Single Use Devices

The presentation is solely meant for Academic purpose

“The Guru is none other than the Creator, Lord Brahma;

He verily is Lord Vishnu, the Preserver,

and

He truly is Maheshvara, the Destroyer.

He is the supreme Brahman himself,

To such a Guru I offer my Salutations”

3

‘ No stronger condemnation of any hospital or ward could be

pronounced from the single fact that zynotic (infectious)

disease have originated in it,or that such a disease has

attacked other patients than those brought in with them’

- florence nightingale

Some of the slides an the material are borrowed and I acknowledge Dr. Gita Nataraj from KEM, Mumbai and the HISI newsletter on SUDs reprocessing

The entire story is borrowed from experiences of others and self

I do not claim to be an expert and am as much a student eager to learn

I acknowledge the contributions of technical staff and nursing for implementation of the program and the entire Infection Control colleagues at Delhi Apollo, particularly Dr. Leena Mendiratta

5

Original device: “The term ‘original device’ means a new, unused entire

single-use device.”

Single-use device: “The term ‘single-use device’ means a device that is

intended for one use, or on a single patient during a single procedure.”

Reprocessed: “The term ‘reprocessed’, with respect to a single-use

device, means an original device that has previously been used on a

patient and has been subjected to additional processing and

manufacturing for the purpose of an additional single use on a patient.

Critical reprocessed single-use device

Semi-critical reprocessed single-use device

6

7

8

30% of all hospitals reuse one / more SUDs

Not all SUDs can be reused / reprocessed

50% of hospitals reuse through a third party processor

9

10

2002;7(1):53-59

Conclusions:

•No significant overall difference in temperature sensing

accuracy and deflection angle of new and used ablation

catheters.

•Nevertheless, individual differences in deflection

characteristics between new and used catheters are

occasionally seen and warrant screening of reprocessed

catheters prior to their reuse 11

CONCLUSIONS: Reuse of medical devices labelled "single use only" is common in Australian hospitals. Most devices appear to be unsuitable for reuse. Complete cessation of this practice of reusing single-use medical devices would stop potential cross-infection, but this would cost and estimated $2.5 million or more per case prevented

12

13

•Tradition of re-use – reports on re-use of pacemakers are

available from Europe, North America and Asia (India) with no

reported adverse effects

•During 1996, in Sweden, 5% of pacemakers were re-used

devices, with no evidence that re-use has increased patient risk.

•Re-use of pacemakers may be considered, provided that their

sterility, mechanical and electrical integrity can be ensured and

operating procedures are respected. Re-used pacemakers

should only be given to patients whose life expectancy is

estimated to be less than that of the pacemaker.

A Randomized Study of the Safety and Efficacy of Reused Angioplasty Balloon Catheters M Zubaid, CS Thomas, H Salman, I Al-Rashdan, N Hayat, A Habashi, MT Abraham, K Varghese, L Thalib Department of Cardiology, Chest Diseases Hospital, Kuwait and Department of Community Medicine, Faculty of Medicine, Kuwait University

Conclusions: When performing coronary angioplasty, reused catheters are as effective (similar angiographic success) and safe (similar clinical success) as new catheters. (Indian Heart J 2001; 53: 167–171)

14

The issue really is not whether or not to reprocess, but what constitutes safe and appropriate reuse of disposable items.

15

……. requires that 510(k)s for listed reprocessed SUDs include “validation data, regarding cleaning and sterilization, and functional performance demonstrating that the [SUD] will remain substantially equivalent to a predicate device after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification.”

On April 30, 2003, FDA identified in the Federal Register those critical reprocessed SUDs whose exemption from 510(k) would be terminated.

On April 13, 2004, FDA identified those semi-critical reprocessed SUDs whose exemption would be terminated.

