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By Mollie Shields-Uehling, President and CEO,
SAFE-BioPharma Association 

 As a global standards organization, SAFE-BioPharma has a unique perspective into developing and future IT trends in the life sciences, especially as they relate to use of our global digital identity and digital signature standard. Our staff works closely with member companies which are using the standard in a growing range of applications. We also work closely with non-member organizations to help them develop proof-of-concept studies and pilots utilizing the standard.

Based on these activities we have been able to identify three IT trends that will shape the life sciences in 2012.

1. STANDARDS-BASED INTEROPERABLE DIGITAL IDENTITIES

Industry leaders are rapidly increasing use of these unique digital identities among employees, collaborators, and clinical investigators. Issued once every three years, they take the place of multiple on line identities and can be used to control access to information and physical facilities. They also provide the ability to apply legally-binding digital signatures to electronic documents. The benefit of interoperability is that the digital identity is recognized and accepted by US government agencies, by other companies

2. CLOUD COMPUTING IN CLINICAL TRIALS

As demonstrated in a study between the National Cancer Institute and company-based cancer researchers, significant time and cost savings are realized when trial-related documents are accessed from the cloud rather than delivered by courier or mail. Interoperable digital identities (NCI researchers using government provided digital credentials; company researchers using SAFE-BioPharma digital credentials) give researchers access to the cloud-based electronic documents as well as the capability to apply legally-binding digital signatures. (Read The Paperless, Cloud-Based Clinical Trial; It’s Happening Now )

3. ELECTRONIC TRIAL MASTER FILES

Trial Master Files - the central record containing the files associated with clinical trials - are one of the last areas where clinical development records are primarily paper-based. Multiple pilot studies scheduled to start in the next few months indicate that pharmaceutical companies are preparing to make the process electronic. Companies will use SAFE-BioPharma digital identities to manage access to documents and to provide participants with the ability to apply legally-binding digital signatures.

The global SAFE-BioPharma digital identity and digital signature standard is used throughout the biopharmaceutical and healthcare communities to meet specific security and confidentiality needs. It was created with participation from the US Food and Drug Administration and the European Medicines Agency. The standard and its ongoing development is managed by SAFE-BioPharma Association, a non-profit supported by its members. For more information visit http://www.safe-biopharma.org/.

Mollie Shield-Uehling is President and CEO of SAFE-BioPharma Association. In this role she directs the business and strategic activities of SAFE-BioPharma Association. She has more than 20 years of international trade and biopharmaceutical industry experience. She is a member of the association’s Board of Directors.

Last month, I had the opportunity to chair the Global Pharma Sourcing Conference in Philadelphia. A recurring theme of the conference was the need to rigorously supervise and certify suppliers by implementing “trust, but verify” strategies. This got me thinking about the Kosher supervision and certification in the Food and Over the Counter (OTC) supply chain.

To learn more about how to keep a Kosher supply chain, I spoke with Rabbi Eliyahu Safran, Vice President - Communications and Marketing at Orthodox Union (OU) Kosher. OU is non-profit communal organization founded in 1898 and the world’s largest and most widely recognized kosher certification agency.

The Organization certifies more than 500,000 products produced in over 8,000 plants around the world. In today’s global environment, the OU certifies close to 300 facilities in China, as well as facilities in Argentina, India, Egypt and Turkey and some 80 other nations.

“Many of the brands you trust, rely on the OU for their kosher certification, including: ADM, Cargill, Coca Cola, DSM, General Mills, Hebei Welcome Pharmaceutical, H.J. Heinz, Hershey’s, Kraft/Nabisco, McCormick & Co., Nestlé, Novartis, Procter & Gamble, Pillsbury, Quest, Reynolds Aluminum, Rhodia, Unilever, and thousands more,” explained Rabbi Safran.

Contrary to popular belief, obtaining kosher certification does not involve a Rabbinical blessing over food products, or the manufacturing plants. So what is Kosher? The word kosher means proper or acceptable and it has entered the English vernacular with that meaning.

“Kosher laws have their origin in the Bible, and are detailed in the code of Jewish law. Kosher regulations are about the process, the purity and the traceability of ingredients. You may be surprised at the extent of Kosher regulations.” explained Rabbi Safran. “Kosherizing a food production or industrial facility requires a structured and meticulous process including equipment sterilization,” he added.

