SB 1177 Risks Medical-Product Shortages Despite Industry Concerns
State Sen. Sue Shink, joined by Sen. Rosemary Bayer, has introduced legislation that would restrict the manufacture, sale and distribution of medical products containing polyvinyl chloride, or PVC, and the plasticizer DEHP.
Senate Bill 1177, introduced September 10 and referred to the Senate Regulatory Affairs Committee, would amend the Michigan Consumer Protection Act. Although intended to reduce potential chemical exposure, the bill’s unusually broad scope and compressed timelines could disrupt access to essential medical products and further strain an already fragile healthcare supply chain.
These concerns are not new. Sen. Shink’s office asked MichBio to review draft language in April. MichBio responded with detailed written comments identifying several shortcomings and recommending revisions based on legislation already negotiated with the medical-technology community in California and North Carolina.
Unfortunately, none of those recommendations were incorporated into the introduced bill.
What SB 1177 would require
Beginning January 1, 2030, SB 1177 would prohibit the manufacture, sale or distribution of a “medical solution container” made with PVC or intentionally added DEHP.
Beginning January 1, 2033, it would prohibit medical tubing made with intentionally added DEHP. The bill would also prohibit replacing DEHP with another ortho-phthalate and establish a 0.1% threshold for unintentionally added DEHP.
The scope extends far beyond conventional IV bags and tubing. “Medical solution container” would include products holding medicine, fluid or nutrition administered intravenously or through the mouth, nose, stomach or intestines. “Medical tubing” would include IV tubing, enteral feeding products, respiratory tubing, masks and pediatric nasal cannulas.
Violations would be treated as unlawful practices under the Michigan Consumer Protection Act.
MichBio’s recommendations were not included
In its April 29 comments to Sen. Shink’s office, MichBio expressed support for advancing patient safety but warned that the draft could disrupt market continuity and limit access to critical, life-sustaining products.
MichBio requested three principal revisions:
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Narrow the bill to IV solution containers and IV tubing instead of broadly covering enteral, respiratory and other medical products.
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Move the tubing compliance date from 2033 to 2035 and permit a two-year extension for solution containers when FDA review or manufacturing constraints prevent compliance by 2030.
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Exempt human blood-collection and storage bags, apheresis products, cell-therapy kits and their integral tubing.
MichBio also questioned the proposed PVC prohibition. Similar enacted laws focus on DEHP rather than banning PVC itself. PVC remains widely used because it provides flexibility, kink resistance, transparency, saline compatibility and reliable performance during sterilization. It is found in products ranging from fluid-delivery systems to wound drainage and surgical irrigation equipment.
SB 1177 nevertheless retains the PVC prohibition for solution containers, the broad product definitions, the 2033 tubing deadline and the absence of exemptions or a delayed-compliance process.
California and North Carolina took a more workable approach
Michigan does not need to choose between patient safety and continued access to medical technology. California and North Carolina demonstrate how legislators can pursue material-transition policies while accounting for clinical needs and federal regulatory requirements.
California’s enacted AB 2300 limits its requirements to IV solution containers and IV tubing containing DEHP. It establishes a 2030 deadline for containers and a 2035 deadline for tubing. The law exempts human blood-collection and storage bags as well as apheresis and cell-therapy kits, including integral tubing.
California also allows qualifying manufacturers until 2032 to comply with the container requirement when FDA approval remains pending or adequate manufacturing equipment is unavailable, subject to customer-notification requirements.
North Carolina’s 2025 law adopted the same basic safeguards: a narrow focus on IV products, a 2035 tubing deadline, exemptions for blood-collection, apheresis and cell-therapy systems, and delayed compliance for certain solution containers affected by FDA review or manufacturing constraints.
These provisions did not eliminate the states’ policy objectives. They made the transition more realistic and reduced the likelihood that specialized products would disappear from the market before alternatives are available.
Material substitution is not a simple redesign
Medical-device manufacturers cannot simply replace one material and continue production. A change can affect flexibility, flow, durability, drug compatibility, sterilization, shelf life and biocompatibility.
FDA specifically identifies changes in a device’s material type, formulation or chemical composition as modifications that must be evaluated to determine whether a new premarket submission is required. FDA’s guidance also recognizes that material-related changes can introduce new risks affecting safety or effectiveness.
Manufacturers must identify alternatives, redesign products, validate performance, complete testing, obtain any necessary FDA clearance and scale production. These steps can take years, particularly for specialized products used in blood collection, cell therapy, neonatal care, respiratory support and enteral feeding.
If the Michigan market cannot support the cost of a state-specific product redesign, some manufacturers may stop selling affected products here. Hospitals could face fewer suppliers, higher costs and shortages - not because alternatives are necessarily unsafe, but because compliant products cannot be developed and cleared on the timeline imposed.
A bill that still needs substantial revision
Reducing unnecessary exposure to potentially harmful chemicals is a legitimate policy goal. It must, however, be pursued through requirements that recognize federal oversight, manufacturing realities and the clinical importance of the affected technologies.
MichBio engaged early and offered practical revisions already proven workable in other states. SB 1177 was introduced without them.
Before advancing the bill, lawmakers should narrow its scope, align its timelines with California and North Carolina, add critical medical-product exemptions and provide limited flexibility when FDA review or supply-chain conditions prevent timely compliance.
Patient safety includes reducing chemical exposure. It also includes ensuring that hospitals and clinicians continue to have reliable access to the products required to deliver care.
