Medical Device Communiqué Q2 2013 Demonstrating the Safety of Medical Devices in the Human Body 1 DOJ: The Focus is on GMPs in 2013 2 ROHS II Impacts Medical Device Companies 3 Demonstrating the Safety of Medical Devices in the Human Body UL and the UL logo are trademarks of UL LLC 2013. Before approval by the US Food and Drug Administration (FDA), manufacturers of Medical Device and Biopharmaceutical Equipment must demonstrate the safety of their products, not just on the shelf, but when those products interact with the human body. Depending on the degree and duration of their direct contact with the patient, those products must be tested to assess multiple internationally accepted biocompatibility standards. The testing standards are broad and demanding. Testing must assess potential biological hazards, chemical and physical properties and interactions with the human body. Products are also subject to basic microbiological and virology testing; shelf life testing for devices and packaging; and validation of cleaning, reprocessing and sterilization. UL (Underwriters Laboratories) testing services now extend from concept through post-marketing follow-up. UL expanded its testing services to cover the entire product life cycle through its acquisition of MDT (Medical Device Testing GmbH). Germany-based MDT is ISO/IEC accredited and GLP certified. MDT s addition to UL supports the expansion of UL s South Bend laboratory, enabling the company to provide test data confirming both the performance and safety of Medical Devices.
DOJ: The Focus is on GMPs in 2013 The US Department of Justice s (DOJ) top areas of focus for 2013 include one area of particular importance to the Medical Device industry. In a speech earlier this year, Maame Ewusi-Mensah Frimpong, Deputy Assistant Attorney General for DOJ s Consumer Protection Branch (CPR) said, We will be taking an especially hard look whenever patients are placed at an unacceptably high risk of harm by violations of current Good Manufacturing Practices. Although Frimpong s statements were aimed at an audience of Pharmaceutical company personnel, her emphasis on Good Manufacturing Practices (GMPs) applies with equal force to companies throughout the Life Science industry. Frimpong offered five recommendations for companies. Those recommendations and corresponding best practices employed by our clients form the topic of an in-depth paper developed by UL Quality, Compliance and Learning. Here is an overview of Frimpong s recommendations and best practices demonstrated by our clients: 1. Make sure the right people are trained in the right topics. Best Practice: automating role-based qualification programs that include seven key elements. 2. Identify and react to problems. Best Practice: build communication touch points into your training program to enable timely quality-related notifications, change control notification, adverse event summary reporting, audit reports and product update notices. 3. Make sure people are satisfied and engaged. Best Practice: integrate quality training and qualification programs with corporate functions including corporate compliance, human resources, sales and marketing, safety education and corporate communication to a strong, cohesive commitment to the company s culture, employees, clients and subcontractors. 4. Ensure that people and policies are working in harmony. Best Practice: clients are using ComplianceWire to electronically capture supervisor observations, employee feedback, production-line performance data, SOP adherence and online quiz results to confirm employee understanding of high-risk SOPs. 5. Gain visibility into what people are doing: Best Practice: scheduling reporting tools giving managers continuous visibility into overall compliance. UL provides practical tools ranging from the ComplianceWire Dashboard; assignment, completion and user reports; advanced reporting tools and audit services. Many Life Science companies Pharmaceutical, Medical Device and Biopharmaceutical have already implemented compliance programs that address key points made by Frimpong. Most companies can do more to ensure consistent compliance responsible to DOJ s 2013 area of focus. Frimpong assured compliance professionals that DOJ recognized many companies had implemented strong compliance programs capable of detecting problems, misconduct and inadequacies before they became criminal offenses and that DOJ s enforcement priorities and approach will recognize those programs in a meaningful way. Page 2
ROHS II ImpaCTS medical device COMPanies The original European Directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment exempted Medical Devices (RoHS). That changed with the recast of the Directive, now commonly known as RoHS II, which applies to Medical Devices and monitoring and control equipment placed on the European Union market. What RoHS Means for the Industry RoHS restricts the use of certain hazardous substances in designated products in Medical Devices (Category 8) and monitoring and control instruments (Category 9). Medical Devices were exempted under the original RoHS but are required to comply with the RoHS II Directive by July 22, 2014. The hazardous substances restricted under RoHS II are: cadmium, hexavalent chromium, lead, mercury and two polybrominated flame retardants. Regulated products are prohibited from containing more than 0.1% by weight of homogenous material (except cadmium, which is limited to 0.01%), meaning that the material cannot be mechanically separated into different materials. RoHS II covers manufacturers, importers and distributors. Note that medical devices are already regulated under the EU s Medical Device Directive (MDD). Compliance with the technical documentation requirements under MDD do not comply with the requirements of RoHS II. Compliance must RoHS II requires companies to provide a Declaration of Conformity. Completing the Declaration involves four steps: 1. Conducting a supplier and material confidence assessment; 2. Collecting supplier declarations, material declarations and analytical test results; 3. Reviewing the information collected for quality and trustworthiness; 4. Conducting ongoing, periodic assessments to ensure the process and output are accurate and current. Page 3
