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FDA Issues Final Guidance on Reusable Medical Devices

FDA Issues Final Guidance on Reusable Medical Devices

Endoscopes Linked to “Superbugs” Lead to New FDA Guidance for Reusable Medical Devices UPDATE The FDA has released the slides from their presentation on Reprocessing Medical Devices. Get the slides here. In light of the fatal “superbugs” that have been plaguing hospitals after using endoscopes, the FDA has released new guidance for reusable medical devices. While the risk of getting an infection of this type is low, there is still a risk. With that in mind, the FDA has updated their thinking with the release of Reprocessing Medical Devices in Health Care Settings. The FDA is also intending on putting together an advisory panel to review and discuss the transmission of “superbug” infections via endoscopy procedures. The purpose of the panel is to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes and other endoscopes, as well as automated endoscope reprocessors, based on available scientific information. The committee will make recommendations on: The effectiveness of cleaning, high level disinfection, and sterilization methods; the amount and type of premarket validation data and information needed to support labeling claims and technical instructions; the appropriate use of other risk mitigations, such as surveillance cultures; best practices and guidelines for 3 reprocessing duodenoscopes and endoscopes at user facilities to minimize the transmission of infections; and recommended approaches for ensuring patient safety during ERCP procedures, including a discussion of appropriate patient selection. It will be interesting to note how the regulations will adapt to meet the needs of patients with the increase in antibiotic-resistant...
Don’t Forget Safety Testing and the Value of Risk Management!

Don’t Forget Safety Testing and the Value of Risk Management!

Establish the Safety of Your Medical Device with IEC 60601 Compliance In our experience, the most frequently forgotten aspect of medical device development and commercialization from emerging companies is establishing a safety profile of a product. While clinical data or clinical trials may be necessary for establishing safety for some products, many Class II devices that follow a 510(k) clearance pathway require minimal, if any, clinical data to support safety claims. Once the need for clinical data is either planned for or eliminated, establishing the safety of a medical device through additional testing tends to be less of a priority. Depending on the technology incorporated into your medical device, applicable safety standards need to be identified during the design stages of the product. The most widely accepted benchmark for establishing safety for electrical medical devices is a standard called IEC60601-1, where compliance has become an acceptable means for satisfying electrical safety requirements for the commercialization of electrical medical devices in the European Union. 60601-1 has undergone revision recently. The third edition is enforced now in the EU and the second Edition is currently applicable in the U.S. The FDA will require the use of the third Edition of the standard for new devices as of June 30, 2013. In this new edition of the standard, there is strong emphasis on risk assessment, ISO 14971 and, in the U.S, a focus on device usability as an important factor contributing to the safety of the device. Product testing to 60601-1 is a very technical exercise that involves laboratory testing against the standard by a test house, such as Underwriters Laboratories. If...
Implement 21 CFR Part 820 Controls Early On

Implement 21 CFR Part 820 Controls Early On

Benefits and Risks of Moving to the Cloud Migrating to the Cloud: What are the Benefits? According to the National Institute of Standards and Technology, the cloud is “a model for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.” Most companies’ IT infrastructure use less than 30% of their capacity. It took years to get the capacity to where it is today, and it takes months to increase capacity. Employing qualified resources to maintain such an infrastructure is difficult and expensive. Cloud providers utilize about 65% of their capacity and can add capacity quickly. In short, cloud providers benefit from economies of scale, which enables them to lower individual usage costs and centralize infrastructure costs. Companies benefit by only paying for what they consume. Companies can increase or decrease their usage rapidly, and can spend less time managing complex IT resources. Not only do efficiency improvements reduce costs, the nature of some costs can change from being capital investment in hardware and infrastructure (CapEx) to a pay-as-you go (OpEx) model. Maximizing IT capacity utilization, improving IT flexibility and responsiveness, and minimizing cost are not the only advantages of the cloud. Collaboration can be one of the most important advantages of cloud computing. Multiple users, from around the world, can collaborate more easily on documents and projects. Because the information is hosted in the cloud, and not on individual computers, business owners can collaborate with external stakeholders in a secure environment with nothing...
Is Your Medical Device a Secret Safety Risk?

