There is no way around government regulation. Yes, it has its purpose, and many regulations are designed to keep the public safe, but there are others that just seem burdensome. It’s enough to drive a good libertarian crazy.
One federal agency, tasked with keeping the public safe, is the FDA. It is a massive agency with 14,648 (2013 est.) employees and a budget of $5.1 billion. It is a part of the Department of Health and Human Services (DHHS).
According to the FDA’s website, the agency is responsible for “protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective.”
They are also responsible for “protecting the public from electronic product radiation, assuring cosmetics and dietary supplements are safe and properly labeled, regulating tobacco products and advancing the public health by helping to speed product innovations.”
On the points of medical device safety and speeding product innovations, the agency has the role of regulating the companies that design, manufacture, repackage, relabel and import medical devices through its Center for Devices and Radiological Health (CDRH).
The FDA also is one of the watchdogs over the cybersecurity of medical devices along with the Department of Homeland Security (DHS), OEMs, end users and security experts.
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In August, Congress passed the Food and Drug Administration Reauthorization Act of 2017. Essentially, the Act reauthorizes several user-fee programs, most notably, the Medical Device User Fee Amendments (MDUFA). It enhances the pre-market review process. President Donald Trump signed the bill into law. The Act will be in force from October 1, 2017 to September 30, 2022.
Among other things, the impact of this legislation will be to speed up and make more transparent the premarket FDA device review process. This should benefit patients by getting new medical devices to market more quickly, while maintaining high standards for patient safety.
The Reauthorization Act also requires that “Not later than 270 days after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall post on the Internet website of the Food and Drug Administration a report on the continued quality, safety, and effectiveness of devices (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) with respect to servicing (as defined in subsection (c)).”
This report, by the HHS Secretary, must contain eight elements, including “the status of, and findings to date, with respect to, the proposed rule entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments” published in the Federal Register by the Food and Drug Administration on March 4, 2016 (81 Fed. Reg. 11477).”
“I will say that with all the pending regulatory questions from the HR 2118, we have started assessing our third-party repairs and PMs, and are working to develop multiple plans to be able to take action on whatever decision is finally made,” says Joshua Virnoche, MBA, CBET, manager of clinical engineering for JPS Health Network in Fort Worth, Texas.
“Obviously, over-regulation hurts everyone, the service industry, health care providers, and the patient, but providing a concrete baseline standard can prevent third parties from ‘corner cutting’ as a way to undercut the OEMs,” he says.
“I feel with the parts component, a company that goes through the 510k approval process can provide us with an equivalent part with savings over the OEM, and I’m still comfortable using 510k approved third-party parts. That being said, there are certain cases over the last year where the OEM pricing has become more competitive, and sometimes better than a third party,” Virnoche adds.
The HR 2118 proposed legislation that Virnoche refers to was introduced in the U.S. House on April 25, 2017. It is titled the: “Medical Device Servicing Safety and Accountability Act.” That legislation, among other things, would amend the Federal Food, Drug, and Cosmetic Act to require the registration of establishments that service devices. In May, it moved to the Health Subcommittee of the House Committee on Energy and Commerce. As of November 2017, no further action has been taken and there have been no votes on the legislation.
The legislation would have to be passed by both the House and the Senate before going to the president for his signature before becoming law.
Medical Devices and FDA Review
When an OEM of medical devices wants to bring a new product to market, they have a few approaches depending on the device and its use. If they want the device cleared, they need to first receive 510(k) (named for a section in the Food, Drug, and Cosmetic Act) clearance from the FDA. Manufacturers are pleased that the new legislation allows them to start selling their new products in a more timely manner.
The FDA can either “clear” the device or “approve” it. The difference is that to get clearance, the submitter of a 510(k) form must show that the device is “substantially equivalent to a device that is already legally marketed for the same use,” according to the FDA’s website.
For approval (premarket approval or PMA), the “PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.” This process requires a more stringent review than the 510(k) process as it is generally reserved for high-risk devices.
Lower risk Class I devices and some Class II devices are considered to be 510(k) exempt and do not require FDA review. Although these devices are exempt, they must still “be suitable for their intended use, be adequately packaged and properly labeled, have establishment registration and device listing forms on file with FDA and be manufactured under a quality system (with the exception of a small number of Class I devices that are subject only to complaint files and general recordkeeping requirements),” according to the agency’s website.
Not only does the FDA regulate the types of medical devices that might come to mind like imaging equipment, but also “simple items like tongue depressors and bedpans, heart pacemakers, dental devices and surgical implants and prosthetics.”
In addition to clearing or approving medical devices, the FDA also tracks devices in case a device should present a risk to the public and must be recalled.
Medical device OEMs must pay registration fees to the FDA along with fees when new devices are listed with the agency. Fees are also collected when the OEM develops a new device and takes it to market. Part of the purpose of these fees is to help the agency with its goal of bringing safe devices to patients in as expedient a manner as possible.
Evaluating the Safety of Servicing
On March 4, 2016, the FDA opened a “docket” requesting comments from those involved in the servicing of medical devices. All FDA dockets are administered under the Federal Dockets Management System (FDMS) located at Regulations.gov and allow for submission of comments electronically.
The docket was later followed up with an FDA public workshop titled; “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers, October 27-28, 2016.”