Completing the Declaration of Conformity is a complex, time-intensive process that requires a broad range of capabilities and resources. UL provides the services for compliance with RoHS II as well as additional standards that apply to medical devices that may include the MDD, IEC 60601 Third Edition, ISO 14971 and ISO 13485. Services include: Training that covers current restricted substance regulations and the process and documentation requirements of the expanded RoHS II; Gap analysis that assesses processes for risk management and Quality Management Systems. The analysis results in a report that identifies process and procedure gaps to the RoHS II Directive, providing a guide for modifications to existing processes that comply with RoHS II requirements; Review of documents from suppliers to identify any additional information that may be required to demonstrate that all elements are in place to establish due diligence in the supply chain; Analytical testing: UL is an active participant in the IEC Technical Committee, which is responsible for the IEC s 62321 international standard for RoHS analytical testing; Ongoing assessments to ensure that production remains in compliance with the RoHS II Directive. This due diligence reflects any changes to materials, parts and subassemblies; Development of technical documentation, quality management systems, and supplier and material assessment processes. Although most medical devices are covered by RoHS II, implantable medical devices are among the electrical and electronic products covered by the Directive. It is important to remember that RoHS II is a CE Mark Directive, meaning that each product covered by the Directive must conduct the necessary technical testing, prepare the accompanying documents and affix the required CE mark to each product. Page 4
FDA s EYE on MDR Inadequate Medical Device Reporting (MDR) procedures are in the top five for violations identified by FDA investigators when inspecting Medical Device facilities. Poorly written procedures, insufficient information, late transmission of complete reports to FDA, incomplete documentation, poor training all these failures show up in 483s, Warning Letters and even product recalls. Medical Device companies have good reason to pay attention to the frequency of MDR violations throughout the industry. MDR is just one part of the Food and Drug Administration s Center for Devices and Radiological Health s (CDRH) expanding scrutiny of Medical Device post-market surveillance. Every year, the FDA receives several hundred thousand medical device reports of confirmed or possible device-related serious injuries, deaths and malfunctions. Still, FDA notes, While MDRs are a valuable source of information, this passive surveillance system has notable limitations, including the potential submission of incomplete or inaccurate data, underreporting of events, lack of denominator (exposure) data and the lack of report timeliness. The FDA s September 2012 report, Strengthening Our National System for Medical Device postmarket Surveillance left no doubt about the FDA s focus moving forward. The report proposed a strategy for improving the current system for monitoring the safety and effectiveness of medical devices in the marketplace. FDA s strategy envisions an integrated national medical device postmarket surveillance system that communicates timely and accurate information on the benefits and risks of medical devices; identifies potential safety issues in real-time; reduces the burdens and costs of medical device postmarket surveillance; and facilitates the approval of new devices. Few Medical Device companies would argue with FDA s vision. The value of the strategy, unsurprisingly, lies in the details. In April 2013, FDA attempted to provide some of those details when it issued an update to the September 2012 report. That update describes several initiatives the FDA plans in order to advance its vision of a national postmarket surveillance system. Among the initiatives is the modernization of adverse event reporting and analysis through: Implementation of a mobile application for voluntary adverse event reporting; Piloting an initial functional release of the FDA Adverse Event Reporting System; Implementation of prospective data mining tools in at least three major device areas to enhance identification of highquality adverse event reports and report trends and clusters; Identification of gaps in current methodological efforts to promote data standardization, interoperability, and linkage between registries and disparate data sources. Those initiatives are still in the planning stage. While it s worthwhile for Medical Device companies to understand what the FDA plans for the future, it is even more important for companies to recognize the scrutiny the FDA is applying to MDR procedures in today s facilities. Inadequate MDR systems are likely to remain in the top ten of FDA s inspectional observations. Staying off the FDA s hit list depends on understanding and complying with MDR requirements consistently and thoroughly. Page 5
About ul Quality, Compliance and Learning UL Quality, Compliance and Learning is a business line within UL Life & Health s Business Unit. UL is a global independent safety science company offering expertise across five key strategic businesses: Life & Health, Product Safety, Environment, Verification Services and Enterprise Services. UL Quality, Compliance and Learning develops technology-driven solutions to help organizations mitigate risks, improve business performance and establish qualification and training programs through a proprietary, cloud-based platform, ComplianceWire. For more than 30 years, UL has served corporate and government customers in the Life Science, Health Care, Energy and Industrial sectors. Our global quality and compliance management approach integrates ComplianceWire, training content and advisory services, enabling clients to align learning strategies with their quality and compliance objectives. Since 1999, under a unique partnership with the FDA s Office of Regulatory Affairs (ORA), UL Quality, Compliance and Learning has provided the online training, documentation tracking and 21 CFR Part 11-validated platform for ORA-U, the FDA s virtual university. Additionally, UL maintains exclusive partnerships with leading regulatory and industry trade organizations, including AdvaMed, the Drug Information Association, the Personal Care Products Council, and the Duke Clinical Research Institute. Page 6