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Grant Ramaley

Health Care

New Medical Device Standard Puts Health Care at Risk

Most medical device manufacturers are small and vulnerable to high costs of compliance

Published: Monday, March 5, 2012 - 18:25

One of the greatest challenges that I have in discussing standards is trying to put things in a context so that all people affected by them can understand how they matter. So I want to start with a simple picture and a remarkable snapshot in time. It shows how small medical-device companies are making major contributions to health care, and begins another story that explains how one standard is threatening to undo these gains.

The photograph below was taken in Brazil, by a team of missionary dentists that brought a new portable dental system to their village. At first, no one came; in fact, I was told most of the children were terrified. In some places like this village, “dentistry” means getting teeth pulled with a pair of pliers. When word got around that a new dental system was being used, and that the children could get their teeth fixed, not pulled, the lines grew so long, the children could no longer fit in the picture. Many people may not know this, but this is a typical experience for many dentists working in remote locations. The World Health Organization has indicated that the most prevalent childhood disease is dental caries (tooth decay). So when dental care arrives in a remote area, so do the crowds.


This picture fits with my discussion as to how technical standards are used in medical-device regulations. These regulations apply to anything used in the treatment of patients. From tongue depressors to dental hand pieces, from thermometers to pacemakers—if it’s used for treating a medical condition, it’s a medical device. Because this is such a critical area to regulate in any society, it’s more important than ever to make sure that these devices are safe and effective. That’s why medical-device regulations are among the most strenuously enforced and challenging regulations in the world. However, since only 10 percent of medical devices are considered “high risk” (e.g., critical life support equipment), regulatory agencies try to be sensitive to make sure that the majority of lower-risk medical device are not overly regulated, which can have a bad effect on the health care system. Doctors and patients need these devices. About 80 percent of medical-device manufacturers are small companies, and they develop half of all the new innovations that reach our doctors. They are also the most vulnerable to costs of compliance.

Dental units, like the one used in Brazil, are considered a low-medium risk, and they are made only by small manufacturers. They are not entirely without risk, though, since they have air-compressors that can get hot, and they are powered by electricity, which can, under certain unusual conditions, become a shock hazard. In fact, some regulatory authorities require that these types of devices be tested to a basic safety standard, to make sure they do not present electrical or mechanical hazards.

Testing can cost thousands of dollars. Medical devices are normally tested against a standard from the International Electrotechnical Commission (IEC) titled IEC 60601–1—“Medical electrical equipment, Part 1—General requirements for basic safety and essential performance.” In the testing lab, safety testing engineers use humidity chambers, induce simulated fault conditions, and measure temperatures and electrical currents to see whether the equipment remains within the safety limits of the standard. Standards are used by medical-device regulators to gain confidence in a product’s safety. Testing the dental unit sold to Brazil cost nearly $12,000 in 2002. It was considered the most expensive testing ever undertaken, but since the testing labs all charged the same, it had to be paid. If the product had not gone through the testing, the product could not have been legally sold in Brazil, where product testing to IEC 60601–1 is a regulatory requirement.

This brings us back to the photograph. The impact on health care in Brazil and many other countries is directly influenced by the cost of applying standards. This is one of the biggest problems affecting health care to date. Testing labs are private companies with an interest in growth. A more expensive standard supports their growth, while hampering medical device manufacturers trying to legally provide their equipment to doctors.

In fact, the IEC 60601–1 standard has been completely overhauled since the above dental unit was tested. Testing the same unit that went to Brazil would now cost closer to $39,000 if the new, third edition of IEC 60601–1 is put into force. One executive at the company that made this dental unit indicated that they would not sell to any country that required testing to the third edition of IEC 60601–1. Had it been required in 2002, the children in this picture would have been hiding from the dreaded pliers instead of getting their teeth fixed.


About The Author

Grant Ramaley’s picture

Grant Ramaley

Grant Ramaley is the director of regulatory affairs for Aseptico Inc., a manufacturer and marketer of dental support equipment in the United States and Canada since 1975.  Ramaley also is co-chairman of the Regulatory Affairs and Standards Committee for the Dental Trade Alliance, Convener for the ISO 13485 Medical Device Working Group at the International Accreditation Forum, and Technical Committee Advisor to the Global Harmonization Working Party.


