I 

116TH CONGRESS 

1ST SESSION H. R. 3044 

To establish the Medical Device Sterilization Challenge, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 30, 2019 

Mr. LIPINSKI introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on 

Science, Space, and Technology, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions 

as fall within the jurisdiction of the committee concerned 

A BILL 

To establish the Medical Device Sterilization Challenge, and 

for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Device Steri5 lization Challenge Act of 2019’’. 

6 SEC. 2. MEDICAL DEVICE STERILIZATION CHALLENGES. 

7 (a) AUTHORITY.—Not later than 180 days after the 

8 date of enactment of this Act, the Commissioner of Food 

9 and Drugs shall establish a program to be known as 


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1 ‘‘Medical Device Sterilization Challenge’’ for carrying out 

2 prize competitions described in this section under section 

3 24 of the Stevenson-Wydler Technology Innovation Act of 

4 1980 (15 U.S.C. 3719) relating to sterilization of medical 

5 devices. 

6 (b) PRIZE COMPETITIONS.—In carrying out the pro7 gram, the Director shall provide for prize competitions, 

8 including at least one prize competition to seek solutions 

9 with respect to each of the following goals: 

10 (1) Reduction of the human health hazards as11 sociated with ethylene oxide sterilization, including 

12 through reduction of— 

13 (A) the exposure to workers in such facili14 ties; and 

15 (B) environmental emissions of ethylene 

16 oxide. 

17 (2) Reduction of the amount of time required to 

18 effectively sterilize devices by a factor of 2 or more 

19 to sterilize the same type and number of devices over 

20 commonly-used ethylene oxide technology without a 

21 proportional increase in cost. 

22 (3) Achievement of rapid implementation of 

23 new sterilization agents or methods that minimize 

24 conversion costs without decreasing facility through25 put. 


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1 (4) Provision of new or improved approaches to 

2 measuring, monitoring, and controlling ethylene 

3 oxide emissions, including detection at very low lev4 els. 

5 (5) Analysis of public health risks of emissions 

6 from currently-available data with respect to emis7 sions of public health or provision of— 

8 (A) new or improved tools that use data to 

9 better model emissions over time at the regional 

10 or local scale; or 

11 (B) actionable information on the health 

12 and environmental impacts of ethylene oxide 

13 sterilization to government, industry, and mem14 bers of the public. 

15 (6) Enabling of minimally disruptive conversion 

16 of exiting device sterilization facilities that use ethyl17 ene oxide to convert to less-toxic methods of steri18 lization. 

19 (c) PRIZE COMMITTEES.— 

20 (1) IN GENERAL.—The Director of the Center 

21 for Devices and Radiological Health shall assemble 

22 a prize committee with respect to each prize com23 petition that shall define the scope and detail of, and 

24 provide the requirements for, the prize competitions 


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1 under this section. Such committee shall be com2 posed of— 

3 (A) members from the Federal agency, de4 partment, or office that most appropriately cor5 responds with the topic of the prize competi6 tion, including— 

7 (i) with respect to a prize competition 

8 under subsection (b)(1), the Director or 

9 designee of the National Institutes of 

10 Health; 

11 (ii) with respect to a prize competition 

12 under paragraphs (2), (3), (5), and (6) of 

13 subsection (b), the Director or designee of 

14 the National Science Foundation; and 

15 (iii) with respect to a prize competi16 tion under paragraphs (4) and (5) of sub17 section (b), the Administrator or designee 

18 of the Environmental Protection Agency; 

19 and 

20 (B) representatives of any other entities, 

21 as determined appropriate by the Director, in22 cluding State and local governments and the 

23 private sector. 

24 (2) DEFINING TOPIC AREAS.—The prize com25 mittee may modify and define the scope of the prize 


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1 areas described under subsection (b), so long as such 

2 modification is in accordance with descriptions in 

3 such subsection. 

4 (3) INCENTIVE FOR PRIZE COMPETITION.—The 

5 prize committee for each prize competition shall de6 termine the incentive for such prize competition. In 

7 determining the incentive, the committee may con8 sider— 

9 (A) a cash prize; 

10 (B) access to Government facilities, a coop11 erative research and development agreement, or 

12 other method; 

13 (C) with respect to for a product of use or 

14 promise to the Federal Government, a commit15 ment by the Federal Government to purchase a 

16 set number of units of a product from at an 

17 agreed-upon price before the product is brought 

18 to market; 

19 (D) participation in entrepreneurship men20 toring programs; 

21 (E) consultation and mentoring through 

22 the regulatory pathway towards approval for 

23 use; or 

24 (F) any other incentive provided for by 

25 law. 


