Medical Compliance Update for Medical Devices

Megan Williams

With medical devices flooding healthcare organizations — Frost & Sullivan predicts that by 2020 there will be over 20 billion medical devices in use — hospital leaders can’t afford to fall behind on compliance. An effective medical device procurement strategy that aligns with organizational goals requires both an awareness of current medical compliance standards and proactive planning. Here’s what’s new with compliance requirements for medical devices.

Simplified Classification

At the end of 2018, the FDA’s final rule aimed to simplify procedures for classifying and reclassifying medical devices, as detailed by the Federal Register. Why does that matter? The final rule allows the FDA to classify class III devices (higher-risk devices or those automatically assigned to the category by law in lieu of classification orders) to class I or II.

UDIs and Convenience Kits

The FDA’s unique device identification (UDI) system requires that the label and device package bear a UDI. There is an exception for those devices that are packaged within convenience kits, since there is already a label with a UDI on the kit itself.

New FDA guidance — issued April 26, 2019 — clarifies key concepts around convenience kits, packaging, who the end user is and the definition of a medical procedure kit. It includes examples using a non-sterile orthopedic device set, single-use disposable medical procedure kit, and a sterile kit containing both single-use and reusable medical devices packaged together, among others, to illustrate the agency’s perspective on convenience kits. The guidance does not apply to in vitro diagnostic (IVD) devices that are subject to IVD labeling requirements, nor does it apply to products that are combined together.

Imaging Requirements

Imaging providers will be subject to new guidance documents under the FDA. The guidance, “Medical X-Ray Imaging Devices Conformance with IEC Standards,” ties into the regulation of X-ray solutions subject to the Federal Food, Drug & Cosmetic Act (FD&C Act). It aims to align with the act’s Electronic Product Radiation Control subchapter in order to meet the standards of the International Electrotechnical Commission. The goal is to deliver a more effective review of project submissions to ensure a better streamlining process.

Device Approvals

Recent device approvals include:

A new alloy for implants. Approval has been issued for a new alloy that facilitates the design of smaller, stronger implants that lessen soft-tissue disruption, encourage quicker recovery and support better outcomes for patients undergoing surgical procedures for spinal, orthopedic and other issues. This is the first alloy approved for use in an implant that is not made from iron, cobalt or titanium.

Optimizer Smart System for chronic heart failure. This device has been approved for patients with chronic, moderate-to-severe heart failure who are not suited for treatment with devices used with cardiac resynchronization therapy. The device has several components including a battery charger, programmer, implantable pulse generator and software.

MitraClip valve use expanded. A new indication for a heart-valve repair device intended to reduce moderate-to-severe or severe mitral regurgitation has been approved. In its first approval in 2013, the MitraClip Clip Delivery System was approved for the reduction of mitral regurgitation in patients whose heart failure symptoms resulted from abnormalities of the mitral valve and whose risks for mitral valve surgery were prohibitive. The new indication now includes patients with normal mitral valves who have developed heart-failure symptoms and moderate-to-severe or severe mitral regurgitation due to diminished left-heart function, despite their treatment with optimal medical therapy.

The P&T Community has up-to-date lists of additional device approvals.

An Increasing Security Concern

Healthcare continues to be uniquely vulnerable to cyberattacks, and the proliferation of connected medical devices is complicating that vulnerability.

Hospital leaders tasked with making smart decisions around medical devices need to be acutely aware of the inherent risk of the internet of things and how that risk intersects with medical compliance. The average hospital room today will house between 15 and 20 medical devices, according to HITInfrastructure, and the majority of them will be networked. This creates the twofold issue of more access points for mal-actors, and more points of vulnerability and direct access to patients.

The FDA has answered with additional guidance of postmarket management to mitigate and manage cybersecurity threats from medical devices, as well as premarket submission requirements for device manufacturers.

A New Take on Strategy

While best practices for medical device procurement have largely focused on value analysis and navigating group purchasing organizations, these new challenges will require the engagement of clinicians and technology teams. This is to ensure that medical compliance requirements are met and that decisions align with broader organizational goals.

To stay on top of compliance requirements, here are a few resources to help:

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