For over thirty (30) years healthcare provider
organizations have been choosing independent service organizations (ISO) to
service medical devices based on their needs and expectations. The FDA is
currently examining the possible regulation of ISO servicing of medical devices
due to OEM and stakeholder concerns. However, no real world evidence
exists suggesting an increased safety risk with ISO serviced devices.
Indeed, the ECRI Institute, a laboratory that tests medical products, recently conducted an independent analysis of the FDA’s data on adverse events resulting from malfunctioning reusable medical devices. The ECRI Institute’s analysis indicates that a mere 0.005% of the reportable events were related to servicing regardless of who (manufacturer or independent service organization) performed the service. This analysis was similar to the extensive searches ECRI Institute performed and presented in September 1998 at an AAMI/FDA conference. The conclusion then and now is that there is no evidence of safety risk based on whether an independent or a manufacturer performs service, repair and maintenance. FDA historically has not regulated for the same reasons.
Some original equipment manufacturers (OEM) of medical devices argue that only they can produce quality repair and service. These allegations are self-serving and are intended to limit provider choice. In addition, OEMs are attempting to limit provider choice by withholding information, and access to parts/tools/codes/manuals. OEMs are contributing to the problem rather than improving patient safety, quality service, and provider rights.
Currently, the FDA is compiling a report that will be sent to Congress this summer on its position on the possibility of regulating servicing of medical devices. At the same time, various industry and stakeholder groups are drafting standards for service as the deliberation continues concerning who should have the final choice in determining in what manner to keep devices in safe and effective operating condition.
As a provider organization focusing on patient care and safety it is important that you preserve the ability to have options in managing a safe and effective ways to repair, service, and maintain your inventory of medical devices.