Quality regulation for medical equipment, medicine, and dental products, and…

A completely free market

This should only make sense. With a free market, you have multiple companies competing with each other. Each one striving hard to outdo the other, trying to develop new solutions and alternatives, and new, more effective, more efficient equipment. And, of course, with some degree of quality control, bad drugs are kept off the market, shoddy equipment isn’t sold, and patients can rest easy.

The ISO 13485 is an ISO standard, first published in 2003, representing certain requirements for a comprehensive management system, and for the designing and manufacturing of medical instruments and equipment. The ISO 13485 supersedes earlier documents, including the 1997 EN 46001 and 46002.

The 13485 is a stand alone document, but is harmonized with the ISO 9001. One difference between these two documents; the 9001 requires for an organization to demonstrate continued improvement on all products, while the 13485 only requires that a quality system be implemented and maintained.

The document is very important, as it is generally seen as the first step for any medical device manufacturer in the process of achieving compliance with regulatory requirements. Medical Devices, dental tools and In-Vitro Diagnostic Medical Devices must conform to EEC-decrees 93/42/EEC and 98/69/EEC, and their adherence must be assessed to prove conformity before any sales are permitted. The most common method to prove conformity would be Quality Management System certification, according to ISO 9001 and/or 13485 by a Conformity Assessment Body, or CAB. A positive assessment will be authorized for CE identification, and permission to sell within the European Union will be granted.

The ISO, or International Organization for Standardization, is an international-standards-setting organization composed of a number of representatives from a number of national standards organizations from all participating countries. The ISO is stationed in Geneva, Switzerland.

The ISO defines itself as a non-governmental organization, although it often sets standards that become law, either through the use of treaties or national standards. This makes the ISO much more powerful than your average non-governmental organization. The ISO is generally considered a consortium with strong governmental links.

As of this writing, the ISO has 157 national members from a total of 195 countries in the world. There are three membership categories for ISO participants:

Member Bodies

National bodies considered to be the most representative standards body in each participating country. These are the ISO members with voting rights.

Correspondent Members

Countries that lack their own standards organizations. These members stay up to date on the going-ons within the ISO, but do not actually participate in the initiating or voting on standards.

Subscriber Members

Countries with small or struggling economies, these members pay reduced membership fees and follow the development of ISO standards.

What the ISO has done for the medical industry has been very helpful. Before the ISO, it was much easier to buy, well, crummy, unreliable equipment. Today, an ISO-certified company can be trusted to create quality dental products.

The first experiments on humans focused on dentistry, particularly, dental implants to replace missing or damaged teeth. However, titanium has also been used in many other fields in medicine. In particular, hip implants and metal plates. Titanium bonds so well to bone that it can be put to use in any operation involving the repair of fractured, damaged, or lost bone matter.

In dentistry, a titanium implant is not, by the way, one hundred percent titanium. Rather, the implant is comprised of a titanium crown capped with porcelain. The implant bone bonds to the titanium and continues to grow around it, like normal, healthy bone matter.

One problem that titanium implants can present is that it can be difficult to form the titanium to fit the bone once it has been implanted. Zirconia implants, on the other hand, can bond more easily without fear of gaps between the implant surface and the implant itself. This problem can lead to further complications down the road, with follow-up operations being conducted to close the gaps and prevent infection. However, this can be sidestepped with thorough scanning beforehand to make absolutely certain that the titanium crown matches the socket.

Besides just implants, further medical uses for titanium include surgical instruments used in image-guided surgery. Titanium is also used in wheelchairs, crutches, and similar products, as the metal combines both high strength and low weight.

The fact that it is light and strong, as well as easily colored, makes titanium very popular in body piercing. Titanium can be anodized to produce various colors and is non-toxic. Many sculptors even use anodization to aid in creating artworks out of titanium.

It’s interesting to note what exactly is going on with the titanium/bone bond. In the 1970’s, the term osseointegration was established, implying that an actual chemical bond between titanium and bone was taking place. In fact, further studies have shown that osseointegration actually refers to the absence of interfering tissue. In other words, it’s more of a grip than a chemical bond. However, certain treatments can be employed to ensure a chemical bond around four weeks after implantation. Furthermore, a chemical bond may occur naturally over several months.

Between zirconia and titanium, the push is definitely going towards zirconia, but, titanium will always be around. It bonds very well to bone, it’s light, it’s strong, and it’s non-toxic. For replacement joints, titanium is still the best option we have, and, if implanted correctly, titanium is still a solid choice for dental implants.