ISO 13485 & MDR Blog

How to use ISO 13485:2016 to manage implantable medical devices

A medical or surgical device is meant to interact with the human body during surgery, while some devices are intended to stay in a human body for an extended period of time. Devices that interact with the human body but do not stay in it are referred to as non-implantable medical devices. Implantable devices are those which stay in the human body with a medical objective for an extended period of time, or even a lifetime.

These implantable devices are very critical; for example, in the year 2010, DePuy, a subsidiary of Johnson & Johnson, recalled its hip implants from the market following a series of lawsuits enumerated well into the billions of dollars against its hip implants. Those devices had malfunctioned badly within human bodies. The complaints from those using the DePuy metal-on-metal hip systems included metallosis, immobility, infection, and dislocation. There was not only one incident, but several other incidents similar to the DePuy recall; for example, Zimmer Biomet also issued recalls of its shoulder implants. Management of these implants is therefore very crucial. Thus, the ISO 13485:2016 standard gives additional requirements to manage such devices, since these devices pose extra risks and hazards to the patient.

What is an implantable medical device?

The implantable medical device is defined in the ISO 13485:2016 standard under clause 3.6 as a “medical device which can only be removed by medical or surgical intervention and which is intended to:

  • be totally or partially introduced into the human body or a natural orifice, or
  • replace an epithelial surface or the surface of the eye, and
  • remain after the procedure for at least 30 days.

The standard explicitly clarifies the implants from any ambiguity, and all requirements for implants apply to devices within the scope of the above definition. The standard also clarifies active implantable devices, which are intended to remain in the body permanently after the procedure.

Requirements for implantable devices

Clause of ISO 13485:2016 explains particular requirements for implantable medical devices. It includes the following requirements:

Records for Traceability – Under this requirement, the standard mandates that organizations maintain records of traceability regarding:

  • Components: A medical device is an assembly of components, so an organization should maintain records to trace out the batch of each component used. For example, a batch of a specific spring used in a medical device should be listed on its production card or in the ERP of the manufacturing order. This is done so that production conditions for manufacturing the spring of that component can be traced out.
  • Materials: The main body in the assembly of an implant is made up of some specific material grade, and the records and identification of that material should be maintained. For example, a batch of devices should have the material stated on its production card, along with material testing certificates.
  • Conditions for work environment: If the work environment can affect product quality or safety, then it needs to be documented in records so that it can be traced out from production cards. For example, records of the hardening process of a component in a furnace should include work environment records such as its temperature, pressure, oxygen-free environment, and other environmental conditions in the furnace, because the hardening process affects the quality, i.e., hardness of the part, and also the safety of the product in different cases.

Records of distribution – The organization must mandate that all suppliers who are involved in distribution of these devices maintain all records of distribution to the final destination so that when the product is returned, there is traceability to the manufacturer’s system. This means that these devices should be uniquely identified in the distribution records so that the supplier can share this unique number with the manufacturer, which gives the manufacturer the ability to investigate the return of the product into its own traceability system.

Records of consignee – All shipment package records that include the name and address of the consignee shall be maintained. This will help the organization to recall the product easily from the warehouses of end suppliers if any non-conformity is found after delivery.

Records of identity of personnel in inspection or testing – Organizations must maintain a record of the identities of personnel (performing any inspection or testing) for every batch of implantable devices (requirement of Clause 8.2.6). This can be done with the help of production cards that contain the names of personnel (signatures also, in some industries) involved in important processes of manufacturing, such as inspection or testing.

ISO 13485:2016 saves implant supplier companies from manufacturing oversight

Medical implants are sensitive products, as they yield high financial profits for manufacturers and suppliers, but the slightest mistake can ruin everything. A slight manufacturing oversight can send a company backwards financially due to lawsuits and claims. Therefore, the standard mandates that manufacturing companies document each and every process for manufacturing and supplying of medical implants.

Not only will these processes help to avoid any non-conformity in the delivery of medical implants, and effectively recall a product prior to its delivery for the end consumer, but also, in the case of early findings of malfunction, they can enable organizations to minimize the losses, to investigate the case effectively, and pinpoint the root cause in order to correct the problem, take corrective action, and resume the delivery of conforming implants.

Use our free Diagram of ISO 13485:2016 Implementation Process to learn where management of implantable devices fits into the ISO 13485 implementation.