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William Anderson

FDA Compliance

Is Your Medical Device ‘State of the Art?’

Chances are it is, despite what some Notified Bodies have declared

Published: Tuesday, June 3, 2014 - 11:33

Not knowing the answer to the question posed in the title of this article has led many medical device manufacturers to undertake expensive and unnecessary retesting of their previously certified products.

In Annex 1 of the “Medical Device Directive 93/42/EEC—Essential Requirements—Section 2,” the directive states, “The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art.”

But what is “state of the art?” Many companies were mistakenly told that “state of the art” meant using the latest standards. Even though most of their devices had a perfect safety record and exemplary records of clinical performance, they were expected to meet newer, basic safety standards, including IEC 60601-1 3rd edition. Incidentally, this was done despite frequent notice from the European Commission to Notified Bodies that such an interpretation of “state of the art” was incorrect.

Although the European Notified Bodies (NB) all agreed that standards such as IEC 60601-1 were voluntary for CE marking, the criteria within the standards were conveyed to industry as legal qualifications. This, of course, meant that the voluntary standard would have to be obtained and used, rendering its use as mandatory.

Although retesting medical devices was never required by law for CE marking, many NB were indicating that receiving a CE Mark depended on a costly reassessment of devices to the criteria in IEC 60601-1. Unless such an effort had been taken, the manufacturer could be denied a CE certificate (and in fact, some manufacturers were denied a CE certificate for just such a reason).

“State of the art” does not force the use of latest standards

According to the European Commission, “state of the art” does not mean “ensuring use of latest standards.” The European Commission has recently requested that the NB organization, Team NB (an organization of Notified Bodies), remove such a statement from its Notified Body “Code of Conduct.” The commission also told Team NB to take down a document titled “Frequently Asked Questions Related to the Implementation of EN 60601-1:2006 With Respect to MDD 93/42/EEC,” which included the statement “Even if the manufacturer does not use harmonized standards for demonstrating that the medical device meets the legal requirements, the mere fact that a harmonized standard is replaced by another harmonized standard indicates that the state of the art has changed, and that additional effort and evidence will be needed. This state-of-the-art requirement is mentioned in ER 2 of the MDD.” (ER 2 refers to the Medical Device Directive Essential Requirements statement mentioned at the beginning of this article.) Upon the European Commission’s request, Team NB took down the document.

The European Commission with the help of the Notifying Authorities (regulators that manage the NB) is trying to stop perfectly good medical devices from exiting the European Union due to an improper understanding of what “state of the art” actually means. Many of these products have impeccable safety records and were being threatened off the market for not meeting the latest voluntary standards. The European Commission stepped up efforts to communicate with regulators throughout Europe that standards must remain voluntary and are not to be used as the sole measure for the legal requirement for “state of the art.”

So what is the “state of the art?”

“State of the art” is explained in the standard EN ISO 14971:2012—“Medical devices—Application of risk management to medical devices.”

The explanation of its meaning and what it does not mean is located in Annex D.4. EN ISO 14971 interprets “state of the art” as, “best practices as used in other devices of the same or similar type.” This also includes “standards used for the same or similar devices.” A product with a proven safety record justifies whatever standards or solutions it has been relying on for safety and performance. Current clinical use and safety records that should be routinely collected by the manufacturer can be used to validate many solutions adopted to achieve a high degree of safety and performance.

It is commonly understood that many ideas promulgated into IEC and ISO standards come from predication and prediction. To put it another way, if something has worked well in the past, it should work well in the future. This common-sense logic is what drives standards development at its core. It is also a fundamental approach adopted by the Food and Drug Administration’s (FDA) Office of Device Evaluation during its 510(k) “clearance” process: Name a good predicate device, and identify its safety and performance characteristics. The closer your product matches those characteristics, the more likely the FDA is to clear your new device for sale in the United States. This is how one product is used as a type of standard for a newer product.

But aren’t the latest standards better?

Latest standards should also include proven methods. For example, the latest EN 60601-1:2013 standard has a noise test that is derived from long-established noise thresholds for safety. Some of these thresholds mirror regulations used by the Occupational Health and Safety Administration (OSHA).

Is this standard then required? Absolutely not. You could use any other valid means to reduce risks related to noise, even your own methods. In fact, your methods and standards might be better for your purposes than those found in official standards. For instance, noise limits for safety are often much higher than would be acceptable to most medical professionals. Would you want your dentist to use a dental drill that was as loud as your kitchen blender?

European standards do, however, give an immediate “presumption of conformity” with the legal requirements (as stated in the Medical Device Directive). Meaning, the NB would prefer that you use existing legal, traceable standards as opposed to your own standards. Doing so will help avoid potentially longer conversations with a NB auditor. Simply saying, “It is quieter than a blender” is not going to be enough. It is best to use a technical standard that is appropriate to the device you are making.

Furthermore, some standards eliminate or reduce risks that are hard to trace back to a specific device. For instance, standards related to sterilization prevent cross-infection. And electromagnetic compatibility standards ensure that electronic devices do not interfere with each other in an operating room. In short, use existing appropriate standards when you can; finding the ones that are most acceptable in Europe is not difficult.