On September 29, 2005, FDA updated and consolidated the lists of the critical and semi-critical reprocessed SUDs that would no longer be 510(k) exempt

16

17

…simply because they are not designed to be taken apart for adequate cleaning

…. or to perform as specified after first use. In addition, many of the materials utilized in the various

components of single use medical devices, both plastics, glues and metals, may not withstand the chemical environment of the solutions utilized

Also, the temperatures required for autoclave sterilization may deform many components and subsequently compromise their performance and safety

December 15, 2009

18

Eucomed White Paper - The Reuse of Single Use Devices

Canadian Medical Device Technology Companies (MEDEC): the

authors refer to a 2001 review where several reprocessed single

use devices were retrieved from hospitals in the United States and

in Europe.

In total, 136 devices were obtained from hospitals on both

continents and included clip appliers, clamps, staplers, cautery

devices, tracers and electrophysiology (EP) catheters.

Examination revealed that at least half of these products had

packaging defects, were contaminated with residual blood or

tissue, and/or experienced functional failures.

19

MEDEC - German report, 2001 (Andreas Beck)

where 727 angiography catheters and guide wires

were studied

The results showed numerous physical variations

in devices including nicks, kinks, roughness,

erosion, tears and changes in material properties.

The author concluded that the refurbishment of

devices intended for single use by both healthcare

facilities and third party reprocessors is

inappropriate and a risk to patient safety

20

SGNA believes that patients deserve the same standard of care regardless of practice setting.

The reuse of SUDs is a complex issue that must be balanced with the assurance of patient safety and the delivery of quality health care. These concerns cannot be overlooked when evaluating the legal, ethical, financial, and technical aspects of reusing SUDs.

In the absence of substantial scientific evidence to prove the safety and effectiveness of reprocessed critical medical devices in the endoscopy setting, SGNA maintains the position that critical medical devices originally manufactured and labeled for single use should not be reused.

Adopted by the SGNA Board of Directors, February 1998; Revised May 2002, October 2005, August 2008.

21

The WHO has stated ‘the safest and most unambiguous method for ensuring that there is no risk of residual infectivity on surgical instruments is to discard and destroy them by incineration … this strategy should be universally applied to those devices and materials that are designed to be disposable.’

22

WHO Infection Control Guidelines for Transmissible Spongiform

Encephalopathies, WHO/CDS/CSR/APH/2000.3. March 23-26, 1999

The use of a reprocessed single use device provides no direct benefit to the individual patient or her physician

…Relies on voluntarily reported adverse events..

…Studies on the safety, quality and cost-effectiveness are needed…..

23

24

A) PTCA balloon catheter refurbished by a third

party and soiled with contrast medium and

blood.

B) A comparison of a PTCA balloon and a

household match demonstrating the small

size of the catheter and how difficult it would

be to ensure effective cleaning of such a

small device

B A

25

A

B

26

A) Proteinaceous contamination on the

inner surface of a guiding catheter.

B) XPS Scan / Spectrum confirming that

the reddish contamination is blood.

C) Scanning electron micrograph (SEM)

photograph to confirm the presence of

a red blood cell

A B C

27

Reddish brown contamination observed over the

full length of the third party reprocessed

endoscopic stapling device

28

A) Flaking marker on a reprocessed balloon catheter, which

may result in release of particles into the patient’s

bloodstream.

B) Marker of a new balloon catheter.

C) Aluminium contamination in the lumen of a balloon

catheter.

A B C

29

A) The coil of new, unused biopsy forceps.

B) The coil of reprocessed biopsy forceps

A B

30

Degradation-time curves demonstrating how different polymers degrade over time

…..Another challenge when reusing catheters is that it is difficult to predict when a

catheter will degrade to a degree that it will break…..

When and if depends on the type of polymer used and how it is manufactured.

While some plastics degrade over time and show signs of wear others seem to fail

spontaneously

David L. West et al. “Scientific & Regulatory Consideration for the Review and

Approval of Reprocessed Single Use Devices Pre - market Submissions

31

Photograph showing kinks along a reprocessed

single use catheter as a result of previous usage

or reprocessing

When attempting to flush the single use devices a distribution of the contamination rather than cleaning was achieved…..

