What Everyone Must Know About Reusable Medical Devices

That sterility is among the most critical factors concerning medical devices is beyond question. The FDA has a set of clearly defined rules and requirements concerning sterilization of medical devices. This agency makes any firm reprocessing another manufacturer’s medical device the legal manufacturer and invests it with all the responsibilities for compliance, especially concerning sterility.

When a medical device company fails to prove sterility, it is almost certain to witness either a voluntary recall or one that is mandated by the FDA. This rule applies even to those companies that are reprocessing their own medical device. In case the device is to be re-sterilized by the user facility, the company doing it must adhere to strict and precise cleaning and sterilization instructions, and should validate them.

While reprocessing of single use devices has received a lot of attention concerning their regulatory requirements, attention to reprocessing reusable medical devices and their attendant regulatory requirements is also equally important.

A very interesting and valuable webinar from Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.

John Chapman, a senior medical device regulatory and compliance professional, will be the speaker at this session. Please enroll for this highly educative, 60-minute webinar by visiting https://www.traininng.com

John will explain the topic of reprocessing reusable medical devices by covering these areas of this topic:

• Reasoning behind labeling requirements
• Regulatory requirements
• Intended use and design
• Standards/guidance
• Validating cleaning and sterilization.

This webinar is aimed at professionals who deal with medical devices in some or another manner, such as Design Engineers, QA Managers, Quality Engineers, Regulatory Affairs Managers, Manufacturing Engineers and Hospital Operating Room Nurse Supervisors.

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About the speaker: In his over 35 years in the medical device regulatory and areas, John Chapman has spent over 15 years with the European Union’s medical device directive, 93/42/EEC, and has led two device companies to ISO Quality System certification and CE marking. The regulatory due diligence he has performed on over a dozen acquisitions in the past 12 years have exposed him to numerous Quality Systems, including consent decrees as well as many notified bodies.

John has participated in several FDA remediation projects involving non-compliance with all QMS sub-systems. A contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004; he co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.