title: Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.
abstract: Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features of the drug safety evaluation process could, if adopted and adapted for NAIMDs, lead to better and more systematic evaluations of the latter.
authors.affiliation: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands. jpanesalvado@gmail.com.|Alcon, Novartis, Fort Worth, Texas, USA. jpanesalvado@gmail.com.|Eu2P European Programme in Pharmacovigilance and Pharmacoepidemiology, University of Bordeaux Segalen, Bordeaux, France. jpanesalvado@gmail.com.
authors.forename: Josep
authors.identifier: 0000-0001-5308-7232
authors.initials: J
authors.lastname: Pane
authors.affiliation: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.|Eu2P European Programme in Pharmacovigilance and Pharmacoepidemiology, University of Bordeaux Segalen, Bordeaux, France.
authors.forename: Preciosa M
authors.initials: PM
authors.lastname: Coloma
authors.affiliation: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.|Eu2P European Programme in Pharmacovigilance and Pharmacoepidemiology, University of Bordeaux Segalen, Bordeaux, France.
authors.forename: Katia M C
authors.initials: KM
authors.lastname: Verhamme
authors.affiliation: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.|Eu2P European Programme in Pharmacovigilance and Pharmacoepidemiology, University of Bordeaux Segalen, Bordeaux, France.
authors.forename: Miriam C J M
authors.initials: MC
authors.lastname: Sturkenboom
authors.affiliation: Alcon, Novartis, Fort Worth, Texas, USA.
authors.forename: Irene
authors.initials: I
authors.lastname: Rebollo
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000818:Animals; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D004869:Equipment Safety / Q000379:methods*; D004864:Equipment and Supplies / Q000009:adverse effects*; D005062:European Union; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods; D018570:Risk Assessment / Q000379:methods*; D014481:United States