred to as ME EQUIPMENT and ME SYSTEMS.”

*Note: ALL CAPITAL LETTERS identifies a defined term for the IEC 60601 series of standards within this blog. “IEC” is an acronym for the International Electrotechnical Commission. IEC is a non-profit, non-governmental international standards organization that prepares and publishes International Standards for all electrical, electronic, and related technologies.

All clause references in this blog are to both IEC 60601-1:2005 (3rd edition) and IEC 60601-1:2005 (3rd edition) + Amendment 1:2012, or the consolidated version IEC 60601-1:2012 (edition 3.1), but the actual text comes from edition 3.1.

Definitions 

The ME EQUIPMENT definition (sub-clause 3.63) is:

“…equipment…

a)    provided with not more than one connection to a particular SUPPLY MAINS, and

b)    intended by its MANUFACTURER to be used:

1)    in the diagnosis, treatment or monitoring of a PATIENT; or

2)    for compensation or alleviation of disease, injury, or disability.”

and “…having an APPLIED PART or transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT….”

Note: The above definition aligns well with the description of medical electrical devices in the European Medical Device Regulation.

From the definition above, we know that a device can have up to one power cord, or be hard-wired to the building’s power by one power line, and/or be battery powered.

We also need to understand the term APPLIED PARTS (sub-clause 3.8): “Part of…ME EQUIPMENT…in NORMAL USE necessarily comes into physical contact with the PATIENT for…” the device “…to perform its function.” Classification of the different types of APPLIED PARTS and other classifications (there are eight different classification criteria in the IEC 60601 Standard) need to be completed early in the process of setting up a test plan for design verification to determine the applicable testing requirements, and to develop an appropriate test plan.

Examples within Scope of IEC 60601-1:2005

Examples of electrical medical products fitting the definition above are broad and include battery-operated thermometers, gamma imaging systems, endoscopic cameras, and infusion pumps. IEC 60601-1 may also apply to many ACCESSORIES (sub-clause 3.3) used with ME EQUIPMENT.

Examples not within Scope of IEC 60601-1:2005

The scope of IEC 60601-1 also identifies which devices are not included in the IEC 60601 series:

  • “in vitro-diagnostic equipment…IEC 61010 series;
  • implantable parts of active implantable(s) … ISO 14708 series…;
  • medical gas pipeline systems…ISO 7396-1…”

IEC 60601 & ISO 13485

Design verification must confirm that design outputs (i.e., – product specifications) meet design inputs (e.g., – product must meet IEC 60601-1 requirements).

Many projects don’t identify all the applicable IEC 60601 standards. This could cause multiple nonconformances during an audit by the national regulatory body (i.e., FDA, EU Notified Body), or that you don’t obtain approval to sell and distribute your device from the national regulatory body.

A test plan, with multiple test protocols, is developed from the product specification. This test plan should identify all the requirements of the IEC 60601 series of standards, in addition to any other applicable standards and regulations that apply to the device before performing device testing.

Third-Party Testing

IEC testing can be performed by a third-party test house (i.e., – a safety certification agency, such as a BV, UL, CSA, TÜV SÜD),  an independent test lab (i.e., Medical Equipment Compliance Association), or the manufacturer can conduct the testing if they have the proper equipment, trained personnel and a good understanding (i.e., – used the Standard on several projects, and successfully tested previous similar electrical medical device(s) by a third-party test lab, and been approved by a national regulatory body) of the Standard (s). However, for OSHA compliance in the USA, IEC testing should be performed by an Nationally Recognized Testing Laboratory (NRTL).

Design verification reports generated from the test process are either the applicable IEC 60601, and IEC 80601 series of standards test report forms or the manufacturer’s generated test reports.

The Author

Leo Eisner 2024 What is the IEC 60601 Scope?If your company needs help with IEC 60601-1 gap analysis, preparation of the risk management file for the third edition, or training on the Standard, please contact Leo Eisner (the “60601 Guy”). Leo also created a training webinar series on IEC 60601-1, 3rd edition.

