Medical Device Packaging and Next Generation Tyvek® Maintaining approval for medical devices and sterile packaging during the transition White paper Abstract A significant modification in the technology used in the manufacture of Tyvek® material found in a wide variety of medical devices and sterile packaging will now require manufacturers of currently approved Tyvek®-based products to re-evaluate them for continued compliance with applicable standards and regulations. This white paper presents the details of the production transition regarding Tyvek®, and summarises the likely steps necessary to ensure the continued recognition of previously approved medical devices and packaging that incorporate Tyvek® material. TÜV SÜD Contents 1 INTRODUCTION 3 2 MEdicaL DEvicE STERILE PacKaging REQuirEMEnts and Standards 4 3 TYVEK® and MEdicaL DEvicE PacKaging 5 4 THE TYVEK® MEdicaL PacKaging Transition ProJEct 6 5 REQuirED Actions For Maintaining EU NotiFIED BodY CErtiFication 7 6 REQuirED Actions in OTHER Jurisdictions 8 7 OTHER Transition ConsidErations 9 8 How can TÜV SÜD HELP You? 10 About TÜV SÜD expert Dr. Jan Havel Team Leader for Sterilisation and Biocompatibility, TÜV SÜD Product Service Dr. Jan Havel is a sterilisation product specialist and auditor for the Medical and Health Services group at TÜV SÜD Product Service. He serves as a team leader for TÜV SÜD experts in the validation of sterilisation processes, reprocessing, sterile packaging processes and biocompatibility testing for medical devices. Dr. Havel is an active member of the ASTM International’s Technical Committee F02 for Flexible Barrier Packaging and is Senior Product Specialist for the related topics and provides internal and external trainings for Sterilisation, Reprocessing, Packaging, Risk Management and Usability for Medical Devices. 2 Medical Device Packaging and Next Generation Tyvek® | TÜV SÜD Introduction Tyvek®-brand polyethylene material manufacturers (SPMs) to file formal has been widely used by manufacturers notifications with their respective EU DuPont Company, the of certain medical devices and medical Notified Body or other national manufacturer of Tyvek®, device packaging because of its regulatory authorities in connection has transitioned to a resistance to microbial penetration with previously approved medical in sterile applications. However, the devices and packaging that incorporate modified manufacturing DuPont Company, the manufacturer of Tyvek® material. In addition, in some process in the production Tyvek®, has transitioned to a modified jurisdictions, manufacturers of medical of Tyvek®. manufacturing process in the production devices that pose the greatest risk to of Tyvek®. This modification will require patients may be subject to additional many medical device manufacturers testing in order to maintain their device (MDMs) and sterile packaging recognition. TÜV SÜD | Medical Device Packaging and Next Generation Tyvek® 3 Medical device sterile packaging requirements and standards The European Centre for Disease of initial sterilisation and packaging until validation, and affect the sterility, safety, Prevention and Control estimates that the time of use, thereby helping to or efficacy of sterile medical devices.” over four million patients in the prevent the spread of infection. Revalidation is required since packaging European Union (EU) acquire a characteristics or density could affect healthcare-associated infection each Under the requirements of the EEC the absorption or penetration of year, directly resulting in at least directives and the EC directive sterilising chemicals, the effectiveness 37,000 deaths and contributing to as applicable to medical devices, of the sterilisation process, the integrity many as 110,000 additional fatalities.1 packaging materials and systems used of package sealing or the safety of Since infections due to poor hygiene to preserve the sterility of medical sterilised devices. account for approximately 20 to 30 devices must conform to percent of all healthcare-associated the requirements of the EU’s harmonised ISO 11607 has become the infections, rigorous hygiene and version of ISO 11607, Packaging for internationally-accepted standard for sterilisation practices are a primary terminally sterilized medical devices. sterile packaging materials and systems focus of efforts to reduce overall Part 1 of the standard, ISO 11607-1, used with medical devices, and has infection rates in healthcare settings. addresses requirements for materials been adopted by medical device used in sterile barrier systems and authorities in most countries around Most medical devices and apparatus packaging systems, while Part 2, ISO the world. Although the U.S. Food and designed to come in direct contact 11607-2, covers