During surgery, medical or surgical equipment should interact with the human body, while certain equipment should stay in the human body for a long time. Instruments interacting with, but not remaining in, the human body is known as non-implant medical devices. Implantable devices are those that stay for a longer duration or even a lifetime in the human body with a medical aim.

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For example, in 2010, DePuy, a Johnson & Johnson company, recalled its hip-implants from the market in a series of lawsuits against its hip-implants well in the millions of dollars. These devices have been badly malfunctioning in human bodies. Metallosis, immobility, infection, and dislocation were complaints by DePuy’s metal-on-metal hip systems. Not only one occurrence, but it was also several additional identical events to the DePuy reminder. Zimmer Biomet, for instance, sent reminders of their shoulder implants. Consequently, the management of these implants is highly important.

What is an implantable medical device?

Under ISO 13485:2016 under Clause 3.6 the Implantable Medical Apparatus is described as a medical appliance that can be removed only through a medical or operational procedure and intended to:

  • To enter the human body, or a natural orifice, fully or partially, or substitute for the epithelium surface or ocular surface, remaining for at least 30days following a procedure.”
  • The standard fully explains the ambiguity of implants, and all implant standards apply in accordance with the aforesaid definition to devices. The guideline also emphasizes active implantation instruments, which should stay permanently in the body following the treatment.

Implantable equipment requirements

Article 7.5.9.2 of ISO 13485:2016 outlines the specific specifications for implantable medical equipment. These are the preconditions:

Records for Traceability – Under this criterion, companies keep standard traceability records for the following mandates:

Components: A medical device is a component assembly so that an organization should keep records to trace every component that was used. For example, on his production card or in the ERP of the production order, it should indicate a batch of a certain spring used on a medical device. This is done in order to determine the conditions of production for the production of the source of that component.

  • Materials: The primary body in the assembly of an implant consists of a specified material grade, which must be maintained in records and identification. In addition to material testing certificates, for instance, a batch of devices should contain material on their production card.

Records of distribution – The organization must require that all suppliers participating in the distribution of these devices keep all distribution records to the final destination so that when the product is returned, it can be traced back to the manufacturer’s system. This means that these devices should be uniquely identifiable in distribution records so that the supplier may share this unique number with the manufacturer, allowing the manufacturer to examine the product’s return into its own traceability system.

Records of consignee – All shipment package records with the consignee’s name and address must be kept. If a nonconformity is discovered after delivery, the organization will be able to simply recall the product from the warehouses of end suppliers.

Records of identity of personnel in inspection or testing – For each batch of implantable devices, organizations must keep a record of the identities of persons undertaking any inspection or testing (requirement of Clause 8.2.6). This can be accomplished with the use of production cards that carry the names of individuals (and, in some industries, signatures) involved in critical manufacturing procedures like inspection or testing.

ISO 13485:2016 prevents manufacturing supervision by implant supplier businesses

Medical implants are sensitive goods that give manufacturers and suppliers high financial profits, although a minor mistake might destroy all. Due to the legal proceedings and claims, modest fabrication supervision can financially return a corporation. The standards mandate so require manufacturers to document every process of medical implant manufacture and supply.

These processes not only help to prevent any incompliance in medical implant delivery and effectively retract a product for the end consumer but also can help companies reduce losses in case of early findings of malfunction, investigate the case and determine the root cause to reverse the problem, take corrective actions to remedy the problem.