The OU inspects every facility where certified products are manufactured. It also requires the use of authorized ingredients from approved and qualified sources. To ensure compliance to its standards, the OU conducts unannounced, periodic inspections. “Our responsibility is making sure that things are done right. We answer to a higher authority, and are not motivated by profit,” said Rabbi Safran.

To achieve this goal, the OU employs over 600 Rabbinic Field Representatives located throughout the world - from Europe to Australia, from the China to South Africa. OU Field Representatives are proficient in modern manufacturing techniques, chemical & biological processes, as well as the intricacies of Jewish Kosher law. The agency’s New York headquarters staff consists of over 50 Rabbinic Coordinators supported by ingredients registry staff, ingredient specialists, flavor analysts and other support staff. To keep track of supply chain and product information the OU utilizes a comprehensive state-of-the-art computerized database that contains information on more than 250,000 food ingredients.

Like our industry, the OU uses a “Risk Based Approach” in its auditing process. “A facility producing a simple product, like spring water, may be inspected a couple of times a year. On the other hand, a product with a complex formula and many ingredients, or one with Red Flag Ingredients (like Glycerin) would be inspected a lot more frequently ” said Rabbi Safran. “For some high risk products, the OU has round the clock constant supervision of the facility” he added.

Partnering with the OU enables companies to leverage the organization’s vast resources. OU staff has a thorough understanding of manufacturing processes, ingredients, chemistry of additives and the procedures manufacturers employ in converting raw materials to finished products and incorporating all these resources in the kosher certification process. OU maintains a comprehensive database of approved and certified suppliers. Manufacturers rely on OU for recommendations on kosher ingredient as well new sources of raw materials and pre-certified alternate suppliers.

In recent years, over the counter Pharmaceutical and Nutritional companies have reached out to OU to obtain certification. Novartis was the first mainstream Pharmaceutical Company to achieve OU certification for its Triaminic Cough Syrup. The company has since added Maalox and Benefiber to the family of OU certified products.

Mead Johnson has OU certified many of its Enfamil, ProSobee and Poly-Vi-Sol Multivitamin products. OU also certifies products from Perrigo Holland, Maxx Performance, Robell Research, Health Management Resources and Soluble Products.

“Although we live in a society where trends come and go, as long as people need to eat, they are going to buy products that assure quality and integrity. As a result, they will look to the OU symbol as a clear indicator of both,” concluded Rabbi Safran.

So the next time you get a shipment from a supplier, maybe you should check if they keep a “Kosher” Supply Chain.

In his recent speech to Congress, President Obama stated “…I agree that there are some rules and regulations that put an unnecessary burden on businesses at a time when they can least afford it. That’s why I ordered a review of all government regulations.”  The review and potential elimination of federal regulations would have significant impact on the Health and Life Science Industry.

In response to the President’s order, the Department of Health and Human Services (HHS) recently published their “Plan for Retrospective Review of Existing Rules” aimed at improving regulation and regulatory review. The HHS regulatory review plan focuses on the elimination of rules that are no longer justified or necessary and considers strengthening, complementing or modernizing rules where necessary and appropriate.

This article reviews Food and Drug Administration (FDA) & Centers for Medicare and Medicaid (CMS) regulations affected by HHS’s retrospective regulatory review and their effect on the Health and Life Science Industry.

CMS has been proactive in reviewing obsolete, unnecessary or burdensome requirements. The agency has recently identified opportunities to improve patient care and outcomes by removing these impediments. In May 2011 CMS issued a final rule permitting hospitals to use telemedicine to obtain services from a practitioner credentialed at a distant hospital. This change improves the ability of rural and critical access hospitals to provide a broader spectrum of care and services to their patients while reducing provider burden. According to the retrospective plan, CMS intends to publish additional rules in the near future to alleviate other identified bottlenecks.

On a related move, in April 2011 the FDA issued a final rule regarding the regulation of telemedicine equipment. The Medical Device Data System (MDDS) Rule classified most Healthcare IT infrastructure, including telemedicine devices, as Class I medical devices. MDDS requires manufacturers of such devices to meet certain regulatory requirements including Registration & Listing, compliance with Quality System regulation and Adverse Event reporting.  Since the MDDS rule went into effect, manufacturers of telemedicine systems including AMD Global Telemedicine, CISCO and Polycom have registered with the FDA as medical device manufacturers. Tying the two initiatives together means that CMS approved hospitals can use telemedicine but the hospitals must ensure that telemedicine devices comply with FDA rules.

