By Juul Dings | 9 March 2019
Prepare now for the arrival of the Medical Devices Regulation (MDR) in May 2020. Because the MDR, the new European law for medical devices, is legislation that will be enforced. This was apparent from the meeting organized by Olympus on 24 January in Leiderdorp.
Under the guidance of Juul Dings, Marketing Manager at Olympus, around 70 attendees (mainly medical technicians, clinical physicists, buyers and department managers) were able to hear the impact of the MDR on maintenance of medical equipment.
Role for healthcare institutions
The MDR for medical devices will take effect in just a year. This new European legislation will have a major impact on all applications of medical technology. Virtually everyone in healthcare will be confronted with the new rules. Risk classes for medical devices are changing and healthcare institutions can suddenly be seen as a manufacturer, with all legal requirements and obligations. Lawyer Erik Vollebregt is closely involved in the new legislation and assists and advises companies and hospitals in its implementation. “Until now, Dutch legislation has focused on manufacturers. With the new legislation, healthcare institutions now also have a role in the safety and quality of medical equipment, “he said. “A lot is going to change for lab technicians and clinical physicists. Especially for hospitals with their own maintenance department or with in-house production of IVDs and devices. ”The maintenance intervals and specifications prescribed by the manufacturer or supplier must be the starting point when carrying out maintenance and repairs to medical equipment. In addition, the care institution is explicitly responsible for the (external) technician being authorized and competent to carry out maintenance and modifications to medical devices in accordance with the manufacturer’s instructions.
Only for intended purpose
Medical equipment may only be used under the MDR as intended by the manufacturer. A CE marking has been issued for that use and other, off-label use is prohibited. If a device is used in a different way, the user is seen as a manufacturer. Vollebregt said a lot is involved. “For that use you have to acquire CE marking yourself, build up documentation, set up training, do post-market research, and specify the frequency of preventive and periodic maintenance. The replacement of parts of a device, which happens a lot in hospitals, is now more clearly arranged. Non-original parts must be validated and supporting evidence must be available that the change does not affect performance or safety features or the intended purpose.”
Stricter frameworks and classification
Components that change the performance of a medical device become a device in itself and must therefore be marked CE separately. And some cleaning and sterilization products for medical equipment and in-house produced medical devices also fall under the MDR. The legislation also sets further requirements for medical software. The MDR defines requirements for hardware, properties of IT networks and IT security measures (including protection against unauthorized access) that are required to use the software for its intended purpose. For example, a calculation tool for the interpretation of measurements can be seen as a medical device. Vollebregt: “Most software now falls into risk class I but will later go to IIa or higher.
For the end of May of next year there must therefore be a CE certificate from a notified body. Users must therefore consult with the supplier to see if that will succeed on time. Because otherwise a new software release may not be used after May 2020. As a user you need to have an idea of what that means for patient care.”
Manufacturers are now viewing their entire portfolio, and Vollebregt expects many of them to reduce and change their range. “So prepare well for the MDR. Because the bill contains many harsh sanctions, also for healthcare institutions.”
More administrative burden
Henk Imming (chairman of the Association of Hospital Instrumentation Technicians VZI) sketched a picture of the emergence of legislation on medical equipment. In the pre-CE era there was plenty of development and modification of medical devices. There was hardly any IT and technicians could pioneer in medical technology. With the introduction of the CE quality mark, manufacturers and suppliers became very cautious with modif actions and there was more supervision of compliance with laws and regulations. The next step was the Medical Technology Covenant in 2011, which guaranteed the quality and safety of medical technology.
Impact still uncertain
According to Imming, the impact of the MDR is currently difficult to estimate. He does expect more administrative burden for instrumental services due to post-market surveillance and more supervision of suppliers on preventive maintenance. In addition, there will be more influence from suppliers on the maintenance of medical equipment. “There are already many requests from suppliers for information,” Imming said. “It could even happen that manufacturers are going to do maintenance of equipment themselves, although I don’t expect that. The MDR is also about software products. Updates, data breaches, infection and cyber attacks are, after all, a major risk. Software products come in higher risk classes. Even class 3 is possible. I think the MDR for medical information technology will have even more impact than for medical technology. "
But the MDR also offers opportunities, Imming said.
All relevant information about medical equipment can be stored in a central database for asset management systems. This offers room for, for example, more uniform maintenance protocols. “That would be a good development, because more than five hundred of those protocols are now in circulation for infusions, for example. E-learning modules can also be stored in the database. And information then becomes accessible to suppliers and hospitals. In addition, more cooperation agreements will be drawn up with industry. It seems to me positive if there is more constructive cooperation, also between medical and information technology. ”
At the beginning of 2017, a sounding board group and a working group were set up with almost thirty medical technology companies together. A program of requirements has now been drawn up for both organizations and individual technicians, including a code of conduct, a training plan, the presence of documentation, and the handling of original and non-original parts. The plan is to introduce GOZ certification in mid-2019 and link it to ISO audits. In the absence of ISO, a separate external audit must be performed. “Institutions that meet the GOZ requirements can apply for the GOZ quality mark,” Knaven said. “The certification is at the organizational level, whereby the competencies of individual technicians must be recorded and verifiable within the organization. There will be a uniform pass for technicians from companies with the label. The GOZ card has an NFC chip that specifies which products the technician can maintain. The chip can be read with a smartphone.”
