PRISYM ID is a leading label lifecycle management solutions provider, with many year's experience implementing compliant solutions for our customers. Here we discuss best practices and interesting industry updates that we've come across.
By Tim Fischer What is hot in the medical device industry? Regulation around labeling for the medical devices industry has evolved significantly in the last 40 years. From the challenge being the creation of exact definitions for labeling in the 1970s, to the release of the Health Industry Barcode Supplier Labeling Standard in the 80s, and issues such as multi-language labeling, symbology and e-labeling in the 90s & early 2000s, today’s hot topic is UDI. Moreover, with the EU Council and Parliamentary Committees having signed off new Medical Device & In Vitro Diagnostic (IVD) regulations in June 2016, UDI is set to remain a hot topic years from now.
The US Food and Drug Administration (FDA) published its latest draft guidance on UDI, entitled: “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).”
The increase in clinical trials complexity, coupled with the significant rise in trial drug costs, is having an industry-wide need for more flexible and cost-effective clinical supply operations.
The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulatea transformation of labeling infrastructure and approach among global device manufacturers.
Leveraging your supplier is one of the five key principles of the GAMP 5 ‘Risk-based approach to compliant GxP computerised systems’. A guideline document - written for the industry, by the industry – GAMP 5 outlines how organisations can successful achieve project delivery within the life sciences industry.
Ignoring the warning signs of non-compliance is no longer an option Data shows that more than half of all FDA recalls of medical devices since Q1 2014 have been caused by packaging and/or labeling error. One of the most high profile recent examples was the Class I recall of a Peripheral Infusion System, where major mislabeling risked the incorrect use of the product by physicians and raised the potential for serious patient injury or death.
At PRISYM ID we’re keen to understand how medical device, pharmaceutical and clinical trial companies check the labels they print for quality.
Medical device and pharmaceutical organizations are constantly looking at ways to avoid labeling errors which are a major reason for FDA product recalls. In a recent survey conducted by PRISYM ID, 67% of respondents admitted that human error was the most frequent cause for their labeling errors and 45% frequently experienced quality issues throughout their label production process.
Medical device manufacturers are up against the clock to ensure they are ready by the 24 September 2016 to meet the FDA UDI compliance deadline. Our recent survey found that 33% are not confident or unsure if they are ready for an inspection, while 23% admitted that implementing a label system as the biggest issue.