According to the FDA, the workshop included four general themes: “1) Establish working definitions for third-party and OEM activities. 2) Discuss benefits and challenges that stakeholders encounter, potential benefits and risks to patients/users, and failure modes of devices introduced as a result of performing activities associated with third-party entities. 3) Identify current best practices and discuss alternative methods to mitigate risks associated with performing activities associated with third-party entities. 4) Determine whether specific procedures are necessary for each activity as it relates to third-party services performed.”
The original request for comments included questions like; “What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities? Specific examples should be submitted” and “What are the potential risks (patients/users) and failure modes (devices) introduced as a result of performing the previously defined activities on medical devices? Please speak to issues common to all devices as well as specific risks with specific devices.”
Maybe most important to the HTM and ISO community was the question: “What information do third-party entities need in order to perform these activities in a way that results in safe and effective operation of the medical device? Please provide specific examples.”
Another question that seemed to put the onus on non-OEM service was this question: “These activities are performed by OEMs and various third-party entities, including hospitals and humanitarian organizations. Are the risks different depending on who performs the previously mentioned activities?”
The feedback received in response to the docket came from a variety of stakeholders including OEMs, HTM professionals, ISOs, professional associations and health care systems.
The FDA identified several themes that interlaced the comments gathered from stakeholders. Among the most prominent themes were the need for quality management systems, the need for specialized training, the importance of utilizing quality replacement parts and the availability of those parts and the availability of full specifications.
The goals and motivations of all stakeholders in this issue are not aligned. Some have competing interests. Many of the concerns were expressed in our October 2017 cover story; “Right to Repair; Pushing for Access and Concessions.” In that story, we stated that “The frustration for the HTM profession for several years has been the general inaccessibility of service manuals, passwords, replacement parts and/or access to training that fits into their employer’s budget.”
While some issues related to this topic have begun to be addressed at the state level, the overlapping issue of service manuals, service keys and passwords is a point of contention that has been ongoing. These issues also revealed themselves in the FDA docket submissions, where the ability to provide quality repairs is often seen as hampered by the lack of accessibility to these items.
Also, an attempt to address the question of “What information do third-party entities need in order to perform these activities in a way that results in safe and effective operation of the medical device?” was made by George Mills of The Joint Commission.
In January of 2017, he added a new element of performance (EP) (EC.01.01.01, EP 3), which states: “The organization has a library of information regarding inspection, testing, and maintenance of its equipment and systems. Note: This library includes manuals, procedures provided by manufacturers, technical bulletins, and other information.” (Unfortunately, Mills has since left The Joint Commission).
Many Biomeds Lack Access
There is the concern that some service providers will be cut out of contention when it comes to the formation of any new standards from trade organizations that could influence the FDA. One of those newly proposed standards comes from the Medical Imaging and Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA).
This again gets back to the concern about the withholding of passwords, equipment manuals and service keys by manufacturers. This practice, which has long vexed those in the HTM community, has been ignored by MITA, according to the International Association of Medical Equipment Remarketers and Servicers Inc. (IAMERS), a diagnostic imaging trade association. IAMERS cites MITA’s imaging standard for servicers.
Part of the organization’s concern is that MITA submitted comments to the FDA docket that it seeks to have all servicers of medical equipment providing the same level of quality and safety. This standard is expected in light of the fact that not all service providers have access to the resources needed to service that equipment.
IAMERS’ contention is that the MITA standard would have the effect of excluding independent diagnostic imaging servicers from contracting with end users. They contend that the MITA standard would induce the same standards on ISOs that the FDA imposes on manufacturers (21 C.F.R. 820) with no means for those servicers to access passwords, equipment manuals and service keys.
Many equipment buyers have learned that the one juncture of leverage they have is to request service manuals, software keys and passwords at the point of purchase. This should be a part of every negotiation. When capital purchases are not being made, this leverage is not a viable option.
FDA Recognizing Personal Medical Technology
The FDA has recently announced some innovative ways it is helping in the development of new devices. In an October 24, 2017 press release, quoting FDA Commissioner Dr. Scott Gottlieb, the FDA announced a new development tool that would be useful in providing feedback to engineers who design heart failure devices.
“First, we’ve completed our first qualification of a medical device development tool (MDDT) to provide a more objective platform for developing devices in a key area of medicine – cardiovascular health,” Gottlieb says.
“Today’s newly qualified MDDT is a 23-item questionnaire that measures health information that is reported directly by patients with heart failure. The tool can be used to measure a heart failure patient’s health status, including clinical symptoms and the physical and social limitations caused by this condition. Such a tool has the potential to help engineers designing heart failure devices to more efficiently and accurately quantify how much their device could actually improve a patient’s quality of life,” he adds.
“By qualifying the tool under the FDA’s new, voluntary program, it will make it easier for product developers to rely on the outputs of this newly qualified tool as part of their development plans. Innovators can trust in advance that the agency has already found the outputs of these measures to be reliable,” the statement continues.
According to a spokesperson at the FDA: “[The] FDA is still gathering and analyzing information to make an informed decision on changes in policy regarding those engaged in third-party service and repair. Our official remarks and proposals will be available in mid-May when our congressionally mandated report on the subject is due to become public.”
As the FDA moves forward in its oversight of medical equipment and the safety of the public, it has several arguments to consider. What side it will come down on is not yet known, but that decision could impact the day-to-day work of biomeds and ISOs.
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