The FHI initiative meets the requirements of the Covenant and the MDR and has been well received by stakeholders such as NVZ, NFU, VWS and the Inspectorate, Knaven said. “I expect that within a year many companies will already have the GOZ quality mark.”
No delay possible
Ir. René Drost (owner of NAMCO Zorg & Technologie and co-creator of the Medical Technology Covenant) said that the date of introduction of the MDR has been set, that everyone in the care sector must be aware of the regulations and that the Inspectorate will enforce and possibly impose fines. The MDR was published in May 2017, after a start-up period from 2010. The development of legislation has accelerated following the debacle with the PIP breast implants. “There are currently many meetings about the MDR. Nobody can ignore it anymore. Administrative fines are adjusted annually and are expected to increase under the MDR. The MDR is a law, while the Covenant was started as a field standard at the time. For all these reasons, we must assume that postponement is out of the question. Certainly it will be maintained, although monitoring is not yet clearly defined by the IGJ. "
Audits and post market surveillance
Audits can take place according to the NAMCO system. It focuses on safe operations, with 7 workflows around them: acceptance / release, the competent and competent professional, maintenance, file creation, management, connection to the quality and safety management system and managing exceptions with regard to personnel and equipment. Such an audit takes 2 to 3 days. One of the new aspects in an audit is the reuse of materials, Drost said. “If a hospital chooses, it is important: who registers reuse, when and how often does that happen, and in which system does that registration take place?”
Post-market surveillance is also an important point of attention: who talks to manufacturers? Is that someone from Purchasing, or a user, or another employee? Has the surveillance been laid down in agreements with manufacturers or suppliers? And is that data quickly available? As a third sensitive point, Drost mentioned the deployment of external technicians. Far from always a clear choice is made for “each device” about “outsourcing”.
The requirements for external experts can be laid down in a contract, but the testing of competence and competence sometimes leaves something to be desired. “That’s why I think the FZ GOZ quality mark is a great initiative.”
Finally, Drost emphasized to take the MDR seriously: “It is not a project that anyone can add to it. The Board of Directors has final responsibility. Make a plan together, do not limit yourself to only medical equipment, organize audits and make sure you have a well-founded story and are aware of the rules.”
No more waiting
In the plenary discussion, Erik Vollebregt also emphasized once again that the MDR is a serious matter: “It is a law, and it is being enforced. Don’t wait until you are overtaken by the facts. The IGJ has until now mainly focused on medicines, with medical technology for a long time as a poor child. But lately the IGJ has been on top of that, with hefty fines. The deadline will not postpone, so you can no longer wait. “Juul Dings agreed:” I have been in contact with the IGJ about the MDR and let them know that they are going to enforce it. The MDR is European, but perhaps local interpretation is possible.”
Luc Knaven believes that the Brexit can be a wake-up call as a whole: “There is now reasonable panic about a no-deal Brexit, in particular about the availability of medical devices. It’s about no less than 40 percent of all medical devices. ”Henk Imming mentioned the challenge of bundling IT knowledge, partly in view of the new risk classes for medical software. “There are many reports about hacking or simply incorrect software installation. What will also play are software updates. Can they only be installed by the supplier in the future? These are important points for attention.”
The price of safety
René Drost clarified that the MDR is about patient safety. “And precisely for the patient, aids are often adapted in hospitals. For technicians that is often the case, it is enormously motivating to help care in that way. But under the MDR you are bound by more strict rules. Because before you know it, you are a manufacturer. It must also be documented for replacement parts that that part meets all specifications. So you have to think about what you expect from parts suppliers. "
One of the attendees asked whether good risk management within the MDR is sufficient with a view to patient safety. Drost did not think so: “With a risk analysis you cannot ignore the law.” Vollebregt endorsed that: “You are liable for a product. You can’t get there with just a risk analysis. "
But someone will still dare to make adjustments to a device, someone in the room wondered. “Can you still place a device on a cart to use it in another department?” Vollebregt replied that that does indeed raise questions. “Perhaps the device is sensitive to vibrations and needs to be calibrated after transport. Then you have to prepare a procedure for that. You can possibly ask the manufacturer to help you make the device mobile.”
The MDR will therefore entail many changes, certainly also with regard to the maintenance of medical equipment. The speakers called on the attendees not to wait with the preparations for the MDR, and not to assume that the deadline will be postponed. The Inspectorate will enforce, with no small fines. Although not everything is clear yet, the deadline is set. And everyone in healthcare will be confronted with the MDR.
Dings, Juul. “Impact of the MDR on maintenance of medical equipment", 9 March 2019. [pdf in dutch]