In his comment on October 5 (Why the maintenance rights dialogue needs to be further expanded), Lars Thording clearly stated the challenges faced by the right to restoration movement in the healthcare sector, including patient safety, network security, and the need to promote further healthcare innovation. However, solutions to these challenges should not force the entire industry to succumb to the lowest common denominator. Instead, it should require all service companies to meet the same safety, quality, and regulatory requirements when repairing complex and sensitive medical equipment. These requirements exist in part of the service industry and should apply to all industries.
Thording is definitely right, that patient safety is and should be the primary consideration when servicing medical equipment. The U.S. Food and Drug Administration (FDA) has established measures to monitor and ensure the safety of equipment that repairs these complex machines. The problem is that these requirements currently only apply to original equipment manufacturers (OEMs). Non-OEM service companies are still not regulated and are not responsible for any quality or safety requirements of the FDA.
All service companies should assume the same obligations, rather than being inconsistently responsible for only a part of the service industry. This includes registering with the FDA so that the FDA can better protect patient safety by understanding where and how activities such as remanufacturing or improper services occur, and who is doing these activities. It also means additional oversight of independent service organizations (ISO) through quality management system requirements, inspections, document review required by remanufacturing guidelines, better data collection and release of survey results related to the service industry.
Thording also raised the issue of network security. we agree. As we have seen, cyber security in the healthcare sector is still a problem faced by vendors of all sizes.In fact, the Ministry of Health and Human Services recently Send out a warning On the picture archiving communication system-makes the intermediate image vulnerable to attack. Opening up medical equipment by making it “easier” to be hacked or openly sharing sensitive intellectual property rights will exacerbate this problem. Although some systems may pose maintenance challenges for inadequate third-party service providers, these systems are already in place to protect network security, patient privacy, and valuable data.
Speaking of intellectual property rights, we know that intellectual property protection is essential to incentivize and encourage continuous innovation. However, the “right to repair” movement’s call for original equipment manufacturers to abandon proprietary service materials and trade secrets sent the wrong message to medical innovators. If developers and manufacturers cannot recoup their time, energy, and financial investment in medical innovation, why bother?
President Biden and his administration are right to exclude medical devices from the executive order that promotes competition in the US economy. This is not an oversight, but instead emphasizes the recognition of the classification differences between products traditionally targeted by the “right to repair” campaign, such as consumer products and FDA-regulated products that are used to diagnose diseases, maintain life, and guide complex healthcare interventions.
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