Medical devices are controlled and regulated by the Food, Drug, and Cosmetic Act (Code of Federal Regulations 21, 2010), which demands registration of any medical devices, which meets the definition of a medical device before starting selling it. It states that manufacturers are responsible for ensuring that e.g.: products are safe and labeled according to FDA’s labeling regulations, before any selling permission is given.
Medical devices sector is a highly delimited part of economy; its regulatory procedures ensure patient safety, security and product quality. In fact it has significant implications for the overall industry’s performance. Each year, the number of medical devices and drugs on the market rise, and so do the amount of recalls and safety notifications. Due to a high number of safety issues, counterfeits and adverse events the FDA designed to increase level of scrutiny and controls over this economic sector. It examines the sold devices and all problematic subjects through commonly generated feedbacks, comments and customers’ reported reactions. It reviewed devices safety features based on reports “voluntarily” provided by concerned manufacturers or device users. Openly accessible devices are subject of “post-marketing” examination, which is described in Medical Device Reporting (MDR) regulation (21 CFR 803). Medical Device Reporting (MDR) is a tracking “tool” that FDA uses in order to supervise the product performance. It allows detecting possible device-associated safety issues and conducting satisfactory benefit-risk assessments.
Every year, the FDA obtains thousands of medical reports suspecting device – related patients’ injuries or death. In the year 2000 they received 69,959 medical device adverse event notifications and by 2009, the number had increased to 540,204 reports (FDA, 2010).
In the 1990s the FDA recognized that it does not receive enough sufficient data to comprehend origin causes of medical-device problems. Therefore medical device adverse event reporting (MDR) changes were introduced to The FDA Modernization Act of 1997 (FDAMA) and became effective on February 19, 1998.
In 2000, changes to the implementing regulations (21 CFR 803 and 804) were applied to reflect those modifications in the Act (FDA, 2014a). The Medical Device Reporting (MDR) regulation (21 CFR 803) covers obligatory requirements for manufacturers, importers, and device user facilities to report device-related adverse events and product troubles to the FDA. In fact all parties elaborated along the medical devices’ supply chains are indebted to prepare and submit outlined reports immediately after adverse events or product errors appear. In past MDR form was completed manually and then sent or faxed to the FDA. The process was too time consuming and arduous.
On February 13, 2014, the FDA announced a final rule on Electronic Medical Device Reporting (eMDR) that compels manufacturers and importers to submit MDRs to the FDA in an electronic form that it can be processed, reviewed, and archived much more effective. The FDA defined two options for submitting eMDRs: eSubmitter (application that allows submission of MDRs one at a time) or Health Level 7 Individual Case Safety Reports (HL7 ICSR – allows reporters to submit MDRs either as a batch or individually as XML files from their own complaint handling system). Manufacturers and importers had to start submitting MDR reports electronically from Aug. 13, 2015. Modernization of medical devices reporting system minimalizes the submission time to 12 min or less. It makes reviewing and controlling processes much more efficient and effective. For all who missed the deadline, they must request an exemption form for still submitting adverse events via paper or fax.
Currently, FDA tries to encourage patients and care givers to report any problems related to medical devices as “…unreported problems increase the potential for harm to patients and nurses alike” (FDA, 2014b). Those hearsays, along with data captured from other sources deliver critical material helping to increase patient safety. Regrettably, not all device harms or errors are reported; yet unmentioned problems escalate probability of possible injury to patients or care providers.
MDR: Electronic Submission Requirements – Correcting Amendments
Currently the IMDRF (International Medical Device Regulator Forum), the FDA and the European Commission are focusing on an internationally harmonised and constant method to ensure patient safety and best patient care. They try to achieve it by planning a consistent and steady statute for Unique Device Identification (UDI – system identify and marking medical devices along pharmaceutical distribution channel) with the support of global standards.
In the Federal Register of September 24, 2013 (78 FR 58786), FDA issued the “Unique Device Identification System” concluding UDI rule. The UDI rule also amended 21 CFR part 803 and became effective on December 23, 2013. FDA’s the “Medical Device Reporting: Electronic Submission Requirements” final regulation (eMDR rule), requires changes to the Code of Federal Regulation citations of some provisions within part 803. Some of the citations used by the UDI rule have to be revised and updated. In fact all modifications will affect federal regulation 21 CFR Part 803 covering medical device reporting. It will specify what manufacturers, user facilities and importers should include in adverse event reports: identifying device number such as model, catalog, serial or lot number; expiration date; and UDI appearing on device label or package. The final rule also specifies FDA Form 3500A standard, the document on which adverse event occurrence should be reported to the agency. Considering the challenges involved with UDI compliance, FDA decided to mitigate any dismissals between UDI and eMDR to help eliminating any unnecessary problems for affected companies (Eisenhart, 2015).
If you want to know more about eMDR do not hesitate to contact KVALITO Consulting Group.
Author: Florian Schnettelker