32

Demonstration of the distribution of contamination rather than

removal as assessed using the radionuclide method of detection

2001, Roth, Heeg, and Reichl

….Most of the inspected devices showed residual contamination in the

hinges and under the isolation coats .This was especially true for

harmonic scalpels. These findings indicate that the cleaning agent

penetrates into the device and dilutes the blood but cannot then be

flushed out of the device. Therefore, contamination and disinfection

solution remain in the devices ……

A single-use bladder pressure transducer cover was not changed between patients, resulting in cross-infection due to Pseudomonas aeruginosa. One patient developed septicaemia and died of a sub-arachnoid haemorrhage

A lithotriptor stone retrieval basket, which was a single-use device, had been reprocessed and appeared to be satisfactory for use. During the procedure,the cable was tightened and snapped, resulting in the basket remaining in the patient. Further surgery was required to retrieve it.

33

Single-use Medical Devices : Implications and Consequences of Reuse

MHRA DB 2006(04) v2.0 December 2011




The cost is reduced by ½ to 1/10

34

The main complication in performing true cost-benefit calculations in relation to refurbishment and reuse of single use devices is the challenge created by the increased patient risk involved.

How can a price be assigned to increased patient risk?

Some studies touch directly upon the problems associated with creating a true financial cost-benefit analysis, while others ignore this complication entirely and therefore reach questionable financial conclusions

This does not include the hidden costs related to the risks of using refurbished single use devices, such as HAI, complications, litigation, staff injuries etc.

35

Single-use Medical Devices : Implications and Consequences of Reuse


Personnel costs: Cost of employing technical and qualified personnel for pre-cleaning immediately after the point of use, assembly, dismantling and replacement activities, maintenance and cleaning, repairs, wear and tear, sterilisation, sterilisation checks (chemical and biological), packaging, etc. In addition, personnel and/or costs for longer procedure time, re-operation and infections should be considered.

Investment costs: Costly apparatus (capital equipment), buildings (designated for storage/spare parts); centralised sterilisation unit and special apparatus (autoclaves, machines for washing the devices, ultrasonic baths, means of cleaning, chemical products, disinfectants, lubricants, etc).

Administrative costs: Systems used to communicate the results and establish traceability, managing reserves of spare parts/stock, distribution, transport, insurance premiums, documentation, validation procedures, auditing third party refurbishers, recording accidents and injuries involving members of staff, etc.

Utility costs: Cost of providing the utilities associated with the sterilisation process (electricity and water consumption [including drainage]).

Miscellaneous costs: Overheads, protective clothing (gloves, masks, safety glasses, double-thickness packaging materials), provision of safety training in connection with the re-utilisation of instruments, cost of treating post-operative infections and handling complaints

36

Cost-effectiveness……? We are doing a study

37

Potential Risks Examples

Potential for cross infection

Any component of Microbial world esp Blood borne viruses

Inability to clean and decontaminate

Features of a device that make cleaning difficult are: acute angles, coils, long or narrow lumens, spécial surface coatings etc.

Residues from chemical decontamination agents

Disinfectants may be absorbed by plastics and leach out during use, resulting in chemical burns or a risk of sensitization of the patient or user.

Material alteration

Plastics may soften, crack or become brittle during exposure to elevated temperatures or pressure during the sterilization process or exposure to cleaning agents and chemical sterilants

Mechanical failure Some devices may experience stress during each cycle of reuse, leading to fatigue-induced failure and fracturing e.g. single-use drill, burrs, saw blades, craniotomy blades catheters

Reaction to endotoxins If the device has a heavy bacterial load after use, which cannot be adequately removed by cleaning

Transmission of CJD, Prions





Clinical evidence does not indicate increased risk in controlled

settings

Reuse is not a harmless procedure – Document Integrity and Safety

Continued surveillance for adverse events is required

The procedure has to be regulated

The cost is reduced by ½ to 1/10

38

The FDA classifies single-use medical devices according to the

level and type of control needed to ensure that the devices are

safe and effective.

- Class I devices need the fewest controls

- Class II devices require "special controls."

- Class III is the most stringent regulatory category and

medical devices that fall under this category require a

premarket approval

Class I and Class II devices are the best candidates for

reprocessing, with some notable exceptions.

