In the fast-paced world of high-tech manufacturing, it’s easy to get caught up in the quality and risk-management challenges of production, supply chain management, and regulatory expectations. Keeping costs down, however, gets harder to do as OEMs make more complex products, expect faster times to market, and demand more vendor services.

So chances are that trying to find better ways to reduce environmental impacts (especially if you think you’re already doing a good job in this regard) is low on your to-do list. However, getting serious about managing “environmental” costs can make a big difference to your bottom line—and there is a new ISO standard that can show you the way.

ISO 14051:2011 tackles environmental management through material flow cost accounting (MFCA). It provides a general framework to help companies better understand the environmental and financial consequences of their material and energy use practices, so that they can identify opportunities for improvement. This cuts costs linked to waste and emissions, enhances environmental performance, strengthens corporate culture, and perhaps most importantly, builds your brand.

MFCA traces and quantifies material input and output flows and stocks within an organization. The system helps identify material and energy-use practices and understand them in costs and physical terms. The information can then be applied to reduce losses and increase gains.

This tool has been around for decades and is especially well developed in Japan. The new ISO standard was developed by ISO technical committee ISO/TC 207, Environmental Management, led by Katsuhiko Kokubu, professor of social and environmental accounting atKobeUniversity.

“Many organizations are unaware of the full extent of the cost of their material losses because this data is often difficult to extract from conventional information, accounting, and environmental management systems,” says Kokubu. “MFCA produces such precise and clear data that it can motivate managers to enhance material productivity and significantly reduce unnecessary waste, far more effectively than conventional means.”

This approach can be used in all industries that consume materials and energy, including extractive, manufacturing, service, and other industries. It can be implemented by organizations of any type and scale, with or without environmental management systems in place, in emerging economies as well as in industrialized countries. MFCA can also be utilized throughout the supply chain, both upstream and downstream, to help develop an integrated approach to improving material and energy efficiency.

“The bottom line is that not only do organizations increase profits, they improve their environmental performance and contribute to sustainable development,” says Kokubu.

Some of these improvements include:

• Increased production efficiency through capital investment
• Appropriate and accurate evaluation of investment items
• Cost reduction through changes to product design and raw materials, which allows precise evaluation of manufacturing cost
• Identification of specific targets for on-site improvement activities
• Reduced supply chain and social costs
• Reduced costs for raw materials, waste disposal, etc.
• Energy savings

In general, the costs for any capital investments suggested by MFCA can be recovered within 1-2 years through improved efficiencies.

The MFCA framework presented in ISO 14051:2011 includes common terminologies, objective and principles, fundamental elements, and implementation steps.

ISO 14051 is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat through the ISO Store or by contacting its marketing, communication, and information department.

Nancy J. Stark is president of Clinical Device Group, a medical device clinical consultancy based in Chicago. Recently she has noticed an increase in requests for clinical evaluations and offers advice about how to write them to meet the requirements of notified bodies.

“Where you begin depends on where you are now,” says Stark. “Either you are writing a clinical evaluation for a new, pre-approval device or for a device that is already commercial. In the first case, you are asking the question, ‘Do I need new clinical data for certification?’ In the second case you are bringing your documentation up to date.”

Question: How do you proceed if you are still designing the device?

Stark: If you’re still in the stage of designing your device, start by identifying its intended uses. Then evaluate the existing clinical data to determine if it is sufficient to support safety and performance per the Essential Requirements of the Medical Devices Directive or the Active Implantable Medical Devices Directive, or if you need additional clinical data. If additional data are needed, you have the choice of revising the intended use or performing a clinical investigation.

Once you believe the data are sufficient, you convince top management to grant a CE Mark and sign the Declaration of Conformity to your previously certified quality management system. Finally, you will discover the truth when the notified body comes to make an inspection call.

Q: What if you have a commercial device that is already on the market?

In this case the notified body has informed you that the clinical evaluation is overdue or needs updating. They may give you a grace period, but you are expected to get busy. Follow the same process of evaluating the existing data to determine if it is sufficient to support safety and performance for the intended uses. If the report concludes the existing data are insufficient you are in a difficult situation—you’ll need to suspend sales until additional data are acquired.

