October 15, 2018
Just recently, a number of advisories concerning recalls of healthcare products were observed to increase. These advisories being referred to are a result of product recalls conducted in accordance with the guideline issued in mid of 2016. The objective of this guideline is to provide a step-by-step procedures on conducting a product recall, which is enacted to establish an effective system for monitoring of health products. In order to provide you an overview of the current post surveillance system in the Philippines, Qualtech has collected information on product recall from PFDA database where subsequent analysis and interpretations have been made. Qualtech considers that knowing these information on product recalls would help us understand the reason behind each requirements commonly asked for by PFDA evaluators during the initial registration submissions.
Overview of post market activity in medical device in Philippines
In the last five years, the number of product recalls was found to follow an increasing trend with around 87 advisories issued at the time of this writing. The purposes of such advisories where categorized into three (3), namely, (1) Notice on unregistered Products (2) Voluntary recall, and (3) others (which includes products with misleading advertisements, PFDA Office Matters, Termination of Recall, among others). From 2013 to 2018, all recorded advisories comprise 55% warnings regarding the use of unregistered products, 30% of voluntary recalls due to issues found in certain medical device products, and the rest (15%) makes up other non-product related advisories which are deemed irrelevant for this discussion (Figure 1).
Figure 1. Advisory types published from year 2013-2018
Let’s take the time to reflect on the trend shown below (Figure 2). The skyrocketing numbers of advisories can be observed in 2017 to 2018, and is expected to go even higher in the latter year. This same trend is observed for voluntary recalls and notices on unregistered products. This significant increase in the last 2 years may indicate a more efficient system being implemented by PFDA on its medical device surveillance program, hence promoting higher detection rates for the post market status of medical devices sold in the Philippines.In the succeeding paragraphs, the background of all recall incidents shall be discussed.
Figure 2. The trend of product recall from 2013 to 2018
The cases of voluntary recalls in the previous year were primarily due to device issues attributed to their use safety, functionality and labelling errors. As for 2018, the distribution of unregistered medical devices has been rampant, which accounts for the higher number of product recalls this year.
Analysing reasons behind the increase in these numbers:
Unregistered Devices
Starting from year 2013, a number of products found to be unregistered makes up around 60% of the total product recalls which prompted PFDA to implement more stringent requirements in labelling, with special attention given to the placement of Importer Information and Registration numbers on each selling unit container of every device.
It’s highly imperative to get your devices registered first to Health Regulatory Agencies specific to each country prior to its market. However, with the high level of documentations and lengthy evaluation process taking more than 180 days at an average, some manufacturers would tend to avoid this significant delay by simply marketing their devices right away. Some would include unregistered devices in a kit or set or system, and some would include unregistered models to their previously registered devices. While it’s quite understandable that these delays in marketing strategies would have a significant effect on the business, it should also be noted that the Health Regulatory Agencies do a fairly high amount of work just to protect the public from all the possible health risks associated with using these devices. This paramount responsibility puts a lot of pressure among evaluators as they will also be the one to take the all the blame if something bad happens to the public. With all due respects to PFDA and the entire nation using the device, manufacturers should therefore take social responsibility in complying with the all regulatory requirements before making these devices available for public use.
Compliance with device safety as evidenced with complete and proper documentations will be of help in expediting the approval process and getting your devices to market. With its 18 years of unparalleled experience in product registration, license management and in-country representations, Qualtech assures its clients with high quality regulatory services that help manufacturers easily register and market their devices in the Philippines and in other countries in Asia. We assist in the preparation and organization of submission dossiers in accordance with current regulatory guidelines.
Voluntary recalls
Out of the total number of medical device recalls from year 2013, voluntary recalls make up around 29% of all cases primarily due to performance issues (40%), existing safety issues (24%) and labelling errors (16%).
Figure 3. The type of voluntary recalls
Safety issues arise from inherent functionality issues, incompatibility of raw materials used, improper storage conditions affecting the devices’ stability, and inappropriate device use. Therefore, PFDA commonly ask for specific documents so as to appropriately control the recurrence of such incidents. Let’s take a short look on these documents commonly sough for by evaluators.
