The concept of what medical devices can do is constantly being expanded, and in the process old concepts are making way for new applications. This is particularly true in the case of absorbable implants. We’ve understood the principle since Roman times, when absorbable sutures were first used. Now the idea is paving the way for medical devices that deliver pharmaceuticals, or degrade when their work is done (like absorbable stents and bone fracture applications). The field even includes TEMPs (Tissue Engineered Medical Products). And standardization is right there, with the new ISO/TS 17137 that’s just been released. It’s titled “Cardiovascular implants and extracorporeal systems – Cardiovascular absorbable implants.” And it’s a must for those involved in this field.
The new technical specification provides you with the requirements for
- Intended performance,
- Design attributes,
- Materials,
- Design evaluation,
- Manufacturing,
- Sterilization,
- Packaging, and
- Information supplied by the manufacturer.
It supplements the ISO 14630 on non-active surgical implants. And it would also be appropriate for use with device specific standards like the ISO 25539 series on endovascular devices.
The standard was developed to address the increase in devices that are designed to degrade (either entirely or partially), with emphasis on the involvement of the human cardiovascular blood system. They can be metabolized, absorbed or even excreted.
The focus in this specification is on the device, not on any medicinal product that it might be delivering. It also does not address the delivery mechanism by which the device may be introduced into the patient (like angioplasty devices for example).
These devices present particular problems for the manufacturer, particularly in the area of packaging, since the devices are sensitive to temperature and moisture. You’ll be interested in using this specification to help define the particular challenges you’ll face with your product and various methods for mitigating these types of risks.
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