What is the best approach for writing a clinical evaluation?

You need a team of at least three individuals: a medical writer, an information specialist, and a statistician.

You will also need a written procedure for how to proceed, a report template (useful, but not required), and access to literature databases such as Medline. Medline is easy to use and is operated by the U.S. National Library of Medicine. It is available to anyone with a browser. Medline provides access to 5400 worldwide journals in 39 languages, dating from 1947 to the present. And it is free.

A typical clinical evaluation involves the following steps and durations:

1. Identify key questions—1 week.
2. Identify databases to search—overlaps.
3. Identify search scope, keywords, search strings—1 week.
4. Review abstracts, discard with reasons—1 week.
5. Acquire articles—2 weeks.
6. Read articles—1 week.
7. Weight articles for relevance, discard with reasons—overlaps.
8. Weight articles for statistical validity—1 week.
9. Medical writer summarizes literature—2 weeks.
10. Review sponsored clinical trials, if any—0-2 weeks.
11. Review risk management system and complaint file—2 weeks.
12. Write final evaluation—1 week.

The first step of a clinical evaluation report is evaluating the existing literature data—what is the best way to do this?

The Global Harmonization Task Force (GHTF) Study Group 5 document “Clinical Evaluation,” coupled with MEDDEV 2.7.1 Rev 3, which is slightly easier to read, are the guidances that tell us how to do the literature evaluation. A good approach is the following:

1. Define the key questions.
2. Identify the databases to search (Medline, Embase, MAUDE, Cochrane).
3. Define scope of search and search strategies using a qualified information specialist.
4. Scan the abstracts to identify articles for review.
5. Acquire full texts of articles.
6. Weight articles for technical significance, discard anything with a low weight.
7. Have a statistician weight the articles for statistical significance, discard anything with a low weight.
8. Review only those articles with the highest weightings. The literature data are evaluated to determine if they support safety and performance of the device for its intended use. I like to prepare a separate literature review and attach it to the main clinical evaluation as an annex. The literature review annex has several required elements including the search strings used by the information specialist, a list of abstracts scanned, the articles reviewed, their weights and justification for those weights, and full-text copies of the articles.

What’s next?

Review any existing clinical investigations your firm may have sponsored.

These data are reviewed separately from the literature because you have closer access to the details. The writer asks questions such as: “Was the Declaration of Helsinki followed?” or “Were adverse events resolved?” If not, those facts are noted in the report but the data are not used.

Once the writer is satisfied that ethical and administrative requirements were correct, he/she reviews the study results to see if they support safety and performance of the device for its intended use. I like to prepare a separate sponsored study review and attach it to the main evaluation as an annex.

How do you handle any complaints that might be on file?

You must examine the complaint file against the risk management system. The notified body will review the file to see if complaint handling, as dictated by the risk management system, supports the safety and performance of the device for its intended use. I like to prepare a separate risk management review and attach it to the main evaluation as an annex.

The medical writer then takes the literature review, sponsored study review, and risk management review altogether and reaches an overall conclusion of whether the existing data support the device’s safety and performance for the intended use, or if additional clinical data are needed newly. If new clinical data are needed, you know what happens.

If the data are sufficient, then the clinical evaluation is filed away in the technical file, a written procedure describing the writer’s strategy is incorporated into your quality management system, and you wait with baited breath until the notified body inspector comes.

Nancy J. Stark is president of Clinical Device Group (www.clinicaldevice.com). Contact her at 773-489-5706 or njstark@clinicaldevice.com

At the end of April the U.S. Senate approved a fiscal 2013 spending bill that provides $2.5 billion for the FDA, including $10 million to fund an expansion of the agency’s Chinaoffice.

The Transforming Food Safety and Protecting Patients Initiatives within the bill provide $10 million in new resources for the FDA to improve collaboration with Chinese inspectors and increase the FDA’s presence in and expertise onChina.