Is Your Medical Device a Secret Safety Risk?

WHEN: Thursday February 26th WHERE: Your office TIME: 1.30pm – 3.00pm REGISTER HERE Compliance with IEC 62304 is required for all electromedical devices where basic safety is dependent on software or firmware. But many device companies remain unaware that the devices they manufacture must meet this standard. That may be because there’s confusion stemming from a key guidance, in which the requirement is called both voluntary – and mandatory. To help you unravel the complexities of IEC 62304, Rita King of MethodSense has partnered with FDAnews to present a 90-minute webinar on February 26, 2015 that will clarify who the rule affects, what it requires , and what you need to do to ensure FDA approval of your products. At the heart of the requirement is patient safety – whether or not software impacts on what is called the Essential Performance (EP) of your device – thus putting a patient at risk in the case of a software failure. This level of risk can be hard to discern at the manufacturing level. For example, what would happen if a hoist manufacturer didn’t properly vet the software that signaled it to lower the patient at a certain speed? Lowering a patient too quickly (or not all) can quickly turn into a risk management nightmare, with IEC 62304 regulatory – and legal – implications. Register NOW and you will find out how to secure FDA approval of your device by clearly demonstrating that your product safety testing is adequate. Specifically, you will learn: How to identify the two biggest pitfalls: documentation and software pedigree. How to understand and address 3 significant non-compliance factors: software...
How to Structure a New Medical Device Business

How to Structure a New Medical Device Business

There’s More to Being a Medical Device Business than IP and R&D An emerging medical device business tends to focus their energy on product development and R&D. This is understandable because medical device founders are often first experienced innovators. As innovators, there’s a natural affinity to maintain a continued focus on product development and maturation. Having a clear IP position and strategy is an important factor for attracting capital, which could further emphasize the importance of R&D, product development and market analysis. Nevertheless, being and growing as a viable medical device business catering to the U.S. market requires much more than R&D, positioning your IP and measuring how big your market is. It involves developing an operational framework that structures your organization as a medical device company (Figure 1) and enables the commercialization of your product. Some Medical Device Business Requirements: Regulatory Affairs Risk Assessment and Risk Management found in FDA Guidances and ISO 14971 Compliance to IEC 62304 to manage software risks Quality Management Design Controls that are included in FDA 21 CFR Part 820 QMS requirements you might find in Part 820 and ISO 13485 FDA 21 CFR Part 11, if your device incorporates software Safety Complying with IEC 60601-1 3rd Edition and its collateral standards Clinical data or a clinical trial When wrestling with regulatory, quality and safety issues, executives fresh to the medical device industry often take uncertain or delayed steps as they navigate the path to becoming a medical device company. The biggest mistakes we see emerging medical device business executives make include delaying the development of their regulatory strategy and their quality system, which...
Life Science Cloud Vendor Selection Part 2

Life Science Cloud Vendor Selection Part 2

Technology Strategies to Ensure Benefits and Mitigate Risk Options to Discuss with your Life Science Cloud Vendor Cloud computing is defined to have several deployment models, each of which provides distinct trade-offs which are migrating applications to a cloud environment. NIST defines the cloud deployment models as follows: Private cloud: The cloud infrastructure is operated solely for an organization. It may be managed by the organization or a third party and may exist on premise or off premise. Community cloud: The cloud infrastructure is shared by several organizations and supports a specific community that has shared concerns (e.g. mission, security requirements, policy, and compliance considerations). It may be managed by the organizations or a third party and may exist on premise or off premise. Public cloud: The cloud infrastructure is made available to the general public or a large industry group and is owned by an organization selling cloud services. Hybrid cloud: The cloud infrastructure is a composition of two or more clouds (private, community, or public) that remain unique entities but are bound together by standardized or proprietary technology that enables data and application portability (e g , cloud bursting for load-balancing between clouds). Choosing the correct deployment can depend on who needs to access the service, budget and security concerns. Private clouds are the most secure and most expensive. Private clouds allow companies to have isolated sections of a cloud where you can launch resources in a virtual network. You can have complete control over your virtual networking environment and place your backend systems, such as databases or application servers with no Internet access. You can limit...