Companies that manufacture and sell medical devices and their components carry a heavy burden of public trust. Medical devices shoulder tasks ranging from alerting diabetics of spikes in blood sugar to performing heart surgery on patients with robotic arms. If the devices fail, lives could be lost. For this reason, the manufacture of medical devices faces some of the stiffest regulatory compliance burdens of any industry in the world.
Still, when manufactured to proper safety standards, medical devices work miracles of healing and disease management. We depend on them, and we depend on medical device manufacturers to follow adequate safety practices so that they are dependable. Here are four important safety practices for medical device companies to implement:
1. ISO 14971 Risk Management
ISO 14971 is a safety standard promulgated by the International Organization of Standardization. It describes processes that manufacturers of medical devices can use to assess the hazards associated with the device. ISO 14971 can be used in the risk assessment of software as a medical device (SaMD) and of in vitro diagnostic medical devices, as well as traditional medical devices.
The standard applies to all stages of the life cycle of a medical device, targeting risks like biocompatibility, electricity, radiation, moving parts, data, and systems. It requires manufacturers to establish objective criteria for determining acceptable risk, although it doesn’t lay out specific risk levels.
Most recently updated in 2019, ISO 14971 pertains to such safety standards as:
- Inherent design safety. This could include ensuring connectors that can’t be connected to the wrong input; removing features that have the potential to be used in error; improving the readability and detectability of displays, controls, and labels; and automation of functions so as to avoid human error from user manipulation.
- Protective measures for manufacturing or the device itself. This could include physical safety guards, shielded components, and locking software or hardware; alerts for hazardous conditions like a depleted battery; use of low-maintenance technologies; and warning screens about required data inputs and other conditions necessary for safe operation.
- Safety information. This could include providing instruction manuals or training on safe operation.
Medical device manufacturers in the US, Canada, Europe, and many other jurisdictions must comply with ISO 14971:2019 in order to legally sell medical devices or their parts in those jurisdictions. Manufacturers should get off on the right foot by implementing compliant risk management controls in line with ISO 1497. If already operating, they should continually bolster their ISO 14971 to remain compliant.
2. IQ OQ PQ
IQ OQ PQ refers to a quality management system meant to validate the installation of new equipment. Any equipment used in the manufacture of medical devices should be subjected to a rigorous IQ OQ PQ process before the resulting medical devices should be deemed safe for use. If a manufacturer does not have an IQ OQ PQ plan in place, the priority should be to establish one.
IQ OQ PQ breaks down as follows
- Installation qualification. The “IQ” of the standard refers to the process of validating the equipment at the time of installation to determine if it has been installed in accordance with the manufacturer’s specifications.
IQ can apply to both hardware and software. The FDA describes IQ as verifying that the ““system has the necessary prerequisite conditions to function as expected.”
Once the equipment has been installed, IQ can be re-validated during a major improvement or modification.
- Operational qualification. One IQ has been validated, the OQ of the equipment must be validated. OQ is used to determine if the equipment is operating within the performance ranges specified by the manufacturer.
Note that OQ does not necessarily require operation of the machine in active production. That comes at the next stage of qualification. In the OQ phase, each component of the equipment is tested for operational viability.
- Performance qualification. In the final step of the qualification process for new equipment, PQ validates the equipment as a whole, in a test run of production.
PQ must be performed according to a thorough test plan, as the equipment has not yet been fully validated until it has performed to satisfaction.
IQ OQ PQ can be performed in-house or by a third-party auditor. This Dickson article notes that IQ OQ PQ is especially important in industries where the quality of the product could potentially impact consumer safety.
3. Clinical research
Quality control in device manufacture and equipment installation are critical safety measures, but both the US and Europe have made moves toward more stringent requirements for clinical research. Manufacturers should expect that extensive clinical research will be required to validate medical device safety.
Medical device manufacturers who do not have the capacity for in-house clinical trials usually partner with a third-party clinical research organization (CRO) to perform the kind of clinical trials that will verify the safety of the company’s medical devices. Clinical trial requirements vary from jurisdiction to jurisdiction, so check with applicable regulatory agencies, like the FDA in the US.
4. Post-market surveillance
Once it passes clinical trials, a medical device may be brought to market. However, evolving standards of medical device safety require post-market surveillance. These are methods and practices of monitoring the device after the device is brought to market, to remain vigilant for safety issues that might not have been revealed in clinical trials.
Depending on the regulatory jurisdiction, different post-market surveillance standards will have to be met. Medical device manufacturers should expect more and more scrutiny of device safety after they have been brought to market, and should establish a plan to detect any defects that emerge once the device has gone to market, as well as an action plan to report those defects to the applicable authority and act swiftly to recall or correct unsafe medical devices.
Manufacturers entering or evolving into the medical device field have a complicated regulatory landscape to navigate. However, with appropriate attention to required and recommended safety measures, medical device manufacturers can retain their position, not only as a growing and profitable sector, but as a safeguard and guarantor of public health and safety.
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