This is in response to increasing pressure to adequately inspect the rapidly increasing trade coming fromChina. From October 1, 2006 to September 30, 2011—the  Fiscal Years (FYs) 2007-2011—the total number of shipments of FDA-regulated products from China increased approximately from 1.3 million to 2.1 million. Of the 2.1 million entry lines arriving in FY 2011, 30 percent were drugs and devices and 12 percent were human food products—all in need of adequate review and inspection.

The $10 million ($4.4 million for food inspection and $5.6 million for inspection of drug plants) is intended to:

• Strengthen FDA inspection and analytical capabilities by increasing its presence inChinaby sixteen inspectors and by adding three U.S.-basedChinaanalysts.
• Broaden the range of its inspections. In addition to inspecting Chinese facilities that manufacture food and medical products for export to the United States, the FDA will inspect sites of clinical trials and conduct follow-up inspections to ensure that firms continue to produce and manufacture food and medical products under safe conditions, and that they apply sound production practices. 
• Provide unique opportunities for engagement with Chinese regulatory counterparts. Direct observation of FDA inspections can bolster Chinese regulators’ understanding of FDA requirements and processes and strengthenChina’s inspectional capacity.
• Support Chinese regulators’ knowledge ofU.S.safety standards through workshops and seminars. These opportunities help facilitate dialogue and encourage scientific exchange on the critical role of inspections in improving the safety and quality of food and medical products.

Considering the volume of incoming trade from China, an extra $10 million won’t go very far; the best bang for these bucks will come from improving relationships with Chinese regulators to streamline communication, understanding, collaboration, and their buy-in to our needs—which means our 16 inspectors heading for China must be highly skilled relationship-building ambassadors as well as thorough inspectors.

In June 2011 the FDA issued draft guidance for industry entitled “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.” Building on the recommendations within that document, the agency released two new nanotechnology-related guidances in April:

• Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives
• Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products

The overall tone is cautionary, rather than restrictive. The FDA is using these documents to re-emphasize how nanotechnology can inherently change the behavior of materials, which can potentially affect the safety, usage, and regulatory status of products made from these materials.

For foods the FDA warns that nanotechnology can:

• Affect the identity of the food substance
• Affect the safety of the food substance
• Affect the regulatory status of the use of the food substance
• Require a regulatory submission to FDA

 “Altering the manufacturing process of a notified food contact substance to either produce components in the nanometer scale or increase the proportion of nanometer-scale components,” continues the FDA, “can sometimes be a significant manufacturing change that could result in a substantive change to the specifications and/or in the identity of the food contact substance or its impurities, and/or levels of impurities.” The FDA also points out that a food substance manufactured for the purpose of creating very small particle sizes with new functional properties likely would not be covered by an existing GRAS (generally recognized as safe) determination.

For cosmetics, the FDA warns that:

• Cosmetics are not subject to premarket approval; however, they must be safe for consumers under labeled or customary conditions use and be properly labeled
• Cosmetics manufactured using nanomaterials are subject to the same legal requirements as any other cosmetics
• In general, the processes currently in use for assessing safety are appropriate for cosmetics containing nanomaterials; however, standard safety tests may need to be modified or new methods developed to evaluate new or unusual properties or functions exhibited by nanomaterials

The FDA recommends that the safety assessment for cosmetic products using nanomaterials should address a number of important factors, including:

• Physio-chemical characteristics 
• Agglomeration and size distribution of nanomaterials at the toxicity testing conditions that should correspond to those of a final product
• Impurities
• Potential product exposure levels and the potential for agglomeration of nanoparticles in the final product
• Dosimetry for in vitro and in vivo toxicology studies
• In vitro and in vivo toxicological data on ingredients and their impurities, dermal penetration, irritation (skin and eye) and sensitization studies, and mutagenicity/ genotoxicity studies
• Clinical studies to test the ingredient, or finished product, in human volunteers under controlled conditions

“Industry remains responsible for ensuring that its products meet all applicable legal requirements, including standards for safety—regardless of the emerging nature of a technology involved in the manufacturing a product,” writes the FDA. “We encourage industry to consult early with the agency to address any questions related to the safety, effectiveness, or other attributes of products that contain nanomaterials, or about the regulatory status of such products.”

