As Medical Device Makers Go Wireless, Compliance Must Be Top of Mind
Wireless technology broadens application possibilities of medical devices for healthcare staff, patients and insurers, while boosting business for manufacturers. Despite the market potential, some device makers delay going wireless because of additional compliance steps this requires.
Medical devices have traditionally been hard-wired, and going wireless requires compliance with both the Food & Drug Administration’s (FDA) and Federal Communications Commission’s (FCC) regulations. Manufacturers who already employ wireless technologies need to keep up with the latest regulatory developments, yet few are aware of the FDA’s recent recommendations for these products. Even though they are only recommendations, not mandatory standards, the agency expects they be given due consideration.
One Product, Two Sets of Regulations
Even though a wireless medical device must play by both the FDA’s and FCC’s rules, its primary function remains medical. As such, the FDA requirements are primary and the FCC requirements are secondary. A device must first prove its compliance with the FCC regulations, and then proceed to demonstrate FDA compliance.
Wireless Technology Determines FCC Requirements
While medical device makers are well-versed in the FDA regulations, the FCC world is comparatively new to them. The FCC’s main requirements for this type of product are presented in Title 47 of the Code of Federal Regulations (CFR). While the regulatory document — with more than 100 parts — may seem forbidding, in reality, each part regulates a specific technology or a combination of technologies using the same radio spectrum. A medical device will only need to comply with the requirements relevant to the type of wireless technology it uses, and the same is true in terms of the scope and types of tests.
When selecting a radio for the product, a manufacturer has two options. One is to buy an FCC pre-certified radio module, which has already been tested. In this case, only limited testing on the system level will be needed to demonstrate that the finished product is compliant. Generally, this is the most cost- and time-effective route. If a company prefers to design and manufacture its own radio, a full scope of wireless testing is required to certify the radio and product.
Do Not Dismiss the FDA Recommendations
While there are some generic FDA requirements relevant to all medical devices, each product is unique and must be evaluated individually to applicable technical standards.
Every medical device must be tested to satisfy the FDA’s minimal requirements for safety and electromagnetic compatibility (EMC) as well as according to the international standards IEC 60601-1-x, Part 1: General Requirements for Safety and EMC and IEC 60601-2-x, Part 2: Particular Type of Medical Equipment.
Additionally, the August 2013 version of “Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff” makes several new recommendations that a wireless medical device needs to follow. Even though they are not mandatory, the FDA expects them to be addressed in an application for approvals. Few medical device makers are aware of the following recommendations:
- Explain why and how a specific wireless technology was selected. Each technology performs differently, and its choice automatically impacts the product’s performance and the device’s security and susceptibility to interference from other electronic devices.
- Demonstrate that the quality of wireless service has been considered.
- Establish that the device can co-exist with other radio equipment nearby without interference. Today, healthcare facilities use a myriad of wireless devices: from cell phones and pagers to tablets and laptops. Minimizing interference reduces the possibility of a technology error in an environment where decisions about people’s health and lives are made every day.
- Prove that the device has reasonable security measures in place to protect wireless signals and data from unauthorized access.
- Explain how other electronic devices might interfere with the radio portion of the device.
- Enclose operations instructions in the user documentation for both medical staff and patients, if necessary.
- Enclose maintenance and care instructions for the device.
Add on Risk Management
The FDA also expects that manufacturers perform risk management as part of their quality system under Title 21 CFR Part 820. A pre-market submission to the FDA will need to describe the following points in the section on the risk-based approach to verification and validation:
- Quality of wireless service: A wireless medical device might experience a delay in administering or terminating therapy depending on how fast data is transferred back and forth between a medical device and other medical or IT infrastructure equipment.
- Wireless coexistence: A device’s radio channel might interfere with other wireless devices nearby. Multiple devices in a hospital use various wireless technologies and might interfere with each other on the radio portion of the spectrum.
- Security of wireless signals and data: When patient information is transferred wirelessly, it must be properly encoded to prevent unauthorized access. Not only will such data breach compromise patient’s privacy, it might jeopardize the healthcare delivery.
- EMC of the wireless technology: Yet another consideration is how susceptible a medical device’s interface is to the electromagnetic interference (EMI) from nearby devices that do not use radio transmission, such as a computer.
Embrace Wireless to Stay in the Game
Avoiding going wireless can be detrimental to a medical device manufacturer as the healthcare market has truly embraced the technology. Viewing compliance as an ally from the start can reduce the element of uncertainty in the development process for product managers, engineers, purchasing, marketing and everyone else in the organization whose role is vital in helping the product to succeed in the market. After all, compliance ensures the product is safe and performs well to the satisfaction of the end user. This is the area where a consultation with a test lab could add significant value.
While the product is still in the concept stage, a test lab can advise the manufacturer about the general regulatory requirements and suggest wireless technology options suitable from the point of view of technical certification. When the product idea takes a definite shape, the test lab can determine exact requirements based on technical specifications. This approach introduces a substantial degree of confidence into the regulatory compliance process, increasing the probability that the product passes the tests and gets to market on time and on budget.