Another area of review in recognition of changing technologies is FDA’s bar code rule. A request for comment was made August 11, 2011 to initiate the review of this rule and help the FDA evaluate alternative technologies. It will be interesting to see if the bar code rule will be replaced with ePedigree and RFID requirements.

As part of the regulatory review process, FDA plans to Increase the Use of Electronic Reports and Submissions. FDA is embarking on a major campaign to revise its regulations to increase use of electronic information in the way it conducts business. To support this effort, FDA requested $400 M in 2010 to transform operational and regulatory processes to increase use of electronic systems and information. This would not only speed processing of NDA’s and clinical study data among others, but also would be more in line with how businesses process information using eMDR and similar programs. On its immediate agenda are regulatory revisions to permit electronic submission of clinical study data for drug trials, post-market reporting for drugs and biological products, and registration and listing of drugs and medical devices. FDA is also looking to require electronic package inserts for human drug and biological products.

In another initiative, FDA is reviewing its current Good Manufacturing Practices (cGMP) regulations for drugs. These revisions would accommodate advances in technology and control of components. Taken together, FDA anticipates that the revisions would provide greater assurances of safety and quality and address some of the challenges presented by the globalization of the pharmaceutical industry.  FDA recognizes that changes to cGMP regulations do not generally reduce costs, though there is a presumption of unquantifiable public health benefits from improvements to good manufacturing practices. Examples of such benefits include supply chain security for drugs and establishment of preventive controls, which improve product safety and reduce the harms associated with poorly manufactured or produced products.

The implementation of HHS’s retrospective regulatory review appears to provide a needed push to streamline regulations and reduce obstacles while still ensuring the safety and welfare of patients. It is a move in the right direction.

By Daniel R. Matlis

I’m sure you have heard the philosophy question: If a tree falls in a forest and no one is around to hear it, does it make a sound? The engineer in me says YES, when the tree falls it will create sound waves.

As a Strategist, the corollary is: If a research report is published and no one is around to read it, does it make an impact?

I pondered this question when we released our research report: “Global Supply Chain Visibility, Control & Collaboration; Regulatory Necessity, Business Imperative.”

Last week, the Senate Committee on the Health, Education, Labor and Pensions (HELP) conducted a hearing on “Securing the Pharmaceutical Supply Chain.”  This hearing is part of the process to reauthorize the FDA user fee legislation and examine the safety and integrity of the pharmaceutical supply chain.

Allan Coukell, Director of Medical Programs at Pew Health Group testified as an expert witness at the hearing. The following excerpt from Mr. Coukell’s Senate testimony references findings from Axendia’s research report “Global Supply Chain Visibility, Control & Collaboration; Regulatory Necessity, Business Imperative.”

“A recent survey of pharmaceutical industry executives [by Axendia] determined that 70 percent had key suppliers in China and close to 60 percent in India. About half of those surveyed were from companies with annual revenues of one billion dollars or more. 94% of those surveyed saw their greatest supply chain risk as raw materials sourced outside the United States.”

In addition to the Senate, Axendia’s Life Science Supply Chain research has made an impact on the following organizations:

• The Pew Health Group white paper: “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs“
• CBS’ 60 Minutes segment by Dr. Sanjay Gupta titled “The difficult fight against counterfeit drugs.”  The segment producer interviewed me on findings from this research. 
•  Dr. Roger Williams, CEO of the US Pharmacopeial Convention referenced our findings in his article: “Ensuring Drug Quality: A Complex Task in a Globalized Era“

I am pleased to see that findings from this research study have made an impact on the Life Science ecosystem.

Thanks for being around to read this; I hope it made a positive impact.

To discuss how your organization can leverage the findings and recommendations from this research, please schedule a briefing by emailing info(at)axendia.com

At this year’s Camstar Customer Conference  Larry Dube, Vice President for Operations at NP Medical, presented a session entitled “quality (with a small q): Prevention, Analysis and Improvement.” Mr. Dube has a track record of successfully leading Medical Device organizations through cultural change and is a proponent of lean manufacturing.

NP Medical is an OEM supplier of drug and fluid access devices and components that ultimately help guard both patient and healthcare provider once incorporated into the world’s most precise medical device technologies.

I recently had the opportunity to speak with Mr. Dube about his approach to quality in the Medical Device industry. This article distills key points of our conversation.