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1 (4) JUDGING CRITERIA.—The prize committee 

2 for each prize competition shall establish judging cri3 teria for the competition that shall include— 

4 (A) potential for the solution to become a 

5 commercial product or service or advance 

6 knowledge to further the public good; 

7 (B) consideration of how likely the solution 

8 is to lead to subsequent research, development, 

9 or manufacturing in the United States; 

10 (C) the degree to which the solution will 

11 reduce the public health burden created by 

12 ethylene oxide sterilization of medical devices; 

13 and 

14 (D) the degree to which the solution will 

15 reduce emissions and the environmental health 

16 burden created by ethylene oxide emissions 

17 from the sterilization of medical devices. 

18 (5) CONSIDERATION.—In carrying out this sec19 tion, the committee shall take into consideration the 

20 best practices provided for in the challenges and 

21 prizes toolkit made publicly available on December 

22 15, 2016, by the General Services Administration. 

23 (d) ACCEPTANCE OF FUNDS.—In addition to such 

24 sums as may be appropriated or otherwise made available 

25 to the Director to award prizes under this section, the DiVerDate Sep 11 2014 04:09 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3044.IH H3044

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1 rector may accept funds from other Federal agencies, and 

2 State and local governments to award prizes under this 

3 section. 

4 (e) ELIGIBILITY.—Notwithstanding section 24(g)(3) 

5 of the Stevenson-Wydler Technology Innovation Act of 

6 1980 (15 U.S.C. 3719(g)(3)), a group may be eligible for 

7 an award under this section if 1 member of such group 

8 is a citizen or permanent resident of the United States. 

9 (f) COMPLETION OF PRIZE COMPETITIONS.—The 

10 prize competitions carried out under this section shall be 

11 completed not later than the date that is 5 years after 

12 the program is established under subsection (a). 

13 (g) AUTHORIZATION OF APPROPRIATIONS.—There is 

14 authorized to be appropriated $20,000,000 to carry out 

15 this section, to remain available until expended. 

16 SEC. 3. AGENCY ACTIVITIES TO SUPPORT NOVEL AND 

17 EARLY-STAGE TECHNOLOGY FOR MEDICAL 

18 DEVICE STERILIZATION. 

19 (a) NATIONAL SCIENCE FOUNDATION.—During the 

20 5 year period beginning on the date of the enactment of 

21 this Act, the National Science Foundation shall use exist22 ing authority to award grants on a competitive basis to 

23 investigator-initiated research projects that may lead to 

24 the development, implementation, and assessment of novel 


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1 sterilization methods, including traineeships for those who 

2 perform this research in academic and industrial settings. 

3 (b) NATIONAL INSTITUTES OF HEALTH.—The Direc4 tor of the National Institutes of Health shall— 

5 (1) support or conduct research on the health 

6 effects of— 

7 (A) novel sterilization methods, particu8 larly those methods that are well-suited for ma9 terials for which ethylene oxide is currently the 

10 best available sterilization method, including re11 search on the efficacy of the method on a broad 

12 range of materials commonly used in medical 

13 devices, on individuals who receive medical de14 vices; 

15 (B) emissions from such novel sterilization 

16 methods on individuals in the surrounding com17 munities; and 

18 (C) ethylene oxide, particularly on the mor19 bidity secondary to occupational or environ20 mental exposure at levels measured near 

21 sources that emit ethylene oxide; and 

22 (2) award grants, on a competitive basis, to en23 able institutions to support graduate students and 

24 postdoctoral fellows who perform research on novel 


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1 sterilization methods in both academic and industry 

2 settings. 

3 (c) ENVIRONMENTAL PROTECTION AGENCY.—The 

4 Environmental Protection Agency shall support or conduct 

5 research on how products, processes, and systems used to 

6 produce proposed alternatives to ethylene oxide steriliza7 tion will affect the environment. 

8 SEC. 4. GAO REPORT. 

9 Not later than 10 years after the implementation of 

10 this Act, the Comptroller General of the United States 

11 shall submit to Congress a report on the impact and the 

12 effectiveness of the provisions of this Act at achieving the 

13 goals described in subsection (b). 

Æ 


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