Modernizing our product portfolio to meet global regulations and standards
To keep delivering the trusted solutions your patients depend on, the Shiley™ portfolio of endotracheal and tracheostomy tubes has been modernized for a global society. That means we’ve taken the necessary steps to keep our portfolio at the highest level while helping you — and your patients — breathe easier.
These steps include:
- Modernizing our product portfolio to meet global regulations and standards
- Removing materials of concern from our products
- Raising the bar for clinical and performance standards
- Increasing transparency and accessibility
The result is our state-of-the-art Shiley™ endotracheal and tracheostomy tube product portfolio designed to meet the latest regulations and standards, support the needs of doctors and caregivers, and — most critically — advance patient outcomes.
Modernizing our product portfolio to meet global regulations and standards
If you looked for a harmonized international standard for medical devices, you wouldn’t find one. It doesn’t exist. So, we took the initiative ourselves. We modernized our product portfolio to meet the needs of clinicians and patients, while aligning with global regulations, medical device standards, and regulatory organizations. It’s one more way we’re helping to advance patient care across borders.
Removing materials of concern from our products
We take patient safety and comfort very seriously. That’s why we decided to remove harmful materials from our products. These materials are defined as substances that:
- Meet the criteria for classification as carcinogenic, mutagenic, or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation
- Are persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB), according to REACH Annex XIII
- Can cause an equivalent level of concern as CMR or PBT/vPvB substances
Phthalates, such as DEHP, have been identified as toxic for reproduction and have endocrine disrupting properties. Latex has been identified as causing allergenic responses.
The state-of-the-art Shiley™ endotracheal and tracheostomy product portfolio is made with latex-free, non-DEHP materials.
Raising the bar for clinical and performance standards
We’re invested in quality that endures. To enhance clinical and performance expectations and standards, we have engaged in external evaluations of clinical effectiveness and verification of performance claims and compliance.
To fulfill our commitment to aligning with global regulations, medical device standards, and regulatory organizations, we have agreed to the following requirements:
- External evaluation of clinical effectiveness by independent expert panel (CER) and determination of PMS needs
- External reference laboratories verification of performance claims and compliance with applicable common specifications
To this end, we are committed to:
- Updating CER every 2 years
- Updating Periodic Safety Update Report (PSUR) every 2 years
- Providing trend reports that record any increase in the frequency or severity of non-serious incidents or expected undesirable effects, particularly when they may affect the risk assessment of the device
We have also ensured that our modernized product documentation, including all instructions for use (IFU), conform to standardized notations and markings.
Increasing transparency of and accessibility to product performance information
We believe transparency and accessibility are key to accountability. We want you and your patients to be able to access vital information whenever you need it. In alignment with regulations that require Unique Device Identification (UDI) to facilitate the traceability of all medical devices sold in the region, our products are now marked with a device identifier (DI), and each batch and production series will be marked with a production identifier (PI).
Access to product performance information will be streamlined through the new EUDAMED database, which includes information on UDIs, the registration of economic operators (except for distributors) and devices, certificates, clinical and performance investigations, post-market surveillance, vigilance, and market surveillance.
Delivering consistently high quality amid a dynamically changing industry
In the world of respiratory care, change happens fast. Standards rise. Markets shift. Research reveals unmet needs. New technologies present new opportunities. Amid all this dynamic change, however, our commitment to delivering high-quality products has never wavered.