Organizations in the Life Sciences – including those in medical device manufacturing – have strict document-specific regulations to adhere to. In addition, these regulations are enforced by inspections. If these inspections don’t provide the regulatory bodies with confirmation that compliance is being met, warning letters are issued out to the companies. Subsequently, many companies are forced to pay out fines.
With the myriad of document conversion tools available within content management and content authoring systems, organizations often struggle to meet these challenges in a consistent, centralized and automated manner. Unfortunately, there can be expensive consequences for not formatting documents correctly.
The Code of Regulations: Section 820: Medical Devices states that medical device manufacturers must maintain several different types of documents, two of which are Device History Records and Device Master Records. In both of these cases, manufacturers must maintain their documents as “compilations of records”. If unable to successfully compile accurate and effective DHRs and DMRs, the organizations run the risk of being in conflict with regulations. Something as simple as not compounding documents correctly can cost medical device manufacturers a lot of money in fines.
If organizations are not using an automated document assembly and conversion system to compile their DHRs and DMRs, they are forced to conduct extensive manual effort to comply with the regulations. This can substantially increase the occurrence of errors which can lead to citations and warnings. The number of observations related to challenges with Device History Records is a particular area of concern.
Influx of warning letters
The requirements for medical device manufacturers to respond to system surveillance inspections increased sharply since ~2010. Despite declining in 2013 to 1,151, the numbers remain high after a 37% increase in inspection observations in 2012. (See 2013 Annual FDA Medical Device Quality System Data for details.)
Of the 164 warning letters issued in 2012, 51 were related to Device History Records. In 2013, 44 warning letters were issued related to Device History Records showing that while the numbers are improving there is still a fairly long way to go, particularly for foreign firms. In 2013, 4% of US firms that were inspected were issued warning letters compared to 16% of foreign firms.
Avoiding the costs of non-compliance
It is apparent that there are a variety of costs associated with non-compliance. These include extensive effort to patch up manual processes with more manual work, a likely reduction in credibility with the FDA with increased scrutiny in the future, and potential production disruptions resulting in revenue loss.
How can medical device manufacturers avoid such risk? By using an automated system to convert disparate documents to the only acceptable document format – PDF – and further combine those documents into compound files for ease of access for the end user. As a result, manual errors are eliminated, and organizations can rest assured that their knowledge workers are concentrating on more important tasks, instead of focusing on the minute details of document formatting.