Medical Device Manufacturers "Latest and Greatest" Tools and Industry Trends
By Dale McGeehon
The U.S. Food and Drug Administration (FDA) issued draft guidance July 9, 2013, for medical device manufacturers that proposes formal changes to existing 1997 guidance, most notably dropping the two-year rule for malfunctions and obligations after selling a 510(k).
The changes either are new or put into writing what has been FDA practice over the last few years, say two FDA and healthcare practice attorneys with Morgan, Lewis & Bockius LLP, who summarized the guidance in an article in The National Law Review. Medical device manufacturers should carefully consider the draft guidance and determine whether they want to submit comments before the October 7, 2013, deadline, say the attorneys.
Medical Device Reports Revised
"The new draft guidance provides detailed recommendations and clarifications on manufacturers' obligations for submitting medical device reports (MDRs), maintaining MDR procedures, and related recordkeeping requirements," write the attorneys, Elizabeth Bierman and Michele Buenafe. "The draft guidance also includes sections addressing frequently asked questions and common reporting errors."
MDR regulations require manufacturers, importers, and user facilities to report significant adverse events -- such as a death or serious injury -- involving medical devices to the FDA. The manufacturers also must report to the FDA when they learn that one of their devices has malfunctioned and would likely cause or contribute to a death or serious injury if the malfunction occurred again.
Removal of Two-Year Rule on Reporting Devices Malfunctions
One of the changes involves the removal of the so-called two-year rule for malfunctions. Historically, the FDA has taken the position that if a malfunction causes a death or serious injury, future malfunctions of the same type must be reported. The existing 1997 guidance says that the presumption would cease if the malfunction did not cause or contribute to a significant event for two years.
The new draft guidance, however, says that if manufacturers want to stop reporting a malfunction that had contributed to a serious injury or a death they will need to send in a request to the FDA for an exemption. That request will need to be supported with evidence that the malfunction had not contributed to any other serious injuries or deaths.
The attorneys point out that it's not clear in the draft guidance how much data -- such as one year's or two years' worth -- would be needed support the request for the exemption. Perhaps that is what those who wish to comment on the guidance can speak about.
Changes to Contract Manufacturer Arrangements
"FDA would expect only one report from either the specifications developer or the contract manufacturer for one reportable event," says the agency in its 1997 guidance regarding contract manufacturer arrangements. "Nevertheless, there must be a written agreement which identifies which party is responsible for completing Form 3500A."
This is the form used by distributors, importers, applicants, and manufacturers to report adverse events and product problems. It is mandatory in such events.
In the past few years, the FDA has been requiring what is not stated in the 1997 guidance: that it needs an exemption when only one entity reports in a contract manufacturer arrangement. The new draft guidance puts into writing this practice. It states that both the specifications developer and contract manufacturer must submit MDR reports unless the agency issues an exemption to allow reporting by only one entity.
Obligations After Selling a 510(k)
The draft guidelines provide a clarification when a device requiring marketing certification is sold from one manufacturer to another. In such instances, manufacturers need to submit a 510(k) that demonstrates that the device to be marketed is safe and effective.
The draft guidelines say that seller of the device will remain responsible for submitting MDRs for all of the devices that it made before the sale. The requirement would be in effect even if the parties have agreed that the buyer will assume the MDR responsibility. However, FDA can grant an exemption.
Reporting Events in Scientific Articles
Manufacturers of medical devices may need to keep track of serious adverse events that are reported in scientific articles and other literature, under the new draft guidance. If those articles report adverse events, then the manufacturers may need to contact the authors and obtain additional information about those events.
The manufacturers may be allowed to describe multiple events in one report if the maker is unable to obtain sufficient information for a complete report for each reportable event. However, the draft guidance recommends that the maker submit a separate report for each event type, if multiple events are identified, and for each device, if more than one generic device type is implicated, the attorneys say.
About the Author
Dale McGeehon is the head blogger for Polymer Solutions Incorporated, a medical device testing lab that solves complex challenges for medical product manufacturers. Dale has been a science journalist and editor for three decades, and covers material testing on the PSI blog.
How UiPath robots are helping with the NHS backlog
The COVID-19 pandemic has caused many hospitals to have logistical nightmares, as backlogs of surgeries built up as a result of cancellations. The BMJ has estimated it will take the UK's National Health Service (NHS) a year and a half to recover.
However software robots can help, by automating computer-based processes such as replenishing inventory, managing patient bookings, and digitising patient files. Mark O’Connor, Public Sector Director for Ireland at UiPath, tells us how they deployed robots at Mater Hospital in Dublin, saving clinicians valuable time.
When Did Mater Hospital implement the software robots - was it specifically to address the challenges of the pandemic?
The need for automation at Mater Hospital pre-existed the pandemic but it was the onset of COVID-19 that got the team to turn to the technology and start introducing software robots into the workflow of doctors and nurses.