It never hurts to be reminded of the obvious, which unfortunately can be overlooked or forgotten in the rush to market, or through incomplete science or testing.

It would be prudent for manufacturers who use nanotechnology to review these guidances to see the latest in FDA thinking. The FDA is also investing in an FDA-wide nanotechnology regulatory science program to further enhance its scientific capabilities, including developing necessary data and tools to identify properties of nanomaterials and assess the impact they may have on products—so expect more guidance (and more informed scrutiny and assessment) from the FDA in the future.

 If you aren’t already there, maybe you should think about Brazil.

With a population of about 200 million, Brazil is one of the largest medical-device markets in the world. It has a well-developed, evolving, and fairly reasonable regulatory system in place that is similar in many ways to the EU (although it has some significant differences, too).

With an increasingly competitive global market, Brazil represents a stable, untapped market for many companies. Any company interested in expanding their product lines into Brazil will be interested in reading Underwriters Laboratories’ guide to the medical device approval process in Brazil entitled “Medical Device Approvals in Brazil: A Review and Update.”

Released in September 2011, this is an excellent overview of Brazil’s current regulatory framework and the requirements for manufacturing, importing, or selling medical devices in the country. It also discusses the registration and certification process required of all device manufacturers, importers, and distributors, and the steps necessary to secure and maintain approval for medical devices.

Resolution RDC No. 185 of October 22, 2001 is the primary regulation covering registration of all medical devices, except for in vitro diagnostic (IVD) devices, which are covered by Resolution RDC No. 206 (November 2006). The classification structure for medical devices in Brazil corresponds to that used in the European Union (EU) under Council Directive 93/42/EEC concerning medical devices.

Brazilis a member of the Southern Common Market, also known as MERCOSUR, which includesArgentina,Paraguay, andUruguay. “As such, the process for the registration of medical devices in Brazil has been partially harmonized with that of these countries, theoretically easing the process of gaining admission to these other markets,” states Underwriters Laboratories (UL).

All medical devices imported into or distributed within Brazil must first be registered with the Agência Nacional de Vigilância Sanitária, also known as ANVISA or the National Health Surveillance Agency. This agency is responsible for the registration of medical devices and for the maintenance of a registered products database. UL indicates that, “unlike the EU Notified Body system, the 510(k) system of the Food and Drug Administration (FDA) in the United States, or the Canadian Medical Device Conformity Assessment System (CMDCAS), ANVISA performs all registration and inspection functions within the agency.”  

Only companies based in Brazil can apply for ANVISA registration. That means companies that do not have subsidiaries in Brazil must depend on Brazilian-based third parties, such as hosting companies, distributors and dealers, to obtain ANVISA registration for medical devices.

The certification process starts with Instituto Nacional de Metrologia, Normalização e Qualidade Industrial, also known as INMETRO, or the National Institute of Metrology, Standardization and Industrial Quality. This group is responsible for accrediting certification organizations that certify products for compliance with applicable requirements and authorize the use of approved certification marks. This certification scheme is known as the Brazilian Conformity Assessment System (SBAC).

“To qualify for INMETRO certification, medical device manufacturers must have their products tested to SBAC-recognized standards by an INMETRO-accredited testing laboratory,” states the report.

Once a medical device has been tested to the requirements of the appropriate technical standard and all user manuals have been translated into Portuguese, an applicant can proceed with the INMETRO certification process. This involves reviewing documents, pre-license inspections, certifications, and product marketing.

After a certification body has completed its review of test reports and user manuals as well as its pre-license factory inspection, and has determined that a device and the device manufacturer are compliant with all applicable requirements, the certification body issues an INMETRO certificate (valid for five years).

“Like most other product certification systems,” states UL, “maintaining an INMETRO certification requires certain periodic activities. For an approved medical device to remain INMETRO-certified for the full five-year certification period, a manufacturer’s facility is subject to annual surveillance inspections. An annual INMETRO inspection should take place approximately 12 months after the original certification has been issued, and at succeeding 12 month intervals for the duration of the certification period.”