In many organizations functional boundaries and silos have developed over the years regarding who is responsible for quality. Most Life-Science manufacturers are organized in well-defined and delineated functional areas, each with specific roles and responsibilities. Each of these functional areas have traditionally operated as silos or stove pipes, having their own well defined, independent and often unaligned goals, objectives and incentives. This level of independence has led to the “catapult effect”, where deliverables are thrown over the wall to the next functional area to deal with. See the article at http://axendia.com/blog/2007/06/13/tilting-at-windmills/

Mr. Dube’s perspective is that quality is everyone’s responsibility, not the exclusive domain of the Quality Department. “In some Medical Device companies, the organizational culture has developed in such a way that certain people are responsible for making the products and then they throw it all over the wall to somebody else to inspect it. In that scenario, the Quality Department ends up ultimately owning the responsibility for the product quality. This is just inefficient. I’m a big proponent of lean manufacturing and that is the antithesis of lean manufacturing,” he told me.

The implementing of a culture of quality (small “q”) throughout an organization, rather than leaving the entire responsibility to the Quality (large “Q”) Department is a major adjustment for many Life Science companies. As Mr. Dube commented: “It’s a big shift in ownership and mentality for the responsibility for quality; and changes the focus of the Quality Department to Quality Assurance.” This QA process is more akin to an auditing or verification process aimed at ensuring that processes remain within their validated parameters and specification rather than ongoing inspection of the product.

Driving this need for change at NP Medical is the high volume of product and the impossibility of testing hundreds of millions of units per year. To enable this culture shift, NP is implementing an MES strategy.

NP Medical plans to achieve several objectives with their MES implementation. First there are some savings from labor recapture (from replacing a manual paper-based process). More importantly, MES provides the capability to capture information automatically, monitor processes in real-time and the ability to react more quickly to process or product quality issues. According to Mr. Dube: “The sooner we can figure out that there’s something wrong, the easier it is to understand the root cause, and implement corrective actions.” And lastly, there is the savings from limiting scrap costs and tying up inventory.

The ultimate goal for NP Medical’s MES implementation is to have inspection by exception as opposed to inspections as the rule. Achieving this goal requires a phased approach: collect data, continue testing, compare data to test results, implement analytics software, look at correlation between certain process parameters and establish control limits. As a better understanding of the process develops it may require some modification to the automation equipment or tooling upgrades in order to provide the types of control needed. If a process parameter is important but unable to meet control limits, the design parameters may need to be revisited. And this is where the MES system can help as noted by Mr. Dube: “Just like it can help get to root causes of a particular problem, it can also help to justify making go/no go types of decisions. If I’m not getting what I expected out of this particular process I can stop.”

Moving to an MES environment is not just about implementing the technology. A company must have not only the resources needed to make this type of investment but also the willingness to commit to changing the organizational culture as well as long-term vision to implement based on long-term results. Unfortunately, there is generally an external trigger, some sort of compelling event (like an FDA audit or a product recall) that drives the decision to implement a technology solution.

Whatever the reason for implementing MES, a key outcome of the successful implementation of an MES strategy is that quality must become everyone’s job. “Putting information in the hands of the operators permits them to make assessments now and adjustments now and allows the transition to a corporate wide culture of quality to happen,” concluded Mr. Dube.

Winston Churchill said that “Democracy is the worst form of government except all the others that have been tried.” Similar arguments have been made by most constituents in the Medical Device ecosystem about the 510(k) process. Seeking ways to improve the 510(k) process the FDA’s Center for Devices and Radiological Health (CDRH) commissioned the Institute of Medicine (IOM) to evaluate and provide recommendations for improving this process.

On July 29, 2011, the IOM released its long awaited report on FDA’s 510(k) clearance process. The IOM report concludes that “the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM recommends that the “FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the Device Life Cycle.”

The response from both FDA and industry was swift and direct. Although all seem to agree that the 510(k) process needs to be improved neither the FDA nor industry stakeholders are willing to start from scratch to implement them.

Jeffrey Shuren, MD, Director of CDRH, noted that: “FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.”

Comments from industry groups were more forceful in their disapproval of the IOM report recommendation.  Medical Device Manufacturers Association (MDMA) President and CEO Mark Leahey stated in part “…we completely disagree that the 510(k) pathway is ‘flawed’ and that the FDA needs to eliminate it. While we are pleased that the IOM recognizes the crucial role medical devices have in health care, it is also important to remember that studies prove the 510(k) process has a strong track record on patient safety, and a complete overhaul of the system is simply not warranted.”

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed) was more specific in his statement: “The report’s conclusions do not deserve serious consideration from the Congress or the Administration. It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure. This would be a disservice to patients and the public health.”