I. Performance Tests
Functionality issues could be assessed with thorough study of device’s performance test reports, parallel to its intended function. This implies that performance test items are considered unique for each device type, not to mention the added enhancements and distinct technological (or ‘state of the art’) features built within the device. While most performance tests suitable for each device are already outlined in the International Standards, it should be always kept in mind that the test items listed therein aren’t exhaustive, therefore, it is not advisable that manufacturers limit themselves to conducting those tests alone. Tests required for high technology devices such as robotic exoskeleton devices, for example, should not simply be limited to safety-related control alone, rather, should also include test to measure neuro-stimulation (if applicable), environmental sensing, among others.
II. Existing Patient Safety Issues
Existing Patient Safety Issues includes “Raw materials specification” and “Physical Description “. Incompatible raw materials are examined with careful review of Raw Materials Specifications as provided in the Certificate of Analysis and Material Safety Data Sheet, Biocompatibility Tests, and Batch Inspection Release Certificate. With the increasing number of hazardous chemicals being published recently, materiovigilance has become a trend to most health agencies, most especially with PFDA. Each raw material making up the device are now evaluated for its various chemical reactions such as possibility of forming degradation materials / chemical substances that may impair product use safety, biocompatibility, physical incompatibility, and potential to cause toxicological reactions. Taking surgical kits as an example, examination of every raw material making up each component is particularly of significance, whether the component directly contacts the patient or not due to this same reason.
III. Labelling
Labelling errors are also prevalent, consisting almost 16% of the total voluntary recall cases in the Philippines. While photos of labelling and/or packaging are the most leniently prepared document of all the above mentioned requirements, it should also be kept in mind that this element is considered of high importance to end users, patients and regulators alike. Labels are supposedly meant for educating the user on how to use the device properly. Complete and essential information such as device calibration must also be included in the packaging or labelling materials, so as to avoid critical errors during diagnosis and treatment course. Labels also serves to aid regulators in identifying the traceability of devices registered and to be imported and distributed all throughout the country.
What’s special in the Philippine labelling requirements is that, apart from providing the photo of actual and sticker labels of all labelling materials, the manufacturer also needs to provide a label artwork, which shows the placement of all labelling information in the final device packaging.
Although the documentary requirements mentioned above were given special emphasis, it should be noted that the other requirements not mentioned in this article are just as equally important. Moreso, the documented evidences depends upon the overall nature of the device. The requirements discussed above are just some of the most commonly asked for based from our experience in the registration for non-active medical devices.
Conclusion
With the number of medical devices flooding the Philippine market, it is highly plausible that stricter regulatory requirements are implemented inasmuch as public health welfare is of the utmost concern. We should understand that every special requirement from respective countries are possibly rooted to the history of recalls and past incidents which have adversely affected the public. Cliché as it may sound, but keeping abreast of the recent adverse events and recalls associated with device use in certain countries of interest, and paying close attention to every special requirement being sought for in those countries would be of help in getting your products registered in a timely manner. Moreover, it is also a part of the manufacturer’s social responsibility to assure that the medical devices being sold in the market is safe and of high quality. Noncompliance would result not only to the long term impact on the business but also to the overall reputation of the manufacturer to regulatory agencies worldwide.
With the new regulations coming, tougher guidelines and requirements for incoming medical devices should be anticipated, along with highly developed systems aimed at post market surveillance for devices available in the market. Manufacturers therefore, should put more efforts proportionate to these stringent guidelines to be imposed not only by PFDA but as well as in other countries.
Qualtech provides one-stop regulatory services for its clients intending to place their medical devices in Philippine Market and other countries in Asia. We cater to provide clients with high quality regulatory services not only during the initial registration process but also for post authorization applications (amendments, renewal, etc.). We also provide you with the latest updates on regulatory requirements and offer consultation services related to compliance with national regulatory requirements. Feel free to contact us for more information.
Reference:
https://ww2.fda.gov.ph/attachments/article/349656/FDA%20Circular%20No.%202016-012.pdf