Medical IT Device Security: Why Medical Device Manufacturers Must Take the Lead and Drive Regulatory Compliance

Hospitals have increasing concerns that medical IT systems will endanger patient safety if security updates like MS security patches are not applied. There is backlash from hospitals against medical device vendors that prevent these updates from occurring or cause unnecessary delays. The FDA is encouraging complaints to be reported against the manufacturer in incidents that may lead to death or serious injury where a device becomes unstable do to lack of security or virus updates. Many vendors expect their Medical IT devices to stay static and will not authorize patch updates. Security flaws can result in systems that do not function as intended and can represent a significant risk to patient safety. Keeping such a device static is contradictory to ensuring that such a device is safe and effective per its intended use.

Of course, hospital IT departments may address the risk of these un-patched systems by applying these patches without the vendor’s approval causing potentially new undocumented risks to the medical device. Manufacturers must take the lead and drive regulatory compliance for these IT based medical devices.

Areas Covered in the seminar:

• Presenting current regulatory and industry viewpoints on this critical issue
• Showcasing how taking the lead benefits the vendors in setting the standard and ensuring high product quality in this very competitive industry
• Expounding on the weaknesses in vendors approaches to security and patch update validation and offering strategies that are adaptable and efficient to meet customer and regulatory requirements

Who Will Benefit:

This Webinar will provide valuable assistance to regulated companies on how to drive regulatory compliance for IT based medical devices. The employees who will benefit include:

• Regulatory & Compliance Management
• Quality Systems Management
• Hospital IT Management & Staff
• Software/IT System Validation Management & Staff
• Internal and External Auditors

Instructor Profile:

Lori Kahler is the Director of Quality Assurance and Regulatory Affairs for the Cardiovascular IT Business Unit at Agfa Healthcare. For the past seven years at the company, Lori has been responsible for establishing and achieving the strategic direction and development of all quality and regulatory activities related to the cardiovascular IT product portfolio. These efforts included implementing and achieving ISO 9001:2000, ISO 13485:2003 and CDN MDR (CMDCAS) registration as well as MDD 93/42/EEC (Annex II) certification; and managing the successful execution of all related EMC, electrical and safety testing to achieve the CB Scheme Test Certificate, CE Mark clearance and ETL Listing approval for all cardiovascular products providing entry into over 40 countries.

Lori has had a varied technical background prior to joining Agfa Healthcare. For seven years Lori was Author and Technical Editor for Simon & Schuster's Macmillan Computer Publishing division (QUE, SAMS-NET) and focused mainly on web development marketed to intermediate and advanced users. Lori authored Special Edition – Using Netscape LiveConnect and was contributing author on Special Edition – Using the Internet, Special Edition – Using Netscape 3.0 and Sams Teach Yourself Money 99 released in the fall of 1998. Lori was Technical Editor of publications that included Launching a Business on the Web, Using Internet Relay Chat and Que's Computer & Internet Dictionary. For nine years Lori was also an instructor and consultant at the Brown University Learning Community and conducted courses for management and executive training and implemented a personalized training program for physically-challenged employees.

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