State Legislative Alert – An Act Relative to the Digital Right to Repair
A bill that would permit third parties to repair a range of electronic products and have access to diagnostic information as well as OEM-sanctioned parts, is the subject of a hearing on Beacon Hill on September 26. The bill, as written, (H. 143 and S. 96) would exempt Class III medical devices but would allow third party repair companies to repair all other devices. The bill also mandates that medical device manufacturers make proprietary product information, diagnostic technology and replacement parts available to any such entity.
A delegation of MassMEDIC members met with the Co-Chair and staff of the Joint Committee on Consumer Protection and Professional Licensure in early June, expressing concern with the bill’s implications for patient safety and device performance. MassMEDIC called for a full (all classes of medical devices), exemption from any provision of the proposed bill in meetings with Sen. Barbara L’Italien of Andover, Committee Co-Chair, and staff of the House Committee.
The bill’s sponsors and supporters central focus is on the repair of consumer electronics and agricultural equipment. A similar bill, which did not include the Class III medical device exemption, was introduced in the last session and was designated for further study. It appears as if the Legislature may move further on this bill during this session, which ends on July 31, 2018. As mentioned, hearings have been scheduled for September 26 at the State House in Boston, a preliminary step in moving the bill forward.
MassMEDIC will conduct a briefing on this legislation for members only on September 19 at 10:30 a.m. at its offices – 650 Albany Street, Boston. At that time, we will provide background information on the legislation, its provisions, and likely timetable. All members impacted by this bill are urged to attend this important meeting.
Call to Action
MassMEDIC members are urged to contact their State Legislators to voice their opposition to H. 143 and S. 96, as introduced. In doing so, please stress the following points:
- The bill would allow third party repair organizations to repair patient-sensitive medical devices, thereby creating further risk to patients having medical procedures.
- The original manufacturers, which have worked with doctors, nurses and medical technicians to design and test the safety and efficacy of these devices, are most knowledgeable and best suited to repair and maintain these devices.
- The original intention of this legislation was to lower costs associated with repairing consumer electronic products. This is fine for iPhones, tablets and laptops but not for invasive, highly-calibrated medical devices that are deployed in a range of medical procedures.
- The exemption of only Class III medical devices does not address the issue of patient safety and increased risk of using devices that may be repaired by unauthorized parties, i.e. not subject to the same quality standards as the original manufacturers.
- The FDA is currently considering its position on third party repair and refurbishment. A national policy, that takes into account the increased level of risk to patients, needs to be fully reviewed and considered. A system where there could be potentially be 50 separate policies on third party repair of medical devices, would limit patient and provider access to available innovative medical technologies.
- MassMEDIC is calling for a total exemption of medical devices from the proposed “Digital Right to Repair” bills.
- Massachusetts should not be the first state in the nation to endanger the health and safety of patients by allowing unqualified repair companies to undertake these specialized repairs.
Thank you for your grassroots support of this campaign to exempt medical devices from these bills.