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By: Michael P. Bruyere and Samantha Skolnick
From operating rooms to a local pediatrician office; we know that medical devices have altered the medical field in a significant way. As technology, has improved; making our homes smarter and allowing our cars to essentially drive themselves; medical devices have seen great technological advances. Now devices can communicate with each other and exchange information even if they are from different manufacturers. Interoperable medical devices are defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as devices that can exchange and use information through an electronic interface with another medical/nonmedical product, system, or device. Interoperability is essentially the means in which medical devices communicate and interact with each other. Yet, errors such as inconsistent units of measurement between the devices prompted the FDA to step in with guidance for the manufacturers.
The FDA issued its final guidance and recommendations on interoperability to ensure the safety and reliability of the communication between medical devices. The 21- page document, released on September 6, 2017, focuses on considerations that ought to be involved in the advancement and overall design. There were also suggestions for the material to be included in premarket submissions and labeling of devices. The guidance directly highlights that interoperability should be an objective for manufacturers; verification, validation and risk management activities should be taken; and manufacturers should be specifying the relevant features in a user- friendly way.
The FDA opines that manufacturers should perform a risk analysis and perform testing that considers; the perils that could be linked to interoperability, who the users of the devices may be, misuses that would be reasonably foreseeable, and a combination of foreseeable events that could result in an overall dangerous situation. The FDA advises that manufacturers should keep in mind the diverse users while designing the device and in formulating the instructions; since such considerations may affect the limitations on the device or the user. The FDA even suggests developing entirely different instructions for different users. The guidance document states that interoperable systems should sustain basic safety and key performance during normal and fault conditions. The manufacturers should be designing an interoperable medical device that can appropriately allay risks connected with a wide range of potential error scenarios. The guidance document also suggests that the devices endure a sufficient level of testing to prove that the interactions on the electronic interface are performing in the appropriate manner. The testing ought to be based on the purpose of the interface and should comply with the planned specification. Another general takeaway from the guidance document is that difficulties or misapplication of the devices can be curtailed by making the functional, performance, and interface standards readily available to all users.
Simply put, the goal is to make sure these devices are communicating in a way that ensures the safety of the patient and the operator of the devices. Manufacturers who are submitting applications up to 60 days after the publication of the guidance will not be required to comply with the recommendations. Yet, the agency is willing to review any information submitted to them regarding interoperability. The guidance document is not legally binding, but it highlights the impact of technological advancements on medical devices and the safeguards that should be in play. And as we read the guidance document on our latest smartphone or tablet, we are reminded of the tremendous impact technology has on our lives and continues to have.
If you have any questions or would like more information, please contact Michael Bruyere at [email protected] or Samantha Skolnick at [email protected].