The current size and anticipated continued growth of the Brazilian market presents significant opportunities for manufacturers of medical devices. Brazil’s regulatory approval scheme for medical devices is similar to that found in other countries. In addition, Brazil relies on national versions of widely accepted international standards to assess product compliance.

As organized and integrated as this sounds, the length of time between filing an application for a registration of a medical device and the final government approval can be lengthy. “The International Trade Administration of the U.S. Department of Commerce estimates that it can take as little as three months or as long as two years to achieve product registration, depending on the type of submission to ANVISA, such as new registration, update, or revalidation,” says UL.

Underwriter Laboratories is an experienced and knowledgeable accredited certification body in Brazil. It has been accredited by INMETRO to evaluate and test products, devices, equipment, material, processes, and services for compliance with the standards recognized by SBAC. For more information contact Tara Kambeitz, UL’s global marketing manager for health sciences, at Tara.L.Kambeitz@us.ul.com.

On March 19, the FDA announced guidance for a medical device ISO 13485:2003 voluntary audit report submission program. The document provides a strategy for responding to Section 228 of the Food and Drug Administration Amendments Act of 2007, which states that:

“For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality system standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.”

Starting June 5, 2012, the FDA will launch a voluntary pilot program that allows device manufacturers that have been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) using the 13485:2003 standard to voluntarily submit those results to the FDA to be considered for a possible one-year bye from FDA inspection.

“If, based on that report,” the guidance states, “FDA’s analysis or compliance decision meets the requirements of the FDA’s Medical Device Compliance Program 7382.845 for “Situation II,” that there is minimal probability—in light of the relationship between the quality system deficiencies observed and the particular device and manufacturing processes involved—that the establishment will produce nonconforming and/or defective finished devices,then FDA intends to use the audit results as part of its risk assessment to determine whether that establishment can be removed from FDA’s routine inspection work planfor one year from the last day of the ISO 13485:2003 audit.”

If FDA reviewers accept a manufacturer’s most recent ISO 13485 audit report, that company is exempted from FDA quality system inspection for one year from the date of its most recent ISO 13485 audit. 

“The world is using 13485 and many quality-management systems audits are being performed by other regulators and third-party authorized auditing bodies,” says Kim Trautman, associate director for international affairs for the Center for Devices and Radiological Health. “The FDA wants to explore how we can leverage off some of these other audits and utilize some of the trusted partners’ work in auditing manufacturers.”

 The program is only available to manufacturers that have already registered their devices for sale in the U.S.and established FDA GMP-compliant quality systems. Furthermore, qualifying manufacturers must also have ISO 13485 certification in place prior to participation in the program.

Manufacturers should make arrangements with their regulatory third-party auditors prior to the scheduled audit to ensure that the audit and its report will be eligible for the pilot program. The FDA will consider for eligibility under this pilot program ISO 13485:2003 audit reports sent to the FDA within 90 days from the last day of the most recent audit. Reports can be either a full assessment of the establishment’s Quality Management System (QMS) or a surveillance audit of the establishment’s QMS.

“We will use ISO 13485 as a risk-based process for planning and using FDA resources and inspection resources wisely,” adds Trautman. “We are very excited to launch this new program and hope that manufacturers take this opportunity. FDA wants to use this experience to help further develop a medical device single-audit program. We’re excited to possibly use information that’s already available to help us optimize the use of FDA resources and really put those resources toward the places that need the most attention.”

The agency has launched an online video, slide presentation and transcript covering key aspects of the program. See the original guidance at:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm212795.htm.

What a difference some wording makes!

On March 6, the U.S. Food and Drug Administration issued a warning letter to Breathable Foods Inc. for false or misleading statements regarding its product AeroShot. It was told this “caffeine inhaler” could pose risk to children and adolescents and in combination with alcohol.

