What happens when you take four of the leading international medical device standards associations and ask them to develop a "unified" set of guidelines for companies and organizations that develop devices to follow?

The answer is a database called the Medical Device Standards Portal, and it was founded by the Association for the Advancement of Medical Instrumentation (Arlington, Virginia), American National Standards Institute (Washington) ASTM International (West Conshohocken, Pennsylvania) and the German Institute for Standardization (Berlin). In addition to containing documents from these organizations, the database also contains information from the FDA, International Electrotechnical Commission, International Organization for Standardization (both Geneva, Switzerland) and various European regulations.

"I was sort of the quarterback in all this," John Pace, ASTM Vice President of Publications and Marketing told Medical Device Daily. "We had to get nearly four different organizations all on one page and in agreement to come up with this product. This product is aimed at healthcare manufacturers, device makers, anyone who has an interest in medical devices."

Pace's organization, ASTM International, is said to be one of the largest voluntary standards development organizations in the world a trusted source for technical standards for materials, products, systems, and services, and is one of the major contributors to the web portal, which took nearly three years to organize.

"All of the standards on the web portal have an international reach," Pace told MDD. "It's truly a global market place one stop shop."

The portal is being touted as a user-friendly single source for critical documents and contains more than $75,000 worth of information. Upon initial launch all documents will be available and fully indexed in a PDF format that can be easily downloaded. There are plans for the documents to be available in HTML format by the end of this year.

"There have been various companies who have tried to put together something like this in the past, but those attempts were adequate at best, and very expensive," Pace told MDD.

He said this attempt is a bit different as it ties in standards with regulation and it accurately reflects the changes in standards for both the organizations.

"If a new standard comes out it will show the difference, so a person doesn't have to flip through 15 pages of a document to see the change," Pace said.

The portal also enables users to:

• Search and link between standards,

• Compare revisions via color-coded highlighting,

• Add comments and attachments to share with others,

• Integrate company practices alongside the standards.

• Make notations directly in the standards and share

your analysis online with others; and

• Integrate company practices and policies into the

standards, preserving and passing on expertise.

He added that the extra features not only enhance the quality of the portal, but they push it past previous offerings by organizations in the past.

But the true test is to see if the portal can develop a clientele that will help sustain it. Pace said he tends to think that there is a great need for the product and he has already seen the inquiries trickle in.

"I think there is quite a bit of demand for [Medical Device Standards Portal]," Pace said. "The first day we introduced news about the product, we received about 40 or 50 inquiries through email. We were astonished."

Pace didn't get into specifics regarding the price, but he said that it would be on a sliding scale, depending on the subscribers needs. He added that one of the goals with the portal was to have it be an affordable cost for companies during these tough economic times.

"Most importantly, this service is going to be cost effective and affordable," he said.

More information on the portal is available at medicaldevicestandards.com.

Omar Ford, 404-262-5546;
omar.ford@ahcmedia.com