Have you had your OJ today?

A good place to start looking for the latest standards is the Official Journal of the European Union. All standards listed in the journal provide for some degree of legal conformity with the essential requirements for safety and performance of the Medical Device Directive. There are lists of standards under each European Directive (e.g., medical devices, toys, machinery). So if you want to meet the legal requirements in Europe, the best standards to use for medical devices are listed under Directive 93/42/EEC at the Europa website.

The most technologically advanced solutions are not the “state of the art”

The authors of EN ISO 14971:2012 write that “state of the art does not necessarily mean the most technologically advanced solution.” This simply means that solutions that have never been tried may not be valid. Time and trial are the best way to validate a solution to a problem. This is why “state of the art” is focused on proven solutions more than newer solutions. As an example, EN 60601-1:2006 presented a radical shift in basic safety testing that had never been tried; the standard has undergone more than 400 alterations; and its Annex Z was discovered to be completely unreliable. So which would you turn to for “state of the art”—a known proven solution, or a standard that was still being fine-tuned?

The Great and Powerful Z

Every “European norm” (aka European harmonized standard) contains a uniquely European Annex Z, the most important annex to consider. Annex Z will tell you how much of the technical standard can be used to meet the legal requirements for CE certification. Often, a standard will have a very limited ability to meet the legal “essential requirements,” and the Annex Z will tell you which individual legal requirements are not covered. This means you must find another way to address the legal requirements that are not covered.

Important note: The Annex Z to EN 60601-1:2006/A1:2013 shows that most of the essential requirements of the MDD are not covered. This is quite opposite to what was indicated in the previous standard’s Annex Z. This will require many medical device manufacturers to reevaluate their conformity with the essential requirements by January 1, 2016, as indicated in the notations in the May 16, 2014 release of the Official Journal of the European Commission.

Can you prove your medical device is safe?

If you have records that your device has been on the market for several years and that it has not had any safety-related complaints, you must be doing something right.

Your product may be “state of the art” for meeting the Medical Device Directive just as it is. EN ISO 14971:2012 indicates that “state of the art” includes use of “standards for same or similar devices.” If you did not change the device, then whatever standard or solutions that contributed to such a high level of safety provide evidence toward it being “state of the art.” If there is good evidence your solutions work, you must clearly document them and pair them with your field data.

Field data prove your solutions are “state of the art”

Collecting field data from actual clinical use of your device is not only crucial, it is also required by law and expected by most management system standards (e.g., ISO 13485 and ISO 14971). Make time to put these data to good use and support your claims of good safety and clinical performance.

Has a product been on the market treating millions of patients since 2002? Have you been relying on other solutions from other technical standards that are working well? Your field data will help you prove your methods are “state of the art.” Regulators such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and the European Commission are working hard to support products with a valid record of safety, but you have to provide the evidence.

How safe is your medical device? Prove it!

Unless your product is a single-use device, chances are you will have to do a little more work to figure out how many patients have been treated by your medical device. It is important to document how many individual devices are in use, and how many patients have been treated by each one.

For example, if one serialized device treats 250 patients a year and you have had 1,000 of them in use for one full year, you can claim to have provided a medical benefit to 250,000 patients. If you are not sure how many patients are treated by an individual device, make an effort to poll your customers to find the average number of patients treated per day and begin to work from there. This is some of the most important, valuable data you will ever collect. It should also be part your regular monitoring activities. This is the foundation under your “state of the art” solutions.

Complaints are a good thing

The other key part of your monitoring is to keep good records of complaints. The FDA definition of a complaint is very broad. Most complaints are not very serious and have nothing to do with basic electrical or mechanical safety. A good complaint file system demonstrates that your company is actively collecting complaint information. Put it to good use. It can be used to prove there are no safety issues that would warrant retesting the product. If you have treated 250,000 patients and have collected 25 customer complaints that have nothing to do with electrical safety, this provides evidence your device provides a high degree of electrical safety.

Periodically, check external adverse event databases, such as the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Some serious complaints are not always reported to the manufacturer.

Whatever methods you used for designing, manufacturing, and testing a product with a good safety record could very well be defined as a “state of the art.” Under pressure from the regulatory authorities in Europe, NB are widening their view of this legal requirement, and it is more important than ever that you do the same. As newer technical standards come and go, some things should stay the same. “State of the art” is characterized by products that have a good record of safety and performance. You should have most of the evidence you need to support your “state of the art.” It is just a matter of taking the time to put it to better use.

Discuss

About The Author

William Anderson

William (Bill) Anderson is an IRCA-certified lead auditor for a series of ISO standards that includes but is not limited to ISO 9001, ISO 13485, ISO 15189, and ISO 17025. He is also a lead auditor with various CABs and performs medical device audits to the European Union Medical Device Directives of 90/385, 93/42 and 98/79. Anderson is also a certified lead auditor for ISO 13485 under Health Canada’s CMDCAS program.

Comments

Very well written. Provide

Very well written. Provide insgihts to Medical device and regulation. Interesting article to read. Take about 15 mins