Where do we go from here?

Most constituents agree that improvements to the current 510(k) process are needed.
IOM’s recommendations for the “Ideal Medical-Device Regulatory System” are a worthy goal to strive for. The IOM committee defined the following six attributes of an Ideal Medical-Device Regulatory System (not presented in any priority order)

• The process should be based on sound science.
• The process should be clear, predictable, straightforward, and fair.
• The process should be self-sustaining and self-improving.
• The process should facilitate innovation that improves public health by making medical devices available in a timely manner and ensuring their safety and effectiveness throughout their Life Cycle.
• The process should use relevant and appropriate regulatory authorities and standards throughout the Life Cycle of devices to ensure safety and effectiveness.
• The process should be risk-based.

The IOM’s proposed “approach” for the Ideal Medical-Device Regulatory System sounds a lot like FDA’s Total Product Life Cycle approach. The Top priority in CDRH’s 2011 Strategy is the full implementation of a Total Product Life Cycle approach. To support this effort, The Agency plans to integrate premarket, postmarket, and compliance information and functions to take into consideration all of the relevant information available to the Center at any stage of a product’s Life Cycle to assure the safety, efficacy, and quality of medical devices. (See: Is Industry Ready To Meet FDA CDRH Top Strategic Priority)

FDA’s 5 year plan further asserts its commitment to a Life Cycle approach. To this end, FDA is working to take steps to facilitate the seamless incorporation of new scientific information available throughout the Total Product Life Cycle into regulatory decision making.

So rather than throwing out the baby with the bathwater, I would suggest that all constituents collaborate to improve the 510(k) process to:

• Provide reasonable assurance that marketed devices, throughout their Life Cycles, are safe and effective according to current standards for the clinical indication at the time of use. 
• Facilitate innovation by allowing prompt access of devices to the market.

Last month, we reported Google’s announcement to discontinue Google Health while Microsoft listed HealthVault as a Medical Device.   Google’s announcement cited lack of adoption and broad impact. For its part, Microsoft has recently registered with FDA as a Medical Device Manufacturer and listed HealthVault as a Class 1 Medical Device.

Microsoft continues to capitalize on Google’s exit and launches “Direct” tool for the transfer of health data from Google Health service to Microsoft HealthVault

“Google has been an important ally in providing customers with access to their data and tools to better manage care online,” said Nate McLemore, general manager, Microsoft Health Solutions Group in a press release. “Microsoft continues to advance the HealthVault platform to increase its value to consumers - by adding important features, such as support for mobile devices, and by collaborating with hundreds of health organizations, including the American Cancer Society, American Heart Association and CVS Pharmacy - to deliver robust health and wellness applications that connect to HealthVault.”

Microsoft leverages the Direct Project messaging protocols established by the Office of the National Coordinator for Health IT to support this type of scenario. The Direct Project specifies a simple, scalable, standards-based way for participants to send authenticated, encrypted health information to known, trusted recipients over the Internet.

Leading Life Science and Healthcare organizations, including Sanofi-Aventis, Duke Clinical Research and Telerx Marketing reported first-hand accounts of their experience with Microsoft SharePoint® -based solutions in a White Paper released today by the analyst and strategic advisory firm Axendia, Inc.  (Read the Press Release at: http://www.prweb.com//releases/2011/6/prweb8582485.htm )

To produce this White Paper, Axendia conducted one-on-one interviews with Life Science and Healthcare stakeholders currently using Microsoft SharePoint-based solutions within their organizations.

“As we conducted one-on-one interviews with key Life Science and Healthcare stakeholders, distinct themes emerged,” commented Daniel R. Matlis, President of Axendia. “IT Professionals touted its ease of deployment and integration with enterprise systems, Process Owners praised the ease of configuration and intuitive interface, while Compliance Professionals liked the ability to manage validation activities by utilizing a platform approach,” he added.

According to research participants, SharePoint provides a strong foundation that enables Life Science and Healthcare organizations to configure functionality and add Off the Shelf modules from a network of independent software vendors. This approach enables them to meet the requirements of a wide variety of users across the ecosystem. Research participants report that SharePoint-based solutions have been adopted across the Life Sciences and Healthcare ecosystem. These solutions support several functional areas including research & development, quality management, manufacturing & operations, clinical data management and customer service.

Findings from this research are available today in a new Axendia White Paper titled: “The State of SharePoint In Life Sciences and Healthcare.”

