Regulatory Compliance for Medical Devices
Medical devices are regulated differently depending on what country they are used in. In the United States, the Federal Drug Administration (FDA) regulates both the manufacturing of and the upkeep of medical devices.
While it may seem as though buying a medical device is a one and done deal, the FDA has stringent guidelines on keeping these devices maintained. From stretchers to robotic surgery technology, the slightest malfunction in a medical device could lead to inconvenience or grave injury for a patient. That’s not to mention the potential lawsuit that a medical practitioner could face.
Therefore, it is incredibly important to keep medical devices updated. This means buying new medical devices frequently, and constantly repairing, calibrating, and cleaning old ones. Below, we detail the basic guidelines in the United States for keeping medical devices maintained.
FDA Compliance
The FDA is in charge of ensuring that medical devices are kept up to date. For manufacturers, this is fairly simple: the FDA releases guidelines based off of rigorous testing and experimentation that detail what medical device manufacturers are allowed to make.
For owners of practices or hospitals, these FDA regulations are more complicated. While there are few if any regulations against physicians buying new equipment, there are a variety of rules the FDA sets out on ensuring that medical devices are frequently repaired, calibrated, and maintained.
What Types of Medical Devices are Regulated?
Interestingly enough, all types of medical devices are regulated. Generally, the FDA sorts medical devices into three grades. These grades class devices on how invasive they are to the human body, among other things. These grades are necessary to ensure a level of safety and reliability. Section 608(c) of FDASIA regularly updates their list of medical devices in each grade. Class I refers to devices such as bandaids, bandages, surgical masks and electric toothbrushes. These devices have few regulations and make up almost half of all medical devices on the market. Class II medical devices are devices that come into sustained contact with a patient. Many diagnostic devices fall into this category, such as blood pressure cuffs, transfusion kits, surgical gloves, and sutures. Class III medical devices are heavily regulated. These devices come into frequent contact with patients and require post-purchase monitoring in most cases seeing as many of them come into close contact with patients’ internal organs. These devices are usually implanted in patients. Class III device examples are breast implants, prosthetics, and defibrillators.
How Often do Devices Need to be Maintained?
The answer to this question depends on the class of the medical device. Generally, Class II and Class III medical devices should be monitored daily, and calibrated as frequently as possible. The FDA lists devices on its website that have to be registered. After registration, the FDA allows for practices or third parties to perform preventative repair and maintenance on these devices. The FDA recommends that this occur as frequently as possible, especially for Class III medical devices. The FDA enforces these guidelines by performing audits every two years.
Most medical devices are on service contracts for a short period of time after purchase. After that, hospitals and private practices typically engage in preventative maintenance, and may outsource this to a third party. Our network connects healthcare providers to technicians who can perform these duties as well as repairs in light of an event.
What is an FDA Audit?
FDA audits happen every two years. These are typically for manufacturers of Class II and Class III medical devices. Manufacturers may or may not receive a notice. It is important to keep up to date with these audits as many of these investigations result in device recall. For hospitals and private practices, audits typically are internal and typically happen bi-annually. While these may only be financial, these checkups are important to keeping hospitals and private practices out of muddy water when it comes to keeping medical devices in working order.
483 Forms
The FDA 483 form is a way for FDA inspectors to detail concerns about a medical device. Over the course of an inspection, the FDA inspector uses the 483 form to list issues about medical devices or practices that may violate FDA rules. It is incredibly important to be aware of what is on a medical devices 483 form, not just for manufacturers, but also for healthcare providers buying new parts for current devices and providers purchasing new equipment. These forms are available in the form of spreadsheets on the FDA’s website.
What’s at Stake
Faulty medical devices can lead to the inconvenience or injury of a patient. Without preventative maintenance, healthcare providers could have to engage in costly repairs for their existing medical devices.
Furthermore, lawsuits against medical device companies and healthcare providers are lucrative for both legal personnel and patients due to hospitals’ vast reserves of funding. It is important to ensure devices are trustworthy to avoid financial pitfalls and the scarier possibility of medical licensing being taken away.
ISO Compliance
ISO is the International Organization for Standardization. While healthcare may be different across international borders, the devices that practitioners use is regulated internationally to ensure quality healthcare.
The ISO serves a few important roles. Firstly, it allows individuals to get certified in maintaining medical devices. Secondly, it creates a comprehensive list of guidelines and regulations for medical equipment. Healthcare providers should be aware of this before hiring a maintenance technician and before buying new medical equipment. The ISO has equally stringent guidelines on the installation and servicing of medical devices; even if a practice or hospital is not involved in manufacturing the medical device, they should be aware that guidelines exist at every point in a device’s lifespan.
Traceability
Finally, it is important for healthcare providers to detail how often their devices are repaired or maintained. This makes it easier for practitioners to stick to regulations and makes the process of device registration far smoother.