Medical Device Non-Compliance Is Breaking the Bank

The risk of being non-compliant in the medical device industry is an expensive proposition. As of Aug. 1, FDA has initiated nearly 30 recalls during 2023 alone, the individual cost of which could top out at more than $600 million.

According to the McKinsey Center for Government, an organization that collaborates with many leading global stakeholders to foster the highest levels of device operations, “non-routine” events that are related to quality — such as recalls and lawsuits — will cost the industry between $2.5 billion and $5 billion per year, on average, for the foreseeable future.

Also becoming increasingly more costly today is the actual attempt to gain and maintain compliance within the confines of specific industry standards, particularly as it relates to the production and distribution of electrical medical equipment and electrical medical systems (ME equipment and ME systems). Launched in 2020, the current version (Version 3.2) of the International Electrotechnical Commission (IEC) 60601-1 series of standards, an international set of guidelines that applies to general safety and essential performance requirements for ME equipment and ME systems is now regarded by FDA as a recognized standard. This designation could potentially raise the manufacturer cost of achieving certification by as much as four times the $10,000-$20,000 based on the standard’s previous versions, according to some estimates.

Defining compliance

Intended specifically for electrical equipment that includes applied parts that meet specific functional criteria, the standards incorporate a range of metrics that validate each electrical medical product that’s made available on the market throughout the United States, European Union, Australia, Canada, Brazil, Japan, Russia, and other countries that adhere to the guidelines.

“Certification to 60601-1 is issued by qualified testing [third-party] laboratories that evaluate the device independent from the device manufacturer,” said Julian Grove, senior systems engineer at Starfish Medical, a leading medical device design service provider based in Victoria and Toronto, Canada. “Achieving compliance means that a device has been designed, documented, and tested in accordance with the applicable clauses within the [established] standard.”

Grove’s colleague Nigel Syrotuck, a lead engineer at Starfish Medical, advised that a formal third-party testing process can take multiple weeks or even months to complete, especially if there is a design flaw or other type of failure that needs to be resolved before the device reaches the market. Syrotuck suggests that engineers consider testing their devices in-house prior to any third-party assessment in order to increase the likelihood that a device will pass through any formal testing as well as to resolve any potential design issues more quickly while reducing potentially avoidable stress on the company’s overall marketing efforts and distribution schedule.

Among the various methods that can be beneficial when testing a device internally is the drop test, an assessment that helps to ensure that a device can be resistant to any stress caused by a potential free fall. Syrotuck and Starfish Medical offer a comprehensive strategy for determining a device’s durability and potential for compliance that can assist in-house testing.

Grove explained to MD+DI that, “IEC 60601-1 has many collateral and particular standards that compliment [the guidelines] for specific types of devices, such as X-ray equipment, or areas of function, for example, alarms. The standards are established through international cooperation of experts in the field of medical device development to hold all new devices coming to market to a threshold of quality that ensures safety.”

Collateral standards specify general requirements for basic safety and essential performance that must be met among any subgroup of ME equipment, such as radiological equipment. A device’s risk is said to generally be defined as the combination of probability that a device could cause harm as well as the potential severity of that harm.

The IEC defines medical equipment based on a three-tiered classification system from those that present the lowest level of safety risks including:

Creepage distance and clearance compliance

Another critical component of being IEC 60601-1 compliant is the regulation of creepage and clearance distances. The focus here is on the isolation that’s required to exist between device parts with different operating voltages in an attempt to prevent unacceptable risks. Creepage is defined as the shortest distance between the path of two conductive parts of a medical device and is measured along the surface of insulation. Similarly, clearance is defined as the shortest distance between two contacts outside the solid insulation.

Differences between IEC 60601 and 62353

The IEC has also implemented a set of standards that oversee recurrent testing practices and the testing of electrical medical devices that have undergone repairs. The IEC’s 62353 series also defines the requirements for electrical safety testing of equipment and systems during routine intervals. The distinction between the two sets of standards, according to Grove, is clear.

“The 60601 is [intended] for initial development and certification of the device,” Grove said. “The 62353 applies to recurring testing, for example, after preventative maintenance of devices that have been produced and perhaps sent to the field. There is overlap in the scope and expectations with 62353 focusing on tests applicable to verifying ongoing safety and excluding design-related clauses.”

History of IEC 60601-1

A series of articles published in 2005 by MD+DI discussed some of the history of the IEC 60601-1 ahead of IEC publishing the third edition of its safety standards.