The pandemic placed an increased administrative strain on the Infection Prevention and Control (IPC) department at Mater Hospital in Dublin. To combat the problem and ensure that nurses could spend more time with their patients and less time on admin, the IPC deployed its first software robots in March 2020.
The IPC at Mater plans to continue using robots to manage data around drug resistant microbes such as MRSA once the COVID-19 crisis subsides.
What tasks do they perform?
In the IPC at Mater Hospital, software robots have taken the task of reporting COVID-19 test results. Pre-automation, the process created during the 2003 SARS outbreak required a clinician to log into the laboratory system, extract a disease code and then manually enter the results into a data platform. This was hugely time consuming, taking up to three hours of a nurse’s day.
UiPath software robots are now responsible for this task. They process the data in a fraction of the time, distributing patient results in minutes and consequently freeing up to 18 hours of each IPC nurse’s time each week, and up to 936 hours over the course of a year. As a result, the healthcare professionals can spend more time caring for their patients and less time on repetitive tasks and admin work.
Is there any possibility of error with software robots, compared to humans?
By nature, humans are prone to make mistakes, especially when working under pressure, under strict deadlines and while handling a large volume of data while performing repetitive tasks.
Once taught the process, software robots, on the other hand, will follow the same steps every time without the risk of the inevitable human error. Simply speaking, robots can perform data-intensive tasks more quickly and accurately than humans can.
Which members of staff benefit the most, and what can they do with the time saved?
In the case of Mater Hospital, the IPC unit has adopted a robot for every nurse approach. This means that every nurse in the department has access to a robot to help reduce the burden of their admin work. Rather than spending time entering test results, they can focus on the work that requires their human ingenuity, empathy and skill – taking care of their patients.
In other sectors, the story is no different. Every job will have some repetitive nature to it. Whether that be a finance department processing thousands of invoices a day or simply having to send one daily email. If a task is repetitive and data-intensive, the chances are that a software robot can help. Just like with the nurses in the IPC, these employees can then focus on handling exceptions and on work that requires decision making or creativity - the work that people enjoy doing.
How can software robots most benefit healthcare providers both during a pandemic and beyond?
When the COVID-19 outbreak hit, software robots were deployed to lessen the administrative strain healthcare professionals were facing and give them more time to care for an increased number of patients. With hospitals around the world at capacity, every moment with a patient counted.
Now, the NHS and other healthcare providers face a huge backlog of routine surgeries and procedures following cancellations during the pandemic. In the UK alone, 5 million people are waiting for treatment and it’s estimated that this could cause 6,400 excess deaths by the end of next year if the problem isn’t rectified.
Many healthcare organisations have now acquired the skills needed to deploy automation, therefore it will be easier for them to build more robots to respond to the backlog going forwards. Software robots that had been processing registrations at COVID test sites, for example, could now be taught how to schedule procedures, process patient details or even manage procurement and recruitment to help streamline the processes associated with the backlog. The possibilities are vast.
The technology, however, should not be considered a short-term, tactical and reactive solution that can be deployed in times of crisis. Automation has the power to solve systematic problems that healthcare providers face year-round. Hospital managers should consider the wider challenge of dealing with endless repetitive work that saps the energy of professionals and turns attention away from patient care and discuss how investing in a long-term automation project could help alleviate these issues.
How widely adopted is this technology in healthcare at the moment?
Automation was being used in healthcare around the world before the pandemic, but the COVID-19 outbreak has certainly accelerated the trend.
Automation’s reach is wide. From the NHS Shared Business Service in the UK to the Cleveland Clinic in the US and healthcare organisations in the likes of Norway, India and Canada, we see a huge range of healthcare providers deploying automation technology.
Many healthcare providers, however, are still in the early stages of their journeys or are just discovering automation’s potential because of the pandemic. I expect to see the deployment of software robots in healthcare grow over the coming years as its benefits continue to be realised globally.
How do you see this technology evolving in the future?
If one thing is certain, it’s that the technology will continue to evolve and grow over time – and I believe there will come a point in time when all processes that can be automated, will be automated. This is known as the fully automated enterprise.
By joining all automation projects into one enterprise-wide effort, the healthcare industry can tap into the full benefits of the technology. This will involve software robots becoming increasingly intelligent in order to reach and improve more processes. Integrating the capabilities of Artificial Intelligence and Machine Learning into automation, for example, will allow providers to reach non-rule-based processes too.
We are already seeing steps towards this being taken by NHS Shared Business Service, for example. The organisation, which provides non-clinical services to around two-thirds of all NHS provider trusts and every clinical commissioning organisation in the UK, is working to create an entire eco-system of robots. It believes that no automation should be looked at in isolation, but rather the technology should stretch across departments and functions. As such, inefficiencies in the care pathway can be significantly reduced, saving healthcare providers a substantial amount of time and money.