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

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.