PCB Safety Requirements for Implantable Medical Devices

If you are a fan of superheroes, then you probably prefer the Avengers or X-men as they seem to be popular these days. Personally, I always liked Superman, Batman, Wonder Woman and the other members of the Justice League of America. Along with Aquaman, Flash and Green Lantern, they seemed to be capable of vanquishing any foe on land, in the air, under the sea and even from outer space. Although, I did not think it was possible that another member could appreciably make the team any stronger, the addition of Cyborg did just that. In contrast to the other members who are completely biological, Cyborg is an integration of man with machine.

This type of biomechanical being may seem far-fetched; however, it is closer to reality than many people realize. And it raises some questions as to how far we should be allowed to go in merging machinery with human beings. There is virtually no opposition to technology that preserves or extends life, such as implantable medical devices. For example, although there are legal restrictions on harvesting live organs, such as kidneys, no one objects to the development of wearable artificial kidneys (WAKs) or pacemakers to regulate the heart rate. Obviously, these devices raise issues of safety for the patient that must be considered at all stages of development and usage. Before exploring how to incorporate safety requirements into the development of the PCBs and electronics that comprise implantable medical devices, letโ€™s take a deeper look at the devices themselves.

Considerations for Implantable Medical Devices

An implantable medical device may be defined as:

A device that is surgically or otherwise inserted into or connected to an internal part of the body for medical purposes and is intended to remain attached afterward.

This includes devices that reside completely within the body and those that may be external to the body and connect to an internal organ, vein, artery, or other body part. A number of these devices that are self-powered are known as active implantable medical devices or AIMDs.

Types of Active Implantable Medical Devices

AIMDs are implantable medical devices that contain electrical/electronic systems and include the following:

๐Ÿ’— pacemakers - heart rate stabilizers

๐Ÿ’— defibrillators - heart fibrillation

๐Ÿ’— neurostimulators - modulate nervous system activity

๐Ÿ’— glucose meters - blood sugar monitoring

๐Ÿ’— micro electrical - mechanical systems (MEMS)

๐Ÿ’— brachytherapy - cancer treatment devices

๐Ÿ’— cochlear implants - hearing devices

๐Ÿ’— infusion pumps - fluid or medication delivery

๐Ÿ’— haemodynamic device - support blood flow

Safety Requirements for Implantable Devices

Implantable medical devices, including AIMDs, are regulated by the Federal Drug Administration (FDA) and usually fall under class 2 or class 3 regulatory requirements. These regulations are in place to ensure that medical device performance can be tracked and appropriate action taken for devices that can potentially cause serious health problems for the patient or even result in death if the device does not meet its objectives or otherwise fails. There are also standards that provide recommendations for designing tests to assess how a device will respond when implanted. These include ASTM F1439-03 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials by the Subcommittee F04.16 on Biocompatibility Test Methods of ASTM, International.

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Developing Safe Implantable Medical Devices

In the U.S., the FDA is the governing body with the authority to allow implantable medical devices into the market as well as recall or remove them, if needed. For class 2 and 3 devices, premarket approval (PMA) may be required. In the European Union (EU), Council Directive 90/385/EEC provides oversight for AIMDs. In addition to adhering to the safety regulations of applicable implantable medical device standards, the design and development of PCBs and electronics for these systems must be done within the framework of ISO 13485 and ISO 14971 for quality management and risk management, respectively. To ensure that your PCB development process adheres to all applicable safety requirements, it is advisable to follow a paradigm, such as the one below.

PCB Development for Safe Implantable Medical Devices

Order of development for safety

Steps for implantable medical device safety development

The potential threat of serious harm or fatality that accompanies the use of implantable medical devices requires that adequate oversight and control of their design, manufacture, and usage be in place to protect the safety of patients. To meet these requirements, it is imperative that your PCB manufacturing be performed by a qualified contract manufacturer (CM) that is committed to quality control. It is also important to incorporate rigorous testing regimens to validate your deviceโ€™s performance and reliability.

Tempo's Advanced Custom PCB Manufacturing Service for Complex Medical Systems Development
  • Works with 4 of the top 10 medical devices manufacturing companies.
  • ISO-9001, IPC-600 and IPC-610 commitment to quality certifications.
  • Accurate quote in less than a day.
  • DFM support from Day 1 of design.
  • Fastest turnkey PCB manufacturing in the industry.
  • Rigid, rigid-flex and flex board capabilities for wearables and embedded biosystems.
  • Custom automated BOM verification tool.
  • Sources components from the most reputable suppliers in the industry.
  • Software-driven robotics assembly.
  • Standard quality testing, including X-ray and inline AOI.
  • Superior open, transparent PCB manufacturing experience.

Partnering with a well-qualified CM is critical for the development of your implantable medical devices. Tempo Automation is the industryโ€™s flagship PCB manufacturing company for fast, high-quality board prototyping and low-volume production. We will establish an open, transparent white box process that optimizes the speed and quality of the development process.

And to help you get started on the best path, we furnish information for your DFM checks and enable you to easily view and download DRC files. If youโ€™re an Altium user, you can simply add these files to your PCB design software.

If you are ready to have your design manufactured, try our quote tool to upload your CAD and BOM files. If you want more information on implantable medical devices or developing them for safety, contact us.

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