What is the IEC 60601 Scope? Read More »

TGA Joint Registry Report

1 Comment / Design Control / By / , ,

Therapeutics Goods Administration (TGA) published an assessment of Australia’s national joint replacement registry report.%name TGA Joint Registry Report

TGA Joint Registry Report

Annually the Therapeutics Goods Administration (TGA) publishes its assessment of the Australian Orthopaedic Association’s National Joint Replacement Registry (AOANJRR) report. This data is crucial to orthopedic companies as a recent source of post-market surveillance for their products and competitors and the development of Post-Market Clinical Follow-up (PMCF) study protocols.

You can download the most recent annual report, and the thirteen supplemental reports, from the following website: (http://bit.ly/AOA2013Reports). As you can see from the list below, this release is more extensive than previous annual reports that did not include the supplementary reports. This should be especially important for spinal companies that will be reclassifying (http://bit.ly/gapanalysiscmda) their CE Marked products from Class IIb to Class III and submitting a Design Dossier in 2014/2015.

2013 Annual Report

  • Hip & Knee Arthroplasty (September 1999 to December 2012) – 213 pages

2013 Supplementary Reports

  1. Analysis of State and Territory Health Data All Arthroplasty – 19 pages
  2. Cement in Hip & Knee Arthroplasty – 15 pages
  3. Demographics and Outcomes of Elbow & Wrist Arthroplasty – 32 pages
  4. Demographics and Outcome of Ankle Arthroplasty – 11 pages
  5. Demographics and Outcomes of Shoulder Arthroplasty – 65 pages
  6. Demographics of Hip Arthroplasty – 28 pages
  7. Demographics of Knee Arthroplasty – 23 pages
  8. Demographics of Spinal Disc Arthroplasty – 11 pages
  9. Lay Summary 2013 Annual Report Hip and Knee Replacement – 13 pages
  10. Metal on Metal Total Conventional Hip Arthroplasty – 13 pages
  11. Mortality following Primary Hip and Knee Replacement – 10 pages
  12. Revision of Hip & Knee Arthroplasty – 21 pages
  13. Unispacer Knee Arthroplasty – 6 pages
Post-Market Clinical Data

The requirement to conduct PMCF studies is not new. The release of MEDDEV 2.12/2 rev 2 in 2012 increased the orthopedic industry’s awareness of this tool’s purpose and importance. In Europe, Notified Bodies are required to verify that manufacturers have included a PMCF protocol as part of the Post-Market Surveillance (PMS) plan. The requirement for PMCF studies is found in Annex XIV of EU MDR. It states that “PMCF shall be understood to be a continuous process that updates the clinical evaluation.” 

Most orthopedics manufacturers attempt to provide a justification for not conducting PMCF studies, yet implant recalls, and the prevalence of revision surgery have increased the scrutiny around these justifications. Hamish Forster, a former Notified Body specialist at TUV SUD, wrote a white paper on “The Post-Market Imperative: Understanding the requirements for effective post-market clinical follow-up.”

TGA Joint Registry Report Read More »

How to Write Design Control Procedures

Leave a Comment / Design Control / By / , ,

The author has reviewed 100+ design control processes in his career, and this blog provides five steps to write design control procedures.

In my previous blog posting, I indicated six things that medical device companies can do to improve design controls. While the last posting focused on better design team leaders (WANTED: Design Team Needs Über-Leader), this posting focuses on writing stronger procedures. I shared some of my thoughts on how to write design control procedures just a few weeks ago, but my polls and LinkedIn Group discussions generated great feedback regarding how to write design control procedures.

No Need to Write Design Control Procedures

One of the people that responded to my poll commented that there was no option in the poll for “zero.” Design controls do not typically apply to contract manufacturers. These companies make what other companies design. Therefore, their Quality Manual will indicate that Clause 7.3 of the ISO 13485:2016 Standard is excluded. If this describes your company, sit back and enjoy the music.

1 Procedure Only

Another popular vote was “one.” If you only have one procedure for design controls, this meets the requirements. It might even be quite effective.

When I followed up with poll respondents, asking how many pages their procedures were, a few people suggested “one page.” These people are subscribing to the concept of using flow charts instead of text to define the design control process. I use the following diagram to describe the design process: The Waterfall Diagram!

waterfall diagram How to Write Design Control Procedures
From the US FDA Website.

