The British Medical Journal (BMJ) has published a research on 20 May, 2016, which tells us about the regulatory acceptance of new medical devices. The fundamental role of this cross-sectional study was to investigate if new medical devices mentioned in the literature had regulatory approval for their effectiveness and credibility, and whether they matched already approved and legally marketed devices.
The US government agency, Food and Drug Administration’s (FDA) database was hunted to check the approvals for these medical devices. The FDA is believed to have outlined different regulatory pathways based on the nature of the medical device. Out of 218 devices mentioned in the clinical studies, 99 devices received regulatory approval. Of these, 43 devices received their regulatory approval before a clinical study was published.
Most of the medical devices were instruments or implants. The regulatory pathways involved were 510(k) clearance, premarket approval and humanitarian device exemption. The regulatory approval was granted in the period April 1997-September 2014
According to the FDA definition, “A medical device can be any instrument, implement, machine, gadget, in vitro reagent, implant, contrivance, or other similar or relate article, including any component, part or accessory.”
In total, 5,574 titles were screened, 493 full text articles and 218 clinical studies were included in the study. Articles recounting a laboratory study or a novel use of any surviving device were omitted because few such devices would result in a clinical study, or most such devices would already have gotten regulatory approval.
PubMed database was searched using the most efficient and relevant search method known as “Boolean term”. The Boolean term is believed to be accurately efficient and gives relevant outcomes. The search term (AND) (OR) was used to find out accurate data for the study. A time lag of four years was placed for regulatory approval on the basis of results shown by previous studies.
The devices were tested for their quality, performance, efficiency, targeted forte and the involvement of academic and industry in the clinical trials being conducted. The FDA database was hunted to authorize the targeted quality of the device.
The regulatory pathways used were the premarket notification (510(k)), premarket approval and the humanitarian device exemption (HDE). The 510(k) is the fast track system which permits the regulatory approval of devices which are significantly comparable to previous legally accepted and marketed devices. However premarket approval pathway was associated with the devices which were not significantly comparable to previous devices. Also, the HDE database was linked with the name of the device, applicant and other relevant associated keywords.
A chi-square test was conducted to collect data about the differences between the regulatory approvals. Two comparable factors for each of the tests were: devices manufactured by industry alone verses devices developed by the academia, devices manufactured both by the academia and company verses the academia alone, devices manufactured by the academia and industry versus devices manufactured by the industry alone.
The study was kept confidential and patients were neither involved in arranging questions nor in the outcome measurement.
A device is considered significantly equivalent if it serves the purpose and has the same technological properties. In case it does not have the same properties, it should be at least as safe and effective as the precedent device.
Industry seems to play a more important role in the development and regulatory approval of a medical device. For the devices manufactured by the academia, chances of regulatory approval increase if they are associated with the industry. However, regulatory approvals associated only with the industry do not come without their own set of problems and risks. The collaboration between the industry and academia is equally intended.
Comparison With Other Studies
There were some other groups who found limited publically available proof that could support the regulatory approval of the new devices. Zuckerman et al evaluated the data to support the evidence of gadget approval and they concluded that only 8 out of 50 gadgets had data to claim that they were significantly comparable to the precedent devices.
Chang et al also found that devices approved by the premarket approval pathway lacked clinical trials and their details varied from the data submitted to the FDA. The dissimilarity between the previous and the current study was due to the varying role of the clinical and industry collaboration through the device manufacturing pathway. The previous study also showed that clinical collaboration was a more important factor than industrial collaboration and that the devices developed with clinical collaboration had six times more chances to step in to a first-in-human study than those without it.
Limitations Of The Study
There were many limitations to this study. Firstly, the analysis of all the medical devices was kept in medical literature only. Secondly, the number of the medical devices that received regulatory approval was misjudged, particularly due to the possibility that the licenses were given specifically by the European Union. Another minus point is that this study could not recognize the difference of superiority in obtaining regulatory approval between the industry and academia.
Why We Need Regulatory Approved Medical Devices
To empower a patient’s access to medically approved, high quality, safe and precise devices, they should be approved through regulations. It is also important to inhibit the access to unsafe and inaccurate methods or gadgets which have had limited clinical trials and precision errors. The purpose of medical devices is to diagnose, treat, cure and lessen the disease spree. It is mandatory for every medical advisor to equip themselves with regulatory approved medical devices to ensure the patient’s safety and well-being.