Medical device : patient safety

Abstract

Numerous data and reports indicate a staggering scale of medical device-related incidents. The Implant Files (2018) uncovered 80,000 deaths and 1.7 million injuries associated with medical devices from the US alone. In the EU, Poly Implant Prosthèse (PIP) was found to be utilizing industrial grade material for its silicone breast implants. The scenario led the European Union to introduce new legislation on medical devices. The objectives of this study were to appreciate challenges with respect to the use of medical devices and patient safety within a hospital setting, to classify medical devices involved in incidents, and to develop a structured approach to focus on patient safety in a central procurement unit. The setting of the study was the Central Procurement Unit (CPSU) at the Health Ministry, which is involved in procuring and distributing medicines and medical devices used for the National Health Service (NHS) in Malta. Literature analysis was carried on medical device barriers to safety using Medline, International Pharmaceutical Abstracts and CINAHL databases covering 2005 to 2019. The study employed an exploratory, qualitative design using an iterative approach. A total of 150 hours of fieldwork was undertaken in the Quality Assurance Unit of CPSU. Devices involved in incidents were classified using the Global Medical Device Nomenclature. Root cause investigation and classification were carried out using an innovative tool developed in this study. Literature review (n=52) revealed nine major themes of medical device challenges to safety. These are healthcare setting, regulatory, device, procurement and evaluation, incident reporting, clinical evidence, patient factors, software, and supplier gaps. A total of 333 medical device incidents that were investigated and closed from 2016 to July 2019 at the CPSU were analysed. The leading devices with incidents were sutures (10.5%), dressings (9.61%), and gloves (6%). The causes of incidents as classified by the Quality Assurance Department of CPSU were defective devices (70%), wrong product (17%), European Council directive non-compliance (4%), unclassified reason (4%), recalls (3%) and complaints (3%). An innovative tool for medical device incidents root cause analysis and classification was developed based on the Amoore tool1. Two new major classification groups (supplier and regulatory compliance) were generated in this innovative tool. Using the developed tool, root cause analysis for the incidents reviewed was described as device (35%), infrastructure (14%), supplier (9%), regulatory compliance (8%), no problem found (6%), operator (2%), clinical and patient factors (1%). For 24%, the cause was unknown due to a lack of data during the incident reporting, indicating a weakness in the reporting system adopted at CPSU. The study led to a structured analysis of medical device-related incidents. An innovative tool for investigating causes of incidents was developed, which could be implemented. The study also sheds light on documentation required in the incident reporting that is now being used in CPSU.