I first saw this diagram in the first course I took on Design Controls. This is on the FDA website too. To make this diagram effective as a procedure, we might need to include some references, such as work instructions, forms, the US FDA guidance document for Design Controls, and Clause 7.3 of the ISO 13485:2016 Standard.

Many Design Control Procedures

The bulk of the remaining respondents indicated that their company has eight or more procedures related to design controls. If each of these procedures is short and specific to a single step in the Waterfall Diagram, this type of documentation structure works well. Unfortunately, many of these procedures are a bit longer.

If your company designs software, active implantable devices, or a variety of device types—it may be necessary to have more than one procedure just to address these more complex design challenges. If your company has eight lengthy procedures to design Class 1 devices that are all in the same device family, then the design process could lose some fat.

In a perfect world, everyone on the design team would be well-trained and experienced. Unfortunately, we all have to learn somehow. Therefore, to improve the effectiveness of the team, we write design control procedures for the team to follow. As an auditor and consultant, I have reviewed 100+ design control processes. One observation is that longer procedures are not followed consistently. Therefore, keep it short. Another observed is that well-designed forms help teams with compliance.

Therefore, if you want to re-write design control procedures, try the following steps:

  1. Use a flow chart or diagram to illustrate the overall process
  2. Keep work instructions and procedures short
  3. Spend more time revising and updating forms, instead of procedures
  4. Train the entire team on design controls and risk management
  5. Monitor and measure team effectiveness and implement corrective actions when needed

The following is a link to the guidance document on design controls from the US FDA website. In addition to the comments I made in this blog, please refer back to my earlier blog on how to write a procedure. You can also purchase Medical Device Academy’s design control procedure and forms.

How to Write Design Control Procedures Read More »

Design Team – Needs a Superwoman Leader

4 Comments / Design Control / By /

mona superwoman Design Team Needs a Superwoman Leader
“Mona Superwoman” by Teddy Royannez (France)

This blog discusses the reasons for a female design team leader and the qualities and skills that she should possess to get maximum results out of her team.

Last November, Eucomed published a position paper titled, “A new EU regulatory framework for medical devices: Six steps guaranteeing rapid access to safe medical technology while safeguarding innovation.” While I have serious doubts that any government will ever be able to “guarantee” anything other than its own continued existence, I have an idea of how the industry can help.

The position paper identified six steps. Each of these steps has a comparable action that could be taken in every medical device company. My list of six steps is:

Only the best leaders have:

  1. Only one approach to design controls
  2. Stronger internal procedures
  3. Cross-pollination by independent reviewers
  4. Clear communication of project status to management
  5. Better project management skills

The most critical element to success is developing stronger design team leaders. Design teams are cross-functional teams that must comply with complex international regulations while simultaneously be creative and develop new products. This type of group is the most challenging type to manage. To be successful, design team leaders must be “Über-Leaders.”

Critical Design Team Leader Skills

The most critical skills are not technical skills but team leadership skills. The role of a design team leader is to ensure that everyone is contributing, without tromping on smaller personalities in the group. Unfortunately, there are more men in this role than women.

Why is this unfortunate? Because men have difficulty when it comes to listening (takes one to know one).

We need a leader that will be strong, but we also need someone that is in touch with the feelings of others and will use that skill to bring out the best of everyone on the team. This superwoman also needs to earn the respect of the male egos around the table. She needs to be an expert in ISO 14971, ISO 13485, Design Controls, Project Management, and managing meetings. Our beautiful heroine must also be a teacher because some of our team members will not know everything—even if they pretend to.

The Über-Leader will always remind the team that Safety & Efficacy are paramount. As team leaders, we must take the “high road” and do what’s right—even when it delays a project or fails to meet our boss’s unrealistic timetable. Superwoman must demand proof in the form of verification and validation data. It is never acceptable to go with an opinion.

She will remind us that compromise is the enemy, and we must be more creative to solve problems without taking shortcuts that jeopardize safety and efficacy. She will work harder on the project than anyone else on the team. She will keep us on schedule. She will whisper to get our attention, but she won’t be afraid to yell and kick our ass.

As Jim Croce says, “You don’t tug on Superman’s cape.” Superwoman is the only exception to this rule.

 

Design Team – Needs a Superwoman Leader Read More »

Scroll to Top