The company states AeroShot provides “breathable energy, anytime, anyplace.” On the website it states the product is intended to be ingested by swallowing. The FDA maintains this labeling is false or misleading because these two claims contradict each other. This could also have major implications as to whether the product is categorized as a dietary supplement or a drug.

FDA is concerned that by calling it “breathable energy” consumers may try to inhale AeroShot directly into their lungs. “Caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied,” states the FDA. Breathable Foods maintains the particles in AeroShot are too big to enter the lungs, yet does not provide research to support this claim.  

The website indicates that AeroShot is “not recommended for those under 18 years of age,” yet the product label states that it is “not intended for people under 12.” This suggests to the FDA “that the product is suitable for children 12 and over. Please provide us with any safety evidence you have relied upon related to the use of your product by children and adolescents so that we can evaluate that evidence.”

Because it is sold as a dietary supplement AeroShot did not require FDA review and approval. However, New York’s U.S. Sen. Charles Schumer met with FDA Commissioner Dr. Margaret Hamburg, who agreed to review the safety and legality of AeroShot.

“I am worried how a product like this impacts kids and teens, who are particularly vulnerable to overusing a product that allows one to take hit after hit after hit, in rapid succession,” Schumer says.

So is AeroShot a supplement or a drug?

According to Neal Fortin, Professor and Director of the Michigan State University Institute for Food Laws and Regulations, who also writes the Food Law Blog (www.foodlawblog.foodlaw.org), states that by definition, according to the FDA, “dietary supplements must be intended for ingestion” and that “a product intended for inhalation is not a dietary supplement.”

“Surprisingly,” says Fortin, “the FDA did not state the consequence of failing to be a dietary supplement—as far as it is intended for caffeine inhalation, Aeroshot would be a drug and medical device.” 

Therefore it would seem the actual size of the molecules of the ingredients in AeroShot is critical to this determination. If the particles are small enough to be inhaled through the lungs, then conflicting information exists about safety and usage that could result in the product being ruled as a drug.

Ultimately the take-away message is to be absolutely certain that, in the rush to get to market, your marketing labels and usage labels tell exactly same story and have all the information required by the FDA; why risk everything you have gained by sloppy marketing so late in the game?

According to the PricewaterhouseCoopers and the mobile operator industry association GSMA report Touching Lives through Mobile Health: Assessment of the Global Market Opportunity, global mobile health revenues could reach US$23 billion by 2017, driven by rapid growth in Europe and Asia. Monitoring services, such as those for chronic disease management, will account for 65 percent of the market, followed by diagnostic services.

Increased use of smartphones and other wireless devices, as well as the proliferation of mobile broadband networks and services worldwide, makes the mobile industry a major player in the future of health care. High-demand applications include interoperability with other systems like electronic medical records and laboratory information systems and real-time monitoring of patient conditions and vital signs.

“By 2017, mobile technology will be a key enabler of health-care delivery reaching every corner of the globe,” says Jeanine Vos, executive director of m-health at GSMA. “With developed countries needing to reduce the cost of universal health care, and developing countries looking to roll out life-saving services to in-need communities, mobile technology can deliver highly effective, scalable and affordable health care beyond the confines of a hospital or doctor’s surgery.”

In terms of market opportunity, GSMA indicates the provision of pervasive m-health services and applications worldwide could provide mobile operators with revenues worth approximately $11.5 billion by 2017. Device vendors could benefit from a revenue opportunity of $6.6 billion, content and application providers $2.6 billion, and health-care providers $2.4 billion by 2017.

However, to make this happen, warns the GSMA, governments, regulators, health-care providers, and device makers must collaborate to support the roll-out and adoption of new m-health services—a task much easier said than done.

“There’s no doubt that collaboration is critical,” says Eleanor Chye, executive director of mobility health care and pharma for AT&T Business Solutions. “Leading carriers, device manufacturers, health plans, and providers all need to come together to help transform m-health from a niche play into wide-scale implementation as a standard of care.”