39

Medical Device Reprocessing

Don Selvey, 2011

Reprocessable Class I devices include: Orthopedic chisels Surgical curettes Surgical gouges General use surgical scissors Non-electric biopsy forceps Orthopedic knives Orthopedic saw blades Chisels Rasps Between 65 and 75% of all single-use medical devices are identified as Class II. Class II single-use devices include: Non-ported trocars for endoscopic procedures Sequential compression devices (compression sleeves) Most laparoscopic instruments, including: scissors, clamps, dissecters and

graspers Recording and diagnostic EP catheters Drills and burrs Flexible snares Class III devices include: Transluminal coronary angioplasty catheters Percutaneous and conduction tissue ablation electrodes Implanted infusion pumps

40

Medical Device Reprocessing

Don Selvey, 2011

S.U.D. List (approval of End-Users and Management and ICC members)

Specialties using S.U.D.

Serial Number for each S.U.D

Number of re-uses specified for each S.U.D

Protocols on Re-processing of S.U.D.

Training of Personnel involved (Part of staff Appraisals)

Functional integrity check to each S.U.D.

Rejection Criteria of each S.U.D

Traceability

Monitoring of S.U.D

Recall Policy

Documentation

Validation by user / third party reprocessor

Monitoring of Policy

41

S.U.D Policy: Components

Initial pre-cleaning on site

Cleaning and rinsing

Decontamination

Marking (number of re-uses)

Packaging

Labeling

Sterilization

Documentation

42

For all devices (narrow lumen/balloon) it is necessary to test the

functional integrity before drying.

The devices shall be inspected for any damage and its functional

integrity verified by the user after the process of cleaning and

decontamination

Assessment of the functional performance on a worst case basis,

i.e., after the maximum number of times the device is intended to

be reprocessed as specified.

Simulation of device in reprocessing cycle and this step should be

specified in the summary of the process design and validation.

The performance tests should be summarized in the process design

and validation documentation

43

Incase the number of usages equals the number of usages as per Policy, approved for that particular article.

Any kinks, curves leading to loss of functional integrity

Blood clots not getting removed

Loss of Lumen patency

Incase signals are not being received

Any leaks

Incase smooth functioning is absent

Incase inflation is not taking place

Incase of breakage

Incase tip is blunted

Incase tip is broken

Incase sharp edge is blunted

44

Ensure drying by either passing dry compressed air through it or drying in controlled environment (biosafety) for devices which are delicate or not able to withstand air pressure

45

46

Marking

Should be ensured that marking does not

compromise on the integrity of the device

Excess air must be removed from packets before sealing

Appropriate packaging shall be carried out to ensure effective sterilisation.

The packaging shall be compatible to the type of sterilization being carried out.

The items shall be wrapped in medical grade packaging.

48

Appropriate labeling of every packed item is done.

The Label should include the following: - Name - Size - Manufacturer - Unique Device No - Usage no - Date of Last Usage - Date of reprocessing

The Unique Device No includes the following essentially in the given sequence: Manufacturer / Serial Number of that particular item- as specified in the approved SUD List / Year of present usage/ Month of present usage/ no of times that particular type of item has been opened on that particular day, (eg Ox / 21 / 2008 / 02/ 01)

These items are then sent for further appropriate sterilization.

49

50

S.U.D. Monitoring

The device should be sterilised by an appropriate sterilisation

method for that device e.g. ethylene oxide gas sterilisation

method

The process of sterilisation should be strictly controlled and as

per the manufacturer’s instructions.

The cycle shall be monitored with physical,

chemical and biological indicators.

The device shall not be released till 72 hours

post- Ethylene oxide sterilization

PCD to be used as simulators

51

Labeling Gun:

Sterilizer number,

Load number,

Batch number,

Date of sterilization

Date of expiry

Sterilization: Validation through Indicators

54

Keeping the track record of that article through appropriate documentation

55

SINGLE-USE DEVICE REPROCESSING GUIDE TEMPLATE

The following single-use devices have been approved for reprocessing by the Medical Executive Committee.

No other single-use device may be reprocessed unless written authorization is obtained from the Medical Executive Committee.