validation requirements Drug Administration (FDA) does not with patients must be sterilised to for the manufacture and assembly of expressly require demonstrated prevent the unintended transmission packaging materials and systems. compliance with ISO 11607, the of infectious organisms. Typically, agency does accept evidence of sterilisation is achieved through the Of particular note in ISO 11607-2 is the certification to the standard in support use of specially-designed, non-reusable requirement to revalidate sterile of manufacturers’ 510(k) pre-market packaging materials that provide a packaging materials and systems submissions for the approval of new barrier against microbial transmission. when “changes are made to the… medical devices. This sterile barrier system effectively packaging materials or packaging maintains device sterility from the point processes which comprise the original 4 Medical Device Packaging and Next Generation Tyvek® | TÜV SÜD Tyvek® and medical device packaging Originally developed in the U.S. by and mailing envelopes. be sterilised after packaging. Finally, DuPont in the 1950s, Tyvek® is an Tyvek® material is strong enough to engineered material comprised of The earliest application of Tyvek® to resist damage that could compromise non-directional fibres that are thinner medical device packaging occurred in the condition of previously sterilised than a human hair. These fibres are the early 1970s, a time when healthcare devices.3 bonded together with heat and facilities were increasingly turning to pressure (no chemical binders) and disposable medical devices as a way Due in large part to these unique spun into sheets using flash-spinning of reducing labour costs associated properties, Tyvek® has become an technology, a proprietary manufacturing with re-sterilising. DuPont researchers important packaging material option process. Tyvek®-based materials determined that Tyvek® was especially for sterile medical devices and is widely and packaging have the advantages well-suited as a packaging material used by device manufacturers of being light in weight while also for disposable medical devices, since worldwide. In addition to its application resistant to punctures or tears, as it provides greater resistance to in the packaging of medical devices, well as providing an effective barrier microbial penetration than medical Tyvek® is now also used to package against liquids.2 Today, Tyvek® is grade papers and other sterile disposable syringes and as a material used in a wide range of applications, packaging materials. Tyvek®’s in the construction of medical grade including vapour barriers in building permeability to air and gas also allows trays and pouches. It is even used as a construction, garments and shoes, for the infiltration of gas and ethylene packaging material for pharmaceuticals. and a variety of packaging material oxide, so that medical devices can TÜV SÜD | Medical Device Packaging and Next Generation Tyvek® 5 The Tyvek® Medical Packaging Transition Project DuPont manufactures a number of manufacturers of its plans to eventually its new manufacturing process to different styles of Tyvek® for the adopt a new flash-spinning technology determine its functional equivalence packaging of sterile medical devices, in the manufacturer of Tyvek® to help with Tyvek® material manufactured the two most popular being Tyvek® ensure the company’s capabilities to with the earlier version of flash-spinning 1073B and Tyvek® 1059B. Tyvek® meet anticipated future demand. technology. Testing conducted by 1073B is a robust packaging material According to the company, the change DuPont as part of the MPTP has offering increased resistance to in manufacturing technology would included assessments of the effects microbial penetration and greater potentially trigger the need to revalidate on the microbial barrier properties of protection against damage from heavy sterile packaging materials and systems the new Tyvek® from sterilisation, and devices or devices with sharp points. previously tested to the requirements from one year real-time aging and one, Tyvek® 1059B is a packaging material of ISO 11607. At a minimum, the three and five year accelerated aging.4 intended for use in sterile packaging transition to a new manufacturing applications for smaller medical technology would require manufacturers Under the MPTP, DuPont has also devices without sharp edges. As to update their documentation to worked closely with regulatory originally manufactured, both Tyvek® reflect the change and potentially to authorities in the EU, the U.S., China, styles 1073B and 1059B comply with adapt and revalidate the process. Japan, Canada and other countries. the material requirements of ISO The goal of these discussions