In the murky regulatory realm, regulators need to proactively address the top issues that currently limit the growth of m-health services, such as certification, interoperability, and standardization. The FDA once again finds itself in the middle, wanting to proceed with care but also feeling the pressure to keep up with the quickly evolving wireless medical market and the benefits it can provide, including lowering the overall cost of health care.

Organizations like the American Medical Informatics Association (AMIA) have suggested holding clinical decision support (CDS) information delivery channels and mechanisms, devices, and applications intended primarily for use by clinicians and other providers to a different regulatory standard compared to those intended for patients, consumers, and their caregivers. The AMIA also questioned the singling out of “stand-alone” CDS delivered via “mobile medical devices” as being suitable for FDA oversight, more than other kinds of clinical software environments, such as desktop computers.

Other key issues raised by the AMIA include:

• The need for the FDA to articulate how it characterizes and defines CDS
• The need to coordinate efforts among federal agencies and public- and private-sector research and practice communities
• The potential limitations if FDA focuses too narrowly on CDS, and considers CDS on mobile devices as somehow separate from CDS based on other delivery methods or contexts
• The importance of addressing rapidly emerging and converging technologies and devices along with new and evolving forms of patient care delivery (such as medical homes and accountable care organizations) and payment methods

“The health sector is exploding with an array of clinical information systems for potential use in a broad range of settings,” says AMIA president and CEO Edward H. Shortliffe. “It is important to have regulations that keep pace with clinicians, many of whom are becoming quite expert at using technology to access pertinent information, thereby streamlining health-care delivery and improving overall health.”

On February 9 European Health and Consumer Policy Commissioner John Dalli called for immediate action from the EU to ensure stringent implementation of the current legislation on medical devices. This was in response to the fraudulent use of non-medical grade silicone in breast implants manufactured by the Poly Implant Prothèse (PIP) Company inFrance. The European Commission is now scrambling to tighten controls on the approval of medical devices and restore patient confidence.

Actions proposed by Commissioner Dalli include:

• Verify the designations of notified bodies to ensure that they are designated only for the assessment of medical devices and technologies that correspond to their proven expertise and competence
• Ensure that all notified bodies in the context of the conformity assessment make full use of their powers, including conducting unannounced inspections
• Reinforce market surveillance by national authorities, in particular, spot checks in respect of certain types of devices
• Improve the functioning of the vigilance system for medical devices—for example, giving systematic access for notified bodies to reports of adverse events and enhancing coordination in analyzing reported incidents
• Support the development of tools ensuring the traceability of medical devices as well as their long-term monitoring in terms of safety and performance, such as Unique Device Identification systems and implant registers

In addition, the European medical device industry trade association Eucomed has suggested using “only the best” notified bodies, developing a single approach to vigilance and market surveillance, and strengthening harmonized standards.  

There is no doubt this will have impact to thoseU.S.companies working in European markets.

“Some doctors, regulators, and even the medical devices industry itself say this affair exposes Europe’s weak regulation system, one that allowed PIP to operate for longer than it could have under a more rigorous regime,” says Kate Kelland in the February 3, 2012 issue of Insurance Journal.

In fact, she points out that the FDA rejected PIP’s application to sell its breast implants in 2000, over a decade ago, for failure to investigate deflation problems and not disclosing the many complains the company had already received from women around the world. 

Medical devices are regulated under the Conformite Europeenne (CE mark) system inEurope; however, gaining this designation is relatively easy.

“Because Europehas no centralized process for approving medical devices, manufacturers don’t go directly to a national or Europe-wide regulator,” states Kelland. “Instead, they seek a CE mark through any one of 70-80 organizations known as Notified Bodies, which largely are private companies. Scientists who published a review of the system in the European Heart Journal in May 2011 found that the fragmentary setup encourages manufacturers to shop around for countries or Notified Bodies most likely to offer hassle-free certification.”

A 2010StanfordUniversitysurvey of medical device manufacturers showed that high-risk devices took an average of 54 months to get through the FDA to market, compared to just 11 months inEurope. The European system is often used as an example of a faster system that works better than the FDA’s. Congress is still considering an overhaul of the device review process and wants to make a decision by the fall. But what sort of impact will the PIP scandal have on the decision-making process?

