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On Monday April 18, 2011, the Medical Device Data Systems (MDDS) final rule becomes effective. Through this rule, the United States Food and Drug Administration (USFDA) classified most Healthcare Information Technology (HIT) Infrastructure as Class I Medical Devices.

Over the last few months, I have had the opportunity to discuss the impact of the MDDS rule with thought-leaders at Healthcare Providers, the FDA, and the HIT Industry.

This article series provides a digest of these interactions with these Industry thought-leaders. In this piece, we will focus on the impact of the MDDS rule on manufacturers of IT systems marketed to Healthcare providers. In our next installment, we will cover the impact of the rule on Hospitals and Healthcare Providers.

The Rule’s Intent

“The intent of the rule is to assure that devices that collect and transfer medical device data that will eventually be used to make clinical decisions are doing so reliably,” said Bakul Patel, Policy Advisor at the Office of the Center Director, Center for Devices and Radiological Health at USFDA.

“I think FDA’s Medical Device Data System rule is a fundamental game changer for Hospitals and Health Information Technology (HIT) vendors,” commented Peter L. Elkin, MD, MACP, FACMI, Professor of Medicine, Vice-Chairman, Department of Internal Medicine and Director, Center for Biomedical Informatics at Mount Sinai School of Medicine in New York.

The Impact on HIT Suppliers

FDA has defined MDDS as a device used to transfer, store, convert or display medical device data.

MDDS devices may include:

• Off-the-shelf or custom hardware
• Software products used alone or in combination
• Electronic or electrical hardware such as a physical communications medium
  • wireless hardware
  • modems
  • interfaces
  • communications protocols

“The advantage for many manufacturers is that it eases the burden and exempts MDDS-type products from premarket review, but they still need to follow the quality standards as for any Class I medical device,” said David Finn, Health IT Officer at Symantec.

“These new FDA requirements would require HIT vendors to follow a rigorous process before they market their products to Healthcare Organizations. MDDS provides an opportunity for each of these individual vendors to kick the tires of their own work and make sure that they are providing the very best offerings that they possibly can to their clients,” said Dr. Elkin.

“Although in general, this new rule eases the burden on many types of medical software, by for example allowing previous Class II or III products to be classified as Class I MDDS, there may be exceptions where previously unclassified products are now becoming regulated,” commented David Finn.

“The regulatory impact of the MDDS final rule will be great, particularly for those Healthcare IT companies that have not adequately prepared themselves for its implementation,” commented Edward J. Johnson Esq., Regulatory Analyst and of counsel for Axendia, Inc. “Perhaps the greatest impact will come in the area of quality systems, where FDA’s expectations of a medical device manufacturer’s quality system and those of an MDDS developer may greatly diverge. Companies that considered themselves software developers or services providers will need to realize they are now considered device manufacturers. Quality activities that had been confined to software development will need to expand their reach into other areas of the company’s operations. They will need to be documented, controlled, monitored and enforced,” he added.

HIT suppliers should begin the MDDS compliance journey by assessing their offerings against these FDA requirements. Suppliers should compile documented evidence of these assessments as well as the rational used to include or exclude specific products from the scope of MDDS rule. Based on the results of their assessment they should develop and implement an action plan to timely meet all applicable FDA regulations.

MDDS Manufacturers must comply with the following FDA requirements: 

• Register and list their MDDS devices with the FDA
• Conform to applicable Quality System regulations (21 CFR § part 820) 
• Comply with Medical Device Reporting (MDR) requirements (21 CFR § 803)

“Another area of significant impact will come in the areas of Medical Device Reporting,” said Ed Johnson. “MDDS manufacturers will need to put policies, processes and infrastructure in place to address MDR requirements. In some cases, these may just be an extension of the manufacturer’s existing customer service program, but elements such as reporting of deaths or serious injuries may be totally new ground for them. FDA will expect the manufacturer to apply the same rigor to reporting corrections and removals or recalls as to its overall quality system,” he continues.

Final Thoughts

“Clearly, the new MDDS regulation has helped to clarify a lot of the uncertainty around medical software products,” added David Finn. “However, it also includes a great deal of granularity and detail and we advise manufacturers and healthcare providers to seek competent regulatory guidance should questions arise,” he observed.

According to Dr. Elkin, “Healthcare organizations that require these standards be met in their RFAs (Request For Application) for systems, in the absence of regulation, can make safer and more informed choices when purchasing HIT systems and solutions.”

Early in my career I had the fortune to have exposure to several strong leaders that really made an impact on my “professional DNA” when we were blazing the wild west of  electronic media and discovering a new world, the world wide web. And when I look back, they were not necessarily conveying profound or new messages, but they were “activists” with a very overt message that was consistent in word and action, “Do something!”

Last week I attended a PA Bio meeting where Caroll Neubauer, Chairman and CEO of B. Braun spoke about the highs and lows of the medical device industry and a flood of memories took me back to those early days. The motivational take-away today was “we can only change if we are active”. When was the last time you were an “activist”?

Read the full article at: http://blog.absorption.com/absorb-this/lead-follow-get-out-of-the-way-or-just-do-something/

The rising trend in stolen pharmaceuticals and medical devices has become a major safety and security issue across the world. According to data from the National Drug Intelligence Center, last year $184 million worth of prescription drugs were stolen in the U.S., a 350% increase from 2007.

Organized crime syndicates have come up with sophisticated and systematic ways to steal pharmaceuticals and medical devices while such products are in-transit, showing dangerous gaps within Global Supply Chain. Once these products are ‘off the radar’ they can be repackaged and put back on the street, or in some cases wind up back in pharmacies and hospitals. This can pose a dangerous health threats to unwitting patients whose medicines or devices have been tainted. According to the Wall Street Journal, “Last year, several diabetes patients lost control of their blood-sugar levels after they unwittingly used stolen insulin, which must be refrigerated.”

To curb this trend, Senators Bob Casey (D-PA), Jay Rockefeller (D-WV), Chuck Schumer (D-NY), Sherrod Brown (D-OH), Amy Klobuchar (D-MN), and Bill Nelson (D-FL), have introduced legislation to make the theft of medical products prosecutable under the Racketeer Influenced and Corrupt Organizations (RICO) Statute. This would give law enforcement access to wiretaps and other sophisticated tools.

To crack down on this trend, the proposed bill would:

• Increase sentences for the theft of medical products and for transportation and storage of stolen medical products, and apply that increase to each current section of federal law that could be used by prosecutors to charge such crimes;
• Enhance penalties for stolen medical product “fences,” including individuals and organizations who knowingly obtain stolen products for resale into the supply chain;
• Increase sentences when harm occurs or trust is broken - In other words, where the defendant is employed by an organization in the supply chain or where there was a death as the result of ingestion of a stolen substance; 
• Make theft of medical products a predicate for the Racketeer Influenced and Corrupt Organizations (RICO) law, giving law enforcement access to wiretaps and other sophisticated tools;
• Provide for civil penalties and forfeiture of ill-gotten gains derived from medical product theft.

Controlling the Life-Science Global Supply Chain to prevent such thefts requires collaboration by the entire Ecosystem, including Brand Owners, Suppliers and Regulators.

Axendia’s research report, “Achieving Global Supply Chain Visibility, Control & Collaboration in Life-Sciences: Regulatory Necessity, Business Imperative” provides specific recommendations Life-Science stakeholders should consider to close the loop across the complete over the complete Supply and Value Chains, from ingredient to patient.

To request a copy of the report, click here.