Addressing compliance challenges for healthcare devices
Dr Reiner Stappen, Vice President Global Technical Service at B. Braun, addresses the compliance challenges for healthcare devices.
One thing we have learned from the COVID-19 experience is that nothing can be taken for granted, especially in healthcare, which has come under immense pressure in recent months to deal with the pandemic and maintain services. For some medical device suppliers, this has been a particularly challenging time, as demand for devices has increased significantly, if only to service rapidly established COVID-only units. Restrictions on movement have meant depleted resources but suppliers have had to continue to deliver and service devices. Naturally, these devices need to be compliant, to meet with stringent regulations. Given installation and maintenance requirements regardless of COVID, organizations need to ensure regulations are always adhered to. But how do you prove it efficiently and cost-effectively?
Understandably, in healthcare, device regulation and compliance are essential to ensure medical device safety for patients and users primarily, but also to get devices approved in the first place and to ensure on-going repairs remain within regulatory requirements. Whether that’s through local regulations, such as the EU’s Medical Device Regulation (which has now been delayed until May 2021), ISO13485, China’s FDA or the US’s 21 CFR 820, what becomes very clear is that it’s a complex compliance market to navigate.
What this all means is that we in the medical industry must stay on top of compliance throughout the lifecycle of a product. This has particular challenges when it comes to field service maintenance. We have to be able to illustrate servicing activities and procedures, to ensure any maintenance work or replacement parts are compliant with local regulations. All of this requires detailed documentation for auditing purposes, especially as an auditor will ask for examples.
We evidence our work using data captured through our ServiceMax field service management software (FSM). Each device has a service job record, which is a mix of automated data, such as data and time, device ID and status, plus there are service requirements, such as spare parts, part requests, labor time and execution and testing results. This means that for each device and each service job, we have complete traceability of the history, location and performance of devices.
When new devices are sold to customers, data is added to our FSM automatically via our SAP sales software. This ensures we always have the latest information within ServiceMax and therefore complete visibility of devices out in the field, including information and status, such as warranty and service contract details. This becomes even more essential when we have to demonstrate that our management of monitoring and measurement devices meets the regulatory requirements. The visibility of devices and field service technicians means we can coordinate measurement through certification and pre-defined, authorized tools and procedures. This has the consequence that we are removing any chance of error in the process, as only authorized tools are available for selection.
In addition to reporting, the collected data enable us to detect regularly occurring errors, understand the reliability of specific device components and therefore manage product lifecycle expectations. We can provide risk assessments of devices, components or locations based on accurate analytics. We can track our KPI's based on multiple reports out of our FSM and work on the continuous development of our processes and team.
Ultimately, FSM enables us to have device service data at our fingertips. By capturing and analyzing devices within one software tool (and not multiple tools with conflicting data formats and manual processes), we can cross-reference and mix and match data requirements depending on the specific needs of local regulators. This ultimately saves us time and money and enables us to focus on the most important task, as at B. Braun, we protect and improve the health of people worldwide.