Effective Date:

Clinical Category Device Manufacturer Model(s) Approved Third-Party

Reprocessor

Device Status

Used Open &

Unused Expired

Ambulatory Surgery Center Quality Programme

56

57

Any adverse event related to the device should be reported in an incident- form

58

“There is no conclusive evidence to substantiate the notion that either morbidity or mortality associated with single use or reuse is different.” National Kidney Foundation Report on Dialyzer Reuse, AJKD 1997

Automated Dialyzer Reprocessing , Minntech 1999

60

$0

$5

$10

$15

$20

$25

1 4 7 10 13 16 19

Co

st

per

treatm

en

t

$0

$5

$10

$15

$20

$25

Reuse Cost Reduction Curve

Cost of Single Use vs. Multiple Use

(Cost per Patient per Year)

$0

$1,000

$2,000

$3,000

$4,000

$5,000

Single Use Multiple Use

Co

st

Dialyzer Cost Reprocessing Cost

Assuming a dialyzer price of $20, costs of

reprocessing of $5, and 15 uses, the cost savings for

one patient are $2,050 every year with reuse

Costs for 50 Patients per Year

(6 Reuses vs. 15 Reuses)

$0

$10,000

$20,000

$30,000

$40,000

$50,000

$60,000

$70,000

6 Reuses 15 Reuses

Co

st

per

year

Reprocessing Cost Dialyzer Cost

61

Daily Checklist For Dialyzer Re-processing System Serial no:____________

Parameters 01.01.20

11 02.01.2011 03.01.11 04.01.11 05.01.11 06.01.11 07.01.11

Calibration

Verification Volume

in ml

( 70[+/-]3 ml )

Pressure Log:

Static Pressure

(Ideally: 20 psi to 55

psi)

Dynamic Pressure

(Ideally: 35 psi to 40

psi)

Exterior Cleaning

with 1% Renalin

Caps:

30 minutes

disinfection with 1%

Renalin

Sanitization

VERIFICATION

If required, a S.U.D. maybe recalled, if decided so by the Infection Control Committee, incase of repetitive incidents if any, or if any such notification from the Manufacturer

62

Appropriate Personal Protective Equipment (gown, gloves, eye-

protection, etc) to be worn while cleaning and decontamination

Care should be taken in the direct handling of intricate or sharp-

edged devices to avoid injury to the handler or damage to the

device.

For devices with lumen special care should be taken while

injecting the cleaning solution into the lumen so as not to cause

damage

63

Cleaning, sterilization, and functional performance

validation of reprocessed SUDs include aspects of

both:

(i) design validation

(ii) and process validation.

Design validation, in this case, should incorporate

both the design of the product and the design of the

processes to be used in reprocessing the device.

64

ATP Results of less than 10 RLU are preferred

Capable of detecting 2mg protein / m2

‘Rapid’ monitor that uses bioluminescence to measure

the levels of ATP on a surface. It works through

collection and quantification of ATP remaining in

organic residues post-cleaning

Green Color-Satisfactory

VALIDATING SINGLE USE DEVICES

•Understanding it’s configuration and application (List of the

parts, mantling and dismantling, manufacturers

specifications)

•Point of use care (Immediate aspiration, flushing)

•Safe transport to re-processing department

• Standard operating protocols of reprocessing

department

•Number of turns, tracking, recall procedure

• Back to user

•Discard after the last use

Steps Validation Responsibility

Integrity & functionality through Visual inspection Device User

Post use pre-cleaning through visual inspection Device User

Safe & covered transport Supervision (Assisting personnel)

Disinfection & thorough Microbiological testing Reprocessing Dept.

Cleaning & microbiology dept.