“Medical device makers have spent the last year urging U.S. officials to approve high-risk products faster, like their European counterparts,” says Alex Nussbaum in a recent article on www.bloomberg.com. He adds that experts like Carl Heneghan, an Oxford University professor, believe the PIP problem, along with other EU device failures, should give lawmakers pause. “All the industry guys in the U.S. say, ‘we should have access to these products much sooner, like in Europe,’” says Heneghan, who is an expert in device recalls. “The flip side is the European people are being used as guinea pigs.”

Rottenstein Law Group inHewlett,New Yorkhopes the breast implant recall will help convinceU.S.regulators that the FDA’s medical device approval process should not be accelerated. In a press release they cite a similar problem where thousands ofU.S.women have suffered injuries as a result of vaginal mesh implants that, in their opinion, were not properly reviewed.

 “Categorized by the FDA as medical devices that the agency can clear for sale based on similarity to medical devices already on the market, and without the benefit of human testing, the implants have so far spawned more than 650 lawsuits filed by patients alleging that they have been significantly injured as a result of having the mesh products implanted,” states the law firm.

It’s a high-tech world full of high-tech solutions that give us comfort and peace of mind. We’ve got risk and quality management practices in place that free us up to charge ahead with business—but do we look back enough over our shoulders, or do we fall victim to complacency—like, “Hey don’t sweat it, if it hasn’t happened yet it’s not going to happen.”  

According to Drew Zavatsky, a section manager for the Office of Risk Management in the Washington State Department of Enterprise Services in Olympia, Washington, complacency could be the greatest risk of all and the toughest to manage.

In the March 2012 issue of Risk Management Magazine (www.rmmag.com), Zavatsky notes that complacency can sneak into any corporate culture. A good example is the Deepwater Horizon disaster that, according to the President’s Commission on the Deepwater Horizon Oil Spill, “exhibits the costs of a culture of complacency . . . There are recurring themes of missed warning signals, failure to share information, and a general lack of appreciation for the risks involved. . . . These findings highlight the importance of organizational culture and a consistent commitment to safety by industry, from the highest management levels on down.”

But it’s natural for humans to be complacent; we like things the way they are. We don’t like to be wrong. We are adverse to change. We want to believe our decisions and preparations are good enough. We don’t want to be criticized for worrying, overthinking, or being critical. Complacency also results from assumptive thought, which is by definition taking a fact or statement for granted (like the Titanic was unsinkable).

Zavatsky defines complacency as a “new type of risk.”

Complacency is often the downside to consistent performance. When systems run well we become too comfortable with the daily routine and lose that edge of diligence as we move on to more obvious problems that are giving us fits.

It is often here where the real culprit appears, notes Zavatsky: the decision to forego a moment of insight. “These decisions seem to happen in just two ways—either by saying ‘I don’t care’ about known risks or by saying ‘I have done enough thinking’ about unknown risks,” he says. “This makes sense, because complacency comes from a place of self-satisfaction—where ‘I don’t know’ and ‘I don’t care’ run rampant.”

So what is the takeaway for risk managers, he asks?

For Zavatsky, dealing with complacency risk requires taking residual risk into account. According to the Federal Aviation Administration’s safety handbook, residual risk is the “portion of total risk that remains after management efforts have been employed” and “comprises acceptable risk and unidentified risk.”

“As a risk manager, it is not enough that I have used enterprise risk management to identify, prioritize, treat and monitor risks,” he continues. “I am also required to consider the residual risks after this process and analyze whether more needs to be done. The natural tendency to become complacent—‘I have done enough thinking’—is countered by asking, ‘Have I done enough thinking?’ and ‘Am I ignoring residual risk?’

Zavatsky believes the best way to neutralize complacency risk is maintaining a culture that embraces enterprise risk management at all levels, especially at the top. “At a minimum,” he says, “such an organization is much more responsive to risks and their treatments. It is very unlikely to hear an ERM-savvy CEO say, ‘I don’t care about these risks.”