EN60601-1 standard a health risk

Good on you Grant for being one of the few voices of sanity on this.

I have been working on retro-application of Ed3 for 2 months and the standard, its introduction, testability, avoidance of conflict of interest and cost-benefit design are an abomination and a perfect example of the European bureaucratic disease that's killing the EU.

Clearly, in 'improving' the standard, 'compliance cost containment" was accidentally left off the desirable goals list in the power point.

Retrospective application of this standard to existing equipment designs in EU is unjustified and described by one candid US test engineer as the Test House Stimulus Package. Revision of a standard does not make existing product designs suddenly unsafe, as one TUV guidance document admits. Post market surveillance should be keeping it safe. Despite this, our US Isolation transformer manufacturer was quoted $100,000 to update certification to Ed3 on existing and perfectly safe products, even though their transformers comply with IEC 61558-1 and thus require no significant design changes - just some labelling. How is this justifiable? Unfortunately, higher entry costs favour the biggest manufacturers over small ones so there will be no resistance from them.

The particularly disappointing aspect is the self-serving untruth spread by test laboratories, that EN60601-1:2006 is 'mandatory'. As Grant says, this statement is simply untrue. Only conformance with Essential Requirements of the MDD is 'mandatory', and while Ed3 is considered state of the art and a very handy route to demonstrating conformance which may even be demanded by some NB's, manufacturer can choose alternatives in consultation with their NB.

Not promoted by the test houses is the fact that you can demonstrate continuing conformance to ER of MDD by doing a gap analysis yourself using available templates, like from Advena Ltd, supported by existing Ed2 test results and a few gap tests, all done possibly in house if you have ISO13485 QMS. The 14222 test items just takes a lot of time.


oh sure non tested and trusted device for medical care is really a risk.

Compliance costs



So what is your recommended alternative?  No standards?  Just put whatever manufacturers want on the market place?  That cure could be worse than the disease.

I work for a small manufacturer (non-medical).  Compliance costs are a huge burden for the company.   Indeed, I would like them to be smaller, but I also recognize these standards are intended to protect public health.  What to do?

I have been in correspondence with my elected officials, using the governmental process to weigh upon the bureaucracy and reduce unnecessary regulations.   Who knows?  It might work.

But, all manufacturers need to recognize the need for some enforced standards and regulations.  No regulations result in an environment which harms eveyrone.


Tom Johnson

How to be heard


Although it is a good idea to contact your Senators and Congressman, I also highly recommend contacting the office of the ombudsman of the Small Business Administration (SBA).  What most people may not know, is that the SBA office of the ombudsman can assist you with getting a response from any US government agency on behalf of a "complaint" you file  through the SBA complaint filing system http://www.sba.gov/ombudsman/1816.  Any agency that is considering use of a standard (OSHA, FDA, EPA, etc) has 30 days to reply to your complaint.  Most commenting periods long pass before SMEs are aware of the impact of a standard that is scheduled for adoption, and sometimes the impact cannot be known until it enters into force. 

Standards and testing labs do provide an important service, but there is also a well understood conflict of interest that cannot be ignored.   When regulators and industry rely on them for any regulatory purposes, all respective interests need to be checked.  Although I've never doubted the technical expertise or intentions of the testing labs I have used.  I have questioned the 300% cost increase for testing to one standard that has not changed in 10 years of service.   This is a longstanding problem that occurs from relying product certification for regulatory purposes, but where regulators have excused themselves from any responsibility for what the testing labs can charge. 

Anytime you get many different stakeholder groups together in a Standards Development process, there is a cost that comes from reaching consensus.  I call it "the common denominator affect".  Usually more requirements get added, to make everyone happy.  Since SMEs are not present, the cost issue is really not taken into consideration.  There is a price to be paid for harmonization, but in some cases, the price is simply too high.

Two executive orders, one recently from the Obama Administration, have been issued reiterating that all government agencies must weigh the cost of any changes to their regulations.  Some interpret that standards that are used for regulatory purposes must pass this same litmus test.   OSHA has had to rethink how testing costs figure into to new standards that will be applied under their electrical safety regulation 1910.303.  They have other more serious concerns related to 60601-1 3rd edition, which have been posted elsewhere.