Inspection, Assembling, Sterility check CSSD

Packing, sterilization (No toxic residues left)

Pyrogen free

Next turn usability Check by user User department

Usable life / No. of turns Sterility Assurance & User / reprocessing

Adequate working of Microbiology

the device, QA dept. headed by

I.C.Chief

68

69

Instrument Single-use device (MRP) (Rs)

Cost per patient when used multiple times

Additional cartridge Cost (Rs)

Saving per patient in multiple use (Rs)

Procedure where device used (Rs)

Harmonic Shear

40,000-50,000

7,000-10,000 approx

Nil 30,000 Advanced and routine Laproscopic surgery

Diagnostic guidewire

1000 250 Nil 750 Interventional Cardiology and radiology imaging

Angioplasty Balloon Catheter

10,000 – 12,000

4,000-5,000 approx

Nil 5,000-6,000 approx

Interventional Cardiology and radiology imaging

Open surgery linear cutter

21,000 – 28,000

4,000-5,000 approx

4,000-6,000 approx

12,000-18,000 Open major abdominal surgery

Endoscopic Linear cutter

22,000 – 36,000

5,000 approx 6,000-8,000 approx

11,000-18,000 Advanced Laproscopic Gastrointestinal Surgery

Mutiload clip applicator

19,700 2,000 per clip applied

Nil 8000 if an average of 6 clips used

Clipping of blood vessels, cystic duct

Skin stapler 734 183 Nil 500 Skin incision approximation

Natl Med J India 2012;25:151–5, Hussain et al

Is it moral or ethical to treat a patient with a

refurbished medical device of unknown and

potentially lower (i)quality, (ii)performance or

(iii)cleanliness than when it was used on the

previous patient?

Informed Consent from Patient…?

Is the treating Physician fully aware……?

70

……But before medical devices can be reprocessed and reused, a third-party or hospital reprocessor must comply with the same requirements that apply to original equipment manufacturers, including:

Submitting documents for premarket notification or approval

Registering reprocessing firms and listing all products

Submitting adverse event reports

Tracking devices whose failure could have serious outcomes

Correcting or removing from the market unsafe devices

Meeting manufacturing and labeling requirements

71

DEADLINES: Manufacturers of reprocessed single-use laparoscopic

and endoscopic electrosurgical accessories who already have 510(k)

clearance for these devices were required to submit supplemental

validation data for the devices by June 29, 2006, or their devices were

no longer legally marketed.

Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted

(Letter Report, 06/20/2000, GAO/HEHS-00-123)

72

……….while the agency reviews all adverse event reports, it places the highest priority on reports involving pediatric deaths, multiple deaths or serious injuries from a single device, fires, burns, or highly unusual events such as radiation exposure, over- or underdosing of radiation, radiation being delivered to the wrong site, and severe allergic reactions (anaphylaxis)

While FDA has made changes to its data collection process regarding reprocessed SUD-related adverse events, the data are not suitable for a rigorous comparison of the safety of reprocessed SUDs compared to similar original SUDs

Rigorous Safety Comparisons Not Possible through Current or Planned Adverse Event Reporting

Neither existing FDA data nor studies performed by others are sufficient to draw definitive conclusions about the safety of reprocessed SUDs compared to similar original devices.

FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk

73

Potential for cost saving

- Health care establishment

- Patients

Dependable supply

Reduction of waste

Ecofriendly - pollution reduction, less

incineration and less use of landfills and dump sites

74

Who should be allowed to reprocess?

Who will provide the guidelines, standards and protocols ?

Who will cross check the quality of the reprocessing and regulatory oversight?

Who will pay for failures?

What if we do away with reprocessing- who would bear the cost?

75

If a device cannot be cleaned, it cannot be re-processed and re-used

If the sterility of a post-processed device cannot be demonstrated, the device cannot be re-processed and re-used

If the integrity and functionality of a re-processed SUD cannot be demonstrated and documented as safe for patient care and or equal to the original device specifications, the device cannot be re-processed and re-used.

If anything sterile is opened, it needs to be decontaminated before re-processing

Validation and documentation of processes and outcomes is mandtory

76

SUDs would be reused – need to identify those that can

and those that shouldn’t

For the developed nations – reuse is a ‘green option’

For resource crunch settings - Reuse is not only cost

saving but also life-saving

Standards need to be laid down and implemented in

healthcare units/ May be a third party reprocessing unit

needs to step in

77

The debate would go on, but the dictum remains….

78

INTEGRITY

STERILITY

79

Documents

Single Use Devices