To request a copy of the White Paper, please visit www.axendia.com/SP-HCLS-WP.html

Healthcare delivery has become increasingly reliant on state of the art medical devices and the multimodal data they produce. As a result, Healthcare Information Technology (HIT) Infrastructures have become vital to the collaboration and communication required to provide high quality care.

The United Stated Food and Drug Administration (FDA) examination of modern medical device networks and computer infrastructures, has led to the classification of most Healthcare IT infrastructure as a Class I medical device. Beginning on April 18, 2011, FDA classified hardware or software products that transfer, store, convert formats, and display medical device data as Class I Medical Devices.

Over the last few months, I have had the opportunity to discuss the impact of the MDDS rule with leading stakeholders 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 focus on the impact of the MDDS rule on Hospitals and Healthcare Providers. In our last installment, we covered the impact of the rule on manufacturers of IT systems marketed to Healthcare providers.

The Impact on Hospital and Healthcare Providers
Under most circumstances, Hospitals and Healthcare Providers using general purpose IT systems would not be considered MDDS manufacturers by the FDA.
“There is, however, the potential for impact on Healthcare providers if they use commercial software or hardware components, MDDS or even unclassified, and if the provider combines or modifies these products and uses them in clinical practice. In such scenario, the provider could be considered a device manufacturer and would need to register with the FDA as well as follow quality systems regulations,” said David Finn, Health IT Officer at Symantec.

“If an entity (e.g. a hospital or a clinical user) takes off-the-self general IT equipment or a MDDS and reconfigures, configures, modifies or adds custom software or hardware outside of original manufacturer’s specification for the intended use as a medical device and specifically for the functionality defined in the MDDS rule, that entity has made a new medical device is considered a manufacturer of a MDDS,” commented Bakul Patel, Policy Advisor at the Office of the Center Director, Center for Devices and Radiological Health at FDA. “As a manufacturer, the entity (e.g. a hospital or a clinical user) is required to comply with the Class I device requirement, which includes quality system regulation, for the part/portion of the equipment that has been reconfigured, configured, modified or to which custom software or hardware has been added outside of original manufacturer’s specification,” Patel added.

“Companies that feel the greatest impact of the MDDS final rule may be those that have customized the MDDS for features and functionality,” commented Edward J. Johnson Esq., Regulatory Analyst and of counsel for Axendia, Inc. “The final rule treats end users that have customized purchased MDDS as device manufacturers in their own right. A MDDS customized by a manufacturer for a customer would be considered a different version of that device. The costs associated with supporting multiple MDDS as devices may ultimately prove too burdensome for some manufacturers; however customers will expect manufacturers to bear them as part of doing business,” he added.

What is Driving the Focus on HIT?
FDA is not alone in driving Hospitals to better control and manage their HIT infrastructures. To address this growing concern, the International Electromechanical Commission (IEC) in collaboration with International Standard Organization (ISO) recently issued IEC 80001-1 “Application of risk management to information technology (IT) networks incorporating medical devices.” This global standard provides a framework with defined roles and responsibilities for Hospitals, Medical Device Manufacturers and IT Suppliers to ensure the safety, effectiveness of data and system security.

For its part, Joint Commission has issued an Alert detailing specific steps Healthcare providers should implement to prevent patient harm related to the implementation and use of HIT and converging Technologies. According to the Commission’s’ Sentinel Event Alert, Issue 42: “As health information technology (HIT) and “converging technologies”-the interrelationship between medical devices and HIT-are increasingly adopted by healthcare organizations, users must be mindful of the safety risks and preventable adverse events that these implementations can create or perpetuate.”

Final Thoughts
“I believe that MDDS requirements for Health IT systems that comply with FDA Quality Systems regulation and Medical Device Reporting can help to ensure that these systems are of high quality and that they assist clinicians in their efforts toward protecting the safety of patient care,” 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 rigor that MDDS will bring to Health Information Technology systems may provide greater certainty and consistency in the way vendors support Interoperability. Interoperability requires the use of a common data infrastructure that could be used for both phenotypic and genotypic data to provide the kind of interoperability needed to do fully automated electronic quality monitoring (eQuality) and improve both quality of research and the quality of the care that patients receive, including data-driven recruitment of subjects,” added Dr. Elkin.

In the next article for this series, we will share findings from Axendia’s whitepaper “Managing Smarter and Connected Healthcare Infrastructures” (sponsored by IBM).

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.”